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

University of Aarhus

Status: Completed

Conditions: Somatoform Disorders; Somatisation Disorder

Treatments: Behavioral: Acceptance and Commitment Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01518647

M-20110265

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

Group Therapy

Experimental group

Description:

ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month

Treatment:

Behavioral: Acceptance and Commitment Therapy

Workshop

Experimental group

Description:

ACT given as a one-day workshop with 15 patients with a following individual consultation

Treatment:

Behavioral: Acceptance and Commitment Therapy

Standard treatment

Active Comparator group

Description:

Standard treatment is one single advisory consultation given 2 weeks after randomization

Treatment:

Behavioral: Acceptance and Commitment Therapy