Health Anxiety From the Pandemic Initiative

NCT07867483 | Completed

• 2 other identifiers: 1029441NFRFR-2022-00309
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Health Anxiety; e-health Interventions; Cognitive Behavioral Therapy; Non-inferiority Trial; Stepped-care; Digital Mental Health; RCT

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention

Secondary Outcomes (2)

• Depressive symptoms

  Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention

• Generalized anxiety symptoms

  Baseline, 90 days(Immediately after intervention ), 1 month post-intervention, and 4 months post-intervention

Other Outcomes (1)

• Program atisfaction

  90 days (immediately after intervention)

Study Arms (3)

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.

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.

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.

Interventions

THIS WAY UP iCBT BEHAVIORAL

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.

THIS WAY UP iCBT

90SecondHealth Anxiety BEHAVIORAL

The 90SecondHealth Anxiety intervention is a 13-week, e-health intervention consisting of 26 health letters, distributed electronically twice per week.

90SecondHealth Anxiety

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• receiving psychological treatment for health anxiety
• self-reported current psychosis
• suicidal ideation or behavior
• severe depression
• substance use disorder
• bipolar disorder
• 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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K6R8, Canada

Location

Study Officials

• Patrick J McGrath, PhD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 9, 2026
• Study Start: April 2, 2024
• Primary Completion: April 26, 2025
• Study Completion: April 26, 2025
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CA (1)