NCT01518647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

January 25, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2016

Completed
Last Updated

May 9, 2017

Status Verified

May 1, 2017

Enrollment Period

3.6 years

First QC Date

January 13, 2012

Last Update Submit

May 8, 2017

Conditions

Somatisation DisorderSomatoform Disorders

Keywords

Bodily Distress SyndromeMedically unexplained symptomsFunctional somatic symptomsFunctional somatic syndromesTreatmentAcceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

  • Global Clinical Improvement Scale

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

    14 month after randomization

Secondary Outcomes (4)

  • SF-36

    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)

    Before randomization, and at 6, 14 and 20 month after randomization

  • WHODAS II

    Before randomization, and at 6, 14 and 20 month after randomization

Study Arms (3)

Group Therapy

EXPERIMENTAL

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

Workshop

EXPERIMENTAL

ACT given as a one-day workshop with 15 patients with a following individual consultation

Behavioral: Acceptance and Commitment Therapy

Standard treatment

ACTIVE COMPARATOR

Standard treatment is one single advisory consultation given 2 weeks after randomization

Behavioral: Acceptance and Commitment Therapy

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

Group TherapyStandard treatmentWorkshop

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Clinic for Functional Disorders

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Somatoform DisordersMedically Unexplained Symptoms

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Mental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Johanne L Agger, MD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2012

First Posted

January 26, 2012

Study Start

January 25, 2012

Primary Completion

August 25, 2015

Study Completion

February 9, 2016

Last Updated

May 9, 2017

Record last verified: 2017-05

Locations

DK(1)