HypochondriasisNCT02735434
Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety
A study testing Internet-based ACT and Internet-based discussion forum in people with Hypochondriasis, run by University of Aarhus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypochondriasis
- What is being tested?
- Internet-based ACT and Internet-based discussion forum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
Read more
- 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.
Read the 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
- Conditions
- Hypochondriasis
- Being tested
- Internet-based ACT, Internet-based discussion forum
- Keywords
- Health anxiety, illness anxiety disorder, ACT, internet
- Medical subject headings
- Hypochondriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based ACTBehavioural
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.
Internet-based discussion forumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based ACT | Experimental | Brief clinical psychiatric assessment to determine eligibility (video-based). Receives: Behavioral: Internet-based ACT |
| Internet-based discussion forum | Active comparator | Brief clinical psychiatric assessment to determine eligibility (video-based). Receives: Other: Internet-based discussion forum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whiteley-7 index
Health anxiety symptoms
Measured: 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 outcomes (9)
Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)
Measured: At baseline (i.e. at self-referral)
Diagnosed somatic illnesses measured with questions from the Danish study for Functional Disorders (DanFund)
Measured: At baseline (i.e. at self-referral)
Quality of life measured with the World Health Organisation Well-being Index-Five (WHO-5)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: At baseline (i.e. at self-referral), and 3 and 9 months after randomisation
Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist)
Measured: At baseline (i.e. at self-referral)
General health status and functioning measured with the Short Form 12 Health Survey (SF-12)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypochondriasisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Lisbeth Frostholm, PhD, Principal investigator, Aarhus University HospitalCharlotte U Rask, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735434
- Sponsor's protocol ID
- 09032016
- Status last verified
- Mar 2017
- First submitted
- 1 Apr 2016
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 34997899Hoffmann 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.
PubMed 32404226Hoffmann 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.
PubMed 31496462
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Acceptance and Commitment Therapy for Patients With Health Anxiety: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02735434
- Acronym / sponsor ID
- 09032016
- Conditions
- Hypochondriasis
- Keywords
- Health anxiety, illness anxiety disorder, ACT, internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Karolinska Institutet
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based ACT | Experimental | Behavioral: Internet-based ACTBrief clinical psychiatric assessment to determine eligibility (video-based). |
| Internet-based discussion forum | Active comparator | Other: Internet-based discussion forumBrief clinical psychiatric assessment to determine eligibility (video-based). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based ACTThe 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. | Behavioural | Internet-based ACT |
| Internet-based discussion forumThe 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. | Other | Internet-based discussion forum |
Primary outcome
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
9 secondary outcomes
Demographic questions measured with questions from the Danish study for Functional Disorders (DanFund)
Time frame: 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)
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
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
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
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
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
Somatisation measured with the Bodily Distress Syndrome Checklist (BDS Checklist)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 34997899Risor 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.
- Derived from this study: PubMed 32404226Hoffmann 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.
- Derived from this study: PubMed 31496462Hoffmann 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.
- Homepage for the Research Clinic for Functional Disorders, Aarhus University HospitalLink provided by the sponsor.
Related trials for Hypochondriasis
Active, not recruiting
Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders
Anxiety Disorders, Obsessive-Compulsive Disorder
Recruiting
Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
Panic Disorder, Social Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisbeth Frostholm, PhD principal investigator
Aarhus University Hospital
Charlotte U Rask, PhD principal investigator
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based ACT and Internet-based discussion forum in people with Hypochondriasis, run by University of Aarhus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02735434, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.