Plain English Summary
Not provided at time of registration
Trial website
http://www.klinikum.uni-heidelberg.de/speziALL.106406.0.html
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01GK0601
Study information
Scientific title
Acronym
speziALL
Study hypothesis
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
Ethics Committee of the Medical Faculty, University of Heidelberg. Approved on 19 March 2007 (ref: S-074/2007)
Study design
Cluster randomized controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
22/10/2007
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
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.
Participant 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
Recruitment start date
22/10/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Psychosomatic and General Clinical Medicine
Heidelberg
69115
Germany
Sponsor information
Organisation
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF])
Sponsor details
Hannoversche Strasse 28-30
Berlin
10115
Germany
Sponsor type
Government
Website
Funders
Funder type
Not defined
Funder name
German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) Grant Number 01GK0601
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23305192
Publication citations
-
Results
Brettschneider C, König HH, Herzog W, Kaufmann C, Schaefert R, Konnopka A, Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with somatoform disorders., Health Qual Life Outcomes, 2013, 11, 3, doi: 10.1186/1477-7525-11-3.