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Generalized Anxiety Therapy Effectiveness (GATE)

Primary Purpose

Generalized Anxiety Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
digital CBT
Psychoeducation
Sponsored by
Big Health Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Generalized Anxiety Disorder, GAD, anxiety, digital CBT

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults aged ≥22 years old Score ≥15 on the 7-item Generalized Anxiety Disorder questionnaire (GAD-7) Diagnosis of GAD Current resident of the USA Oral and written fluency in English Regular access to the internet via a mobile or tablet device using Android ( 8 or higher) or iOS (13 or higher) Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form Exclusion Criteria: Must not be currently receiving or be expecting to start psychological treatment for anxiety during study participation, or have previously received Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for anxiety in the past 6-months (self-report) If on psychotropic medication, this must be stable for at least 60 days Past or present psychosis, schizophrenia, or bipolar disorder, or current OCD Past 12 months alcohol or substance use disorder of moderate or greater severity Moderate or greater suicide risk Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT or psychoeducation Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures Any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities

Sites / Locations

  • Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital CBT

Psychoeducation

Arm Description

digitally-delivered CBT for anxiety accessed via mobile app

psychoeducation delivered via digital written materials

Outcomes

Primary Outcome Measures

Generalized Anxiety Disorder Questionnaire (GAD-7)
Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity
Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)
A single-item measure scored between 1 and 7 where scores of 1 or 2 indicates clinically significant improvement, a score of 3 indicates mild improvement, a score of 4 indicates no change, and scores from 5 to 7 indicate deterioration

Secondary Outcome Measures

Generalized Anxiety Disorder Questionnaire (GAD-7)
Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity
Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)
A single-item measure scored between 1 and 7 where scores of 1 or 2 indicates clinically significant improvement, a score of 3 indicates mild improvement, a score of 4 indicates no change, and scores from 5 to 7 indicate deterioration
Patient Health Questionnaire (PHQ-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Sleep Condition Indicator (SCI-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 32 where higher scores indicate better sleep
Clinical Global Impression - Severity (CGI-S)
A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Generalized Anxiety Disorder Symptoms

Full Information

First Posted
February 17, 2023
Last Updated
September 21, 2023
Sponsor
Big Health Inc.
Collaborators
Boston University
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1. Study Identification

Unique Protocol Identification Number
NCT05748652
Brief Title
Generalized Anxiety Therapy Effectiveness
Acronym
GATE
Official Title
Clinical Effectiveness of Digital CBT for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Big Health Inc.
Collaborators
Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.
Detailed Description
This study aims to examine the effectiveness of app-based digital CBT for anxiety compared to psychoeducation in individuals with a diagnosis of Generalized Anxiety Disorder. The primary outcomes are anxiety symptom reduction and remission after 10 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Generalized Anxiety Disorder, GAD, anxiety, digital CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital CBT
Arm Type
Experimental
Arm Description
digitally-delivered CBT for anxiety accessed via mobile app
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
psychoeducation delivered via digital written materials
Intervention Type
Device
Intervention Name(s)
digital CBT
Intervention Description
An app-based intervention based on principles from cognitive behavioral therapy for anxiety.
Intervention Type
Other
Intervention Name(s)
Psychoeducation
Intervention Description
Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity
Time Frame
10 weeks post-randomization
Title
Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)
Description
A single-item measure scored between 1 and 7 where scores of 1 or 2 indicates clinically significant improvement, a score of 3 indicates mild improvement, a score of 4 indicates no change, and scores from 5 to 7 indicate deterioration
Time Frame
10 weeks post-randomization
Secondary Outcome Measure Information:
Title
Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
Validated questionnaire; a 7-item scale with total scores between 0 and 21 where higher scores indicate greater severity
Time Frame
6 and 24 weeks post-randomization
Title
Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)
Description
A single-item measure scored between 1 and 7 where scores of 1 or 2 indicates clinically significant improvement, a score of 3 indicates mild improvement, a score of 4 indicates no change, and scores from 5 to 7 indicate deterioration
Time Frame
24 weeks post-randomization
Title
Patient Health Questionnaire (PHQ-8)
Description
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Time Frame
Weeks 10 and 24 post-randomization
Title
Sleep Condition Indicator (SCI-8)
Description
Validated questionnaire; an 8-item scale with total scores between 0 and 32 where higher scores indicate better sleep
Time Frame
Weeks 10 and 24 post-randomization
Title
Clinical Global Impression - Severity (CGI-S)
Description
A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Generalized Anxiety Disorder Symptoms
Time Frame
Weeks 10 and 24 post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged ≥22 years old Score ≥15 on the 7-item Generalized Anxiety Disorder questionnaire (GAD-7) Diagnosis of GAD Current resident of the USA Oral and written fluency in English Regular access to the internet via a mobile or tablet device using Android ( 8 or higher) or iOS (13 or higher) Participant is able and willing to comply with protocol requirements, has been informed of the nature of the study, and has signed the IRB-approved informed consent form Exclusion Criteria: Must not be currently receiving or be expecting to start psychological treatment for anxiety during study participation, or have previously received Cognitive Behavioral Therapy (CBT) or Acceptance and Commitment Therapy (ACT) for anxiety in the past 6-months (self-report) If on psychotropic medication, this must be stable for at least 60 days Past or present psychosis, schizophrenia, or bipolar disorder, or current OCD Past 12 months alcohol or substance use disorder of moderate or greater severity Moderate or greater suicide risk Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT or psychoeducation Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures Any condition that the investigator believes would make participation in the study not in the best interest of the subject or would preclude successful completion of study activities
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Generalized Anxiety Therapy Effectiveness

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