Research Clinic for Functional Disorders
Aarhus, 8000, Denmark
NCT Number: NCT01518647
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.
Looking for future studies?
Notify Me20 year–50 year
All sexes
Interventional
Not applicable
Aarhus, 8000, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals
Time frame: 14 month after randomization
Questionnaire, patient-rated improvement of health since the beginning of the study.
Time frame: Before randomization, and at 6, 14 and 20 months after randomization
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Time frame: Before randomization, and at 6, 14 and 20 month after randomization
Time frame: Before randomization, and at 6, 14 and 20 month after randomization
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Time frame: Before randomization, and at 6, 14 and 20 month after randomization
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
University of Aarhus
Other
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)
Acronym: Stress-4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01518634
Medically Unexplained Symptoms, Mental Disorders
Aarhus, Denmark
View Trial DetailsNCT04835103
Medically Unexplained Symptoms, Mental Disorders
Douliu, Taiwan
View Trial DetailsNCT05631860
Bodily Distress Syndrome, Chronic Disease
View Trial DetailsNCT05611606
Bodily Distress Syndrome, Chronic Disease
View Trial Details