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

ISRCTN	ISRCTN55280791
DOI	https://doi.org/10.1186/ISRCTN55280791
Secondary identifying numbers	01GK0601

Submission date: 17/10/2007
Registration date: 19/10/2007
Last edited: 16/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Wolfgang Herzog
Scientific

Department of Psychosomatic and General Clinical Medicine
University Hospital Heidelberg
Thibautstr. 2
Heidelberg
69115
Germany

Study information

Study design	Cluster randomized controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	speziALL
Study objectives	To determine whether a newly developed specific psychosomatic short-term group intervention for patients with functional/ somatoform complaints can effectively be implemented in primary care and leads to improvements in patients' outcomes.
Ethics approval(s)	Ethics Committee of the Medical Faculty, University of Heidelberg. Approved on 19 March 2007 (ref: S-074/2007)
Health condition(s) or problem(s) studied	Functional/ somatoform complaints and disorders
Intervention	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 psychosomatic short-term group intervention for patients with functional/ somatoform complaints in primary care will be developed. It integrates psychodynamic-interpersonal and cognitive-behavioural elements and emphasizes psychoeducation and resource activation. By experiencing the group process, new perspectives on awareness, self-reference, emotional involvement and relationship patterns shall be opened. The GPs of the intervention group are trained to conduct the new group intervention in their offices together with a psychosomatic specialist. In each practice of the intervention group the participating patients are treated with the new short-term group intervention. The group format is 10 weekly sessions of ninety minutes each and one booster session. GPs and psychosomatic specialists are supervised in conducting the groups. Patients in the control group receive enhanced medical care. This trial is carried out in cooperation with: Prof Joachim Szecsenyi Department of General Practice and Health Services Research University Hospital Heidelberg Vossstr. 2 Heidelberg 69115 Germany and Prof Hans-Helmut König Health Economics Research Unit, Department of Psychiatry University of Leipzig Johannisallee 20 Leipzig 04317 Germany
Intervention type	Other
Primary outcome measure	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 outcome measures	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.
Overall study start date	22/10/2007
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	Both
Target number of participants	Aiming at 242 (2 x 121) patients and assuming a drop-out rate of 20% and further 20% loss to follow-up, initially 378 (2 x 189) patients should be enrolled in the trial.
Key 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.
Key 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
Date of first enrolment	22/10/2007
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Germany

Study participating centre

Department of Psychosomatic and General Clinical Medicine

Heidelberg
69115
Germany

Sponsor information

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF])
Government

Hannoversche Strasse 28-30
Berlin
10115
Germany

Website	http://www.bmbf.de
"ROR"	https://ror.org/04pz7b180

Funders

Funder type

Not defined

German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) Grant Number 01GK0601

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/01/2013		Yes	No