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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Somatisation Disorder, Somatoform Disorders

Intervention / Treatment
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* Behavioral: Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories Moderate or severe impact on daily life Symptoms lasting for at least 2 years Age 20-50 years Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish. Exclusion Criteria: Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS Patients with treatment demanding psychiatric disease as dominating problem A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3) Abuse of alcohol, narcotics or drugs Pregnancy at time of inclusion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Therapy<br>ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month | Behavioral: Acceptance and Commitment Therapy<br>* Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals<br>|
| Experimental: Workshop<br>ACT given as a one-day workshop with 15 patients with a following individual consultation | Behavioral: Acceptance and Commitment Therapy<br>* Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals<br>|
| Active Comparator: Standard treatment<br>Standard treatment is one single advisory consultation given 2 weeks after randomization | Behavioral: Acceptance and Commitment Therapy<br>* Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Clinical Improvement Scale | Questionnaire, patient-rated improvement of health since the beginning of the study. | 14 month after randomization | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bodily Distress Syndrome, Medically unexplained symptoms, Functional somatic symptoms, Functional somatic syndromes, Treatment, Acceptance and Commitment Therapy