Evaluation of a specific psychosomatic short-term group intervention for patients with functional/ somatoform complaints in primary care. A cluster randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55280791

Enrollment

378

Registered

2007-10-19

Start date

2007-10-22

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional/ somatoform complaints and disorders Mental and Behavioural Disorders Functional/ somatoform complaints and disorders

Interventions

All GPs receive a training programme in early diagnosis and management of functional/ somatoform complaints in primary care that has already been evaluated. In addition, a manualised specific psycho

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1,112 General Practitioners (GPs) within 45 minutes outreach around Heidelberg are invited to take part in the trial by letter. The first 36 of them who agree to participate are included in the trial. They are stratified by group experience (yes/no) and training in Psychosocial Primary Care (PPC) (yes/no) and randomly assigned to the intervention or control group. The GPs recruit patients to participate in the trial according to following inclusion criteria: 1. The presence of functional/somatoform complaints (persistent [at least 6 months] bodily complaints for which no sufficient organic explanation can be found) 2. The somatoform disorder is the main treatment issue (co-morbidities are allowed) 3. Indication for short-term group intervention 4. Age 18-70 years 5. Distance from the practice to the place of residence not more than around 30 kilometers 6. Written informed consent Patients selected by the GPs are additionally assessed for somatoform disorders by the Patient Health Questionnaire (PHQ-15) and the Whitely-7 (WI-7). GPs' selection of patients is examined separately to assess its representativeness.

Exclusion criteria

Exclusion criteria: 1. Ongoing psychotherapy 2. Substance abuse (benzodiazepins, alcohol, drugs) 3. Severe psychiatric disorder: major depression (PHQ-9), psychosis, dementia or neurodegenerative disorders 4. Impairment by severe acute organic disease (Karnofsky index lower than 70%) 5. Unable to understand German language 6. Ongoing juridical proceedings due to pension or compensation for personal suffering

Design outcomes

Primary

Measure	Time frame
Physical quality of life (Physical Component Summary [PCS] of the Short From-36 Health Survey [SF-36]) will be assessed before the intervention and 3 and 9 months after the intervention.	—

Secondary

Measure	Time frame
Patients' characteristics: 1. Mental comorbidity (Patient Health Questionnaire, German version [PHQ-D]), assessed before the intervention and 3 and 9 months after the intervention. 2. Functional impairment (PHQ-D, SF-36) , assessed before the intervention and 3 and 9 months after the intervention. 3. Mental quality of life (Mental Component Summary [MCS] of the SF-36), assessed before the intervention and 3 and 9 months after the intervention. 4. Health related quality of life (EQ-5D), assessed before the intervention and 3 and 9 months after the intervention. 5. Health care utilization, disability days, direct and indirect medical costs (German version of the Client Sociodemographic and Service Receipt Inventory [CSSRI]), assessed before the intervention and 9 months after the intervention. 6. Illness perception (Illness Perception Questionnaire [IPQ], Brief Form), assessed before the intervention and 3 and 9 months after the intervention. 7. Control beliefs (Illness and Health Locus of Control Questionnaire [KKG]), assessed before the intervention and 3 and 9 months after the intervention. 8. Emotional awareness (Toronto Alexithymia Scale [TAS-20]), assessed before the intervention and 3 and 9 months after the intervention. Additionally the group process will be monitored from the perspective of the patients and the therapists. The training programme and its effects on GPs' competence will be evaluated, including difficulty experienced by the physician in the physician-patient relationship (Difficult Doctor-Patient Relationship Questionnaire [DDPRQ-10]). The evaluation will be carried out immediately after the training course, immediately after the group intervention and 9 months after the group intervention.	—

Measure

Time frame

Patients' characteristics: 1. Mental comorbidity (Patient Health Questionnaire, German version [PHQ-D]), assessed before the intervention and 3 and 9 months after the intervention. 2. Functional impairment (PHQ-D, SF-36) , assessed before the intervention and 3 and 9 months after the intervention. 3. Mental quality of life (Mental Component Summary [MCS] of the SF-36), assessed before the intervention and 3 and 9 months after the intervention. 4. Health related quality of life (EQ-5D), assessed before the intervention and 3 and 9 months after the intervention. 5. Health care utilization, disability days, direct and indirect medical costs (German version of the Client Sociodemographic and Service Receipt Inventory [CSSRI]), assessed before the intervention and 9 months after the intervention. 6. Illness perception (Illness Perception Questionnaire [IPQ], Brief Form), assessed before the intervention and 3 and 9 months after the intervention. 7. Control beliefs (Illness and Health Locus of Control Questionnaire [KKG]), assessed before the intervention and 3 and 9 months after the intervention. 8. Emotional awareness (Toronto Alexithymia Scale [TAS-20]), assessed before the intervention and 3 and 9 months after the intervention. Additionally the group process will be monitored from the perspective of the patients and the therapists. The training programme and its effects on GPs' competence will be evaluated, including difficulty experienced by the physician in the physician-patient relationship (Difficult Doctor-Patient Relationship Questionnaire [DDPRQ-10]). The evaluation will be carried out immediately after the training course, immediately after the group intervention and 9 months after the group intervention.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026