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

University of Aarhus180 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Somatisation Disorder Somatoform Disorders

Interventions

Acceptance and Commitment TherapyBEHAVIORAL

Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Clinic for Functional Disorders

Aarhus, Denmark

Outcomes

Primary Outcomes

Global Clinical Improvement Scale

Questionnaire, patient-rated improvement of health since the beginning of the study.

Time frame: 14 month after randomization

Secondary Outcomes

SF-36

Questionnaire, patient-rated. Assessment of physical, social and mental functioning

Time frame: Before randomization, and at 6, 14 and 20 months after randomization

Visual Analogue Scale for pain and worst symptom

Time frame: Before randomization, and at 6, 14 and 20 month after randomization

Symptom Checklist (SCL)

Questionnaire, patient-rated. Assessment of physical, social and mental functioning

Time frame: Before randomization, and at 6, 14 and 20 month after randomization

WHODAS II

Questionnaire, patient-rated. Assessment of physical, social and mental functioning

Time frame: Before randomization, and at 6, 14 and 20 month after randomization

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.