Clinical trial NCT01518647: Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Somatisation Disorder
Somatoform Disorders
Keywords: Bodily Distress Syndrome
Medically unexplained symptoms
Functional somatic symptoms
Functional somatic syndromes
Treatment
Acceptance and Commitment Therapy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Global Clinical Improvement Scale
timeFrame: 14 month after randomization
Secondary outcomes:
measure: SF-36
timeFrame: Before randomization, and at 6, 14 and 20 months after randomization
measure: Visual Analogue Scale for pain and worst symptom
timeFrame: Before randomization, and at 6, 14 and 20 month after randomization
measure: Symptom Checklist (SCL)
timeFrame: Before randomization, and at 6, 14 and 20 month after randomization
measure: WHODAS II
timeFrame: Before randomization, and at 6, 14 and 20 month after randomization
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Research Clinic for Functional Disorders
Study officials:
affiliation: Aarhus University Hospital
name: Johanne L Agger, MD
role: PRINCIPAL_INVESTIGATOR
References: