[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Abandonment psychotherapy nurses
Abandonment psychotherapy therapist
Control
Included criteria: Age 18-60 years, met DSM-IV criteria for MDD and BPD
Excluded criteria: Having DSM-IV psychotic disorder, bipolar I disorder, severe substance dependence, mental retardation and inability to speak french, medical condition precluding antidepressant medication or likely to significantly influence psychiatric outcome
Intervention Characteristics
Intervention 1
Intervention 2
Control
Social functioning
Borderline severity
Hospital admission
Suicide attempts repetition
Completed suicide
Country: Switzerland
Comments: Protocol no. 03-088/03-011
Authors name: Andreoli
Institution: Psychiatry department, University Geneva
Email: antonio.andreoli@bluewin.ch
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: Fifty-two patients with BPD (46% of the total samplein UPP) were included in the present study.
Excluded criteria: The presence of schizotypal or antisocial PD was the exclusion criterion in UPP, based on the clinical experience that patients with these PDs do not benefit from the kind of group therapy applied in the CP. Other exclusion criteria were on going alcohol or drug dependence, psychotic disorders,bipolar I disorder, untreated attention deficit hyper-activity disorder (adult type), pervasive developmental disorder (e.g. Asperger’s syndrome), organic syndromes, and being homeless
Pretreatment: After randomization, patients in the two treatment conditions did not differ significantly in socio-demographic variables
Intervention Characteristics
Intervention 1
Control
Social functioning
Quality of life
Borderline severity
Interpersonal
Drop-out
Hospital admission
Completed suicide
Sponsorship source: This research was funded by the South-EasternNorway Regional Health Authority, Oslo UniversityHospital, Ullevål, and“Extra Stiftelsen, Helse ogRehabilitering”. The funding sources had no role inthe study design; the collection, analyses, andinterpretation of data; the writing of the report; orthe decision to submit the paper for publication
Country: Norway
Authors name: Bjørnar T. Antonsen,
Institution: Department of Personality Psychiatry, Oslo University
Email: bjornar.antonsen@medisin.uio.no
design: randomised controlled trial
sex: 22/38 females (57.9%)
age: eligible: 31.8 years on average
location: UK
setting: partially hospitalised/outpatient
exclusions: schizophrenia, bipolar disorder, substance misuse, mental impairment, evidence of organic brain disorder
level of functioning/severity of illness: "individuals with severe borderline personality disorder who frequently harmed themselves and attempted suicide, while exhibiting severe levels of depression, suffering from high levels of symptomatic distress, and demonstrating comorbidity for affective disorders" (Bateman 1999, p. 1568)
DIB scores at baseline: group 1 mean score = 7.9, SD = 0.4; group 2 mean score = 7.6, SD = 0.5
BPD diagnosis according to: DSM-III-R (both sets of criteria of SCID and DIB had to be met)
means of assessment: both SCID and DIB-R
group 1 (EG): mentalisation-based treatment (MBT) oriented partially hospitalisation 5 days a week: once-weekly individual psychotherapy, thrice-weekly group analytic psychotherapy, once-weekly expressive therapy (psychodrama techniques oriented), once-weekly community meeting; monthly meeting with case administrator and medication review by resident psychiatrist
group 2 (CG): standard treatment in the general psychiatric services: regular psychiatric review with psychiatrist when necessary (twice-monthly on average); inpatient admission as appropriate (90%, average stay 11.6 days) with discharge to non-psychoanalytic partial hospitalisation focusing on problem solving (72%, average stay 6 months) and standard aftercare (100%, outpatient and community follow-up by every-2-week visits by a community psychiatric nurse); no formal psychotherapy
duration: up to 18 months (average length of stay in EG: 17.4 months
concomitant psychotherapy: none
concomitant pharmacotherapy: antidepressant and antipsychotic drugs prescribed as appropriate, polypharmacy was discouraged
outcomes considered in this review
self-rated: interpersonal problems (IIP), depression (BDI), anxiety (STAI), general psychopathology (SCL-90-R-GSI)
observer-rated: number of patients with self-harming behaviour during last 6-month period, number of patients with suicide attempt during last 6-month period (both assessed via the Suicide and Self-Harm Inventory, a semi-structured interview)
time-points used here: 18 months (post-treatment)
analyses: per protocol (22 randomised to each group, only 19 per group analysed since treated per protocol)
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: The inclusion criteria for both studies were: age 18 or older; severe mental illness diagnosis (i.e., DSM-IV major depression, bipolar disorder, schizoaffective disorder, or schizophrenia and meeting of NH, VT, or NJ state criteria for severe mental illness); and current DSM-IV diagnosis of PTSD. In addition, Study 2 required that participants meet criteria for severe PTSD (i.e., Clinician Administered PTSD Scale score ≥65; Weathers et al., 1999).
Excluded criteria: The exclusion criteria for both studies were: psychiatric hospitalization or suicide attempt in the past 3 months, and current substance dependence. In both studies, participants were not excluded based on self-injurious or parasuicidal behavior, suicidal ideation, or suicidal intent.
Pretreatment: No demographic, clinical, or functional differences were found between the groups at baseline.
Intervention Characteristics
Intervention 1
Control
Quality of life
Borderline severity
Sponsorship source: This work was supported by the National Institutes of Health [R01MH064662, F31MH103969, F31MH100773] and the Center for Substance Abuse Prevention.
Country: USA
Authors name: Alexandra Kredlow
Institution: Department of Psychological and Brain Sciences
Email: mueser@bu.edu
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Participants were 95 patients with a BPD diagnosis as assessedwith the Structured Clinical Interview for DSM-IV Axis IIPersonality Disorders (SCID-II) (Weertman et al. 2000) and atotal score on the BPDSI (Arntz et al. 2003) of at least 20, reflectingsevere BPD
Excluded criteria: Exclusion criteria were the presence of schizophreniaor bipolar disorder, as determined by the StructuredClinical Interview for DSM-IV Axis I Personality Disorders(SCID-I) (Van Groenestijn et al. 1999), substance abuse requiringspecialist treatment, organic brain disorder, IQ below 80, andinadequate mastery of the Dutch language.
Pretreatment: The treatment groups did not significantly differ from each other on any of the baseline variables
Intervention Characteristics
Intervention 1
Control
Quality of life
Borderline severity
Interpersonal
Drop-out
Sponsorship source: This study is in part funded by ZonMW, the Netherlands Organization for Health Researchand Development (grant no. 171002402).
Country: The Netherlands
Authors name: Elisabeth M. P. Laurenssen
Institution: Dutch Knowledge Centre for Child and Adolescent Psychiatry, Utrecht, The Netherlands;
Email: a.laurenssen@ kenniscentrum-kjp.nl
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: Inclusioncriteria for the study were that patients fulfilled the SCID IIcriteria for BPD, were over 20 years of age, and sufferedfrom severe symptoms of BPD. Severe symptoms includedparasuicidal behaviour (such as cutting, other forms of selfharm,impulsive overdosing of medicines), attempted suicide,considerable emotional instability affecting social andprofessional life, and previous unsuccessful treatments(one or more), where the patient withdrew from treatmentor was still suffering from severe symptoms despite treatment
Excluded criteria: Exclusion criteria were: schizophrenia spectrumdiseases/psychoses, bipolar disorder (type I), neuropsychiatricdisorder and severe substance abuse problem(which clearly impaired commitment to treatment). Axis Idisorders were diagnosed according to SCID-I (First et al.1997), and the presence of neuropsychiatric disorder andsubstance abuse was assessed by a clinician
Intervention Characteristics
Intervention 1
Control
Quality of life
Borderline severity
Drop-out
Selfharm, parasuicidal, suicide plan and attempts
Country: Finland
Authors name: Leppanen
Institution: Social and Health Services, Mental Health Services,
Email: virpi.leppanen@ouka.f
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention 1
Control
Included criteria: diagnosis of DSM-IV Borderline Personality Disorder18-60 years of agehave had two suicidal or non-suicidal self-injurious behaviours in the past five years with one occurring in the past ten weeksbe literate in Englishprovide informed consent to participate in the study
Excluded criteria: not meet DSM-IV criteria for a psychotic disorder, bipolar disorder or, dementianot have evidence of an organic brain syndrome or mental retardation based on clinical interviewnot participated in DBT treatment during the past year
Intervention Characteristics
Intervention 1
Control
Social functioning
Borderline severity
Proportion of patients with ED visits
Drop-out,
Proportion of patients hospitalized
Suicide
Country: Canada
Comments: The clinicaltrials.gov identifier for this study is NCT01193205
Authors name: McMain
Institution: Centre for Addiction and Mental Health, Toronto, ON
Email: shelley.mcmain@camh.ca
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Overall
Included criteria: Inclusion criteria were males and females aged 18–65 years, fulfilling diagnostic criteria for BPD and substance dependence in accordance with the Diagnostic and Statistical Manual of Men-tal Disorders, 4th Edition (DSM-IV) [35], and currently under-going treatment at a substance dependence treatment clinic.
Excluded criteria: Ex-clusion criteria were schizophrenia, schizoaffective disorder, bi-polar disorder type I, cognitive impairment (including mild cognitive impairment: IQ 85), autism spectrum disorders, psy-chopathy, participation in psychotherapy outside of the study (ongoing or terminated less than 90 days before inclusion) and not being able to communicate in the Swedish language without an interpreter
Intervention Characteristics
Intervention 1
Control
Social functioning
Borderline severity
Interpersonal
Drop-out
Selfharm
SAE
Hospitalsadmission
Suicide
Sponsorship source: This work was supported by the Swedish Research Council for Health, Working Life and Welfare (grant number 2007-0457); by ALF-funding from Stockholm County Council and Karolinska In-stitutet, Stockholm, Sweden (grant number 20080487); and by the Stockholm Centre for Dependency Disorders.
Country: Stockholm
Comments: This research project, MBT for Dual Diagnosis – A RCT was a registered clinical trial (ISRCTN 9898268
Authors name: Phillips
Institution: Department of Psychology
Email: bjorn.philips@psychology.su.se
Wrong comparator
Wrong study design
No data
No data
Review
Review
Review
Wrong patient population
Wrong study design
Wrong patient population
Wrong study design
Wrong comparator
Wrong study design
Wrong comparator
Wrong study design
Wrong study design
Wrong study design
No data
No data
Wrong comparator
No data
Wrong patient population
Wrong patient population
Wrong patient population
Wrong patient population
Wrong comparator
No data
Review
Wrong patient population
No data
No data
Wrong patient population
Wrong comparator
Wrong comparator
Wrong outcomes
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Judgement Comment: Patients were allocated to groups using pre-generated block randomization scheme
Quote: "Patients were randomly assigned to one of the two treatment conditions."
Judgement Comment: Insufficient information on sequence generation
Use of a minimisation method (Bateman 2010).
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Judgement Comment: Insufficient information on sequence generation
Judgement Comment: Randomization was done by an independent researcher, awayfrom the site, using a computer algorithm.
Judgement Comment: Randomization list was prepared using appropiate statistical methods by a person who had no contact with the patients.
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Judgement Comment: Randomization perfomred using standard random block design in block sizes of four
Quote: "The study was a randomized controlled trial with 2 parallel arms, in which efforts were made to keep external raters unaware of the patient’s treatment assignment. The randomization was conducted by the KTA using an urn procedure. The randomiza- tion was made in blocks and the researchers were not informed of the block size."
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Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Judgement Comment: Treatment allocation was masked to clinicians in charge. Allocation was prepared in sealed envelopes.
Judgement Comment: Insufficient information on allocation concealment
Central allocation at the university (Bateman 2010).
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Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: Insufficient information on allocation concealment
Judgement Comment: Insufficient information on allocation concealment
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Judgement Comment: The statistician prepared 42 envelopes each containing two allocations to each of the condition in random order.
Quote: "The study was a randomized controlled trial with 2 parallel arms, in which efforts were made to keep external raters unaware of the patient’s treatment assignment."
Quote: "KTA prepared sealed randomization envelopes with information about each patient’s treatment assignment."
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Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Judgement Comment: The psychiatrist was blinded to treatment choice. No description of participants being blindend.
Judgement Comment: Insufficient information on blinding
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Judgement Comment: Insufficient information on blinding of participants and personnel
Judgement Comment: Insufficient information blinding of participants and personnel
Judgement Comment: Insufficient information on blinding of participants and personnel
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Judgement Comment: Single blinded
Judgement Comment: Insufficient information blinding
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Detection bias due to knowledge of the allocated interventions by outcome assessors
Judgement Comment: Outcome assessors were blind to treatment assignment
Quote: "The raters were blind to the treatment condition."
Outcome assessors were blind (Bateman 2010).
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"Assessments were performed by an investigator who was blind to the treatment methods." (Bellino 2010, p. 76)
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Quote: "was used in Study 2. <b>In both studies, clinician-rated assessments were performed by Masters or Ph.D. level trained clinical interviewers who were blind to treatment condition.</b> Monthly calls were conducted with"
Judgement Comment: Research assistants were psychologists with an MSc degree, and were blind fortreatment condition
Judgement Comment: BPDSI-IV interviews were blinded and conducted bythree interviewers: two psychiatric nurses and a physician
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Judgement Comment: Assessors were blinded to treatment assignment
Judgement Comment: Insufficient information blinding
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Attrition bias due to amount, nature or handling of incomplete outcome data
Judgement Comment: Figure 1 presents the progression of participants over the study.ITT analysis was performed.No apparent sources of bias
Quote: "All results were analysed using an intention-to-treat approach based on treatment assignment."
Judgement Comment: No apparent sources of bias
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Quote: "one session. 2.5. Statistical analysis <b>Intent-to-treat analyses were conducted using mixed-effects linear regressions model continuous outcomes, and generalized linear models for dichotomous outcomes to evaluate the effect of CBT on the outcomes. Baseline</b> was included as a covariate"
Judgement Comment: It was not mentioned how many patients dropped out of the control group
Judgement Comment: Analyses were performed based on the ITT principles. No apparent sources of bias.
Judgement Comment: ITT approach was Applied using the last observation carried forward method for trend analyses. No apparent sources of bias.
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Judgement Comment: No. of drop-outs and no. of patients included in the analysis do not match
Quote: "In the intention-to-treat (ITT) analysis,"
Judgement Comment: No apparent sources of bias
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Reporting bias due to selective outcome reporting
Judgement Comment: Thte study protocol was registred with the Swiss agency for medication control (DR 4235, 2006) No apparent sources of bias
Judgement Comment: No reference to study protocol, but appears to be free from selective outcome reporting
No indication for selective reporting, but Insufficient information to permit judgement of 'Yes' or 'No'.
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Judgement Comment: No reference to study protocol, but appears to be free from selective outcome reporting
Judgement Comment: No reference to study protocol, but the study appear to be free from selective outcome reporting
Judgement Comment: No reference to study protocol, but the study appears to be free from selective outcome reporting
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Judgement Comment: Does not match study protocol, secondary outcomes missing
Quote: "This research project, MBT for Dual Diagnosis – A RCT was a registered clinical trial (ISRCTN 98982683) approved by the Stockholm Regional Ethical Review Board (Registration number: 2007/642-31/1). All"
Judgement Comment: Matches study protocol
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Bias due to problems not covered elsewhere in the table
Judgement Comment: No apparent sources of bias
Judgement Comment: No apparent sources of bias
Judgement Comment: The study appears to be free from other sources of bias
Judgement Comment: The study appears to be free from other sources of bias
Judgement Comment: The study appears to be free from other sources of bias.
Judgement Comment: The study appears to be free from other sources of bias
Judgement Comment: The study appears to be free from other sources of bias