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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Denmark

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.

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 groups in NCT01158430
Study groupRoleWhat they receive
ACT group therapyExperimentalThird 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
ControlNo interventionControl 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.

  1. Health anxiety measured by the Whiteley-7 index

    Measured: 9 months (2nd follow-up)

Secondary outcomes (9)
  1. Social level of functioning measured with Short Form health status questionnaire from the medical outcome status (SF-36)

    Measured: 9 months (2nd follow-up)

  2. 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)

  3. Social level of functioning measured with an alcohol dependency questionnaire (CAGE)

    Measured: 9 months (2nd follow-up)

  4. Illness perception measured with Illness Perception Questionnaire (IPQ)

    Measured: 9 months (2nd follow-up)

  5. Physical symptoms measured with somatisation subscales from Symptom Check List, 90 items (SCL 90)

    Measured: 9 months (2nd follow-up)

  6. 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)

  7. Sick days (the DREAM database - the register-based evaluation of the extent of marginalization)

    Measured: 9 months (2nd follow-up)

  8. ACT process measures measured with Five Facet Mindfulness Questionnaire (FFMQ)

    Measured: 9 months (2nd follow-up)

  9. 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.

  1. First posted8 Jul 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

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)
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 31496462
  • 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.

    PubMed 26281857

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.

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