Anxiety DisordersNCT04895995
Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
A study testing Daylight dCBT Application in people with Anxiety Disorders and Cardiovascular Diseases, run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Cardiovascular Diseases, Anxiety
- What is being tested?
- Daylight dCBT Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2022to 13 Jan 2026
- 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
- Experienced an acute CVD event (i.e., myocardial infarction, stroke/transient ischemic attack, cardiac arrest, unstable angina, congestive heart failure with hospitalization; exclusion of coronary heart disease, atrial fibrillation, and other arrhythmias)
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the detailed description
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. A recent large-scale efficacy trial of digital cognitive behavior therapy (dCBT) for GAD demonstrated significant benefit relative to waitlist control with a large effect size. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention, 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). Assessments will occur at Week 0 (baseline), Week 3, Week 6, and Week 10 (post-treatment).
- Conditions
- Anxiety Disorders, Cardiovascular Diseases, Anxiety, Health Behavior
- Being tested
- Daylight dCBT Application
- Medical subject headings
- Anxiety Disorders, Cardiovascular Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daylight dCBT ApplicationBehavioural
Also called Daylight
Participants will complete up to four modules of digital intervention delivered in a self-paced format.
| Study group | Role | What they receive |
|---|---|---|
| Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder | Experimental | Not described Receives: Behavioral: Daylight dCBT Application |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 10 (post-treatment)
Secondary outcomes (13)
Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)
Well validated 8-item measure of heart-related fear and worry. Scores can range from 0 to 32 with higher scores indicating greater cardiac anxiety.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
Smoking History Questionnaire
Measure of the frequency and amount of recent cigarette use and motivation to quit.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
International Physical Activities Questionnaire (IPAQ)
Well validated self-report measure of how many minutes a day and days a week an individual spends engaged in physical activity.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables
Number of servings per day of fruit and vegetables measured by relevant questions on the WHO STEPS Instrument.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
Modified Morisky Scale
This measures will be used to determine medication adherence. Scores can range from 0 to 6 with higher scores indicating greater adherence.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
Center for Epidemiological Studies Depression Scale 10 Item Version
Validated 10-item self-report measure of depression symptoms. Scores can range from 0 to 30 with higher scores indicating greater depression.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
Sleep Condition Indicator (SCI-8)
This 8-item self-report measure is widely used to characterize sleep quality. Scores can range from 0 to 32 with higher scores indicating greater sleep difficulties.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
Short Form Health Survey (SF-12)
This 12-item measure is widely used to evaluate quality of life related to both physical and mental health with cardiac patients. Scores for each subscale range from 0 to 100 with higher scores indicating greater physical and mental health.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
Anxiety Sensitivity Inventory (ASI-3)
This 16-item self-report measures evaluates individuals' tendency to fear and perceive anxiety-related sensations as harmful. Scores can range from 0 to 72 with higher scores indicating greater anxiety sensitivity.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
Penn State Worry Questionnaire (PSWQ)
The PSWQ is the most commonly used self-report measure of worry in research on CBT and dCBT. Scores can range from 16 to 80 with higher scores indicating greater worry.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
Shame Inventory-Part 1 (SI-P1)
This 3-item self-report measures assesses the frequency, intensity, and adverse effects of shame related to physical and mental health. Scores can range from 0 to 12 with higher scores indicating greater shame.
Measured: Week 0, Week 6, and Week 10 (post-treatment)
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.
Measured: Week 0, Week 3, Week 6
Resolution of Clinical GAD
The proportion of patients no longer meeting GAD-7 clinical severity, operationalized as a score of less than 10 at the 10 week evaluation. Scoring will be the same as described for the GAD-7 above.
Measured: Week 10 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start2 Feb 2022
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- Model description
- The allocation scheme below refers to Phase 2.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Parsons, Ph.D., Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895995
- Sponsor's protocol ID
- 6035E
- Status last verified
- Aug 2026
- First submitted
- 5 May 2021
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36414206
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Assessment of the Feasibility and Efficacy of a Scalable Digital CBT for Generalized Anxiety and Associated Health Behaviors in a Cardiovascular Disease Population
- ClinicalTrials.gov ID
- NCT04895995
- Acronym / sponsor ID
- 6035E
- Conditions
- Anxiety Disorders, Cardiovascular Diseases, Anxiety, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 21 May 2021 (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 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).
Detailed description
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. A recent large-scale efficacy trial of digital cognitive behavior therapy (dCBT) for GAD demonstrated significant benefit relative to waitlist control with a large effect size. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention, 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). Assessments will occur at Week 0 (baseline), Week 3, Week 6, and Week 10 (post-treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The allocation scheme below refers to Phase 2.
| Arm | Type | Receives |
|---|---|---|
| Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder | Experimental | Behavioral: Daylight dCBT Application |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Experienced an acute CVD event (i.e., myocardial infarction, stroke/transient ischemic attack, cardiac arrest, unstable angina, congestive heart failure with hospitalization; exclusion of coronary heart disease, atrial fibrillation, and other arrhythmias)
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Daylight dCBT ApplicationAlso: DaylightParticipants will complete up to four modules of digital intervention delivered in a self-paced format. | Behavioural | Digital Cognitive Behavior Therapy (dCBT) for Generalized Anxiety Disorder |
Primary outcome
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Week 10 (post-treatment)
Well validated self-report measure of generalized anxiety disorder symptoms. Scores can range from 0 to 21 with higher scores indicating greater anxiety.
13 secondary outcomes
Cardiac Anxiety Questionnaire Fear Subscale (CAQ-Fear)
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
Smoking History Questionnaire
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
International Physical Activities Questionnaire (IPAQ)
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
World Health Organization (WHO) STEPS Instrument - Consumption of Fruit and Vegetables
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
Modified Morisky Scale
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
Center for Epidemiological Studies Depression Scale 10 Item Version
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
Sleep Condition Indicator (SCI-8)
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
Short Form Health Survey (SF-12)
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
Anxiety Sensitivity Inventory (ASI-3)
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
Penn State Worry Questionnaire (PSWQ)
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
Shame Inventory-Part 1 (SI-P1)
Time frame: Week 0, Week 6, and Week 10 (post-treatment)
Generalized Anxiety Disorder Scale (GAD-7)
Time frame: Week 0, Week 3, Week 6
Resolution of Clinical GAD
Time frame: Week 10 (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 2 Sep 2026.
- Derived from this study: PubMed 36414206Parsons 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.
- Individual participant dataSharing planned: No
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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.
Marie Parsons, Ph.D. principal investigator
Boston University Charles River Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daylight dCBT Application in people with Anxiety Disorders and Cardiovascular Diseases, run by Boston University Charles River Campus at 1 site in United States.
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 4 inclusion and 8 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 2 Sep 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 United States. 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?
Generalized Anxiety Disorder Scale (GAD-7) (time frame: Week 10 (post-treatment)). 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 NCT04895995, which also lists 1 linked publication.
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 2 Sep 2026.