HypochondriasisACTNCT01158430
Acceptance and Commitment Group Therapy (ACT) for Patients With Health Anxiety
A study testing ACT group therapy in people with Hypochondriasis and Somatization Disorder, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hypochondriasis, Somatization Disorder
- What is being tested?
- ACT group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Another severe psychiatric disorder or if the patient is suicidal.
- Abuse of narcotics or alcohol and (non-prescribed) medicine.
- Pregnancy.
- No informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Research Clinic for Functional Disorders, Aarhus University Hospital
Aarhus C, 8000
About this study
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
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.
Read the 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.
- Conditions
- Hypochondriasis, Somatization Disorder
- Being tested
- ACT group therapy
- Keywords
- Hypochondriasis, Acceptance and Commitment Therapy, ACT
- Medical subject headings
- Hypochondriasis, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT group therapyBehavioural
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| ACT group therapy | Experimental | 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 Receives: Behavioral: ACT group therapy |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health anxiety measured by the Whiteley-7 index
Measured: 9 months (2nd follow-up)
Secondary outcomes (9)
Social level of functioning measured with Short Form health status questionnaire from the medical outcome status (SF-36)
Measured: 9 months (2nd follow-up)
Social level of functioning, emotional disorders measured with relevant sub-scales from Symptom Check List, 90 items (SCL 90)
Measured: 9 months (2nd follow-up)
Social level of functioning measured with an alcohol dependency questionnaire (CAGE)
Measured: 9 months (2nd follow-up)
Illness perception measured with Illness Perception Questionnaire (IPQ)
Measured: 9 months (2nd follow-up)
Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90)
Measured: 9 months (2nd follow-up)
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)).
Measured: 9 months (2nd follow-up)
Sick days (the DREAM database - the register-based evaluation of the extent of marginalization)
Measured: 9 months (2nd follow-up)
ACT process measures measured with Five Facet Mindfulness Questionnaire (FFMQ)
Measured: 9 months (2nd follow-up)
ACT process measures measured with Acceptance and Action Questionnaire - II (AAQ II)
Measured: 9 months (2nd follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypochondriasisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Fink, DMSc, Study director, The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158430
- Sponsor's protocol ID
- 2001001
- Acronym
- ACT
- Status last verified
- Apr 2013
- First submitted
- 16 Feb 2010
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31496462Eilenberg 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.
PubMed 26281857
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01158430
- Acronym / sponsor ID
- ACT / 2001001
- Conditions
- Hypochondriasis, Somatization Disorder
- Keywords
- Hypochondriasis, Acceptance and Commitment Therapy, ACT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT group therapy | Experimental | Behavioral: ACT group therapyThird 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 | No intervention | –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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- Another severe psychiatric disorder or if the patient is suicidal.
- Abuse of narcotics or alcohol and (non-prescribed) medicine.
- Pregnancy.
- No informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT group therapyAlso: Third generation cognitive behavioral therapyGroup 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 | Behavioural | ACT group therapy |
Primary outcome
Health anxiety measured by the Whiteley-7 index
Time frame: 9 months (2nd follow-up)
9 secondary outcomes
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)
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)
Social level of functioning measured with an alcohol dependency questionnaire (CAGE)
Time frame: 9 months (2nd follow-up)
Illness perception measured with Illness Perception Questionnaire (IPQ)
Time frame: 9 months (2nd follow-up)
Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90)
Time frame: 9 months (2nd follow-up)
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)
Sick days (the DREAM database - the register-based evaluation of the extent of marginalization)
Time frame: 9 months (2nd follow-up)
ACT process measures measured with Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: 9 months (2nd follow-up)
ACT process measures measured with Acceptance and Action Questionnaire - II (AAQ II)
Time frame: 9 months (2nd follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
- Derived from this study: PubMed 31496462Hoffmann 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.
- Derived from this study: PubMed 26281857Eilenberg 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.
- Related InfoLink provided by the sponsor.
Related trials for Hypochondriasis
Active, not recruiting
Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders
Anxiety Disorders, Obsessive-Compulsive Disorder
Recruiting
Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
Panic Disorder, Social Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Fink, DMSc study director
The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT group therapy in people with Hypochondriasis and Somatization Disorder, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health anxiety measured by the Whiteley-7 index (time frame: 9 months (2nd follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158430, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.