NCT01518647

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Somatisation Disorder
• Somatoform Disorders

Interventions

Type	Name	Description
BEHAVIORAL	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

Timeline

• Start date: 2012-01-25
• Primary completion: 2015-08-25
• Completion: 2016-02-09
• First posted: 2012-01-26
• Last updated: 2017-05-09

Locations

1 site across 1 country: Denmark