Acceptance and Commitment Group Therapy (ACT) for Patients With Health Anxiety

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01158430
First received: February 16, 2010
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine the effect of Acceptance and Commitment Therapy (ACT) in groups on functional level, emotional problems, and use of health care in patients with severe health anxiety in a randomized, controlled design.


Condition Intervention
Hypochondriasis
Somatization Disorder
Behavioral: ACT group therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Patients With Health Anxiety. A Randomized Controlled Trial of Acceptance and Commitment Therapy (ACT) Group Treatment Compared to a Waiting List

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Health anxiety measured by the Whiteley-7 index [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social level of functioning measured with Short Form health status questionnaire from the medical outcome status (SF-36) [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]
  • Social level of functioning, emotional disorders measured with relevant sub-scales from Symptom Check List, 90 items (SCL 90) [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]
  • Social level of functioning measured with an alcohol dependency questionnaire (CAGE) [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]
  • Illness perception measured with Illness Perception Questionnaire (IPQ) [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]
  • Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90) [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]
  • Health care use (National Patient Register & National Health Service Register (general practitioner (GP) contacts/consultations, specialists, physiotherapists, dentists, GPs' emergency service), The Danish Medicine Agency (medicine consumption)). [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]
  • Sick days (the DREAM database - the register-based evaluation of the extent of marginalization) [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]
  • ACT process measures measured with Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]
  • ACT process measures measured with Acceptance and Action Questionnaire - II (AAQ II) [ Time Frame: 9 months (2nd follow-up) ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: March 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACT group therapy

Third generation cognitive behavioral therapy

Group therapy (ACT) in groups of 9 patients in 9 weekly 3.5-hours sessions & 1 booster session 1 month after 9th session, a total of 35.5 hours

Behavioral: ACT group therapy
Group therapy (ACT) in groups of 9 patients in 9 weekly 3.5-hours sessions & 1 booster session 1 month after 9th session, a total of 35.5 hours
Other Name: Third generation cognitive behavioral therapy
No Intervention: Control
Control group assigned to wait list (treatment as usual). After 9 months they are offered ACT group therapy, but not as part of the research project.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Whiteley-7 score on 21,4 or more (scale 0-100 score points).
  2. Severe health anxiety (diagnosed by SCAN interview).
  3. Age 20-60 years
  4. Patients of Scandinavian origin who understand, read, write and speak Danish.
  5. No lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
  6. In case of a co morbid functional or other psychiatric disorder health anxiety must be the dominating problem.

Exclusion criteria:

  1. Another severe psychiatric disorder or if the patient is suicidal.
  2. Abuse of narcotics or alcohol and (non-prescribed) medicine.
  3. Pregnancy.
  4. No informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158430

Locations
Denmark
The Research Clinic for Functional Disorders, Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Per Fink, DMSc The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01158430     History of Changes
Other Study ID Numbers: 2001001
Study First Received: February 16, 2010
Last Updated: April 12, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Hypochondriasis
Acceptance and Commitment Therapy
ACT

Additional relevant MeSH terms:
Hypochondriasis
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 23, 2014