Back to resultsAcceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4) (Stress-4)
Primary Purpose
Somatisation Disorder, Somatoform Disorders
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Somatisation Disorder focused on measuring Bodily Distress Syndrome, Medically unexplained symptoms, Functional somatic symptoms, Functional somatic syndromes, Treatment, Acceptance and Commitment Therapy
Eligibility Criteria
Inclusion Criteria:
- First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
- Moderate or severe impact on daily life
- Symptoms lasting for at least 2 years
- Age 20-50 years
- Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.
Exclusion Criteria:
- Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
- Patients with treatment demanding psychiatric disease as dominating problem
- A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
- Abuse of alcohol, narcotics or drugs
- Pregnancy at time of inclusion
Sites / Locations
- Research Clinic for Functional Disorders
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group Therapy
Workshop
Standard treatment
Arm Description
ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month
ACT given as a one-day workshop with 15 patients with a following individual consultation
Standard treatment is one single advisory consultation given 2 weeks after randomization
Outcomes
Primary Outcome Measures
Global Clinical Improvement Scale
Questionnaire, patient-rated improvement of health since the beginning of the study.
Secondary Outcome Measures
SF-36
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Visual Analogue Scale for pain and worst symptom
Symptom Checklist (SCL)
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
WHODAS II
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01518647
Brief Title
Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4)
Acronym
Stress-4
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 25, 2012 (Actual)
Primary Completion Date
August 25, 2015 (Actual)
Study Completion Date
February 9, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatisation Disorder, Somatoform Disorders
Keywords
Bodily Distress Syndrome, Medically unexplained symptoms, Functional somatic symptoms, Functional somatic syndromes, Treatment, Acceptance and Commitment Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Therapy
Arm Type
Experimental
Arm Description
ACT given as conventional group therapy in groups of 7-8 patients 3,5 hours each session, 9 sessions during 3 month
Arm Title
Workshop
Arm Type
Experimental
Arm Description
ACT given as a one-day workshop with 15 patients with a following individual consultation
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Standard treatment is one single advisory consultation given 2 weeks after randomization
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Intervention Description
Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals
Primary Outcome Measure Information:
Title
Global Clinical Improvement Scale
Description
Questionnaire, patient-rated improvement of health since the beginning of the study.
Time Frame
14 month after randomization
Secondary Outcome Measure Information:
Title
SF-36
Description
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Time Frame
Before randomization, and at 6, 14 and 20 months after randomization
Title
Visual Analogue Scale for pain and worst symptom
Time Frame
Before randomization, and at 6, 14 and 20 month after randomization
Title
Symptom Checklist (SCL)
Description
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Time Frame
Before randomization, and at 6, 14 and 20 month after randomization
Title
WHODAS II
Description
Questionnaire, patient-rated. Assessment of physical, social and mental functioning
Time Frame
Before randomization, and at 6, 14 and 20 month after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
Moderate or severe impact on daily life
Symptoms lasting for at least 2 years
Age 20-50 years
Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.
Exclusion Criteria:
Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
Patients with treatment demanding psychiatric disease as dominating problem
A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
Abuse of alcohol, narcotics or drugs
Pregnancy at time of inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johanne L Agger, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Clinic for Functional Disorders
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4)
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