Gregory 2008.
Study characteristics | ||
Methods | design: randomised controlled trial | |
Participants |
sex: 24/30 females (80%) age: 28.7 years on average (SD = 7.7) location: USA setting: outpatient exclusions: schizophrenia, schizoaffective disorder, mental retardation, neurological condition that may produce secondary psychiatric symptoms (e.g., stroke, multiple sclerosis, partial complex seizures, or traumatic brain injury) level of functioning/severity of illness: "Only 10 participants (33%) were engaged in part‐time or full‐time employment (Hollingshead categories 1‐7)" (Gregory 2008, p. 30) BPD diagnosis according to: DSM‐IV; in addition, a comorbid diagnosis of active alcohol abuse or dependence (not in full sustained remission) was required for inclusion means of assessment: SCID |
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Interventions |
group 1 (EG): Dynamic deconstructive psychotherapy (DDP; weekly individual sessions over 12 to 18 months; DDP participants were also encouraged to participate in some form of group therapy, usually with interpersonal focus or 12‐step; about one quarter did attend a professionally led group therapy for the first 6 months but none by 12 months) group 2 (CG):Treatment as usual (TAU; if not already in treatment, participants were referred to an alcohol rehabilitation centre and were also given names of psychiatric clinics and therapists in the community; they were also allowed to keep their current psychotherapist, if any) duration: post assessments were done after 12 months; DDP treatment could continue up to 18 months, however concomitant psychotherapy: If not already in treatment, CG patients were referred to an alcohol rehabilitation centre and given names of clinics an therapists in the community. If they had one, TAU participants were allowed to keep their current psychotherapist. EG participants were required to end treatment with their present psychotherapist, unless that person served primarily as a case manager or substance use counsellor; 70.0% of participants received individual psychotherapy or alcohol counselling; 30.0% received an additional professional group therapy, 36.7% participated in self‐help groups concomitant pharmacotherapy: 63.3% of all participants received separate medication management, the mean number of psychotropic medications was 2.9; medication management was provided by the DDP therapist for the EG group patients according to the American Psychiatric Association guidelines for BPD, medications specifically targeting substance use disorders were not prescribed |
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Outcomes |
outcomes considered in this review self‐rated: BPD severity (BEST), dissociation/stress‐related paranoia (DES), depression (DASS‐depression), anxiety (DASS‐anxiety) observer‐rated: self‐harming behaviour (number of patients with parasuicide during previous 3‐month period) time‐points used here: 12 months (post‐treatment) |
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Notes | analyses: per protocol (EG: 10/15 allocated; CG: 9/15 allocated) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "A minimization method was employed for group assignment [...] ensuring comparability of the two groups on key variables or factors [...] The specific factors that we adjusted for included: age, gender, alcohol abuse versus dependence, current alcohol use, antisocial personality disorder, inpatient utilization, and number of parasuicides." (Gregory 2008, p. 31‐32) |
Allocation concealment (selection bias) | Low risk | "participants were assigned by the research coordinator to either the investigation treatment or to treatment as usual (TAU) in the community" (Gregory 2008, p. 31) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "An independent, trained research assistant administered the primary and secondary outcome measures [...] blind to treatment group at the time of interviews, but blindedness was only partial, as she was able to correctly guess group assignment 67% of the time (50% correct guesses were expected by chance alone)." (Gregory 2008, p. 35) |
Selective reporting (reporting bias) | Low risk | Study protocol available (NCT00145678). No indications for selective reporting. |
Treatment adherence? | Low risk | "Six therapists provided DDP, including the principal investigator [who is one of the two developers of DDP] (PI; N = 6 study participants) and five psychiatry residents (N = 9 participants) who were in their third year of residency training [...] After achieving competency, adherence to technique and treatment integrity for resident therapists was assured through weekly group supervision [...] and individual supervision of videotaped sessions with the PI [principal investigator, developer of DDP] every other week throughout treatment." (Gregory 2008, p. 34) |
Allegiance effect improbable? | High risk | Both developers of the experimental treatment are among study authors. |
Attention bias: equal amounts of attention to all groups (obligatory treatment components)? | Low risk | Though participants of the control group did not receive an alternate, obligatory control treatment, but were free to join alternative treatments, they did not receive less professional attention. Indeed, "[...] DDP participants received fewer overall treatment contact hours than did participants receiving community care." (Gregory 2008, p. 39). Also cf. Gregory 2008, Tab. 2, p. 33 |