- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02735434
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
- 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Internet-based ACT
Brief clinical psychiatric assessment to determine eligibility (video-based).
|
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.
|
ACTIVE_COMPARATOR: Internet-based discussion forum
Brief clinical psychiatric assessment to determine eligibility (video-based).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 |
Time Frame |
---|---|
Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)
Time Frame: At baseline (i.e. at self-referral)
|
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)
|
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
|
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
|
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
|
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
|
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
|
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)
|
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
|
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
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Psychological flexibility measured with the Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
|
At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
|
Non-reactivity measured with a subscale of the Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
|
At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
|
Illness perception measured with the Brief Illness Perception Questionnaire (B-IPQ)
Time Frame: At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
|
At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
|
Personality traits measured with the short version of the Big Five Inventory (BFI-10)
Time Frame: Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Working alliance measured with the Working Alliance Inventory, Patient version (WAI-pt)
Time Frame: 2 weeks into treatment, and 3 months after randomisation
|
2 weeks into treatment, and 3 months after randomisation
|
Treatment credibility and expectancy measured with the credibility/ expectancy questionnaire
Time Frame: Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Childhood history questionnaire
Time Frame: Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Traumatic events in childhood measured with the Childhood traumatic event scale
Time Frame: Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Attachment style measured with the questionnaire: Experiences in close relationships - relationship structures (ECR-RS)
Time Frame: Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
|
Treatment evaluation of negative effects measured with the Inventory for the assessment of negative effects of psychotherapy (INEP)
Time Frame: 9 months after randomisation
|
9 months after randomisation
|
Attitudes toward seeking professional help
Time Frame: At baseline (i.e. at self-referral) and at 3 months after randomisation
|
At baseline (i.e. at self-referral) and at 3 months after randomisation
|
Self-reported health care use, work performance and work absence measured with Trimbos/ institute of Health Policy and Management (iMTA) questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Time Frame: At baseline (i.e. at self-referral) and at 9 months after randomisation
|
At baseline (i.e. at self-referral) and at 9 months after randomisation
|
Health care expenditures extracted from Danish national registers, and degree of illness related absence from work extracted from the Danish Register of Sickness absence compensation benefits and Social transfer payments database (DREAM).
Time Frame: At baseline (i.e. at self-referral) and at 9 months after randomisation
|
At baseline (i.e. at self-referral) and at 9 months after randomisation
|
Health literacy measured with the Health Literacy Questionnaire (HLQ)
Time Frame: At baseline (i.e. at self-referral)
|
At baseline (i.e. at self-referral)
|
Values measured with the Sources of Meaning and Meaning in life questionnaire (SoMe-26)
Time Frame: At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
|
At baseline (i.e. at self-referral), and 1, 2, 3 and 9 months after randomisation
|
Negative events and effects of psychological treatment
Time Frame: At 3 months after randomisation
|
At 3 months after randomisation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charlotte U Rask, PhD, Aarhus University Hospital
Publications and helpful links
General Publications
- Risor BW, Frydendal DH, Villemoes MK, Nielsen CP, Rask CU, Frostholm L. Cost Effectiveness of Internet-Delivered Acceptance and Commitment Therapy for Patients with Severe Health Anxiety: A Randomised Controlled Trial. Pharmacoecon Open. 2022 Mar;6(2):179-192. doi: 10.1007/s41669-021-00319-x. Epub 2022 Jan 8.
- Hoffmann D, Rask CU, Hedman-Lagerlof E, Jensen JS, Frostholm L. Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial. Psychol Med. 2021 Nov;51(15):2685-2695. doi: 10.1017/S0033291720001312. Epub 2020 May 14.
- Hoffmann D, Rask CU, Hedman-Lagerlof E, Eilenberg T, Frostholm L. Accuracy of self-referral in health anxiety: comparison of patients self-referring to internet-delivered treatment versus patients clinician-referred to face-to-face treatment. BJPsych Open. 2019 Sep 9;5(5):e80. doi: 10.1192/bjo.2019.54.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09032016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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