Asmand 2015.
Study characteristics | ||
Methods | Design: parallel randomised control trial | |
Participants |
Participants: adult prisoners with antisocial personality disorder Sex: all male Age: in the DBT group 37.5% were aged 20‐25 years; REBT group 50% were aged 20‐25 years; control group range 18‐40 years Unit of Allocation: individual Number randomised: 48 (DBT = 16, REBT = 16, control = 16) Setting: Ilam Prison, Irana Inclusion criteria: AsPD diagnosis; aged 18‐40 years; conviction length > 1 year Exclusion criteria: two episodes of non‐compliance Ethnicity: not stated Baseline characteristics:
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Interventions | Three conditions: dialectical behavioural therapy (DBT); rational emotive behavioural therapy (REBT); or control
Details of conditions:
Duration of intervention: 16 sessions over 20 daysc Duration of trial: 20 weeks Length of follow‐up: 20 days after initial therapy sessionc |
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Outcomes |
Primary outcomes
Secondary outcomes
Other outcomes
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Notes |
aThe review authors have concerns about possible ethical issues, given the particular setting and circumstances of the prisoners in this study. bThe authors provided a very poor description of the two interventions offered and their mode of delivery; the TAU control group may have received individual work but no details were provided. cThe intervention duration was unclearly reported, possibly 16 sessions of 1 hour, possibly over 20 days (1 day per week over a 20‐week period) Study funding: none Declaration of interests: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: Investigators reported use of random number table in the study protocol, however the randomisation process was not reported in the paper. Insufficient reporting to permit judgement of Yes or No |
Allocation concealment (selection bias) | Unclear risk | Comment: We found no indication of any specific measures taken to address allocation concealment. Insufficient reporting to permit judgement of Yes or No |
Blinding (performance bias and detection bias) of participants | Unclear risk | Comment: In a study such as this, full blinding is difficult to achieve because participants would be aware whether or not that they were participating in a psychological intervention and may also be aware of the nature of this intervention. The review authors judged that it would thus not be possible to fully blind participants in this type of study. We found no indication of any specific additional measures taken to reduce the risk of bias that might result from differential behaviours by participants. |
Blinding (performance bias and detection bias) of personnel | Unclear risk | Comment: In a study such as this, full blinding is difficult to achieve because personnel would be aware whether or not they were participating in a psychological intervention and may also be aware of the nature of this intervention. The review authors judged that it would thus not be possible to fully blind personnel in this type of study. |
Blinding (performance bias and detection bias) of outcome assessors | Unclear risk | Comment: The review authors found no evidence of any measures taken to address blinding of outcome assessors. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: Attrition from dropouts/other reasons was not reported in the paper, however there was reference to noncompliance and "...lack of cooperation of some samples and absent prison and more than two sessions..." (quote; p 2, column 2). |
Selective reporting (reporting bias) | High risk | Comment: The trial authors reported four primary outcomes in the study protocol; irrational belief ('irrational beliefs questionnaire'), anxiety ('beke Anxiety questionnaire' [sic]), depression ('Beck Depression questionnaire') and aggression ('agrretion questionnaire' [sic]). Outcomes for depression and aggression were not reported in the paper. |
Other bias | High risk | Comment: The review authors considered there was a high risk for language/comprehension bias as the quality of the translation into English was exceptionally poor. The review authors also had concerns regarding the recruitment and coercion of participants as all were incarcerated in prison and no ethics approvals were reported; "The specimens were randomly assigned to treatment groups of 16 persons consisted [sic] of DBT and REBT group and one control group." (quote; p 2, column 2) |