Allen 2006.
| Methods | Study design: randomised controlled trial | |
| Participants |
Diagnosis: DSM‐IV diagnosis of somatisation disorder Method of diagnosis: participants (18‐70 years) with English fluency and literacy, a DSM‐IV diagnosis for somatoform disorder and a CGI‐SD score ≥ 4 were included Exclusion criteria: unstable major medical condition, medication regimen that has not been stable for at least 2 months prior to baseline, active suicidal ideation, history of psychosis, current psychoactive substance dependence, pregnant women or attempting to conceive, participants in psychotherapy concurrent with the period between baseline and 3 months appointments Total number randomised: 84 Age: for intervention group, M = 45.5 (SD = 8.5); for control group, M = 47.9 (SD = 11) Sex: 89% women; 11% men for intervention group 84% women (n = 36), for control group 95% (n = 39) Severity of symptoms at baseline: not reported Duration of symptoms at baseline: for intervention group M = 24.95 (SD = 11.54) years, for control group M = 25 (SD = 15.12) years Setting: participants were recruited through medical clinics and through advertisements in the community (70% referred by physician), after informed consent they received a telephone screening interview. Treatment: department of Psychiatry of medical school Location: New Jersey, USA Number of treatment centres: 1 Co‐morbidities: 65% current co‐morbid DSM‐IV axis I disorder; 70% (n = 30) for intervention group, 59% (n = 24) for control group Adjunctive therapy: not mentioned Adjunctive medication: not mentioned |
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| Interventions | Participants were randomly assigned to either 1. CBT + PCI (n = 43) Duration: 10 sessions during a period of 3 months Treatment protocol: CBT: manualised intervention for people with somatoform disorder, with detailed guidelines for each session, focused on stress management, activity regulation, emotional awareness, cognitive restructuring, and interpersonal communication (Allen 2006, refs 5 and 6 for details) PCI: standard consultation letter sent to the treating physician including recommendations for the ongoing treatment (Allen 2006, Table 1 for details) Therapist: 4 therapists, master‐ or doctoral‐level psychologists with at least 3 years of supervised training in CBT. All received a special training in CBT for SD before the trial 2. PCI alone (n = 41) Duration: NA Treatment protocol: standard consultation letter sent to the treating physician including recommendations for the ongoing treatment (Allen 2006, Table 1 for details). Therapist/face‐to‐face contact: none |
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| Outcomes |
Time points for assessment: baseline and 3 months, 9 months, 15 months after baseline Primary outcome: 1. severity of somatisation (CGI‐SD) 2. improvement (CGI‐SD) Secondary outcome: 1. participants' rating of physical functioning (MOS‐36) 2. severity of somatic symptoms (SSS) 3. healthcare utilisation (medical records) Potential mediator 1. participant expectations of improvement |
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| Notes |
Date of study: September 1999 ‐ April 2003 Funding source: National Institute of Mental Health Declarations of interest among the primary researchers: none |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random number sequence was used |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and therapists were not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Study personnel were masked to participants treatment condition (independent evaluators), but participants were not blinded, and most outcomes were participant reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | < 20% missing per follow‐up moment |
| Selective reporting (reporting bias) | Low risk | All intended outcomes reported |
| Treatment fidelity | Low risk | The treatment was described in a manual containing detailed guidelines for the conduct of each session (Allen 2006, page 1513) |
| Researcher allegiance | Low risk | No indication that researchers had a preference for 1 of the treatment modalities |
| Other bias | Low risk | No other sources of bias |