Monsen 2000.
| Methods | RCT of matched pairs of participants in 2 parallel conditions | |
| Participants | 40 participants (35 women), all employees of a large Norwegian office company, self referred to company's health service because of pain problems Inclusion criteria: diagnosis of pain disorder associated with psychological factors according to the DSM‐IV Exclusion criteria: pain associated with other medical conditions, such as spine prolapse, neuralgia or chronic disorders manifested in organ systems other than the musculoskeletal system (such as irritable colon) |
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| Interventions | Intervention: PBT: a variant of the affect‐consciousness treatment model, based on Monsen 1999. The PBT group received a mean of 33 individual, 1‐hr sessions during a period of 9 months (ranging from 15 to 41 sessions). Psychotherapy was performed by the project leader who was a well‐qualified clinical psychologist and physiotherapist Control: received TAU: 3 participants received traditional physiotherapy, 5 participants received both traditional physiotherapy and pain‐reducing medication, 3 participants received pain‐reducing medication and 1 participant received psychological counselling. 8 participants in the control group received no treatment during the intervention period. The treatment was performed by the project leader who was a well‐qualified clinical psychologist and physiotherapist |
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| Outcomes | Measured at pre‐treatment, post, and 1 year follow‐up. Measures were VAS Pain scale, SCL‐90‐R, IIP‐C, Minnesota Multiphase Personality Inventory, Affect‐Consciousness Scales and job advancement | |
| Notes | Data used from SCL‐90 scores, IIP and VAS for pain | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomised in two groups of twenty patients each" Comment: randomised but not clearly described how |
| Allocation concealment (selection bias) | Unclear risk | Comment: not clearly described |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: mainly self report measures used (SCL, VAS, IIP): low risk Blind ratings of Affect Consciousness Scales: low risk No psychotherapist was blinded to the treatment delivered Blinding participants to treatment group not possible |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "all patients participated in the assessments at T1 [pre‐treatment], T2 [post‐treatment] and T3 [1‐year follow‐up], except one person in the control group absent at T3 due to complications after child birth" Comment: proportion of missing data not likely to have relevant impact |
| Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to permit judgement. No published report on pre‐specified outcomes |
| Other bias | Unclear risk | Comment: insufficient information to permit judgement |