Boston University
Boston, Massachusetts, 02215, United States
NCT Number: NCT05748652
This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.
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Notify Me22 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 10 weeks post-randomization
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
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: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Big Health Inc.
Industry
Clinical Effectiveness of Digital CBT for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial
Acronym: GATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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