Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group Therapy 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
Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals
|
| Experimental: Workshop ACT given as a one-day workshop with 15 patients with a following individual consultation |
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
|
| Active Comparator: Standard treatment Standard treatment is one single advisory consultation given 2 weeks after randomization |
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
|
Outcome Measures
Primary Outcome Measures
- Global Clinical Improvement Scale [14 month after randomization]
Questionnaire, patient-rated improvement of health since the beginning of the study.
Secondary Outcome Measures
- SF-36 [Before randomization, and at 6, 14 and 20 months after randomization]
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
- Visual Analogue Scale for pain and worst symptom [Before randomization, and at 6, 14 and 20 month after randomization]
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
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Moderate or severe impact on daily life
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Symptoms lasting for at least 2 years
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Age 20-50 years
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Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.
Exclusion Criteria:
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Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
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Patients with treatment demanding psychiatric disease as dominating problem
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A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
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Abuse of alcohol, narcotics or drugs
-
Pregnancy at time of inclusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Clinic for Functional Disorders | Aarhus | Denmark | 8000 |
Sponsors and Collaborators
- University of Aarhus
Investigators
- Principal Investigator: Johanne L Agger, MD, Aarhus University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- M-20110265