GATE: Generalized Anxiety Therapy Effectiveness
Study Details
Study Description
Brief Summary
This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Digital CBT digitally-delivered CBT for anxiety accessed via mobile app |
Device: digital CBT
An app-based intervention based on principles from cognitive behavioral therapy for anxiety.
|
| Active Comparator: Psychoeducation psychoeducation delivered via digital written materials |
Other: Psychoeducation
Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.
|
Outcome Measures
Primary Outcome Measures
- Generalized Anxiety Disorder Questionnaire (GAD-7) [10 weeks post-randomization]
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) [10 weeks post-randomization]
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) [6 and 24 weeks post-randomization]
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) [24 weeks post-randomization]
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) [Weeks 10 and 24 post-randomization]
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
- Sleep Condition Indicator (SCI-8) [Weeks 10 and 24 post-randomization]
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) [Weeks 10 and 24 post-randomization]
A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Generalized Anxiety Disorder Symptoms
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged ≥22 years old
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Score ≥15 on the 7-item Generalized Anxiety Disorder questionnaire (GAD-7)
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Diagnosis of GAD
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Current resident of the USA
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Oral and written fluency in English
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Regular access to the internet via a mobile or tablet device using Android ( 8 or higher) or iOS (13 or higher)
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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:
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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)
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If on psychotropic medication, this must be stable for at least 60 days
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Past or present psychosis, schizophrenia, or bipolar disorder, or current OCD
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Past 12 months alcohol or substance use disorder of moderate or greater severity
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Moderate or greater suicide risk
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Hearing or vision impairment that prevents effective use of the audio-visual content of digital CBT or psychoeducation
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Intellectual disability or any Neurocognitive or Neurodevelopmental disorder that would prevent participants from following study procedures
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston University | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Big Health Inc.
- Boston University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BH-D-01