Acceptance and Commitment Therapy (ACT) Group Treatment for Patients With Health Anxiety - Full Text View

Sponsor:	University of Aarhus
Information provided by (Responsible Party):	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01158430

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: Acceptance and Commitment Therapy (ACT) Other: Treatment as usual & waiting list

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:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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 ]

Estimated Enrollment:	120
Study Start Date:	August 2010
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group therapy, ACT	Behavioral: Acceptance and Commitment Therapy (ACT) 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 31.5 hours Other Name: Third generation cognitive behavioral therapy
No Intervention: Control Control group assigned to treatment as usual and waiting list. After 9 months they are offered ACT group therapy, but not as part of the research.	Other: Treatment as usual & waiting list The control group will receive treatment as usual and will be offered ACT after 9 months, but not as part of the research Other Name: Treatment as usual and waiting list

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Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion criteria:

Another severe psychiatric disorder or if the patient is suicidal.
Abuse of narcotics or alcohol and (non-prescribed) medicine.
Pregnancy.
No informed consent.

Contacts and Locations

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:

Related Info This link exits the ClinicalTrials.gov site

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:	May 11, 2012
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 May 23, 2012