Generalized Anxiety Therapy Effectiveness

Generalized Anxiety Disorder Clinical Trial

— GATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748652
• Other study ID #: BH-D-01
• Status: Completed
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: December 2023
• Source: Big Health Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: February 28, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Device:
• digital CBT
An app-based intervention based on principles from cognitive behavioral therapy for anxiety.

Other:
• Psychoeducation
Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Big Health Inc.	Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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