Doering 2010.
Study characteristics | ||
Methods | design: randomised controlled trial | |
Participants |
sex: 104/104 females (100%) age: 27.3 years on average location: Germany, Austria setting: outpatient exclusions: schizophrenia, bipolar I and Ii disorder with a major depressive, manic, or hypomanic episode during the previous six months, substance dependency (including alcohol) during the previous six months, subjects meeting three or more DSM‐IV criteria for antisocial personality disorder, organic pathology, mental retardation, insufficient command of the German language level of functioning/severity of illness: mean GAF score at baseline was 52.3, i.e. patients had moderate symptoms OR any moderate difficulty in social, occupational, or school functioning. BPD diagnosis according to: DSM‐IV means of assessment: SCID |
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Interventions |
group 1 (EG): Transference‐Focused Psychotherapy (TFP; i.e. twice weekly individual psychotherapy sessions) group 2 (CG): Treatment by Experienced Community Psychotherapist (TBE; i.e. treatment was delivered by therapists known as experienced and particularly interested in BPD patients by the local administrators; therapists were free to choose the frequency of sessions according to their method; therapists' main orientations were: psychoanalytic (19), behavioral (17), client‐centered (4), systematic (4), Gestalt (1), dynamic group (1), psychodynamic (1); psychotherapies continued if deemed necessary by the therapist and the patient and if paid by the insurance company duration: 12 months concomitant psychotherapy: psychotherapy other than the study treatment was not allowed in the EG concomitant pharmacotherapy: medication was not restricted but registered continuously |
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Outcomes |
outcomes considered in this review self‐rated: depression (BDI), anxiety (STAI‐trait), general psychopathology (BSI‐GSI) observer‐rated: BPD severity (mean number of DSM‐IV diagnostic criteria for BPD), suicidality (mean number of patients with suicidal act during previous 12 months), self‐harming behaviour (number of patients with self‐harming behaviour during previous 12‐month period) time‐points used here: 12 months (post treatment) |
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Notes | analyses: ITT, LOCF | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Use of random numbers, matching after inclusion of 35th patient according to severity of self‐harming behaviour during the last year and personality organisation (Doering 2010, personal communication. |
Allocation concealment (selection bias) | Low risk | "The results of the first assessments [screening for inclusion criteria] were sent to a researcher outside the two study centers who performed the randomization." (Doering 2010, p. 5) . "After randomization patients were referred to a therapist." (Doering 2010, p. 6) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Research assistants who conducted assessments before randomization and after one year of treatment were blinded for the therapy delivered." (Doering 2010, p. 7) |
Selective reporting (reporting bias) | Low risk | Study protocol available (NCT00714311). No indications for selective reporting. |
Treatment adherence? | Low risk | "Video recordings of all [EG] sessions were performed and used in the group supervision. [...] Every case was supervised at least every four to six weeks. [...] Experienced community psychotherapists [i.e., CG therapists] attended supervisions according to their usual routine." (Doering 2010, p. 10f.) "For the assessment of adherence and competence of the transference‐focused psychotherapists a German translation of a specific Rating of Adherence and Competence [...] was used. [...] The rating was performed by the supervisor after every video‐guided supervision of a therapy session." (Doering 2010, p. 11) |
Allegiance effect improbable? | Unclear risk | Some of the study authors are experienced TFP therapists, but none was personally involved in treatment development. |
Attention bias: equal amounts of attention to all groups (obligatory treatment components)? | Low risk | Less attention may have been paid to CG patients depending on the CTBE therapist's main orientation; however, every participant was provided the specifically full amount of necessary attention. |