Generalized Anxiety Therapy Effectiveness

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Device: digital CBT; Other: Psychoeducation

• Registration Number: NCT05748652
• Lead Sponsor: Big Health Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-03-01
• Study Start: 2023-03-06
• Primary Completion: 2023-11-15
• Status Verified: 2023-12
• Study Completion: 2024-02-28
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital CBT	digital CBT	digitally-delivered CBT for anxiety accessed via mobile app
Psychoeducation	Psychoeducation	psychoeducation delivered via digital written materials

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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

Trial Locations

Locations (1)

Boston University; 🇺🇸 Boston, Massachusetts, United States