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

Kramer 2011.

Study characteristics
Methods 10‐week trial with 2 arms
  1. Motive‐oriented therapeutic relationship + treatment as usual (MOTR + TAU)

  2. Treatment‐as‐usual (TAU)


Duration of trial: 10 weeks
Country: Switzerland
Setting: outpatient clinic
Participants Method of recruitment of participants: not stated
Sample size: 25
Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV)
Means of assessment: Structured Clinical Interview for DSM‐IV Axis II Disorders (SCID‐II)
Mean age: MOTR + TAU = 30.29 years (standard deviation = 12.43), TAU = 31.27 years (standard deviation = 8.21)
Sex: 77% female
Comorbidity: panic disorder, agoraphobia, alcohol abuse, major depression, bulimia, anorexia, somatoform disorder
Inclusion criteria
  1. Main diagnosis of borderline personality disorder

  2. Between 18 and 60 years old

  3. Able to speak French


Exclusion criteria
  1. An organic disorder

  2. A persistent substance abuse/dependence that might affect brain function (memory, level of consciousness, cognitive abilities)

  3. A psychotic disorder implying pronounced break in reality testing (chronic or intermittent), such as schizophrenia, delusional disorder, bipolar affective disorder I

  4. An acute risk of suicide

  5. Severe cognitive impairment

Interventions Experimental groupTreatment name: MOTR + TAU
Number randomised to group: 11
Duration: 10 weeks
Concomitant psychotherapy: not stated
Concomitant pharmacotherapy: not stated
Control/comparison groupComparison name: TAU
Number randomised to group: 14
Duration: 10 weeks
Concomitant psychotherapy: not stated
Concomitant pharmacotherapy: If necessary, short‐term inpatient treatment was organised, as was adjunct pharmacotherapy
Proportions of participants taking standing psychotropic medication during trial observation period: unclear
Outcomes Primary
  1. Psychosocial functioning, assessed by social role subscale of the Outcome Questionnaire ‐ 45.2 (OQ‐45)


Secondary
  1. Interpersonal problems, assessed by the interpersonal problem subscale of OQ‐45

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

Notes Sample size calculation: not stated
Ethics approval: The study was approved by the Ethics Committee of the Psychiatric Department involved. All patients gave written consent for the data to be used for research purposes.
Comments from review authors: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: randomisation was performed by blocks of 10 participants, using a computer‐based program
Allocation concealment (selection bias) Low risk Comment: The preparation of sealed envelopes containing information on the condition for each participant was done by an independent researcher.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Comment: raters were unaware of the treatment condition.
Incomplete outcome data (attrition bias)
All outcomes High risk Comment: in case of missing values, LOCF used. The process analyses were carried out on a restricted sample of 20 patients (TAU = 10; MOTR +TAU = 10), due to missing values (related to early terminations) of 5 individuals having completed too few sessions to be taken into account.
Selective reporting (reporting bias) High risk Comment: Borderline Symptoms List reported in the protocol did not appear in the publication.
Other bias High risk Allegiance bias
Comment: Casper involved in the development of analysis plan
Attention bias
Comment: To counterbalance the increased time investment in condition 2, the therapists in condition 1 filled in a summary form on the patient’s symptoms and problems.