Schilte 2001.
| Methods | Study design: randomised controlled trial | |
| Participants |
Diagnosis: somatisation Method of diagnosis: participants of 20‐45 years who had ≥ 15 contacts in the past 3 years and who had ≥ 5 somatisation symptoms according to a somatisation scale (based on all symptoms listed in DSM‐IIIR) Exclusion criteria: cancer, AIDS, rheumatoid arthritis, multiple sclerosis, dementia, schizophrenia, mental disorder, and psychosis. Included people with other chronic diseases, such as asthma, osteoarthritis, or cardiovascular diseases Total number randomised: 161 Age: for intervention group M = 38 (IQR = 33‐41), for control group M = 39 (IQR = 36‐41) Sex: for intervention group 80% female (n = 61), for control group 78% female (n = 59) Severity of symptoms at baseline: mean somatisation score (scale 0‐48): for intervention group M = 20 (IQR = 16‐25), for control group M = 22 (IQR = 17‐22) Duration of symptoms at baseline: unknown Setting: participants were recruited in the registration network of primary physicians (primary care). the intervention took place at participants' homes Location: Maastricht area, the Netherlands Number of treatment centres: 77 participants' homes Co‐morbidities: of the 77 participants who actually received the intervention, 34 had an active depressive or anxiety disorder (16 depressive, 30 anxiety) according to the DSM‐IV screening. 2 participants fulfilled criteria of DSM‐IV hypochondriasis and 18 of a DSM‐IV chronic benign pain syndrome Adjunctive therapy: none reported Adjunctive medication: none reported |
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| Interventions | Participants were randomly assigned to either 1.Disclosure intervention (n = 81): Duration: unknown Treatment protocol: treatment consisted of 2 meetings with a disclosure doctor + an optional meeting with the doctor and the GP. They were invited to disclose emotionally important events in their life. If not mentioned spontaneously, the doctor asked questions about family life, health, work situation, and childhood Therapist: a trained disclosure doctor and in the third session also the GP 2.Usual care (n = 80): Duration: NA Treatment protocol: NA Therapist: NA (care as usual by own GP) |
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| Outcomes |
Time points for assessment: baseline, 6, 12 and 24 months after baseline Primary outcome: 1. Healthcare use (number of visits to all health care) Secondary outcome: 1. Subjective health (scale) 2. Severity of symptoms (SCL‐90 subscore) 3. Depressive symptoms (SCL‐90 subscore) 4. Anxiety (SCL‐90 subscore) 5. Sick leave (number of weeks of sick leave over the preceding 6 months) |
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| Notes |
Date of study: unknown, published in 2001 Funding source: Netherlands Organisation for Scientific research 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 | The randomisation was stratified (1 stratum per practice), using a sequence of labelled cards in opaque, sealed, numbered envelopes |
| Allocation concealment (selection bias) | Low risk | An independent person produced the randomisation envelopes, and the research assistant, who did not apply the intervention, executed the randomisation procedure |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Although the general practitioners knew which participant received the intervention, they were not told which participants participated as controls. Participants could not be blinded for the intervention |
| 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 | Low risk | In the intervention group 70/81 (86.4%) participants completed the trial (and questionnaire at 2 years follow‐up) In the control group 67/80 (83.7%) participants completed the trial (and questionnaire at 2 years' follow‐up) (Schilte 2001, page 87) (loss to follow‐up < 20%) |
| Selective reporting (reporting bias) | High risk | Only results at 24 months of follow‐up are reported |
| Treatment fidelity | High risk | No protocol or manual for treatment (Schilte 2001, page 323) |
| Researcher allegiance | Low risk | No indication that researchers had a preference for 1 of the treatment modalities |
| Other bias | Unclear risk | Results were not corrected for baseline imbalances |