Condition category
Mental and Behavioural Disorders
Date applied
28/11/2005
Date assigned
05/01/2006
Last edited
17/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.piso-studie.de

Contact information

Type

Scientific

Primary contact

Prof Peter Henningsen

ORCID ID

Contact details

Dept. of Psychosomatics
University Hospital 'Rechts der Isar'
Langerstr. 3
Munich
81675
Germany
+49 (0)89 4140 4310
p.henningsen@tum.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1359/05

Study information

Scientific title

Acronym

PISO

Study hypothesis

Patients with medically unexplained physical symptoms are 'high utilizers' of the health care system with high psychiatric co-morbidity and severe impairments in quality of life (QoL). There is preliminary evidence that psycho-dynamic-interpersonal therapy (PIT) is beneficial as it reduces the intensity of physical symptoms and increases quality of life. The trial interventions so far lacked generalizability over a larger clinical spectrum of disabling somatoform symptoms. We developed a multi-centre two-arm randomized controlled trial with a primary end point and follow-up after one year. PISO has two new aspects:
1. PISO uses a diagnostic category that is independent of the type of currently dominant symptom and therefore serves as a common point of reference
2. PISO uses a manualized psychotherapeutic intervention that is adapted to the specific lead symptom in the beginning, but later on emphasizes more general aspects of experiencing 'unexplained' physical symptoms across single functional syndromes and somatic specialities
In the trial, we test a bio-psycho-social model of change including psychobiological parameters like heart rate variability and prefrontal/limbic neural activations. If the intervention tested in PISO proves to be efficacious as compared to enhanced medical care it will be useful as an economic and versatile tool that is applicable in cooperation with psychosomatic medicine across a range of somatic specialities.

Ethics approval

05/08/2005, project number 1359/05

Study design

Multi-centre two-arm randomized controlled trial with major end point at 1-year follow-up, the guidelines of Good Clinical Practice (GCP) will be followed, reporting will follow the CONSORT rules.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multisomatoform Disorder

Intervention

Psycho-dynamic-interpersonal therapy (PIT) as a special form of psychosomatic therapy will be compared to enhanced medical care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

SF-36 Physical Component Summary (PCS): In patients with multi-somatoform disorder, symptom-related incapacity is best captured with the PCS. The German version of the SF-36 health survey short form has been validated and is sensitive to change, the assumed effect size of 0.50 is clinically relevant.

Secondary outcome measures

1. IPQ, Brief Form: The brief form of the 'Illness Perception Questionnaire' (BIPQ, Broadbent et al. in submission) provides a quantitative measure of the components of illness representations that has been shown in treatment trials to be sensitive to change. The German version was developed and validated by Gaab (unpublished manuscript).
2. PHQ-D: The 'Patient Health Questionnaire', German version (PHQ-D) is a brief self-report measure for anxiety, depression and other mental disorders. Criterion validity was established with respect to diagnostic gold standards and the PHQ has proven to be a responsive and reliable measure of depression treatment outcome (Löwe et al. 2004).
3. SOMS-7: Seven-day version of the 'Screening for Somatoform Symptoms'. A 53-item instrument for the evaluation of treatment effects in somatoform disorders, covering all somatic symptoms occurring in somatization disorder, according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and International Statistical Classification of Diseases and Related Health Problems - tenth revision (ICD-10) (Rief and Hiller 2003).
4. Whiteley-Index-7: The seven-item version of the Whiteley Index, an established hypochondriasis scale first described by Pilowsky, was developed and validated by Christensen et al. (2003) specifically to assess treatment effects.
5. LEAS: The 'Levels of Emotional Awareness Scale' (Lane and Schwartz 1987, German version: Subic-Wrana et al. 2002) is a projective text based measure that assesses the capacity to describe own emotional experience and the one assumed in others. It will be used as a predictor variable conceptually related to the theory of change assumed for the treatment intervention.
6. Heart rate variability (HRV): HRV measurement and analysis equipment will be present at each centre. Time-domain (RMSSD) and frequency domain (HF-HRV) analysis will be performed during a stress test with the emotional stroop paradigm.

Overall trial start date

01/01/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients screened positive and diagnosed in a structured interview in different somatic specialities with a diagnosis of pain-predominant multi-somatoform disorder and a quality of life (QoL) of 1 standard deviation below population norm in the SF-36
2. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

176

Participant exclusion criteria

1. Age younger than 18 years
2. Insufficient German language ability
3. Insufficient cognitive abilities (Mini Mental State <24)
4. Severe and chronic somatic disease
5. Severe co-morbid mental disorder causing major impairment of social functioning

Recruitment start date

01/01/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Germany

Trial participating centre

Dept. of Psychosomatics
Munich
81675
Germany

Sponsor information

Organisation

Munich Technical University (Germany)

Sponsor details

University Hospital 'Rechts der Isar'
Munich Technical University
Ismaninger Str. 22
Munich
D-81675
Germany

Sponsor type

University/education

Website

http://www.med.tu-muenchen.de

Funders

Funder type

Not defined

Funder name

Sponsor Code: 1359/05

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

German Research Foundation (Deutsche Forschungsgemeinschaft [DFG])/German Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung [BMBF]) Code: He 3200/4-1; 60665-02-2/167/04

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

1. Rief W, Henningsen P. Somatoforme Störungen. In Senf W, Broda M: Praxis der Psychotherapie 3. Aufl. Kap. X/36. Stuttgart: Thieme 2005, p 529-544.
2. Rudolf G, Henningsen P: Die psychotherapeutische Behandlung somatoformer Störungen. Z Psychosom Med Psychother 49 (2003) 3-19.
<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12638085&query_hl=7"; target="_blank">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12638085&query_hl=7</a>;
3. Henningsen P, Hartkamp N, Loew T, Sack M, Scheidt CE, Rudolf G: Somatoforme Störungen. Leitlinien und Quellentexte. Stuttgart: Schattauer 2002.
4. Wöller W, Kruse J (Hg.) Tiefenpsychologisch fundierte Psychotherapie. Basisbuch und Praxisleitfaden. Stuttgart: Schattauer 2001.
5. Guthrie E, Moorey J, Margison F et al. Cost-effectiveness of brief psychodynamic-interpersonal therapy in high utilizers of psychiatric services. Arch Gen Psychiatry 1999; 56: 519-526.
<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10359466&query_hl=10"; target="_blank">http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=10359466&query_hl=10</a>;
6. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22075651

Publication citations

  1. Results

    Sattel H, Lahmann C, Gündel H, Guthrie E, Kruse J, Noll-Hussong M, Ohmann C, Ronel J, Sack M, Sauer N, Schneider G, Henningsen P, Brief psychodynamic interpersonal psychotherapy for patients with multisomatoform disorder: randomised controlled trial., Br J Psychiatry, 2012, 200, 1, 60-67, doi: 10.1192/bjp.bp.111.093526.

  2. Rudolf G, Henningsen P, [Psychotherapy of somatoform disorders]., Z Psychosom Med Psychother, 2003, 49, 1, 3-19.

  3. Rudolf G, Henningsen P, [Psychotherapy of somatoform disorders]., Z Psychosom Med Psychother, 2003, 49, 1, 3-19.

  4. Guthrie E, Moorey J, Margison F, Barker H, Palmer S, McGrath G, Tomenson B, Creed F, Cost-effectiveness of brief psychodynamic-interpersonal therapy in high utilizers of psychiatric services., Arch. Gen. Psychiatry, 1999, 56, 6, 519-526.

  5. Guthrie E, Moorey J, Margison F, Barker H, Palmer S, McGrath G, Tomenson B, Creed F, Cost-effectiveness of brief psychodynamic-interpersonal therapy in high utilizers of psychiatric services., Arch. Gen. Psychiatry, 1999, 56, 6, 519-526.

Additional files

Editorial Notes