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. 2012 Aug 15;2012(8):CD005652. doi: 10.1002/14651858.CD005652.pub2

Steil 2010.

Study characteristics
Methods design: randomised controlled trial
Originally, female participants with a diagnosis of PTSD and at least 4 criteria of DSM‐IV‐BPD were eligible. We refer to the subsample data of those participants fulfilling 5 or more criteria.
Participants sex: 31/31 females (100%)
age: mean age 32.9 years; range 19‐52 years
location: Germany
setting: inpatient
exclusions: lifetime diagnosis of schizophrenic disorder, severe other mental disorder requiring immediate treatment in a different setting (e.g., eating disorder or acute delirium after withdrawal), suicide attempt with clear suicidal intention during last 4 months, severe self‐injuring behaviour during last 4 months
level of functioning/severity of illness: mean number of BPD criteria 5.85
all participants suffered from concurrent PTSD according to DSM‐IV after childhood sexual abuse
BPD diagnosis according to: DSM‐IV
means of assessment: IPDE
Interventions group 1 (EG): DBT for patients with PTSD after childhood sexual abuse (DBT‐PTSD); including: modified DBT skills training group (1 session of 90 minutes duration per week, modules: mindfulness, interpersonal skills, emotion regulation, stress tolerance; but less attention on interpersonal and detention skills as in standard DBT skills group); individual cognitive trauma therapy, exposure and discrimination training (2 sessions of 45 minutes duration per week); psychoeducation group concerning PTSD aetiology and treatment; additional group training in mindfulness‐ and acceptance‐based techniques (three sessions of 20 minutes duration per week); participation in music, arts and exercise therapy
DBT skills training (DBT‐ST), including DBT original skills for interpersonal effectiveness, emotional regulation, mindfulness and distress tolerance; 13 psychotherapy sessions of 120 min each, conducted by 2 therapists (a male and a female) for each group, in groups of 9‐11 participants.
group 2 (CG): waiting list (WL): continuation of already ongoing treatments for 6 months, inpatient DBT‐PTSD treatment afterwards; points of measurement: baseline, 3 months, 4.5 months and 6 months after study inclusion
duration: 3 months of inpatient treatment (i.e. 13 weekly sessions in each condition) + one booster session 6 weeks after dismissal
concomitant psychotherapy: participants of the experimental group did not receive any other individual or group psychotherapy, participants of the waiting list condition continued their usual treatments if any
concomitant pharmacotherapy: depressive episodes were treated with SSRI antidepressive agents (100‐150 mg/d of sertraline, e.g.); difficulties of sleeping were treated with sleep‐inducing antidepressants (50‐100mg/d of trimipramine, e.g.); no benzodiazepines, no neuroleptics
Outcomes outcomes considered in this review
self‐rated: BPD severity (BSL), dissociation (DES), depression (BDI‐II), anxiety (STAI‐state), general psychopathology (SCL‐90‐R‐GSI
observer‐rated:
time‐points used here: 4.5 months, i.e. post residential treatment and one 6‐week follow‐up session
Notes analyses: ITT
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "randomisation was carried out using the procedure proposed by Efron" (Steil 2010).
Allocation concealment (selection bias) Low risk "Care was taken that the randomization was concealed to both the patient and to all persons involved in the study until the written informed consent has been given by the patient." (Steil 2010).
Blinding of outcome assessment (detection bias)
All outcomes Low risk "Interviewers were blinded. [...] the diagnostician who was assessing the patient at follow‐up was masked to the assignment." (Steil 2010).
Selective reporting (reporting bias) Low risk Study protocol available (DBT working group at CIMH), no indication for selective reporting.
Treatment adherence? Low risk Therapists were supervised weekly by the treatment developer.
Allegiance effect improbable? High risk First author developed the treatment approach investigated here.
Attention bias: equal amounts of attention to all groups (obligatory treatment components)? High risk More attention paid to EG.