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Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (Stress-4)

This study is currently recruiting participants.
Verified January 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01518647
First received: January 13, 2012
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Somatisation Disorder
Somatoform Disorders
 Behavioral: Acceptance and Commitment Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Global Clinical Improvement Scale [ Time Frame: 14 month after randomization ] [ Designated as safety issue: No ]
    Questionnaire, patient-rated improvement of health since the beginning of the study.


Secondary Outcome Measures:
  • SF-36 [ Time Frame: Before randomization, and at 6, 14 and 20 months after randomization ] [ Designated as safety issue: No ]
    Questionnaire, patient-rated. Assessment of physical, social and mental functioning

  • Visual Analogue Scale for pain and worst symptom [ Time Frame: Before randomization, and at 6, 14 and 20 month after randomization ] [ Designated as safety issue: No ]
  • Symptom Checklist (SCL) [ Time Frame: Before randomization, and at 6, 14 and 20 month after randomization ] [ Designated as safety issue: No ]
    Questionnaire, patient-rated. Assessment of physical, social and mental functioning

  • WHODAS II [ Time Frame: Before randomization, and at 6, 14 and 20 month after randomization ] [ Designated as safety issue: No ]
    Questionnaire, patient-rated. Assessment of physical, social and mental functioning


Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Therapy
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
Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals
Experimental: Workshop
ACT given as a one-day workshop with 15 patients with a following individual consultation
 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
Active Comparator: Standard treatment
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518647

Contacts
Contact: Johanne L Agger, MD +4578464344 johanne.agger@aarhus.rm.dk
Contact: Per K Fink, Dr. med +4578464310 per.fink@aarhus.rm.dk

Locations
Denmark
Research Clinic for Functional Disorders Recruiting
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Johanne L Agger, MD Research Clinic for Functional Disorders, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01518647     History of Changes
Other Study ID Numbers: M-20110265
Study First Received: January 13, 2012
Last Updated: January 11, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Bodily Distress Syndrome
Medically unexplained symptoms
Functional somatic symptoms
 Functional somatic syndromes
Treatment
Acceptance and Commitment Therapy

Additional relevant MeSH terms:
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013