Jason 2007.
Study characteristics | ||
Methods | RCT, 4 parallel arms | |
Participants | Diagnostic criteria: CDC 1994 Number of participants: n = 114 Gender: 95 (83.3%) female Age: 43.8 years Earlier treatment: NS Co‐morbidity: 44 (39%) with a current Axis I disorder (depression and anxiety most common). Use of AD not stated Illness duration: > 5 years Work and employment status: 52 (46%) working or studying at least part time, 24% unemployed, 6% retired, 25% on disability Setting: secondary care, but recruitment from different sources Country: USA |
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Interventions | 13 sessions every 2 weeks lasting 45 min Group 1: CBT aimed at showing participants that activity could be done without exacerbating symptoms (n = 29) Group 2: ACT focused on developing individualised and pleasurable activities accompanied by reinforcement of progress (n = 29) Group 3: COG focused on developing strategies to better tolerance, reduce stress and symptoms and lessen self‐criticism (n = 28) Group 4: relaxation treatment, introducing several types of relaxation techniques along with expectations of skill practice (n = 28) |
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Outcomes | Several outcomes are reported (~25), among others
Outcomes assessed at 12 months' follow‐up |
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Notes | Fidelity ratings and dropout reported across study arms | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Random assignment was done using a random number generator in statistical software (SPSS version 12)" |
Allocation concealment (selection bias) | Unclear risk | NS |
Blinding (performance bias and detection bias) of participants and personnel? | High risk | Not possible to blind participants or personnel (supervisors) to treatment allocation |
Blinding (performance bias and detection bias) of outcome assessors? | High risk | Blinding not possible for self‐reported measurements (e.g. FSS, BPI) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "The average dropout rate was 25%, but it was not significantly different per condition." The statistical analysis used, the best linear unbiased predictor, is a way to avoid taking missing data into account |
Selective reporting (reporting bias) | Unclear risk | All primary outcomes stated under Methods were reported; however, as the study protocol is not available, we cannot categorically state that the review is free of selective outcome reporting |
Other bias | High risk | Baseline data differences across groups for several important parameters (e.g. physical functioning: ACT group 39.17 (15.65) and relaxation group 53.77 (26.66)) |