Zonneveld 2012.
| Methods | Study design: randomised controlled trial | |
| Participants |
Diagnosis: UPS (according to SCID interview) Method of diagnosis: participants (aged 18‐65 years old, who were able to speak, read, and write Dutch) were eligible if their UPS persisted ≥ 6 months and if their UPS was classified as undifferentiated somatoform disorder or chronic pain disorder according to the criteria of the Structured Clinical Interview for DSM‐IV Axis I Disorders/ Patient edition (SCID‐I/P) Exclusion criteria: UPS not being the principal somatic disease; undifferentiated somatoform disorder or chronic pain disorder not being the principal DSM‐IV‐TR classification; handicaps like cognitive mental impairment with or without blindness impending the participant to participate in the training Total number randomised: 162 Age: for intervention group, M = 46 (IQR = 38‐53); for control group, M = 44 (SD = 35‐52) Sex: for intervention group 79.8% women (n = 67), 20.2% men (n = 17); for control group 82.1% women (n = 64), 17.9% men (n = 14) Severity of symptoms at baseline: undifferentiated somatoform disorder 38.1% for intervention group (n = 32) 39.7% for control group (n = 31); chronic pain disorder 61.9% for intervention group (n = 52), 60.3% for control group (n = 47) Duration of symptoms at baseline: for intervention group M = 8 years, for control group M = 9.5 years Setting: primary care, outpatient clinic and secondary community mental‐health service physicians' received periodical postcards informing them when and how to refer patients. Participants were also recruited via announcements in local newspapers and on websites of patients' associations. Treatment setting unclear Location: Rotterdam area, the Netherlands Number of treatment centres: unknown Co‐morbidities: for intervention group 45.2% had ≥ 1 DSM‐IV axis I disorders (n = 38), for control group this was 37.2% (n = 29) (for details about specific axis I and axis II disorders, see Zonneveld 2012, table 2) Adjunctive therapy: not mentioned Adjunctive medication: not mentioned |
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| Interventions | Participants were randomly assigned to either 1. Group training (n = 84) Duration: 13 weekly 2‐hour sessions in groups of 5‐9 participants (mean 6), in a period of 13 weeks Treatment protocol: treatment consisted of cognitive‐behavioural therapy based on the consequences model. In this model, psychological and social factors, are labelled as consequences of UPS. In the long term, these consequences might produce self perpetuating vicious circles that maintain or aggravate UPS. By changing and reducing the consequences, beliefs are addressed indirectly, after which the beliefs can still be addressed directly. Focus is on improvement of quality of life. Based on this tailored cognitive‐behavioural model, a manual was developed for a group training called 'Coping with the consequences of unexplained physical symptoms' (for details Zonneveld 2012, ref 38). Sessions concern psychoeducation on arousal, habits, activity, emotions, beliefs, physical fitness, information processing, breathing and relaxation, and relapse prevention Therapist: 6 psychologists with a Master's degree, 4 of whom had had at least 3 years' post‐Master's experience with group therapy or CBT, or both and who familiarised themselves with this method 2. Waiting list (n = 78) Duration: 13 weeks Treatment protocol: NA Therapist/face‐to‐face contact: NA |
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| Outcomes |
Time points for assessment: baseline and directly post‐treatment (further follow‐ups are without a control group) Primary outcome: 1. improvement in quality of life (SF‐36, PCS and MCS) Secondary outcome: 1. improvement in quality of life (SF‐36, 8 individual subscales) 2. intensity of psychological problems (SCL‐90‐R, 8 subscales including depression and anxiety) |
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| Notes |
Date of study: participants were recruited between February 2005 and September 2008. The follow‐up ended in December 2009; 1 year after the intervention group of the last randomisation had completed the training Funding source: the study was funded by RIAGG Rijnmond Declarations of interest among the primary researchers: none reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were assigned to the training or to the waiting list according to a computer generated randomisation list |
| Allocation concealment (selection bias) | Low risk | The randomisation was performed by an investigator who had no clinical involvement in the trial and was working in a different building that the building were assessment and enrolment were done |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and trainers could not be blinded for group assignment, as the control condition was a simple waiting list. The data were imported and analysed after participants had completed the trial |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Participants were not blinded and most outcomes were participant reported |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Of the 84 participants in the intervention group, 23 dropped out (27.4%), of the 78 participants in the control group, 6 dropped out (7.7%) (intervention group loss to follow‐up > 20%) |
| Selective reporting (reporting bias) | Low risk | All intended outcomes reported, no means/SDs reported, but on our request these were provided for the meta‐analysis |
| Treatment fidelity | Low risk | The training was manual‐based (Zonneveld 2012, ref 24, 28) |
| 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 |
AIDS: acquired immune deficiency syndrome; BDS: bodily distress syndrome; BSI: Brief Symptom Inventory; CBT: cognitive behavioural therapy; CGI‐SD: Clinical Global Impession Scale for Somatoform Disorders; CIDI: Composite International Diagnostic Interview; DSM: Diagnostic and Statistical Manual of Mental Disorders; GAD: Generalised Anxiety Disorder Scale; GHQ: General Health Questionnaire; GP: general practitioner; GSI: General Symptom Index; HADS: Hospital Anxiety and Depression Scale; HAM‐A: Hamilton Anxiety Rating Scale; HAM‐D: Hamilton Depression Rating Scale; IAS: Illness Attitude Scales; IBQ: Illness Behaviour Questionnaire; ICD: International Classification of Diseases; IDCL: International Diagnostic Checklists; IQR: interquartile range; KKG: Krankheit und Gesundheit; M: mean; MCS: Mental Component Scale; Mini‐DIPS: mini‐Diagnostische Interview bei psychischen Störungen; MOS: Medical Outcomes Study; MUS: medically unexplained symptoms; MWB: Mental Well‐Being; n: number; NA: not available; PCI: psychiatric consultation intervention; PCS: Physical Component Score; PHQ: Patient Health Questionnaire; PRIME‐MD: Primary Care Evaluation of Mental Disorders; PWB: Psychological Well‐Being; ref: reference; SCAN: Schedules for Clinical Assessment in Neuropsychiatry; SCID: Structured Clinical Interview for Mental Disorders; SCL: Symptom Checklist; SD: standard deviation; SDI: Sleep Debt Index; SF‐12: 12‐item Short Form; SIP: Session Initiation Protocol; SPQ: Social Problem Questionnaire; SSS: Severity of Somatic Symptoms; TAU: treatment as usual; UPS: unexplained physical symptoms; VAS: visual analogue scale; WI: Whitely Index.