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

Study Overview
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Brief Summary
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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 To develop an internet-delivered treatment program, based on 'Acceptance and Commitment Therapy' (ACT), for patients with health anxiety. 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
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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 To develop an internet-delivered treatment program for patients suffering from health anxiety based on ACT. 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: a reduction in physical symptoms and symptoms of anxiety and depression increased health-related quality of life more expedient illness perceptions and increased acceptance of symptoms Mediation analyses changes in illness perception and acceptance mediate the effect of iACT

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

Conditions
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Hypochondriasis

Intervention / Treatment
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* Behavioral: Internet-based ACT
* Other: Internet-based discussion forum


Participation Criteria
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Eligibility Criteria
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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 Lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3) Pregnancy Unstable psychopharmacological treatment within last 2 months Former treatment at the Research Clinic for Functional Disorders and Psychosomatics Not providing informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based ACT<br>Brief clinical psychiatric assessment to determine eligibility (video-based). | Behavioral: Internet-based ACT<br>* The 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.<br>|
| Active Comparator: Internet-based discussion forum<br>Brief clinical psychiatric assessment to determine eligibility (video-based). | Other: Internet-based discussion forum<br>* The 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whiteley-7 index | Health anxiety symptoms | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund) |  | At baseline (i.e. at self-referral) | 
| Diagnosed somatic illnesses 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health anxiety, illness anxiety disorder, ACT, internet