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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Therapy | Experimental | ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month |
|
| Workshop | Experimental | ACT given as a one-day workshop with 15 patients with a following individual consultation |
|
| Standard treatment | Active Comparator | Standard treatment is one single advisory consultation given 2 weeks after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals |
| Measure | Description | Time Frame |
|---|---|---|
| Global Clinical Improvement Scale | Questionnaire, patient-rated improvement of health since the beginning of the study. | 14 month after randomization |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johanne L Agger, MD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Clinic for Functional Disorders | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D013001 | Somatoform Disorders |
| D000071896 | Medically Unexplained Symptoms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| 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 |