This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
351
An app-based intervention based on principles from cognitive behavioral therapy for anxiety.
Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.
Boston University
Boston, Massachusetts, United States
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
Time frame: 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
Time frame: 10 weeks post-randomization
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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: Weeks 10 and 24 post-randomization