Health AnxietyHAPINCT07867483
Health Anxiety From the Pandemic Initiative
A study testing THIS WAY UP iCBT and 90SecondHealth Anxiety in people with Health Anxiety, run by IWK Health Centre at 1 site in Canada.
Trial summary
The COVID-19 pandemic intensified health anxiety, a common and costly condition marked by excessive fear of illness and functional impairment. Despite growing prevalence and impact, health anxiety remains under-recognized in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Anxiety
- What is being tested?
- THIS WAY UP iCBT and 90SecondHealth Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteCanada
- Study dates
- 2 Apr 2024to 26 Apr 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- at least 18 years old
- reside in Canada
- be fluent in either English or French
- consent to participate in the study
- have significant health anxiety as determined by scores on the SHHAI-18
Who cannot join
- receiving psychological treatment for health anxiety
- self-reported current psychosis
- suicidal ideation or behavior
- severe depression
- substance use disorder
- bipolar disorder
Show all 9Show fewer
- changes to any antidepressant medication(s) in the last two months
- serious physical illness such as cancer, heart disease, or dementia
- taking sedative medications such as benzodiazepines and/or atypical antipsychotic medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Anxiety From the Pandemic Initiative (HAPI)
The COVID-19 pandemic intensified health anxiety, a common and costly condition marked by excessive fear of illness and functional impairment. Despite growing prevalence and impact, health anxiety remains under-recognized in clinical practice. Scalable, accessible interventions such as internet-based cognitive behavioral therapy (iCBT) are needed to address this gap. A three-arm randomized controlled trial with a waitlist control group was conducted to evaluate two self-guided digital interventions for health anxiety: THIS WAY UP iCBT and 90SecondHealth Anxiety compared to a control group. Canadian adults meeting eligibility criteria were randomized (1:1:1). Assessments occurred at baseline, post-intervention, and at one- and three-month follow-ups. Primary outcomes were health anxiety, depression, and generalized anxiety.
- Conditions
- Health Anxiety
- Being tested
- THIS WAY UP iCBT, 90SecondHealth Anxiety
- Keywords
- Health Anxiety, e-health Interventions, Cognitive Behavioral Therapy, Non-inferiority Trial, Stepped-care, Digital Mental Health, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THIS WAY UP iCBTBehavioural
The THIS WAY UP iCBT program is a 90-day iCBT intervention designed to support individuals experiencing excessive worry about illness, disease, and death. The THIS WAY UP iCBT intervention comprises six sequential, comic-based online lessons, delivered electronically at a rate of one lesson every two weeks. Each lesson follows the narrative of a fictional character navigating health anxiety and acquiring CBT-based coping strategies. The lessons are structured to include four core components: (1) a comic-based narrative introducing key CBT principles, (2) a lesson summary that reinforces core content and provides practical exercises, (3) a downloadable resource section, and (4) a frequently asked questions (FAQ) section.
90SecondHealth AnxietyBehavioural
The 90SecondHealth Anxiety intervention is a 13-week, e-health intervention consisting of 26 health letters, distributed electronically twice per week.
| Study group | Role | What they receive |
|---|---|---|
| THIS WAY UP iCBT | Experimental | The THIS WAY UP iCBT program is a 90-day iCBT intervention designed to support individuals experiencing excessive worry about illness, disease, and death.
The THIS WAY UP iCBT intervention comprises six sequential, comic-based online lessons, delivered electronically at a rate of one lesson every two weeks. Each lesson follows the narrative of a fictional character navigating health anxiety and acquiring CBT-based coping strategies. The lessons are structured to include four core components: (1) a comic-based narrative introducing key CBT principles, (2) a lesson summary that reinforces core content and provides practical exercises, (3) a downloadable resource section, and (4) a frequently asked questions (FAQ) section. Receives: Behavioral: THIS WAY UP iCBT |
| 90SecondHealth Anxiety | Experimental | The 90SecondHealth Anxiety program is a 13-week, e-health intervention consisting of 26 health letters, distributed electronically twice per week. While most letters address a unique topic relevant to health anxiety, a few broader themes were divided across two letters to enhance clarity and depth. The intervention is designed to deliver evidence-based psychological strategies in a concise, accessible format.
Each health letter follows a standardized structure comprising five components: (1) an Introduction providing background and contextual information, (2) a Call-to-Action section offering up to five actionable strategies, (3) a Brief Self-Assessment consisting of seven items with immediate, personalized feedback, (4) a Personal Account, which presents a composite narrative describing an individual's personal experience, and (5) a Rating/Feedback section that invites user input on the usefulness of the letter and suggestions for future topics. Receives: Behavioral: 90SecondHealth Anxiety |
| Waitlist Control Group | No intervention | Participants in this group did not receive any intervention during the 90-day period but were offered access to both programs upon completion of the 3-month follow-up assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health anxiety
Health anxiety symptoms were assessed using the Short Health Anxiety Inventory (SHAI-18). The SHAI-18 is an 18-item self-report instrument that assesses health anxiety over the previous four weeks. Total scores were calculated by summing item responses, with higher scores indicating greater health anxiety. Eligibility required a SHAI-18 score of ≥18, corresponding to the mild-to-moderate range of health anxiety. Total SHAI-18 scores were grouped into three severity ranges: 0-17 (not clinically significant), 18-32 (mild to moderate), and 33-54 (moderate to severe). These ranges were used for descriptive purposes and to support stratification procedures in the study. Total scores range from 0 to 54, with higher scores indicating greater health anxiety severity.
Measured: Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention
Secondary outcomes (2)
Depressive symptoms
Symptoms of depression were measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure that assesses how often respondents have been bothered by a series of depressive symptoms over the prior four weeks. Item scores were summed to create a total score. Total scores range from 0 to 27, with higher scores indicating greater depression severity.
Measured: Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention
Generalized anxiety symptoms
Symptoms of anxiety were measured using the Generalized Anxiety Disorder Scale-7 (GAD-7). The GAD-7 is a 7-item self-report measure that assesses how often respondents have experienced a series of anxiety symptoms over the previous four weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
Measured: Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start2 Apr 2024
- Primary completion26 Apr 2025
- Study completion26 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AnxietyStudies of the same condition, open and under way.
- 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
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick J. McGrath, IWK Health Centre
- Investigators
- Patrick J McGrath, PhD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867483
- Sponsor's protocol ID
- 1029441
- Other IDs
- NFRFR-2022-00309
- Acronym
- HAPI
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants were asked to indicate during Informed Consent whether their de-identified data may be shared with other researchers, provided the study is approved by an ethics board and researchers agree to use the data only for the purposes described in the approved research study. De-identified data from all outcome measures will be made available to approved researchers upon request, provided individual participants have provided consent.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Anxiety From the Pandemic Initiative (HAPI)
- ClinicalTrials.gov ID
- NCT07867483
- Acronym / sponsor ID
- HAPI / 1029441
- Conditions
- Health Anxiety
- Keywords
- Health Anxiety, e-health Interventions, Cognitive Behavioral Therapy, Non-inferiority Trial, Stepped-care, Digital Mental Health, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 26 Apr 2025 (actual)
- Study completion
- 26 Apr 2025 (actual)
- First posted
- 9 Oct 2026 (actual)
- 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.
The COVID-19 pandemic intensified health anxiety, a common and costly condition marked by excessive fear of illness and functional impairment. Despite growing prevalence and impact, health anxiety remains under-recognized in clinical practice. Scalable, accessible interventions such as internet-based cognitive behavioral therapy (iCBT) are needed to address this gap. A three-arm randomized controlled trial with a waitlist control group was conducted to evaluate two self-guided digital interventions for health anxiety: THIS WAY UP iCBT and 90SecondHealth Anxiety compared to a control group. Canadian adults meeting eligibility criteria were randomized (1:1:1). Assessments occurred at baseline, post-intervention, and at one- and three-month follow-ups. Primary outcomes were health anxiety, depression, and generalized anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| THIS WAY UP iCBT | Experimental | Behavioral: THIS WAY UP iCBTThe THIS WAY UP iCBT program is a 90-day iCBT intervention designed to support individuals experiencing excessive worry about illness, disease, and death. The THIS WAY UP iCBT intervention comprises six sequential, comic-based online lessons, delivered electronically at a rate of one lesson every two weeks. Each lesson follows the narrative of a fictional character navigating health anxiety and acquiring CBT-based coping strategies. The lessons are structured to include four core components: (1) a comic-based narrative introducing key CBT principles, (2) a lesson summary that reinforces core content and provides practical exercises, (3) a downloadable resource section, and (4) a frequently asked questions (FAQ) section. |
| 90SecondHealth Anxiety | Experimental | Behavioral: 90SecondHealth AnxietyThe 90SecondHealth Anxiety program is a 13-week, e-health intervention consisting of 26 health letters, distributed electronically twice per week. While most letters address a unique topic relevant to health anxiety, a few broader themes were divided across two letters to enhance clarity and depth. The intervention is designed to deliver evidence-based psychological strategies in a concise, accessible format. Each health letter follows a standardized structure comprising five components: (1) an Introduction providing background and contextual information, (2) a Call-to-Action section offering up to five actionable strategies, (3) a Brief Self-Assessment consisting of seven items with immediate, personalized feedback, (4) a Personal Account, which presents a composite narrative describing an individual's personal experience, and (5) a Rating/Feedback section that invites user input on the usefulness of the letter and suggestions for future topics. |
| Waitlist Control Group | No intervention | –Participants in this group did not receive any intervention during the 90-day period but were offered access to both programs upon completion of the 3-month follow-up assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 18 years old
- reside in Canada
- be fluent in either English or French
- consent to participate in the study
- have significant health anxiety as determined by scores on the SHHAI-18
Key exclusion criteria (9 listed)
- receiving psychological treatment for health anxiety
- self-reported current psychosis
- suicidal ideation or behavior
- severe depression
- substance use disorder
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 |
|---|---|---|
| THIS WAY UP iCBTThe THIS WAY UP iCBT program is a 90-day iCBT intervention designed to support individuals experiencing excessive worry about illness, disease, and death. The THIS WAY UP iCBT intervention comprises six sequential, comic-based online lessons, delivered electronically at a rate of one lesson every two weeks. Each lesson follows the narrative of a fictional character navigating health anxiety and acquiring CBT-based coping strategies. The lessons are structured to include four core components: (1) a comic-based narrative introducing key CBT principles, (2) a lesson summary that reinforces core content and provides practical exercises, (3) a downloadable resource section, and (4) a frequently asked questions (FAQ) section. | Behavioural | THIS WAY UP iCBT |
| 90SecondHealth AnxietyThe 90SecondHealth Anxiety intervention is a 13-week, e-health intervention consisting of 26 health letters, distributed electronically twice per week. | Behavioural | 90SecondHealth Anxiety |
Primary outcome
Health anxiety
Time frame: Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention
Health anxiety symptoms were assessed using the Short Health Anxiety Inventory (SHAI-18). The SHAI-18 is an 18-item self-report instrument that assesses health anxiety over the previous four weeks. Total scores were calculated by summing item responses, with higher scores indicating greater health anxiety. Eligibility required a SHAI-18 score of ≥18, corresponding to the mild-to-moderate range of health anxiety. Total SHAI-18 scores were grouped into three severity ranges: 0-17 (not clinically significant), 18-32 (mild to moderate), and 33-54 (moderate to severe). These ranges were used for descriptive purposes and to support stratification procedures in the study. Total scores range from 0 to 54, with higher scores indicating greater health anxiety severity.
2 secondary outcomes
Depressive symptoms
Time frame: Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention
Generalized anxiety symptoms
Time frame: Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention
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 9 Oct 2026.
- Individual participant dataSharing planned: Yes. Participants were asked to indicate during Informed Consent whether their de-identified data may be shared with other researchers, provided the study is approved by an ethics board and researchers agree to use the data only for the purposes described in the approved research study. De-identified data from all outcome measures will be made available to approved researchers upon request, provided individual participants have provided consent.
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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.
Patrick J McGrath, PhD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THIS WAY UP iCBT and 90SecondHealth Anxiety in people with Health Anxiety, run by IWK Health Centre at 1 site in Canada.
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 5 inclusion and 9 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Health anxiety (time frame: Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.