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

Somatoform Disorders Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518647
• Other study ID #: M-20110265
• 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
• 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

Related Conditions & MeSH terms

• Disease
• Somatisation Disorder
• Somatoform Disorders
• Syndrome

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