Moreno 2013.
| Methods | Study design: randomised controlled trial | |
| Participants |
Diagnosis: DSM‐IV diagnosis of abridged somatisation disorder Method of diagnosis: participants (aged 18‐65 years) were eligible if they were able to understand and read Spanish and fulfilled the criteria for ASD (somatic symptom indexes 4 (men) and 6 (women)). In addition, they had to be stable on pharmacotherapy in the previous month and needed to sign informed consent. The Othmer‐DeSouza test was used as a screening tool Exclusion criteria: any primary psychiatric diagnosis other than somatoform disorders, severe personality disorder, non‐white (not mentioned in design paper), inability to attend intervention sessions Total number randomised: 168 Age: for individual CBT group, M = 43.1 (SD = 11.4); for group CBT group, M = 49.2 (SD 8.6); TAU control group, M = 44.1 (SD = 11.7) Sex: 86% women; 14% men; for TAU group 87.5% women (n = 42), for individual CBT group 82.14% women (n = 46), for group CBT group 89.06% women, n = 57. Severity of symptoms at baseline: not described Duration of symptoms at baseline: most participants had symptoms for > 2 years: for TAU group 79.16% (n = 38), for individual CBT group 87.5% (n = 49), for group CBT group 87.5% (n = 56) Setting: recruitment in primary healthcare centres. Treatment setting not mentioned, but carried out by 2 psychologists Location: provinces of Zaragoza, Mallorca, Huesca in Spain Number of treatment centres: unknown Co‐morbidities: approximately 10% had a co‐morbid depressive disorder, 40% had a co‐morbid anxiety disorder, and 30% had a depressive and anxiety co‐morbid disorder Adjunctive therapy: not mentioned Adjunctive medication: not mentioned |
|
| Interventions | Participants were randomly assigned to either 1. Individual CBT + standardised letter to family doctor (n = 56) Duration: 10 weekly sessions of 1 hour, during a period of 10 weeks Treatment protocol: CBT: muscle relaxation training, behaviour modification, emotional mindfulness, cognitive restructuring, social skills, based on Escobar 1998; standardised letter with treatment advice for GP based on Smith 1991 Therapist: psychologists 2. Group CBT + standardised letter to family doctor (n = 64) Duration: 10 weekly sessions of 2 hours, during a period of 10 weeks Treatment protocol: CBT: muscle relaxation training, behaviour modification, emotional mindfulness, cognitive restructuring, social skills, based on Escobar 1998; standardised letter with treatment advice for GP based on Smith 1991 Therapist: psychologists 3. TAU: standardised letter to family doctor only (n = 48) Duration: NA Treatment protocol: standardised letter with treatment advice for GP based on Smith 1991 Therapist: NA |
|
| Outcomes |
Time points for assessment: baseline, after 10 weeks (immediately after treatment) and 6 and 12 months after treatment (i.e. about 9 and 15 months after baseline) Primary outcome: 1. severity of somatisation (Screening for Somatic Disorders and SSS scale) 2. anxiety and depression (HADS) Secondary outcome: 1. quality of life (SF‐36: reported in Gili 2014) 2. self declared health services (according to design paper (Magallon 2008), but not reported) 3. global improvement (CGI) (according to design paper (Magallon 2008), but not reported) |
|
| Notes |
Date of study: data collection began in March 2008 and ended in June 2010 Funding source: Red de Investigacion en Actividades de Prvencion y Promocion de la Salud Declarations of interest among the primary researchers: authors declared that they had no competing interests |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated random number sequence (Maggalon 2008, p. 4) |
| Allocation concealment (selection bias) | Low risk | Allocation was carried out by an independent person who was not involved in the study (p.602) Using central telephone. Sequence will be concealed until interventions are assigned (Moreno 2013, Magallon 2008, p. 4) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Personnel and participants could not be blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Study personnel that carried our the measurements were unaware of which treatment the participant was given. GPs were also kept blind to intervention, as participants were asked not to reveal their treatment condition. However, some outcomes were participant rated and participants could not be blinded (Moreno 2013, p. 602) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | < 20% drop‐out, and intention‐to‐treat analysis with last observation carried forward |
| Selective reporting (reporting bias) | High risk | Healthcare use and CGI were mentioned in protocol but not reported Quality of life reported in Gili 2014 |
| Treatment fidelity | Low risk | There were 2 different treatment conditions following the same protocol: individual and group formats (Moreno 2013, ref 23) |
| 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 |