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Clinical Trials/NCT02735434
NCT02735434
Completed
Not Applicable

Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety: a Randomized Controlled Trial

University of Aarhus0 sites101 target enrollmentApril 2016
ConditionsHypochondriasis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypochondriasis
Sponsor
University of Aarhus
Enrollment
101
Primary Endpoint
Whiteley-7 index
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Health anxiety is a prevalent, disabling disorder associated with extensive health care expenditures. The lack of easily accessible, evidence-based psychological treatment combined with delayed diagnostic recognition constitute barriers to receiving treatment.

Aim

  1. To develop an internet-delivered treatment program, based on 'Acceptance and Commitment Therapy' (ACT), for patients with health anxiety.
  2. To test the feasibility and effectiveness of the treatment programme in a randomized, controlled trial, comparing the treatment with an active control condition.

Methods 150 patients aged 18 years and older can self-refer through a web-page to apply for participation. Before inclusion patients will undergo a video-diagnostic interview. Patients are randomly assigned to 12 weeks of either, 1) active treatment: consisting of internet-based ACT (iACT) with 7 therapist-guided modules of self-help text, exercises, patient videos and audio-files, or 2) active control condition: consisting of an internet-based discussion forum (iFORUM) with 7 topics of discussion.

All patients will complete self-report questionnaires at baseline, before randomization, at 4 and 8 weeks into treatment, after end of treatment, and at 6-month follow-up.

Detailed Description

Severe health anxiety (illness anxiety disorder) or hypochondriasis, according to the psychiatric classification system ICD-10, is characterized by preoccupation with fear of having a serious illness, which interferes with daily functions and persists despite medical reassurance. Clinical significant health anxiety is prevalent in primary care with 0.8-9.5%, and has a lifetime prevalence of 5.7% in the general population. It is a disabling disorder, associated with extensive use of health care services and occupational disability. Earlier, health anxiety has been considered a chronic disease with poor treatment outcomes. A recent review found effect of both medicine and psychotherapy, but patients may prefer psychotherapeutic treatments. Despite the high prevalence, health anxiety is rarely diagnosed within primary care, and there is limited access to evidence-based treatment for health anxiety. An easily accessible, evidence-based treatment is needed for this debilitating condition. Internet-based treatment is a new approach where patients receive access to a guided self-help program. A meta-analysis has shown equal treatment effects of internet-based treatment compared to "face-to-face" treatment for depressive- and anxiety disorders. Internet-based cognitive behavioral therapy for health anxiety has shown to be cost-effective. ACT is a new effective generation of cognitive-behavioral therapy, with an emphasis on acceptance and value-based exposure that has shown good results for treating health anxiety in a group setting. Internet-based Cognitive behavioral therapy (CBT) for health anxiety has shown promising results but low treatment completion. This may be due to the comprehensive treatment modules and the text-based format. ACT is an experiential behavioral therapy, and aims to activate patients with exercises, videos, audio-files and less text material. Most persons with health anxiety have high health care expenditure. However, some patients with health anxiety avoid contact to the health care system, and may not receive proper treatment. Patient self-referral is a new approach that may facilitate access to treatment. Aim 1. To develop an internet-delivered treatment program for patients suffering from health anxiety based on ACT. 2. To test the feasibility and effectiveness of the treatment programme in a randomized, controlled trial, comparing treatment with an active control condition. Hypothesis Primary hypothesis Patients with health anxiety treated with iACT will at 6-month follow-up report a significant reduction in illness worry compared to the action control condition iFORUM. Secondary hypotheses Patients with health anxiety treated with iACT compared to the active control condition iFORUM will at 6-month follow-up report: 1. a reduction in physical symptoms and symptoms of anxiety and depression 2. increased health-related quality of life 3. more expedient illness perceptions and increased acceptance of symptoms Mediation analyses 4. changes in illness perception and acceptance mediate the effect of iACT

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
March 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Severe health anxiety \> 6 months
  • Whiteley-7 score (scale 0-100 score points) corresponding to 21,4 or more.
  • Age above 18 years old
  • In case of a comorbid functional or other psychiatric disorder health anxiety must be the dominant problem
  • Patients who speak, read and write Danish
  • Access to a computer and internet access
  • Residence in Denmark
  • Exclusion criteria:
  • Acute suicidal risk
  • Abuse of narcotics or alcohol and (non-prescribed) medicine

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Whiteley-7 index

Time Frame: At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation

Health anxiety symptoms

Secondary Outcomes

  • Health anxiety symptoms measured with the Short Health Anxiety Inventory (SHAI)(At baseline (i.e. at self-referral), and 3 and 9 months after randomisation)
  • Quality of life measured with the visual analogue scale (VAS question) from Youth profile, National Institute of Public Health(At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation)
  • Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist)(At baseline (i.e. at self-referral))
  • General health status and functioning measured with the Short Form 12 Health Survey (SF-12)(At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline), 3 and 9 months after randomisation)
  • Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund)(At baseline (i.e. at self-referral))
  • Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)(At baseline (i.e. at self-referral))
  • Quality of life measured with the World Health Organisation Well-being Index-Five (WHO-5)(At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation)
  • Stress measured with questions from the survey Youth stress, Danish Health Authority(At baseline (i.e. at self-referral), before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline) and 1, 2, 3 and 9 months after randomisation)
  • Anxiety, depression, obsessive-compulsive and physical symptoms measured with subscales from the Symptom Checklist (SCL-92)(At baseline (i.e. at self-referral), and 3 and 9 months after randomisation)

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