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

University of Aarhus

Status: Completed

Conditions: Hypochondriasis

Treatments: Behavioral: Internet-based ACT; Other: Internet-based discussion forum

Study type: Interventional

Funder types: Other

Identifiers

NCT02735434

09032016

Details and patient eligibility

About

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.

Full 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

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Internet-based ACT

Experimental group

Description:

Brief clinical psychiatric assessment to determine eligibility (video-based).

Treatment:

Behavioral: Internet-based ACT

Internet-based discussion forum

Active Comparator group

Description:

Brief clinical psychiatric assessment to determine eligibility (video-based).

Treatment:

Other: Internet-based discussion forum