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

Giesen‐Bloo 2006.

Study characteristics
Methods design: randomised controlled trial
Participants sex: 80/86 females (93.0%)
age: 30.6 years on average
location: The Netherlands
setting: outpatient
exclusions: BPD not main diagnosis, psychotic disorders (except short, reactive psychotic episodes), bipolar disorder, dissociative identity disorder, antisocial personality disorder, attention‐deficit/hyperactivity disorder, addiction of such severity that clinical detoxification was indicated (after which entering treatment was possible), psychiatric disorders secondary to medical conditions, mental retardation, no Dutch literacy
level of functioning/severity of illness: mean number of SCID II BPD criteria met at baseline: group 1: 6.70, SD = 0.16; group 2: 7.12, SD = 0.19
BPD diagnosis according to: DSM‐IV
means of assessment: SCID, BPDSI‐IV
Interventions group 1 (EG): Schema‐Focused Therapy (SFT), 50‐minute sessions twice a week
group 2 (CG): Transference‐Focused Psychotherapy (TFP), 50‐minute sessions twice a week
duration: up to three years, depending on treatment success
concomitant psychotherapy: no additional psychotherapeutic treatment allowed
concomitant pharmacotherapy: Prescribing according to good clinical practice, similar to American Psychiatric Association guidelines, by psychiatrists from different orientations (2 SFT therapists, 3 TFP therapists). At baseline, 74.0% of patients used psychotropic medication
Outcomes outcomes considered in this review
self‐rated: none
observer‐rated: Borderline severity (BPDSI‐IV‐total), general psychopathology (SCL‐90‐R‐dutch version)
time‐points used here: 36 months (post‐treatment)
Notes analyses: ITT, LOCF
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Randomization to SFT or TFP was stratified across 4 community mental health centers and was performed [...] after the adaptive biased urn procedure" (Giesen‐Bloo 2006, p. 650)
Allocation concealment (selection bias) Low risk "Randomization to SFT or TFP [...] was performed by a study independent person [...] We used this procedure (1) to keep allocation at each site unpredictable until the last patient to avoid unintentionally affecting ongoing screening procedures [...]." (Giesen‐Bloo 2006, p. 650)
173 patients were screened for eligibility. 85 of them were excluded, reasons are given (40 declined participation, 24 did not meet inclusion criteria, 19 met exclusion criteria, 2 had insufficient availability).
88 randomised, of 45 allocated to SFT, 44 were included in analyses (1 patient excluded owing to unreliable assessments due to increased patient blindness), of 43 allocated to TFP, 42 were included in analyses (1 patient excluded because untraceable after randomisation; never met or spoke to therapist)
Blinding of outcome assessment (detection bias)
All outcomes Low risk "assessments were made [...] by independent research assistants [...] Study researchers, screeners, research assistant, and SFT/TFP therapists were masked to treatment allocation during the screening procedure and the first assessment" (Giesen‐Bloo 2006, p. 650) "most research assistants learned their patients' treatment allocation as the study progressed, as patients talked about their treatment and therapists. However, the results of secondary computer‐assessed self‐report measures [...] concurred with the observer‐rated (interview) findings, making it unlikely that results can be contributed to knowledge of treatment allocation." (Giesen‐Bloo 2006, p. 657)
Selective reporting (reporting bias) Unclear risk No indication for selective reporting, but Insufficient information to permit judgement of 'Yes' or 'No'.
Treatment adherence? Low risk "Weekly local supervision [...], a 1‐day central supervision every 4 months, and a 2‐day central supervision every 9 months. [...] Treatment integrity was monitored by means of supervision. All the raters were independent of the study and masked to treatment outcome. One psychologist, masked to allocation, listened to 1 randomly selected tape of each patient, then stated the treatment administered [...] Other trained therapists for each orientation assessed the TFP Rating of Adherence and Competence Scale or the SFT Therapy Adherence and Competence Scale for BPD." (Giesen‐Bloo 2006, p. 650‐651)
Allegiance effect improbable? Low risk Experts from both therapies supervised therapists.
Attention bias: equal amounts of attention to all groups (obligatory treatment components)? Low risk Equal amounts of attention spent to both groups.