Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population

NCT04895995 | Recruiting

• 1 other identifier: 6035E
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control).

Conditions

Anxiety Disorders; Cardiovascular Diseases; Anxiety; Health Behavior

Outcome Measures

Primary Outcomes (1)

• Generalized Anxiety Disorder Scale (GAD-7)

  Well validated self-report measure of generalized anxiety disorder symptoms. Scores can range from 0 to 21 with higher scores indicating greater anxiety.

  Week 10 (post-treatment)

Secondary Outcomes (13)

• Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)

  Week 0, Week 6, and Week 10 (post-treatment)

• Smoking History Questionnaire

  Week 0, Week 6, and Week 10 (post-treatment)

• International Physical Activities Questionnaire (IPAQ)

  Week 0, Week 6, and Week 10 (post-treatment)

• World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables

  Week 0, Week 6, and Week 10 (post-treatment)

• Modified Morisky Scale

  Week 0, Week 6, and Week 10 (post-treatment)

Study Arms (2)

Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder

EXPERIMENTAL

Behavioral: Daylight dCBT Application

Waitlist Control

NO INTERVENTION

Interventions

Daylight dCBT Application BEHAVIORAL

Participants will complete up to four modules of digital intervention delivered in a self-paced format.

Also known as: Daylight

Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical levels of GAD symptoms as operationalized by a score of ≥10 on the GAD-7
• Age 18 or older.
• Individuals must be in the post-acute phase of their CVD; this is operationalized as \> 2 months post an acute cardiac event.

You may not qualify if:

• Non-English speaker/literate
• No access to a digital device
• Severely vision impaired
• Severe cognitive impairment
• Pending acute surgery or with a life prognosis of fewer than 6 months
• The presence \[by self-report\] of schizophrenia, psychosis, bipolar disorder, seizure disorder, or current substance use disorder other than nicotine
• Initiation or change of psychotropic medication dosage within the past 4 weeks
• Received CBT for anxiety in last 3 months

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• Parsons EM, Hiserodt M, Otto MW. Initial assessment of the feasibility and efficacy of a scalable digital CBT for generalized anxiety and associated health behaviors in a cardiovascular disease population. Contemp Clin Trials. 2023 Jan;124:107018. doi: 10.1016/j.cct.2022.107018. Epub 2022 Nov 19.

  PMID: 36414206 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Cardiovascular Diseases; Health Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Central Study Contacts

Marie Parsons, Ph.D.

CONTACT

617-353-9610; mariepar@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The allocation scheme below refers to Phase 2.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 21, 2021
• Study Start: February 2, 2022
• Primary Completion: December 31, 2025
• Study Completion: March 15, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)