Generalized Anxiety Therapy Effectiveness

Study Overview
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Brief Summary
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This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.

Detailed Description
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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.

Official Title
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Clinical Effectiveness of Digital CBT for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Device: digital CBT
* Other: Psychoeducation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital CBT<br>digitally-delivered CBT for anxiety accessed via mobile app | Device: digital CBT<br>* An app-based intervention based on principles from cognitive behavioral therapy for anxiety.<br>|
| Active Comparator: Psychoeducation<br>psychoeducation delivered via digital written materials | Other: Psychoeducation<br>* Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 weeks post-randomization | 
| 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 | 10 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 and 24 weeks post-randomization | 
| 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 | 24 weeks post-randomization | 
| Patient Health Questionnaire (PHQ-8) | Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity | Weeks 10 and 24 post-randomization | 
| Sleep Condition Indicator (SCI-8) | Validated questionnaire; an 8-item scale with total scores between 0 and 32 where higher scores indicate better sleep | Weeks 10 and 24 post-randomization | 
| 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 | Weeks 10 and 24 post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Generalized Anxiety Disorder, GAD, anxiety, digital CBT