Overview

This trial is active, not recruiting.

Conditions somatisation disorder, somatoform disorders
Treatment acceptance and commitment therapy
Sponsor University of Aarhus
Start date January 2012
End date March 2015
Trial size 180 participants
Trial identifier NCT01518647, M-20110265

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month
acceptance and commitment therapy
Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals
(Experimental)
ACT given as a one-day workshop with 15 patients with a following individual consultation
acceptance and commitment therapy
Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals
(Active Comparator)
Standard treatment is one single advisory consultation given 2 weeks after randomization
acceptance and commitment therapy
Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals

Primary Outcomes

Measure
Global Clinical Improvement Scale
time frame: 14 month after randomization

Secondary Outcomes

Measure
SF-36
time frame: Before randomization, and at 6, 14 and 20 months after randomization
Visual Analogue Scale for pain and worst symptom
time frame: Before randomization, and at 6, 14 and 20 month after randomization
Symptom Checklist (SCL)
time frame: Before randomization, and at 6, 14 and 20 month after randomization
WHODAS II
time frame: Before randomization, and at 6, 14 and 20 month after randomization

Eligibility Criteria

Male or female participants from 20 years up to 50 years old.

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. 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

Additional Information

Official title Treatment of Multi-organ Bodily Distress Syndrome. A Randomized Controlled Trial of the Effects of Acceptance and Commitment Therapy Given as Group Therapy or Workshop Compared to Standard Treatment (Stress-4)
Principal investigator Johanne L Agger, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.