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. 2020 May 4;2020(5):CD012955. doi: 10.1002/14651858.CD012955.pub2

Andreoli 2016.

Study characteristics
Methods 3‐month duration trial with 3 arms
  1. Abandonment psychotherapy (AP‐P)

  2. Abandonment psychotherapy delivered by nurses (AP‐N)

  3. Intensive community treatment‐as‐usual (TAU, control)


Duration of trial: 3 months
Country: Switzerland
Setting: community and hospital
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
  1. 18‐60 years old

  2. Met Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, (DSM‐IV) criteria for major depressive disorder (MDD) and borderline personality disorder


Exclusion criteria
  1. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, (DSM‐IV) psychotic disorder, bipolar I disorder, severe substance dependence, mental retardation

  2. Inability to speak French

  3. Any medical condition precluding antidepressant medication or likely to significantly influence psychiatric outcome

Interventions Experimental group 1Treatment name: abandonment psychotherapy (AP‐P)
Number randomised to group: 70
Duration: 3 months
Experimental group 2Treatment 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 groupComparison 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)
Outcomes Primary
  1. Suicide‐related outcomes, defined as number of suicidal ideations

  2. Mental health status, assessed by the Global Assessment Scale


Secondary
  1. Depression, assessed by the Hamilton Depression Rating Scale ‐ 17 items

  2. Attrition, in terms of patients lost after randomisation in each group

  3. Adverse effects

Notes Sample size calculation: yes
Ethics approval: yes
Comments from review authors: none
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.