Jochems 2015.
Study characteristics | ||
Methods | 12‐month trial with 2 arms
Duration of trial: 12 months Country: The Netherlands Setting: Outpatient |
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Participants |
Method of recruitment of participants: “Subsequently, clinicians were asked to provide their caseload to the PI, who randomly selected ten eligible patients for participation (or if fewer than ten eligible patients were available, all the eligible patients were selected). Clinicians explained to the selected patients the contents and procedure of the study and asked for participation. To enhance the likelihood of participation, patients were given an incentive of €15 for participating.“ (quote, p 3053)
Sample size: subsample = 42
Diagnosis of borderline personality disorder: Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM‐IV)
Means of assessment: “As diagnosed by the psychiatrist of the team using the Diagnostic and Statistical Manual of Mental Disorders‐Text Revision [fourth edition] criteria and obtained from the medical record” (quote, p 3050‐51)
Mean age: no data on subsample. Full sample: motivation feedback = 45.47 years (standard deviation = 10,4), TAU = 42.5 years (standard deviation = 10)
Sex: not stated
Comorbidity: no data on subsample; “Our sample largely represents a broad population of outpatients with diagnoses of psychotic and personality disorders with a variety of comorbid psychiatric disorders”. (quote, p 3061)
Inclusion criteria
Exclusion criteria
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Interventions |
Experimental group
Treatment name: motivation feedback
Number randomised to group: subsample = 16
Duration: 12 months
Control/comparison group Comparison name: treatment‐as‐usual Number randomised to group: subsample = 26 Duration: 12 months Both groups Concomitant psychotherapy: outpatient care Concomitant pharmacotherapy: no data on subsample Proportions of participants taking standing psychotropic medication during trial observation period: unclear |
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Outcomes |
Primary
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Notes |
Sample size calculation: yes
Ethics approval: “This study was approved by the Medical Ethical Committee for Mental Health Care Institutions (MotivaTe‐IT; trial number NTR2968, Netherlands Trial Register, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2968) as well as by the scientific committees of the Western North Brabant Mental Health Center and Breburg Mental Health Center, the specialty mental health institutions where the data were collected.” (quote, p 3050)
Comments from review authors:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a computer‐generated list of random numbers was used to randomly assign each team to a treatment condition, such that all clinicians and patients in the same team were randomized to a similar treatment". (p. 3053). "The randomization sequence was created using software from www.randomization.org with a 1:1 allocation ratio using random block sizes of 1, 2, and 3". (p. 3053) |
Allocation concealment (selection bias) | Low risk | Quote: "the random allocation sequence was performed by authors ECJ and HJD prior to approaching treatment teams, such that treatment teams and their members were still unknown and were numbered blindly before entering team numbers into the computer program". (p. 3053) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: “At baseline, patients were unaware (blind) as to which treatment condition they had been randomized to. Clinicians had to be made aware of treatment condition as those randomized to MF needed to receive the necessary training prior to baseline assessments such that MF could start immediately thereafter. This blinding procedure is common in psychiatric intervention research. At the 12‐month assessment, clinicians and patients were not blind to treatment condition while filling in questionnaires, whereas independent research assistants who looked up information from the medical record and performed interviews with patients were blind to treatment allocation.” (p.3053) |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: skewed dropout population of non‐ethnic Dutch participants in full sample. Only observer data used. Unclear handling of data on subsample data |
Selective reporting (reporting bias) | Low risk | Comment: a protocol was available and the details matched those presented in the report. |
Other bias | Unclear risk |
Adherence bias: Adherence to treatment: Patients and clinicians in the MF intervention group were asked to fill in a Short Motivation Feedback List (SMFL) every month up to 12 months after baseline assessment. (p. 3051). Clinicians were free to decide for themselves how they would structure this conversation with the patient, such as discussing only one item or several, or discussing differences between patient’s and clinician’s vision, and they were free to decide how long this would take. The duration and frequency of SMFL assessments were monitored by the research team. (p. 3051) During the course of the study, clinicians were regularly contacted by the PI to monitor the MF intervention and to discuss progress and experiences together with other colleagues who also participated in the MF intervention. These evaluation sessions took place four times over the course of the study. (p.3051) We did not seek for uniformity in TAU as such diversity reflects reality. (p.3051); although we performed evaluation sessions with clinicians about MF alongside the trial, we have limited insight into what happened during MF sessions as these were neither recorded nor supervised. (p 3061). Attention bias: There was no control on the amount of treatment received in the TAU group, but that was intended from the authors to test the real life setting of psychotherapy. Allegiance bias: no evidence of allegiance bias found |