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Hunter DBT project: randomized controlled

trial of dialectical behaviour therapy in


women with borderline personality disorder
Gregory L. Carter, Christopher H. Willcox, Terry J. Lewin,
Agatha M. Conrad, Nick Bendit

Objective: Deliberate self-harm (DSH), general hospital admission and psychiatric hospital
admission are common in women meeting criteria for borderline personality disorder (BPD).
Dialectical behaviour therapy (DBT) has been reported to be effective in reducing DSH
and hospitalization.
Method: A randomized controlled trial of 73 female subjects meeting criteria for BPD was
carried out with intention-to-treat analyses and per-protocol analyses. The intervention was
DBT and the control condition was treatment as usual plus waiting list for DBT (TAUWL),
with outcomes measured after 6 months. Primary outcomes were differences in proportions
and event rates of: any DSH; general hospital admission for DSH and any psychiatric
admission; and mean difference in length of stay for any hospitalization. Secondary
outcomes were disability and quality of life measures.
Results: Both groups showed a reduction in DSH and hospitalizations, but there were no
significant differences in DSH, hospital admissions or length of stay in hospital between
groups. Disability (days spent in bed) and quality of life (Physical, Psychological and
Environmental domains) were significantly improved for the DBT group.
Conclusion: DBT produced non-significant reductions in DSH and hospitalization when
compared to the TAUWL control, due in part to the lower than expected rates of
hospitalization in the control condition. Nevertheless, DBT showed significant benefits for
the secondary outcomes of improved disability and quality of life scores, a clinically useful
result that is also in keeping with the theoretical constructs of the benefits of DBT.
Key words: borderline personality disorder, deliberate self-harm, disability, quality of life,
randomized controlled trial.

Australian and New Zealand Journal of Psychiatry 2010; 44:162–173


Borderline personality disorder (BPD) is one of only accompaniment to this disorder. It has also been found,
two conditions that includes suicide attempts as a crite- however, that the least prevalent and most changeable
rion for diagnosis in the DSM-IV classification system criteria for BPD are self-injury and behaviours defending
[1], indicating that suicidal behaviour is a common against abandonment [2]. A review suggested that people

Gregory L. Carter, Conjoint Professor and Principal Researcher Terry J. Lewin, Research Manager; Agatha M. Conrad, Research
Centre for Brain and Mental Health Research, University of Development Officer
Newcastle, Newcastle, New South Wales, Australia. (Correspondence) Centre for Brain and Mental Health Research, University of Newcastle,
Dept. Consultation-Liaison Psychiatry, Locked Bag 7, Hunter Newcastle, New South Wales, Australia; Hunter New England Mental
Region Mail Centre, NSW 2310, Australia. Email: gregory.carter@ Health Services, Newcastle, New South Wales, Australia.
newcastle.edu.au Nick Bendit, Staff Specialist Psychiatrist, and Conjoint Lecturer
Christopher H. Willcox, Conjoint Senior Lecturer and Senior Clinical Psy- Centre for Brain and Mental Health Research, University of Newcastle,
chologist Newcastle, New South Wales, Australia; Centre For Psychotherapy, Hunter
New England Mental Health Services, Newcastle, New South Wales,
School of Psychology, University of Newcastle, Newcastle, New South
Australia
Wales, Australia; Centre For Psychotherapy, Hunter New England
Mental Health Services, Newcastle, New South Wales, Australia. Received 17 March 2009; accepted 24 June 2009.

© 2010 The Royal Australian and New Zealand College of Psychiatrists


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G.L. CARTER, C.H. WILLCOX, T.J. LEWIN, A.M. CONRAD, N. BENDIT 163

with BPD improve over the long term, decreasing in sui- conversational model) delivered by trainee psychiatrists
cidality, self-destructiveness and interpersonal malad- showed improvement for the year of treatment, which was
justment, if survival is effectively managed during the sustained at follow up 12 months later. Improvements
turbulent years of youth [3]. Nevertheless, a recent review were shown in frequency of use of drugs (both prescribed
suggested that suicidal behaviour is a common complica- and illegal), number of visits to medical professionals,
tion, and continues to be a chief concern in the clinical number of episodes of violence and self-harm, time away
management of BPD [4]. from work, number of hospital admissions, time spent as
Better treatments for BPD and particularly for the an inpatient and a score on a self-report index of symptoms
suicidal behaviour and suicide deaths experienced by [22]. This group was later followed up for a period of
these patients have been sought for some time. It has been 5 years and was compared to a cohort (non-randomized)
estimated that although 10% will eventually complete of waiting list (WL) patients. The primary outcome was
suicide, this outcome is not readily predictable, and hos- improvement in DSM total criteria scores [23]. In a dif-
pitalization is of unproven value for suicide prevention, ferent Australian study, a retrospective examination of two
possibly producing negative effects [5]. different treatment conditions for BPD patients showed
There have been few effective interventions tested in that those who received a special treatment contract had a
randomized controlled trials (RCTs) to reduce rates of sui- significantly higher total number of admissions but not
cide attempt, parasuicide or deliberate self-harm (DSH) in more presentations to the emergency department than the
BPD. For outpatients, a day hospital programme with a standard treatment group [24].
psychoanalytic treatment component [6] and for female
subjects with multiple parasuicidal behaviours, dialectical Aims
behaviour therapy (DBT) have been shown to be effective
[7]. Both of these therapies have also demonstrated long- The purpose of the present study was to compare DBT
term reduction in suicidal behaviour after the cessation of and the control condition of treatment as usual plus WL
therapy [8–10]. DBT is a team-based treatment combining for DBT (TAUWL) for the primary outcomes (differ-
cognitive, behavioural and mindfulness techniques, deliv- ences in proportions and event rates) of any DSH event;
ered in individual therapy, group-based skills training, out- general hospital admission for DSH and psychiatric
of-hours telephone contact with individual therapist admission for any reason; and mean difference in length
modalities and a therapist consultation group [7]. of stay for any hospitalization. Secondary outcomes were
There have been other trials of DBT with a reduction in disability and quality of life measures.
suicidal behaviours as the primary outcome, replicated out-
side of the University of Washington: RCT in the Nether-
lands [11], a study with inpatients in Germany in a Methods
non-controlled design [12], and a three-arm RCT in New
York [13]. There have also been adaptations of the duration Setting
or ‘dose’ of DBT into a 12 week programme for adoles-
cents [14], 6 months for female veterans [15], 6 months for The Hunter DBT project was undertaken in Newcastle, Australia at
female subjects with active suicidal ideation [16], 28 weeks the Centre for Psychotherapy, a clinical outpatient unit of the Hunter
New England Mental Health Service. Individual DBT therapists and
skills training for depressed women aged >60 years [17]
skills trainers were psychiatrists, social workers, clinical psychologists,
and 20 weeks for bulimic behaviour [18]. DBT has also
psychologists, occupational therapists or nurses by training.
been applied in other female BPD populations: drug depen-
dence [19], veterans [15], opioid dependence [20] with Training
bulimic behaviour [18] and in depressed elderly [17].
DBT has been demonstrated to be effective in RCTs for DBT training for therapists was initially undertaken with a self-
other outcomes including retention in treatment [7,19], directed reading programme using the DBT skills manual [25] and
fewer inpatient hospital days [7], social and global adjust- other materials suggested by the honorary consultants to the study. An
ment [19] and reduction in substance use [19,20]. Never- initial introductory programme was conducted and later extended with
theless, there have been some reservations expressed about DBT consultation sessions conducted in Newcastle. Four members of
the Hunter DBT treatment team attended a 2 week intensive training
the limited research base and methodological limitations
in DBT in New Zealand after the project had commenced.
of the published studies for DBT, especially in the light of
the enthusiastic take up of DBT as a treatment [21]. Study design
There are no RCTs from Australia addressing suicidal
behaviour in BPD, but a non-controlled study of 30 sub- The Hunter DBT project was an RCT of modified DBT. The inter-
jects using a self-psychology intervention (Hobson’s vention condition was based on the comprehensive DBT model, a

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164 HUNTER DBT PROJECT

team-based approach including individual therapy, group-based skills exclusion. Exclusion criteria were presence of a disabling organic con-
training, telephone access to an individual therapist and therapist dition, schizophrenia, bipolar affective disorder, psychotic depression,
supervision groups following the model of treatment developed by florid antisocial behaviour, or developmental disability. Recruitment
Linehan et al. [7]. The main change to the Linehan et al. model was commenced in February 2000 and the last participant finished baseline
the telephone access to individual therapists. In the present study tele- assessment in July 2003.
phone access was delivered using a group roster of DBT individual Participants were referred from treating general practitioners, treat-
therapists (not contact with each participant’s individual therapist) ing psychiatrists or public mental health services (any units of Hunter
between 8:30 a.m. and 10 p.m., and telephone contact with the local Mental Health Services); this process was coordinated by one of the
psychiatric hospital between 10 p.m. and 8:30 a.m. investigators (CW). Referring clinicians were advised of the need for
The control condition was a 6 month WL for DBT while receiving subjects to meet inclusion criteria and the need to maintain current
TAU (TAUWL). Subjects, both in the initial DBT group and in the therapy with the subjects until randomization was complete for the
TAUWL group who came to DBT after 6 months were offered DBT group and during the 6 month wait time for the TAUWL group.
12 months DBT treatment, although the comparison between groups Upon commencement of DBT, participants were asked to discontinue
was restricted to the first 6 months of DBT versus TAUWL. This psychological therapy of any sort for at least the 12 month duration
design was also different to the original Linehan et al. study, which of DBT.
used TAU as the control condition and comparison of groups after
4 months, 8 months and 12 months of DBT therapy.
Assessments and measures
Randomization Baseline assessment included parts of the computerized interview
used in the Australian National Survey of Mental Health and Wellbeing
Randomization was carried out by the research staff and participants [26]: demographics; Composite International Diagnostic Interview
were allocated by selection of sealed opaque envelopes. Randomization (CIDI; selected modules): anxiety, depression, bipolar disorders, alco-
was undertaken after consent to participate and completion of all the hol abuse and dependence, substance abuse and dependence, Interna-
baseline measures and eligibility interview. tional Personality Disorder Examination Questionnaire (IPDEQ) [27];
and the Brief Disability Questionnaire (BDQ) [28]. Other assessment
Treatment procedures instruments included Lifetime Parasuicide Count–2 [29]; Parasuicide
History Interview–3 month period (PHI-2) [30] and the World Health
Treatment (DBT) participants were assigned to the next available Organization (WHO) Quality of Life–BREF version (WHOQOL-
individual therapist. Treatment subjects were also assigned to the rel- BREF) [31]. Two additional questions were asked at the end of the
evant skills training group, meeting weekly with the modules running BDQ: (i) during the last month, how many days in total were you
in the following order: Interpersonal Effectiveness, Emotion Regula- unable to carry out your usual daily activities fully; and (ii) during the
tion and Distress Tolerance. Each module ran for 8 weeks. Groups had last 1 month, how many days in total did you stay in bed all or most
a minimum of four members before commencement and a maximum of the day because of illness or injury.
of eight members. Entry to the skills group occurred only at the com- Assessments repeated 3 months and 6 months after allocation to
mencement of the next skills module. DBT or TAU  WL included BDQ, PHI-2 and WHOQOL-BREF.

Participants Outcomes and blindness of raters

The flow of participants through the study is shown in the CON- Baseline characteristics were determined by research staff before
SORT diagram (Figure 1). Of the 112 participants referred for partici- randomization occurred and hence allocation was blind.
pation in the trial, 16 did not attend the assessment, while 16 were Outcomes were determined for the intention-to-treat analyses by
excluded because they did not meet the criteria for BPD and one was assessors blinded to allocation, extracting information from psychiatric
of no fixed address (NFA). Of the 79 participants eligible for the pro- hospital and general hospital records either by direct examination of
gramme, three did not complete initial baseline assessments and were the clinical records or by extraction electronically from the Hunter Area
therefore excluded from the study, two withdrew consent after assess- Toxicology Service database at Newcastle Mater Hospital [32]. Pri-
ments and treatment were completed and one died by suicide following mary outcomes for the intention-to-treat analyses were the proportion
the baseline assessment period. Additionally, three completed baseline of participants with any hospital admission for DSH and the proportion
assessments but due to a technical error some of their demographic and with any psychiatric hospitalization for any reason; the number of gen-
diagnostic data were not recorded and were missing in those analyses. eral hospital admissions for DSH and the number of psychiatric hospi-
Participants were female, aged 18–65 years, meeting criteria for BPD tal admissions for any reason; the length of stay for hospital admissions
determined by clinical interview by a psychiatrist using DSM-IV for DSH and for psychiatric hospital admissions for any reason.
criteria [1] and having a history of multiple episodes of deliberate General hospital admission for DSH included any episode according
self-harm, at least three self-reported episodes in the preceding to the following definition originally developed for ‘attempted suicide’:
12 months. The psychiatrist assessor had the option of determining if ‘any intentional self-injury or the deliberate ingestion of more than the
prescribed amount of therapeutic substances, or deliberate ingestion of
any potential subjects were unsuitable for inclusion in therapy or unmo-
substances never intended for human consumption’ [33]. Secondary
tivated to participate, although there were no specific criteria for this

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G.L. CARTER, C.H. WILLCOX, T.J. LEWIN, A.M. CONRAD, N. BENDIT 165

Potential participants n = 112 Exclusion n = 33


Referred from clinical services 16 Did not attend, 1 NFA
to Hunter DBT Project 16 Did not satisfy DSM criteria

Eligible participants n = 79
DSM –IV BPD Exclusion n = 3
Recent self-injurious behaviour 3 Did not complete baseline
Female assessment
18 years old

Exclusion n = 3
Randomized
1 Died
76 2 Withdrew consent later

Allocated DBT Allocated TAU+WL


n = 38 n = 35

Per Protocol Per Protocol


n = 26 completed n = 29 completed
3 months treatment 3 months waitlist and
and self-report self-report

Per Protocol Per Protocol


Intent to treat Intent to treat
n = 20 completed n = 31 completed
n = 38: Hospital data n = 35: Hospital data
6 months treatment 6 months waitlist and
for outcomes for outcomes
and self-report self-report

Figure 1. CONSORT Diagram of participant flow. BPD, borderline personality disorder; DBT, dialectical behaviour
therapy; NFA, no fixed address; TAUWL, treatment as usual  waitlist.

outcomes included any presentation without admission for general Analyses


hospital-treated DSH and any presentation without admission to a
psychiatric hospital for any reason. Differences in proportions were tested using χ2 test. Event or count
For participants who received treatment and completed the data were predominately analysed using either Poisson regression or
self-report instruments at 3 months and 6 months after allocation, negative binomial regression when appropriate. Negative binomial
per-protocol analyses were conducted. All reasonable attempts were regression was used when the distribution showed overdispersion (vari-
made to maintain blindness to allocation status for these raters, but this ance much greater than the mean in Poisson distribution) or the good-
could not achieve perfect blindness. Primary outcomes for the ness of fit for a Poisson regression showed large χ2 values or the
per-protocol analyses were undertaken for the proportion of subjects likelihood ratio test of alpha was significantly different from zero. Zero
with any episode of DSH (called parasuicide in the rating scales) and inflated models were used when there was an excess of zero counts in
the number of DSH events. Secondary outcomes were disability scores the data and the Vuong test was significant. Results were expressed as
and quality of life scores: days out of role in the past month and days incidence rate ratios with 95% confidence intervals (IRR: 95%CI). A
spent in bed in the last month; and WHOQOL-BREF scores for all four post-hoc descriptive graphical analysis of the number of general
domains (Physical, Psychological, Social and Environmental). The two hospital admissions for DSH and the number of psychiatric admissions
items thought to be most relevant to disability for this patient popula- for any reason for the period of 12 months (in 6 month blocks) before
tion were chosen a priori for analysis, from the questions following on and after baseline was done to contextualize the pattern of psychiatric
from the BDQ: days spent in bed and days out of role. hospitalizations and general hospital admission for DSH over

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166 HUNTER DBT PROJECT

a longer time frame than the 6 month comparison of treatment group tended to have shorter lengths of stay. For the 6 months of the
effects. study, the mean length of stay overall was as follows: psychiatric hos-
Analysis of variance (ANOVA) was used for between-group mean pital for any reason, total  7.19  27.53 days, con-
differences in age, number of BPD criteria, IPDEQ score and mean trol  9.48  33.63 days, DBT  5.10  20.62 days (F(1,69)  0.14);
number of reported lifetime episodes of self-harm. Mann–Whitney and general hospital for DSH, total  0.88  2.65 days, con-
U-test was used for lifetime median number of DSH episodes (due to trol  1.25  3.54 days, DBT  0.53  1.38 days (F(1,69)  0.90).
non-normally distributed data). A repeated-measures analysis of vari- When the analyses were restricted to those who had any hospital admis-
ance (rANOVA) was used for the mean number of DSH events over sion the mean length of stay was as follows: psychiatric hospital for
three 3 month time periods, covering the period of 3 months before any reason, total  37.53  54.5 days, control  47.43  65.6 days,
baseline until 6 month follow up. DBT  27.64  43.5 days (F(1,10)  0.69); and general hospital for
A rANOVA was also used for the secondary outcomes: BDQ days out DSH, total  3.79  4.47 days, control  4.88  5.78 days,
of role in the past month and days spent in bed in the last month; and DBT  2.56  2.06 days (F(1,13)  0.17). For the per-protocol analy-
WHOQOL-BREF scores for all four domains (Physical, Psychological, ses, there were no significant differences for the proportion of patients
Social and Environmental) over the same three time periods. Because with any DSH episode in 6 months, or for the number of self-harm
these per-protocol analyses are subject to potential attrition bias and episodes for the baseline–3 months and 3–6 months periods. There was
hence a threat to internal validity, we also conducted confirmatory linear a significant effect (linear and quadratic) for time in the rANOVA for
mixed effect model analyses for any result showing a significant benefit the number of DSH episodes over the three time periods, but no sig-
of group (DBT vs TAUWL) or the interaction of group (DBT vs nificant effect for group status.
TAUWL) × time for the secondary outcomes of disability and quality Table 4 lists the per-protocol results for the secondary outcomes, dis-
of life. These confirmatory procedures used intention-to-treat analyses ability and quality of life. There was no significant effect for group or
based on randomization status for all subjects who had baseline data time in the rANOVA for days spent in bed in the previous month or for
available (disability, n  70; quality of life, n  73), using fixed effects days out of role in the previous month. There was a significant beneficial
for group (two levels), time (three levels) and group × time (six levels) effect for group × time (linear), in favour of DBT for days spent in bed
predictor variables. Results are reported as F (derived by taking the ratio but no significant effect for days out of role. Similarly, for days spent in
of the appropriate sums of squares) and p for each significant predictor bed, there was also a significant effect for group (F(1,64.9) = 5.42, p 
variable. These analyses were conducted using the MIXED procedure in 0.05) in favour of DBT in the confirmatory mixed-effects analysis.
SPSS version 15 (SPSS, Chicago, IL, USA). All other analyses were There was a significant beneficial effect for time (linear) and
conducted using SPSS version 14 or STATA SE version 10 (StataCorp group × time (linear), in favour of DBT, for three of the four domains
LP, College Station, TX, USA). of quality of life: Physical, Psychological and Environmental. Similarly
there was a significant effect for time (F(2,57.2)  7.56, p  0.01) and
group (F(1,75.6)  4.58, p  0.05) for Physical Domain; time
(F(2,55.4)  26.68, p  0.001) and group × time (F(2,55.4)  3.28,
Results p  0.05) for Psychological Domain; but only for time (F(2,56.4)  8.06,
p  0.01) for Environmental Domain in the confirmatory analyses.
Table 1 lists the demographic characteristics and Table 2 the clinical There was a significant beneficial effect for time (linear) in the Social
characteristics of the participants at baseline. There were no significant Domain but no significant effect for group. Similarly, there was a
imbalances of any of the a priori selected demographic or clinical vari- significant effect only for time (F(2,57.1)  11.71, p  0.001) for the
ables at baseline. Social Domain in the confirmatory analyses.
The participants were young women, usually single, not in the labour
force (home duties, pensioner or student), with nearly 40% having
some post-schooling qualification. There was considerable exposure to Discussion
traumatic events of sexual, physical and potentially life-threatening
types. The participants showed substantial psychopathology with high
rates of BPD criteria, IPDEQ scores and Axis 1 comorbidity. They had Strengths and weaknesses of the study
a substantial previous history of self-harm events, with external damage
to skin (usually by cutting) and self-poisoning being the most common This was RCT, using opaque envelope technique,
forms. with the main primary outcomes determined by
Table 3 lists the principal outcomes for the intention-to-treat analyses assessors blind to allocation status. These primary out-
and the per-protocol analyses. For the intention-to-treat analyses, there comes for the intention-to-treat analyses were deter-
were no significant differences in proportions for general hospital admis- mined from hospital records and not participant
sion for DSH or for any psychiatric admission. There were no significant self-report, eliminating the potential for a differential
differences for the mean number of admissions of either type. Figure 2 response bias. Participants knew their allocation status
also indicates that admissions of both types were rising in the time before
but were not told specifically of the outcomes of interest.
the baseline of the study, falling for the 6 months of the study and con-
There were no significant imbalances for the a priori
tinuing to fall for the 6 months following the study (when the TAUWL
control group had begun DBT) for both groups. selected demographic or clinical variables at baseline,
The length of stay overall, or the length of stay for those with either indicating a successful randomization procedure. The
type of admission was not significantly different, although the DBT post-hoc pattern of hospitalizations seen in Figure 2,

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G.L. CARTER, C.H. WILLCOX, T.J. LEWIN, A.M. CONRAD, N. BENDIT 167

Table 1. Demographic characteristics of the sample


Groups

Overall (n = 70) TAUWL (n = 33) DBT (n = 37)

Demographic Mean  (SD) Mean  (SD) Mean  (SD) Statistics


Age (years) 24.5  (6.10) 24.7  (6.15) 24.5  (6.12) F(1,68)  0.065
Marital status % % %
Married 25.7 33.3 18.9
Divorced 18.6 21.2 16.2 χ2(2)  2.82
Single 55.7 45.5 64.9
Employment
Employed 18.6 12.1 24.3
Unemployed 5.7 9.1 2.1 χ2(2)  2.72
Not in labour force 75.7 78.8 73.0
Education status
Still at school 4.3 6.1 2.7
Did not complete secondary education 34.3 39.4 29.7
Completed secondary education 22.9 15.2 29.7 χ2(3)  2.56
Post-school qualification 38.6 39.4 37.8
Mean ⴞ (SD) Range Mean ⴞ (SD) Range Mean ⴞ (SD) Range
No. children 0.56  (1.21) 0–5 0.52  (1.12) 0–5 0.59  (1.30) 0–5 IRR 1.44 (0.67–3.08)
Significance levels: ∗p  0.05, ∗∗p  0.01, ∗∗∗p  0.001.

however, suggests a possible imbalance based on gen- admission for DSH, which proved to be relatively infre-
eral and psychiatric hospitalizations at baseline. Princi- quent in both the DBT (21%) and TAUWL (26%)
pal analyses were done on an intention-to-treat basis, groups; and self-reported DSH, which proved to be rela-
based on randomization status, with three subjects tively frequent in both the DBT (75%) and TAUWL
removed from the TAUWL group, one because of (67%) groups. We did not have sufficient data from
death soon after randomization and two because of with- participants to determine whether there was equivalence of
drawal of consent after completion of treatment. The treatment hours in the two groups, and so reported benefits
statistical techniques used were appropriate to the data in secondary outcomes may be due to differences in ther-
analysed [34], in particular the use of either Poisson apy hours rather than the specific effects of treatment. The
regression or negative binomial regression when appro- external validity of the study is not known and so gener-
priate to analyse event (count) data, which has been only alization from these results to any other populations should
infrequently used before in repetition of DSH studies be done with caution.
[35,36]. In the present study the secondary outcomes
(disability and quality of life) were determined by par- Primary outcomes: DSH and hospitalization
ticipant self-report on various measures and so the losses
of participants, particularly from the DBT treatment The current study failed to replicate some of the impor-
group in the per-protocol analyses, may limit the internal tant findings (significant reduction in DSH and reduction
validity of these secondary outcome results. We also in psychiatric hospitalization) from other studies [7,10].
used an alternative analytic model, linear mixed-effect Although there was improvement in both groups over
models for repeated measures data, as confirmatory time, there was no significant differential reduction in
analyses for the secondary outcomes, which strengthens general hospital-treated DSH, psychiatric hospitalization
the validity of these results [37]. or self-reported DSH, for either the binary outcome or
The current study was powered on the basis of a previ- event rates.
ously published study [7], which used the repetition of There are several possible explanations as to why
self-reported ‘parasuicide’ as the outcome of interest (DBT DBT was not effective in this study: regression to back-
26% vs TAU 60%), which had demonstrated a powerful ground (pre-baseline) levels, the Hawthorne effect
benefit of 33% absolute risk reduction, 56% relative risk whereby both groups improved because of the effect of
reduction and a number needed to treat of only three (cal- being in a study, the potentially powerful effect of being
culated by GC). In the present study two different primary in a 6 month TAUWL group for DBT for the control
outcomes were used that approximated the self-reported condition, beneficial effects of the TAU condition avail-
parasuicide outcome in that original study: general hospital able in the Hunter region, modifications to standard

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168

Table 2. Clinical characteristics of the sample


Groups
Statistical
Clinical characteristics Overall (n = 70) TAUⴙWL (n = 33) DBT (n = 37) analyses

% Mean ± (SD) % Mean ± (SD) % Mean ± (SD)


DSM-IV personality disorder criteria
No. BPD Criteria 7.21  (1.02) 7.10  (0.95) F(1,65)  0.28
Abandonment (PD criteria) 83.6 7.15  (0.98) 81.8 83.6 χ2(1)  0.14
Unstable relationships (PD criteria) 94.0 97.0 91.2 χ2(1)  1.10
Unstable self-image (PD criteria) 83.6 81.8 85.3 χ2(1)  0.15
Impulsivity (PD criteria) 52.5 48.5 55.9 χ2(1)  0.36
Suicide and self-harm (PD criteria) 100 100 100 n.a.
Instability of mood (PD criteria) 98.5 97.0 100 χ2(1)  1.04
Chronic emptiness (PD criteria) 61.2 57.6 64.7 χ2(1)  0.35
Inappropriate anger (PD criteria) 86.6 90.9 82.4 χ2(1)  1.05
Dissociation and psychotic (PD criteria) 55.2 66.7 44.1 χ2(1)  3.44
IPDEQ score 0.58  (0.23) 0.56  (0.23) 0.61  (0.23) F(1,68)  1.72
Traumatic events
Ever raped 60.0 63.6 56.8 χ2(1)  0.34
Ever Sexually molested 65.7 63.6 67.6 χ2(1)  0.12
Physically assaulted 47.1 45.5 48.6 χ2(1)  0.07
HUNTER DBT PROJECT

Threatened with a weapon 40.0 45.5 35.1 χ2(1)  0.77


DSM-IV comorbidity (CIDI)
Any substance use disorder 68.6 66.7 70.3 χ2(1)  0.10
Any affective disorder 73.0 75.8 70.3 χ2(1)  0.26
Any anxiety disorder 88.6 87.9 89.2 χ2(1)  0.03
Lifetime self-harm

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Mean lifetime self-harm episodes 96.3  (109.70) 89.7  (103.72) 102.4  (115.98) F(1,71)  0.23
Median lifetime self-harm episodes 53.0 41.0 55.5 91.5
Proportion with any self-harm episode in 67.3 62.1 73.1 χ2(1)  0.75
6 months before baseline
Most recent self-harm episode
Damage to skin or tissue (external) 60.3 60.0 60.5
Self-poisoning 26.0 31.4 21.1 χ2(2)  2.04
Other- hanging, jumping or stabbing 13.7 8.6 18.4
Significance levels: ∗p  0.05, ∗∗p  0.01, ∗∗∗p  0.001.
Table 3. Principal outcomes
Groups

Principal outcomes: intent to treat Overall (n  73) TAUWL (n  35) DBT (n  38) Statistical analyses

Proportion with at least one hospital admission % % %


Psychiatric hospital 19.2 20.0 18.4 χ2(1)  0.03
General hospital: DSH 23.3 25.7 21.1 χ2(1)  0.22
Hospital admissions Mean  (SD) Mean  (SD) Mean  (SD)
No. admissions to a psychiatric hospital 0.75  (2.40) 0.91  (2.64) 0.61  (2.18) IRR: 0.66 (0.14–3.10)
No. admissions to a general hospital: DSH 0.93  (3.29) 1.40  (4.47) 0.50  (1.54) IRR: 0.36 (0.09–1.43)
No. admissions: Total 1.68  (5.43) 2.31  (6.88) 1.11  (3.64) IRR: 0.48 (0.13–1.73)
Hospital presentations without admission
Psychiatric hospital 0.20  (0.55) 0.26  (0.66) 0.16  (0.44) IRR: 0.61 (0.22–1.73)
General hospital: DSH 0.12  (0.55) 0.06  (0.24) 0.18  (0.73) IRR: 3.22 (0.67–15.52)
No. presentations: Total 0.33  (0.88) 0.31  (0.83) 0.34  (0.94) IRR: 1.09 (0.49–2.43)
Principal outcomes: per-protocol
Proportion with any self-harm episode % % %
Baseline–6 months (n  51) 70.6 67.0 75.0 χ2(1)  0.31
No. self-harm episodes Mean  (SD) Mean  (SD) Mean  (SD)
Baseline–3 months (n  55) 6.95  (12.80) 7.59  (14.50) 6.23  (10.83) IRR 0.82 (95%CI  0.34–1.99)
3–6 months (n  51) 7.16  (21.42) 8.42  (26.92) 5.20  (7.47) IRR 0.62 (95%CI  0.23–1.65)
No. self-harm episodes in previous 3 months (n  41) (n  23 ) (n  18 )

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Baseline 19.80  (35.51) 18.08  (40.67) 22.00  (28.60) Group F(1,39)  0.00
3 months 5.95  (11.32) 6.13  (11.41) 5.72  (11.53) Time (Linear) F(1,39)  14.00∗∗
G.L. CARTER, C.H. WILLCOX, T.J. LEWIN, A.M. CONRAD, N. BENDIT

6 months 7.48  (23.80) 9.21  (31.22) 5.27  (7.87) Time (Quadratic) F(1,39)  4.93∗
Group  Time (Linear) F(1,39)  1.31
Group  Time (Quadratic) F(1,39)  0.003
Significance levels: ∗p  0.05, ∗∗p  0.01,∗∗∗p  0.001.
169
170 HUNTER DBT PROJECT

Admissions Type least one parasuicidal act in the period. Linehan et al.
and Group
also examined median psychiatric inpatient days for
2 Psychiatric – TAU+WL
the same three time periods, reporting significant ben-
Psychiatric – DBT
General – TAU+WL efits in favour of DBT only for the 0–4 month and
General – DBT 8–12 month periods, but showing no difference in the
proportion with at least one admission in the full
Mean Number of Admissions

1.5
12 month period. [7]. Similarly, Bateman and Fonagy
also examined two primary outcomes for three time
periods: 0–6 months, 6–12 months and 12–18 months,
1 reporting significantly reduced number of suicide
attempts for all three time periods and reduced self-
mutilating behaviours for two time periods
(6–12 months and 12–18 months) [6]. In the present
0.5 study, after 6 months the proportions of patients with
any episode of DSH were already high in both groups
and so a further period of study would have been very
unlikely to result in a significant difference being
0
(−12 to −6m) (−6 to −0m) (0 to +6m) (+6 to +12m) found in favour of DBT or TAUWL. The mean num-
Time period ber of DSH events, however, was non-significantly
lower in the DBT group for both the 0–3 month and
Figure 2. Psychiatric and general hospital admissions 3–6 month periods, and so it may have been possible
during the 12 months before and after study recruitment: that the 6 month duration of comparison may have
( ) psychiatric (treatment as usual waitlist (TAUWL)); been too short to observe an emerging difference in
( ) psychiatric (Dialectical Behaviour Therapy (DBT); favour of the DBT group. Similarly, hospitalization by
(°) general (TAUWL); (•) general (DBT). proportions and by event rates were also non-signifi-
cantly in favour of DBT, so the 6 month duration of
DBT (including the 6 month duration of DBT, after- comparison may have missed emerging differences in
hours telephone contact by roster of individual thera- favour of DBT.
pists), the possible inferiority of training of DBT In considering other studies, a reduction in parasui-
therapists to that of those in other studies or inferior cide and suicide attempt has been reported in two studies
adherence to the DBT methods despite adequate train- using DBT at the University of Washington [7,10], while
ing, and methodological differences (e.g. the use of another team at the University of Amsterdam reported
hospital-treated DSH measured by hospital records as a reduction in self-mutilation but not suicidal behaviour
primary outcome or possible differences in the popula- [11]. One underpowered study from Duke University
tion used in the study). reported significant decreases in suicidal ideation, but
In the present study the duration for comparison was no significant reduction in number of parasuicide acts or
only 6 months, while the original Linehan et al. study number of hospitalizations [15]. Two other small-sample-
was of 12 months duration [7], and the original Bate- size studies from the University of Washington on drug-
man and Fonagy study was of 18 months duration [6], dependent women with BPD [19] and opioid-dependent
so it could be argued that the current study was too women, showed no difference in parasuicide [20].
brief in duration of treatment comparisons to demon- The current study found that the 6 month rate of hospi-
strate benefits in terms of DSH or hospitalization for tal-treated DSH in the DBT group (21%) was very simi-
BPD patients. We were aware of this argument during lar to the 12 month (26%) and 24 month (23%) rates for
the planning of the current study but believed that a self-report of parasuicide in the USA [7,10]. The 6 month
close examination of these previous studies indicated rate of self-reported DSH in the present study (DBT 75%,
that improvement occurred before 6 months of treat- TAUWL 67%), however, was much higher than the
ment had elapsed. Linehan et al. examined both num- equivalent parasuicide rates (DBT 26%, TAU 60% [7] and
ber of parasuicidal acts and proportion of subjects with DBT 21%, expert control 46% [10]). Later studies separated
any episode of parasuicide in three time periods: suicidal behaviours into two outcomes, suicide attempts
0–4 months, 4–8 months and 8–12 months, reporting and non-suicidal self-injury [10] or suicidal behaviours
significant differences in favour of DBT for all three and self-mutilation [11], making direct comparison with
time periods for reduction in the number of parasui- the current study difficult. The second Linehan et al. study
cidal acts, and for two time periods (0–4 months and (DBT vs treatment by expert control) showed a significant
8–12 months) for the proportion of subjects with at reduction in suicide attempts in favour of DBT, while both
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G.L. CARTER, C.H. WILLCOX, T.J. LEWIN, A.M. CONRAD, N. BENDIT 171

Table 4. Secondary outcomes: disability and quality of life


Group
Overall TAUⴙWL DBT
Variables n ⴝ 48 n ⴝ 28 n ⴝ 20 Statistical analyses
Days in bed (last month) BDQ Group F(1,46)  2.00
Mean  (SD) Mean  (SD) Mean  (SD)
Baseline 4.38  (6.97) 3.96  (7.02) 4.95  (7.05) Time (Linear) F(1,46)  0.18
3 months 4.76  (6.91) 6.02  (8.00) 3.00  (4.65) Time (Quadratic) F(1,46)  0.07
6 months 5.38  (7.24) 7.29  (8.33) 2.70  (4.28) Group × Time (Linear) F(1,46)  4.94∗
Group × Time (Quadratic) F(1,46)  0.51
Days out of role (last month) BDQ
Baseline 12.52  (12.26) 12.46  (12.5) 12.60  (12.23) Group F(1,46)  0.82
3 months 10.24  (10.74) 11.36  (11.42) 8.68  (9.79) Time (Linear) F(1,46)  0.94
6 months 11.02  (11.68) 13.07  (11.59) 8.15  (11.48) Time (Quadratic) F(1,46)  1.61
Group × Time (Linear) F(1,46)  1.63
Group × Time (Quadratic) F(1,46)  0.01
Physical Domain (0–100) WHOQOL-BREF
n  51 n  31 n  20
Mean  (SD) Mean  (SD) Mean  (SD)
Baseline 41.11  (19.95) 40.70  (22.35) 41.61  (16.06) Group F(1,49) 1.91
3 months 48.86  (20.59) 46.29  (21.17) 52.85  (19.52) Time (Linear) F(1,49)  10.04∗∗
6 months 47.83  (21.02) 42.39  (21.46) 56.25  (17.68) Time (Quadratic) F(1,49)  5.40∗
Group × Time (Linear) F(1,49)  6.45∗
Group × Time (Quadratic) F(1,49)  0.04
Psychological Domain (0–100) WHOQOL-BREF
Baseline 18.16  (14.04) 19.41  (13.96) 16.25  (14.30) Group F(1,49)  0.62
3 months 30.23  (21.98) 29.72  (22.77) 31.04  (21.26) Time (Linear) F(1,49)  50.91∗∗∗
6 months 35.13  (19.96) 30.24  (19.68) 42.71  (18.38) Time (Quadratic) F(1,49)  2.27
Group × Time (Linear) F(1,49)  8.94∗∗
Group × Time (Quadratic) F(1,49)  0.60
Social Domain (0–100) WHOQOL-BREF
Baseline 32.02  (22.38) 36.55  (23.73) 25.00  (18.53) Group F(1,49)  0.75
3 months 42.89  (24.59) 43.82  (27.40) 41.45  (20.07) Time (Linear) F(1,49)  20.73∗∗∗
6 months 49.34  (26.29) 49.73  (30.23) 48.75  (19.36) Time (Quadratic) F(1,49)  1.12
Group × Time (Linear) F(1,49)  1.70
Group × Time (Quadratic) F(1,49)  0.62
Environmental Domain (0–100) WHOQOL-BREF
Baseline 49.65  (16.11) 51.15  (15.61) 47.34  (17.00) Group F(1,49) 0.13
3 months 56.89  (17.27) 56.30  (16.43) 57.81  (13.69) Time (Linear) F(1,49)  14.64∗∗∗
6 months 57.27  (16.35) 54.57  (18.16) 61.45  (12.36) Time (Quadratic) F(1,49)  6.69∗
Group × Time (Linear) F(1,49)  5.43∗
Group × Time (Quadratic) F(1,49)  0.00
Significance levels: ∗p  0.05, ∗∗p  0.01,∗∗∗p  0.001.

treatments were associated with a reduction in non-suicidal come, the mean event rate or the mean length of stay
self-injury, meaning no significant difference in non-sui- for those with an admission at the end-point of the trial.
cidal self-injury [10]. A 12 month RCT in Amsterdam com- In the original DBT trial there was a demonstrated ben-
paring DBT to TAU found no difference in the frequency efit for median days of psychiatric hospitalization after
of suicidal behaviours (threats, preparation for attempts 12 months, but no difference in proportions for any psy-
and attempts) nor the proportion with suicide attempt, but chiatric admission or for median number of admission
did find a difference in self-mutilating behaviours for the per person [7]. In the later DBT trial, using a mixed-effect
time × treatment condition and a reduction in the propor- ANOVA, significantly fewer DBT subjects had any
tion with any self-mutilating behaviour in the 6–12 month psychiatric admissions after the year 1 (DBT 20% vs
period [11]. expert control 49%) and year 2 (DBT 23% vs expert
The present study found reductions in psychiatric control 24%) outcomes were combined [10].
hospitalization for both groups over time but again no In the present study there was one death by suicide in
significant benefit in favour of DBT for the binary out- the TAUWL control group, while in studies from the
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172 HUNTER DBT PROJECT

University of Washington there was one death by suicide Conclusion


in the DBT group [7] and one death in the treatment by
expert control group not attributed to suicide but to ‘the For the principal outcomes, the present study found no
cumulative effects of previous suicide attempts’ [10]. differences in self-reported DSH, general hospital-treated
DSH, psychiatric hospitalization or length of stay in gen-
Secondary outcomes: disability and quality of life eral hospital or psychiatric hospital, although there was
considerable improvement in both the DBT and the
Life-threatening behaviours and therapy-interfering TAUWL control groups from baseline levels. Even
behaviours are primary targets in DBT (stage 1 target: ‘out though the present study did not replicate the benefits of
of control behaviours’) followed by quality of life-interfer- reduction in DSH behaviour and hospital admissions
ing behaviours and increasing behavioural skills, which are found in other studies [7,10], several secondary outcomes
also stage 1 targets. Other quality of life and disability issues (disability and quality of life) showed clinically significant
may also be dealt with at a later stage of therapy (stage 2 benefits in favour of DBT, in keeping with the theoretical
target: reducing ‘quiet desperation’). Improvements in dis- predictions for DBT. BPD is a common diagnosis in pub-
ability and quality of life, however, were found in the pres- lic psychiatric services and the present study suggests that
ent study even though there was no differential improvement using DBT in a team approach, very similar to the original
in DSH and psychiatric hospitalization. Linehan et al. treatment model, might produce meaningful
Although there was no significant effect for one mea- improvement in the lives of these patients.
sure of overall disability (days out of role), there was a
significant benefit for DBT for the more specific disability
measure of days spent in bed, an absolute difference of Acknowledgements
4 days per month per person, which we consider to be clin-
ically significant. With 81% of participants either not in the Our thanks go to several people for their contributions to
labour force or unemployed, it may be difficult to interpret the Hunter DBT Project: Dr Chris Hayes, University of
the meaning of the ‘days out of role’ result derived from Newcastle and Ms Susan Burgoyne as investigators in the
the BDQ. Nonetheless, with an average of 11 days out of initial project development; to Peter Sneesby as Masters of
role per month the overall level of disability was high, Clinical Psychology student, University of Newcastle, assist-
which was not surprising for this clinical population. ing with the initial phases of data collection; to Natalia Carter
Both groups had substantially lower scores on quality of and Gillian Maddock who helped with data extraction from
life measures than the Australian population norms: Physical the clinical records; to Dr Kerrie Clover, University of New-
health domain  73.5  18.1, Psychological well-be- castle, for assistance with instrument scoring and data clean-
ing  70.6  14.0, Social relationships  71.5  18.2 and ing; and to Ben Britton who assisted with linear mixed effect
Environment domain  75.1  13.0 [38]. Three of the four models. Our thanks also go to all the staff who contributed
quality of life domains, however, showed significant clinical services: individual therapists Danielle Adams, Mar-
improvement over time for the DBT condition in the present ianne Ayre, Dr Nick Bendit, Susan Burgoyne, Jennifer
study (group × time interaction), while both groups improved Evans, Dr Howard Johnson, Jennifer Koorey, Natalie
over time for the fourth domain (Social). The magnitude of McCall, Chris McCrory, Jane Taylor and Chris Willcox; and
these improvements in quality of life was substantial and skills trainers Marianne Ayre, Dr Nick Bendit, Linda Bragg,
considered to be clinically significant, although the final Michael Currie, Annabel Kelly, Michelle Meyer, Ruth
scores for the Psychological domain still fell short of com- Spence and Don Stewart; and also to Dr Neil Port and Dr
munity population norms by more than one standard devia- Howard Johnson, who undertook the baseline clinical inter-
tion, suggesting considerable residual psychological distress views. We also appreciated the input from external honorary
or dysfunction. consultants Dr Marsha Linehan and Dr Kelly Koerner, Uni-
These improvements in disability and quality of life have versity of Washington, USA; and several episodes of supple-
only rarely been demonstrated or evaluated in RCTs involv- mentary training of DBT therapists by Dr Kate Comtois and
ing subjects with BPD, again making comparison with the Dr Kelly Koerner, University of Washington, USA. Finally,
present study difficult. One study of drug-dependent women without the support and clinical leadership of Dr Howard
with BPD showed overall improvement but no differences Johnson, Director of the Centre for Psychotherapy, this study
in social or global adjustment during treatment or at 12 month would not have been possible.
follow up, with a significantly lower score in the DBT group
at 16 month follow up [19]. A later study of opioid-depen- Declaration of interest: The authors report no con-
dent women showed overall improvement but no benefit in flicts of interest. The authors alone are responsible for
social or global adjustment at any time point [20]. the content and writing of the paper.

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G.L. CARTER, C.H. WILLCOX, T.J. LEWIN, A.M. CONRAD, N. BENDIT 173

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