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Completed

NCT Number: NCT01518647

Acceptance and Commitment Therapy for Patients With Multi-organ Bodily Distress Syndrome (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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Clinic for Functional Disorders

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First time refered patients fulfilling diagnostic criteria for BDS multi-organ type with symptoms for more than 3 of 4 symptom categories
  • Moderate or severe impact on daily life
  • Symptoms lasting for at least 2 years
  • Age 20-50 years
  • Born in Denmark or have Danish parents. The patient understands, speaks, writes and read Danish.

Exclusion criteria

  • Presence og other physical of psychiatric condition, if the symptoms of this condition can not clearly be separated from symptoms of BDS
  • Patients with treatment demanding psychiatric disease as dominating problem
  • A lifetime-diagnosis of psychoses, mania or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
  • Abuse of alcohol, narcotics or drugs
  • Pregnancy at time of inclusion

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

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

Primary outcomes

  1. Global Clinical Improvement Scale

    Time frame: 14 month after randomization

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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)

Acronym: Stress-4

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jan 26, 2012
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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