Condition category
Mental and Behavioural Disorders
Date applied
17/10/2007
Date assigned
19/10/2007
Last edited
16/07/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.klinikum.uni-heidelberg.de/speziALL.106406.0.html

Contact information

Type

Scientific

Primary contact

Prof Wolfgang Herzog

ORCID ID

Contact details

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

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

http://www.bmbf.de

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

  1. 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.

Additional files

Editorial Notes