Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4)

Not Applicable

Completed

• Conditions: Somatoform Disorders; Somatisation Disorder
• Interventions: Behavioral: Acceptance and Commitment Therapy

• Registration Number: NCT01518647
• Lead Sponsor: University of Aarhus

Brief Summary

The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with long lasting health problems with no known medical explanation, defined as multi-organ Bodily distress syndrome (BDS). ACT treatment is given as two different types of treatment, a 9-session group therapy and a 1-day workshop followed by an individual consultation, and both are compared to standard treatment, which is one single advisory consultation. The study includes 180 patients.

Detailed Description

The aim of this study is to test the effect of Acceptance and Commitment Therapy (ACT) in patients with multi-organ Bodily distress syndrome (BDS). BDS is a unifying diagnosis that encompasses a group of closely related conditions such as somatization disorder, fibromyalgia, irritable bowel syndrome and chronic fatigue syndrome. The project consists of a three-armed randomized controlled trial of ACT treatment given as a supplement to standard treatment as either 9-session group therapy or as a 1-day workshop followed by an individual consultation, compared to standard treatment, which is one single advisory consultation.

Primary outcome is patient-rated improvement measured by Clinical Global Improvement Scale (CGI-I). Secondary outcome is functional level (physical, mental and social) measured by the SF-36 Physical Component Summary (PCS). The study includes 180 participants.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-01-13
• Study Start: 2012-01-25
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Primary Completion: 2015-08-25
• Study Completion: 2016-02-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
2. Moderate or severe impact on daily life
3. Symptoms lasting for at least 2 years
4. Age 20-50 years
5. Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.

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Exclusion Criteria

1. Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
2. Patients with treatment demanding psychiatric disease as dominating problem
3. A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
4. Abuse of alcohol, narcotics or drugs
5. Pregnancy at time of inclusion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Workshop	Acceptance and Commitment Therapy	ACT given as a one-day workshop with 15 patients with a following individual consultation
Group Therapy	Acceptance and Commitment Therapy	ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month
Standard treatment	Acceptance and Commitment Therapy	Standard treatment is one single advisory consultation given 2 weeks after randomization

Primary Outcome Measures

Name	Time	Method
Global Clinical Improvement Scale	14 month after randomization	Questionnaire, patient-rated improvement of health since the beginning of the study.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale for pain and worst symptom	Before randomization, and at 6, 14 and 20 month after randomization
SF-36	Before randomization, and at 6, 14 and 20 months after randomization	Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Symptom Checklist (SCL)	Before randomization, and at 6, 14 and 20 month after randomization	Questionnaire, patient-rated. Assessment of physical, social and mental functioning
WHODAS II	Before randomization, and at 6, 14 and 20 month after randomization	Questionnaire, patient-rated. Assessment of physical, social and mental functioning

Trial Locations

Locations (1)

Research Clinic for Functional Disorders; 🇩🇰 Aarhus, Denmark