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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01518647
Other study ID # M-20110265
Secondary ID
Status Completed
Phase N/A
First received January 13, 2012
Last updated May 8, 2017
Start date January 25, 2012
Est. completion date February 9, 2016

Study information

Verified date May 2017
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
Denmark Research Clinic for Functional Disorders Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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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