Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety
Primary Purpose
Hypochondriasis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-based ACT
Internet-based discussion forum
Sponsored by
About this trial
This is an interventional treatment trial for Hypochondriasis focused on measuring Health anxiety, illness anxiety disorder, ACT, internet
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Internet-based ACT
Internet-based discussion forum
Arm Description
Brief clinical psychiatric assessment to determine eligibility (video-based).
Brief clinical psychiatric assessment to determine eligibility (video-based).
Outcomes
Primary Outcome Measures
Whiteley-7 index
Health anxiety symptoms
Secondary Outcome Measures
Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)
Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund)
Quality of life measured with the World Health Organisation Well-being Index-Five (WHO-5)
Quality of life measured with the visual analogue scale (VAS question) from Youth profile, National Institute of Public Health
Stress measured with questions from the survey Youth stress, Danish Health Authority
Health anxiety symptoms measured with the Short Health Anxiety Inventory (SHAI)
Anxiety, depression, obsessive-compulsive and physical symptoms measured with subscales from the Symptom Checklist (SCL-92)
Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist)
General health status and functioning measured with the Short Form 12 Health Survey (SF-12)
Full Information
NCT ID
NCT02735434
First Posted
April 1, 2016
Last Updated
April 27, 2021
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02735434
Brief Title
Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety
Official Title
Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypochondriasis
Keywords
Health anxiety, illness anxiety disorder, ACT, internet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internet-based ACT
Arm Type
Experimental
Arm Description
Brief clinical psychiatric assessment to determine eligibility (video-based).
Arm Title
Internet-based discussion forum
Arm Type
Active Comparator
Arm Description
Brief clinical psychiatric assessment to determine eligibility (video-based).
Intervention Type
Behavioral
Intervention Name(s)
Internet-based ACT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Internet-based discussion forum
Intervention Description
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.
Primary Outcome Measure Information:
Title
Whiteley-7 index
Description
Health anxiety symptoms
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
Secondary Outcome Measure Information:
Title
Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)
Time Frame
At baseline (i.e. at self-referral)
Title
Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund)
Time Frame
At baseline (i.e. at self-referral)
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist)
Time Frame
At baseline (i.e. at self-referral)
Title
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
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
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
Title
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)
Title
Working alliance measured with the Working Alliance Inventory, Patient version (WAI-pt)
Time Frame
2 weeks into treatment, and 3 months after randomisation
Title
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)
Title
Childhood history questionnaire
Time Frame
Before randomisation (i.e. after clinical assessment and up to 6 weeks after baseline)
Title
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)
Title
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)
Title
Treatment evaluation of negative effects measured with the Inventory for the assessment of negative effects of psychotherapy (INEP)
Time Frame
9 months after randomisation
Title
Attitudes toward seeking professional help
Time Frame
At baseline (i.e. at self-referral) and at 3 months after randomisation
Title
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
Title
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
Title
Health literacy measured with the Health Literacy Questionnaire (HLQ)
Time Frame
At baseline (i.e. at self-referral)
Title
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
Title
Negative events and effects of psychological treatment
Time Frame
At 3 months after randomisation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisbeth Frostholm, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charlotte U Rask, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34997899
Citation
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.
Results Reference
derived
PubMed Identifier
32404226
Citation
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.
Results Reference
derived
PubMed Identifier
31496462
Citation
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.
Results Reference
derived
Links:
URL
http://www.functionaldisorders.dk
Description
Homepage for the Research Clinic for Functional Disorders, Aarhus University Hospital
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Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety
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