Acceptance and Commitment Group Therapy (ACT) for Patients With Health Anxiety
This study has been completed.
Sponsor:
University of Aarhus
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
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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:
- 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:
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 May 23, 2013