Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01518647
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Somatisation Disorder Somatoform Disorders Behavioral: Acceptance and Commitment Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : January 25, 2012
Actual Primary Completion Date : August 25, 2015
Actual Study Completion Date : February 9, 2016

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Global Clinical Improvement Scale [ Time Frame: 14 month after randomization ]
    Questionnaire, patient-rated improvement of health since the beginning of the study.


Secondary Outcome Measures :
  1. SF-36 [ Time Frame: Before randomization, and at 6, 14 and 20 months after randomization ]
    Questionnaire, patient-rated. Assessment of physical, social and mental functioning

  2. Visual Analogue Scale for pain and worst symptom [ Time Frame: Before randomization, and at 6, 14 and 20 month after randomization ]
  3. Symptom Checklist (SCL) [ Time Frame: Before randomization, and at 6, 14 and 20 month after randomization ]
    Questionnaire, patient-rated. Assessment of physical, social and mental functioning

  4. WHODAS II [ Time Frame: Before randomization, and at 6, 14 and 20 month after randomization ]
    Questionnaire, patient-rated. Assessment of physical, social and mental functioning



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01518647


Locations
Layout table for location information
Denmark
Research Clinic for Functional Disorders
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Principal Investigator: Johanne L Agger, MD Research Clinic for Functional Disorders, Aarhus University Hospital
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01518647    
Other Study ID Numbers: M-20110265
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
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:
Layout table for MeSH terms
Disease
Syndrome
Somatoform Disorders
Pathologic Processes
Mental Disorders