An interventional study of Acceptance and Commitment Therapy in Somatisation Disorder and Somatoform Disorders, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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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This study's enrollment of 180 is above the median of 50 across 6,515 interventional studies indexed under Syndrome.
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Exclusion Criteria:
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
ACT given as a one-day workshop with 15 patients with a following individual consultation
Behavioral: Acceptance and Commitment Therapy
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
Global Clinical Improvement Scale
Questionnaire, patient-rated improvement of health since the beginning of the study.
Time frame: 14 month after randomization
SF-36
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Time frame: Before randomization, and at 6, 14 and 20 months after randomization
Visual Analogue Scale for pain and worst symptom
Time frame: Before randomization, and at 6, 14 and 20 month after randomization
Symptom Checklist (SCL)
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Time frame: Before randomization, and at 6, 14 and 20 month after randomization
WHODAS II
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Time frame: Before randomization, and at 6, 14 and 20 month after randomization
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of Aarhus