Clinical Trial: Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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
Sponsor: University of Aarhus

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Aarhus

Dates:
Date Received: April 1, 2016
Date Started: April 2016
Date Completion: July 2018
Last Updated: May 2, 2017
Last Verified: March 2017