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

Primary Purpose

Hypochondriasis, Somatization Disorder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ACT group therapy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypochondriasis focused on measuring Hypochondriasis, Acceptance and Commitment Therapy, ACT

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Research Clinic for Functional Disorders, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ACT group therapy

Control

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Health anxiety measured by the Whiteley-7 index

Secondary Outcome Measures

Social level of functioning measured with Short Form health status questionnaire from the medical outcome status (SF-36)
Social level of functioning, emotional disorders measured with relevant sub-scales from Symptom Check List, 90 items (SCL 90)
Social level of functioning measured with an alcohol dependency questionnaire (CAGE)
Illness perception measured with Illness Perception Questionnaire (IPQ)
Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90)
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)).
Sick days (the DREAM database - the register-based evaluation of the extent of marginalization)
ACT process measures measured with Five Facet Mindfulness Questionnaire (FFMQ)
ACT process measures measured with Acceptance and Action Questionnaire - II (AAQ II)

Full Information

First Posted
February 16, 2010
Last Updated
April 12, 2013
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01158430
Brief Title
Acceptance and Commitment Group Therapy (ACT) for Patients With Health Anxiety
Acronym
ACT
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Health anxiety disorder or Hypochondriasis is a prevalent somatoform disorder, but a rarely used diagnosis in clinical practice despite studies having reported prevalence between 0.8-9.5% in primary care (Fink et al, 2004). As a consequence, the disorder is rarely treated. The lack of valid, reliable, and generally accepted diagnostic criteria has been a major obstacle in clinical practice and Hypochondriasis studies, which causes problems particularly in distinguishing Hypochondriasis patients from other patients presenting with medically unexplained symptoms or functional symptoms. In 2004, the investigators introduced a radically revised definition of Hypochondriasis. Hypochondriasis is viewed as a stigmatizing label, and the designation health anxiety has been suggested as replacement. This new diagnosis is empirically established. The essential feature of health anxiety is that the patients present with cognitive symptoms such as unfounded worrying about their health. In contrast to other somatoform disorders, the patients are not necessarily plagued by physical symptoms. The new diagnostic criteria include the symptom 'obsessive rumination about illness' plus at least one of the symptoms 'worry or preoccupation with fears of harboring an illness or with bodily functions', 'suggestibility or autosuggestibility', 'an unrealistic fear of being infected or contaminated', 'an excessive fascination with medical information', or 'fear of taking prescribed medication'. In the current study, health anxiety is diagnosed by use of newly introduced empirically established positive criteria for Health anxiety (Fink et al, 2004). Most patients with health anxiety disorder receive the majority of their care in primary care settings. They are often unhappy with the services they receive, and primary care providers often feel unprepared to address symptoms that primarily appear functional. During the past 5 years, the investigators have treated patients suffering from severe functional disorder (i.e. Bodily distress syndrome or Somatization disorder) in randomized controlled trials (RCTs) - at the Research Clinic. The investigators reject many patients suffering from health anxiety, who have no other treatment opportunities, and there is an impending need for treatment opportunities. The investigators research group has done research in epidemiology, psychopathology and diagnostics of Health anxiety, and the investigators are part of international networks regarding the revision of the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V) and the International Classification of Diseases 11 (ICD-11). RCTs have shown that Cognitive Behavioral Therapy (CBT) has effect on health anxiety (Barsky & Ahern, 2004; Greeven et al., 2007), and one of the trials also showed effect of anti-depressant medication (Greeven et al., 2007). In general, the treatment of health anxiety is sparsely investigated both as to psychotherapy and medical treatment. The investigators wish to examine 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. Health anxiety disorder is a burden for the sufferers and costly for society due to lost working years because of early onset of the disorder and high health care costs. The development of evidence-based treatment offering these patients the same professional treatment as patients with other disorders may lead to better quality of life for the patients and reduction in health care costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypochondriasis, Somatization Disorder
Keywords
Hypochondriasis, Acceptance and Commitment Therapy, ACT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT group therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ACT group therapy
Other Intervention Name(s)
Third generation cognitive behavioral therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Health anxiety measured by the Whiteley-7 index
Time Frame
9 months (2nd follow-up)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Social level of functioning measured with an alcohol dependency questionnaire (CAGE)
Time Frame
9 months (2nd follow-up)
Title
Illness perception measured with Illness Perception Questionnaire (IPQ)
Time Frame
9 months (2nd follow-up)
Title
Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90)
Time Frame
9 months (2nd follow-up)
Title
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)
Title
Sick days (the DREAM database - the register-based evaluation of the extent of marginalization)
Time Frame
9 months (2nd follow-up)
Title
ACT process measures measured with Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame
9 months (2nd follow-up)
Title
ACT process measures measured with Acceptance and Action Questionnaire - II (AAQ II)
Time Frame
9 months (2nd follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Fink, DMSc
Organizational Affiliation
The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
The Research Clinic for Functional Disorders, Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31496462
Citation
Hoffmann D, Rask CU, Hedman-Lagerlof E, Eilenberg T, Frostholm L. Accuracy of self-referral in health anxiety: comparison of patients self-referring to internet-delivered treatment versus patients clinician-referred to face-to-face treatment. BJPsych Open. 2019 Sep 9;5(5):e80. doi: 10.1192/bjo.2019.54.
Results Reference
derived
PubMed Identifier
26281857
Citation
Eilenberg T, Fink P, Jensen JS, Rief W, Frostholm L. Acceptance and commitment group therapy (ACT-G) for health anxiety: a randomized controlled trial. Psychol Med. 2016 Jan;46(1):103-15. doi: 10.1017/S0033291715001579. Epub 2015 Aug 18.
Results Reference
derived
Links:
URL
http://www.functionaldisorders.dk
Description
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Acceptance and Commitment Group Therapy (ACT) for Patients With Health Anxiety

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