Clinical Trials Directory

Trials / Completed

CompletedNCT02735434

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
101 (actual)
Sponsor
University of Aarhus · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALInternet-based ACTThe guided internet program consists of 7 modules activated consecutively over a period of 12 weeks. The content is written psycho education, patient videos, audio-exercises and behavioural exposure exercises. The program is therapist-guided; hence all patients will receive support from primarily the same therapist during the 12 weeks.
OTHERInternet-based discussion forumThe online discussion forum consists of 7 themes touching upon the impact of health anxiety and the patients own coping strategies. The themes are activated consecutively over a period of 12 weeks. The discussion forum is text-based, and only patients will participate in the discussion. The written discussions will be reviewed by a professional for ethical reasons. The discussion forum aims to control for the effect of attention and contacts to the health care system. After 9 months patients in the discussion forum are offered active treatment, but not as part of the research project.

Timeline

Start date
2016-04-01
Primary completion
2017-04-01
Completion
2018-03-01
First posted
2016-04-12
Last updated
2021-04-30

Source: ClinicalTrials.gov record NCT02735434. Inclusion in this directory is not an endorsement.