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

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)

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.

Study Overview

• Status: Completed
• Conditions: Somatoform Disorders; Somatisation Disorder
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Research Clinic for Functional Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Clinical Improvement Scale	Questionnaire, patient-rated improvement of health since the beginning of the study.	14 month after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	Questionnaire, patient-rated. Assessment of physical, social and mental functioning	Before randomization, and at 6, 14 and 20 months after randomization
Visual Analogue Scale for pain and worst symptom		Before randomization, and at 6, 14 and 20 month after randomization
Symptom Checklist (SCL)	Questionnaire, patient-rated. Assessment of physical, social and mental functioning	Before randomization, and at 6, 14 and 20 month after randomization
WHODAS II	Questionnaire, patient-rated. Assessment of physical, social and mental functioning	Before randomization, and at 6, 14 and 20 month after randomization

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Johanne L Agger, MD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2012
• Primary Completion (Actual): August 25, 2015
• Study Completion (Actual): February 9, 2016

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Treatment; Acceptance and Commitment Therapy; Medically unexplained symptoms; Functional somatic symptoms; Functional somatic syndromes; Bodily Distress Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Syndrome; Disease; Somatoform Disorders
• Other Study ID Numbers: M-20110265