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

Not Applicable

Completed

• Conditions: Hypochondriasis
• Interventions: Other: Internet-based discussion forum; Behavioral: Internet-based ACT

• Registration Number: NCT02735434
• Lead Sponsor: University of Aarhus

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

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-12
• Status Verified: 2017-03
• Primary Completion: 2017-04
• Study Completion: 2018-03
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. Severe health anxiety > 6 months
2. Whiteley-7 score (scale 0-100 score points) corresponding to 21,4 or more.
3. Age above 18 years old
4. In case of a comorbid functional or other psychiatric disorder health anxiety must be the dominant problem
5. Patients who speak, read and write Danish
6. Access to a computer and internet access
7. Residence in Denmark

Exclusion criteria:

1. Acute suicidal risk
2. Abuse of narcotics or alcohol and (non-prescribed) medicine
3. Lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (ICD-10: F20-29, F30-31, F32.3, F33.3)
4. Pregnancy
5. Unstable psychopharmacological treatment within last 2 months
6. Former treatment at the Research Clinic for Functional Disorders and Psychosomatics
7. Not providing informed consent

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based discussion forum	Internet-based discussion forum	Brief clinical psychiatric assessment to determine eligibility (video-based).
Internet-based ACT	Internet-based ACT	Brief clinical psychiatric assessment to determine eligibility (video-based).

Primary Outcome Measures

Name	Time	Method
Whiteley-7 index	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 Outcome Measures

Name	Time	Method
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