Somatoform Disorders Clinical Trial
— Stress-4Official title:
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)
Verified date | May 2017 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | February 9, 2016 |
Est. primary completion date | August 25, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Research Clinic for Functional Disorders | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global Clinical Improvement Scale | Questionnaire, patient-rated improvement of health since the beginning of the study. | 14 month after randomization | |
Secondary | SF-36 | Questionnaire, patient-rated. Assessment of physical, social and mental functioning | Before randomization, and at 6, 14 and 20 months after randomization | |
Secondary | Visual Analogue Scale for pain and worst symptom | Before randomization, and at 6, 14 and 20 month after randomization | ||
Secondary | Symptom Checklist (SCL) | Questionnaire, patient-rated. Assessment of physical, social and mental functioning | Before randomization, and at 6, 14 and 20 month after randomization | |
Secondary | WHODAS II | Questionnaire, patient-rated. Assessment of physical, social and mental functioning | Before randomization, and at 6, 14 and 20 month after randomization |
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