Woody 1985.
Study characteristics | ||
Methods | Design: parallel randomised controlled trial | |
Participants |
Participants: methadone‐maintained male outpatients with AsPD and opioid dependencea Sex: all males Age: (for whole samplea) mean = 29 years (SD = 6) Unit of allocation: individual participant Number randomised: 50 with AsPD (breakdown by treatment group not availablea) Number completing: not availablea Setting: outpatient; single site; urban; USA (Philadelphia) Inclusion criteria: male; aged 18 to 55 years; meeting Food and Drug Administration requirements for methadone maintenance treatment; had been receiving methadone for at least 2 weeks but not more than 6 months during their current treatment episode; subgroup met DSM‐III criteria for AsPD (obtained via MPI and SADS) Exclusion criteria: psychosis; persistent or clinically significant organic brain syndrome; serious medical, legal or personal problems that would require movement from local area within 1 year Ethnicity: (for whole samplea) black (62%); white (38%) Baseline characteristics: (for whole samplea) lifetime major depressive disorder (35%); lifetime anxiety disorder, any (20%); lifetime alcoholism (19%); antisocial personality disorder (45%) |
|
Interventions | Three conditions: supportive‐expressive psychotherapy (SE) + standard maintenance (SM); cognitive behavioural therapy (CBT) + SM; or SM only
Details of conditions:
Duration of intervention: 24 weeks Duration of trial: 28 weeks Length of follow‐up: participants were not followed up after the end of treatment. |
|
Outcomes |
Primary outcomes
Secondary outcomes
Other outcomes
|
|
Notes |
aAlthough the study recruited a subgroup with antisocial personality disorder (50/110 had DSM‐III AsPD), investigators did not provide pre/post data nor effect sizes for AsPD participants in the control condition. They reported “(t)he DC group was not included in the present analysis as our major interest was in comparing response to psychotherapy among the various diagnostic subgroups” (p 1083, column 2). Thus, no data extractable on any AsPD subgroup Study funding: National Institute of Drug Abuse and the National Institute of Mental Health Declaration of interests: none |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "Patients were randomly assigned to three treatment conditions. . ." (p 1082, column 1). Comment: No further information given. Insufficient reporting to permit judgement of Yes or No. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared. |
Allocation concealment (selection bias) | Unclear risk | Comment: No information provided. Insufficient reporting to permit judgement of Yes or No. Clarification has been requested from the trial investigators, but no further information was available at the time this review was prepared. |
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 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 | Low risk |
Quote: "Addiction Severity Interviews were done by independent technicians who were not part of the treatment staff and were not aware of patients group assignments" (p 1082, column 2). Comment: Review authors judged that blinding of outcome assessors was adequate for this outcome and that it was unlikely that this blinding could have been broken. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: Unclear whether there were missing outcome data for the AsPD control condition and, if so, whether the numbers of and reasons for such missing data were balanced across intervention groups. Review authors unable to make a judgement unless data from AsPD control condition become available |
Selective reporting (reporting bias) | Low risk | Comment: Review authors judged that the published report included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | Comment: The study appeared to be free of other sources of bias. Review authors noted that, although participants were not paid for attending sessions, they could receive up to USD 55 for completing all the measures required over the course of the project. The case for this was argued in the paper. Review authors considered that this is unlikely to have introduced a source of bias. |