Psychosomatic Intervention for Patients with Multisomatoform Disorder in Different Somatic Specialities

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23215121

Enrollment

176

Registered

2006-01-05

Start date

2006-01-01

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

Multisomatoform Disorder Mental and Behavioural Disorders Somatoform disorder

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 The German version was developed and validated by Gaab (unpublished manuscript). 2.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.	—

Measure

Time frame

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.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 27, 2026