Andreoli 2016.
Study characteristics | ||
Methods | 3‐month duration trial with 3 arms
Duration of trial: 3 months Country: Switzerland Setting: community and hospital |
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Participants |
Method of recruitment of participants: consecutive patients entering the emergency room of the Geneva (Switzerland) Cantonal University Hospital were screened for deliberate self‐harm by specialised emergency room nurses. Overall sample size: 107 Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, (DSM‐IV) Means of assessment: International Personality Disorder Examination (IPDE; Loranger 1995) Mean age: 31.9 years (standard deviation = 10.1) Sex: 84.1% female Comorbidity: major depressive disorder (MDD), substance abuse (10.6%), alcohol dependence (4.1%), alcohol abuse (21.8%) Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group 1
Treatment name: abandonment psychotherapy (AP‐P)
Number randomised to group: 70
Duration: 3 months Experimental group 2 Treatment name: abandonment psychotherapy delivered by nurses (AP‐N) Number randomised to group: 70 Duration: 3 months Both experimental groups Concomitant psychotherapy: When therapists were not available, participants could call the 24‐hour emergency room hotline and receive emergency care from the psychiatric staff of the general hospital. Concomitant pharmacotherapy: Abandonment psychotherapy was applied in combination with an antidepressant medication protocol. Antidepressant medication was prescribed in a standard clinical management format by a psychiatrist who was blind to treatment choice. Most patients (n = 125, 89.3%) were prescribed venlafaxine, with an initial 0.5 mg/kg dosage and an optimal 2 to 3 mg/kg dosage. Repeated drug plasma level monitoring was performed at 2 weeks, 1 month, and 2 months to control for compliance. Venlafaxine was chosen because locally it was the medication most frequently prescribed among these patients. Additional mild neuroleptic medication (quetiapine 25 to 75 mg/day) was occasionally prescribed for brief periods, mostly limited to the first weeks of treatment. Not specified which exact proportions of participants received medication in each group Control/comparison group Comparison name: intensive community treatment‐as‐usual Number randomised to group: 30 Duration: 3 months Concomitant psychotherapy: Treatment‐as‐usual included as many nurse visits as required for two weeks and biweekly thereafter, weekly clinical review and medication adjustment from a psychiatrist, group therapy, social worker support, and as much day care, night hospitalisation and family intervention as needed to deal with suicidal relapse, emergency response. Concomitant pharmacotherapy: weekly clinical review and medication adjustment Proportions of participants taking standing medication during trial observation period: "The rate of subjects who were prescribed an antidepressant medication was lower in the TAU group compared to the AP groups (AP‐P: 68, 97.1%; AP‐N: 68, 97.1%, TAU: 23, 76.7%; Fisher’s exact test: p < .003), but the mean number of days spent in antidepressant treatment (AP‐P: 89.6, SD 32.9; AP‐N: 81.8, SD 36.7; TAU: 70.7, SD 55.9) and the number of participants who completed antidepressant treatment (AP‐P: 47, 67.1%; AP‐N: 48, 68.6%; TAU: 17, 56.7%) did not differ in the treatment cells. Among patients assigned to AP, the number of days spent in antidepressant medication and venlafaxine plasma levels did not differ as a function of type of therapist delivering AP" (Andreoli 2016, p. 280). “The analyses were repeated using […] presence of antidepressant medication, number of days spent in antidepressant medication, […] as covariates […]: the results were not materially altered.” (Andreoli 2016, p. 283) "...when we statistically controlled for the presence of additional antidepressant medication, the observed between‐group differences held.” (Andreoli 2016, p.285) |
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Outcomes |
Primary
Secondary
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Notes |
Sample size calculation: yes Ethics approval: yes Comments from review authors: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: Eligible participants were randomly allocated to treatment by a researcher not involved in the treatment procedures. This was done using a pre‐generated block randomisation scheme developed and held by a statistician, who prepared two series of sealed envelopes. |
Allocation concealment (selection bias) | Low risk | Comment: Treatment allocation was masked to clinicians through sealed envelopes in charge of the treatments. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: Subjects were assessed at intake and at 3‐month follow‐up by well‐ trained psychologists with clinical experience who were blind to treatment assignment. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: Intention‐to‐treat analysis was used and there were relatively low numbers of dropouts. However, the attrition rate was higher in TAU (16.7% who did not come to treatment and 20% who terminated their treatment early) compared to intervention (AP‐P: 5.7% and AP‐N: 2.9% who did not come to treatment and AP‐P: 5.7% and AP‐N: 2.9% who terminated their treatment early). Thus, attrition rates were not balanced between intervention groups and control group. |
Selective reporting (reporting bias) | High risk | Comment: The authors provided no data on the Hamilton Depression Rating Scale 17 items (HDRS‐17: Hamilton, 1960), even though it was stated as an outcome. |
Other bias | High risk |
Treatment adherence: No data were provided on the Hamilton Depression Rating Scale 17 items (HDRS‐17: Hamilton, 1960), even though it was stated as an outcome. Allegience bias: It was unclear who developed the manual for abandonment psychotherapy. It was however mentioned that the developers of the manual were involved in supervision p. 275. Attention bias: TAU patients seem to have received more attention given the inpatient treatment. With regards to medication, the intervention groups had received more antidepressants. Vested interest: Unclear who developed manual for abandonment psychotherapy, but there were no clear indications of vested interest. |