Escobar 2007.
| Methods | Study design: randomised controlled trial | |
| Participants |
Diagnosis: MUS (abridged somatisation disorder) Method of diagnosis: clinicians referred participants when they thought symptoms were a source of distress OR suspected they had a psychiatric origin. Participants were then interviewed using PHQ and PRIME‐MD, participants were eligible if they had ≥ 4 unexplained symptoms for men and ≥ 6 for women Exclusion criteria: severe psychiatric diagnosis, requiring more intensive intervention of major physical disorder that explains any of the symptoms Total number randomised: 172 Age: for intervention group, M = 41.0 (SD = 12.7); for control group, M = 39.6 (SD = 13.4) Sex: 88% women; 12% men; 86.2% women in intervention group (n = 75); 89.4% women in control group (n = 76). Severity of symptoms at baseline:baseline PHQ‐15 score for intervention group M = 14.17 (95% CI = 13.03 to 15.32), for control group M = 13.98 (95% CI = 12.82 to 15.13) Duration of symptoms at baseline: not reported Setting: recruited from 2 university based primary care clinics, intervention at Psychiatry department Location: New Brunswick, New Jersey, USA Number of treatment centres: 1 Co‐morbidities: 92% had a current co‐morbid DSM‐IV axis I disorder; 92.0% of intervention group (n = 80), 91.8% of control group (n = 78) Adjunctive therapy: not mentioned Adjunctive medication: not mentioned |
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| Interventions | Participants were randomly assigned to either 1. CBT + psychiatric consultation letter (n = 87) Duration: 10 sessions of 50 minutes (first session 90 minutes) during 10‐20 weeks (mean of 3 months) Treatment protocol: standardised CBT intervention according to manual, focusing on reduction of reduction of physical distress and somatic pre‐occupation, through training in relaxation techniques, activity regulation, facilitation of emotional awareness, cognitive restructuring and interpersonal communication. Details in book Woolfolk et al. (Woolfolk 2007, ref 18). Consultation letter: a standard consultation letter was sent to the treating primary care physician, originally developed by Smith et al. (Escobar 2007, ref 13), including recommendations about taking care of people with MUPS Therapist: therapists received training on the intervention protocol from 2 of the authors. Therapists' treatment adherence to the study protocol was rated routinely during the study from evaluations of taped sessions 2. Usual clinical care + psychiatric consultation intervention (n = 85) Duration: NA Treatment protocol: a standard consultation letter was sent to the treating primary care physician (see above) Therapist/face‐to‐face contact: none (other than usual care) |
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| Outcomes |
Time points for assessment: baseline and 3 months, 9 months, after baseline Primary outcome: 1. severity of somatisation (CGI + PHQ‐15) 2. improvement of physical symptoms (CGI ‐ improvement) Secondary outcome: 1. participants' rating of physical functioning (physical subscale of MOS‐10) 2. severity of somatic symptoms (VAS) 3. anxiety and depression (HAM‐A and HAM‐D) |
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| Notes |
Date of study: recruitment took place from January 2001 through to February 2005, follow‐up until the end of 2006 Funding source: National Institute of Mental Health Declarations of interest among the primary researchers: none reported See Allen 2006 (similar study, same research group) Additional data provided by Escobar (June 2014) |
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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 |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors were blinded (but had to ask participants…) |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 21‐24% loss to follow‐up directly after treatment; 41‐48% loss to follow‐up 6 months later |
| Selective reporting (reporting bias) | Low risk | CGI scores not reported (but provided later by first author) |
| Treatment fidelity | Low risk | Treatment sessions followed a manual with step‐by‐step guidelines for each session (Escobar 2007, ref 18) |
| 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 |