Generalized Anxiety Therapy Effectiveness

NCT05748652 | Completed DMC FDA Device

• 1 other identifier: BH-D-01
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; GAD; anxiety; digital CBT

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Generalized Anxiety Disorder Questionnaire (GAD-7)

  6 and 24 weeks post-randomization

• Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)

  24 weeks post-randomization

• Patient Health Questionnaire (PHQ-8)

  Weeks 10 and 24 post-randomization

• Sleep Condition Indicator (SCI-8)

  Weeks 10 and 24 post-randomization

• Clinical Global Impression - Severity (CGI-S)

  Weeks 10 and 24 post-randomization

Study Arms (2)

Digital CBT

EXPERIMENTAL

digitally-delivered CBT for anxiety accessed via mobile app

Device: digital CBT

Psychoeducation

ACTIVE COMPARATOR

psychoeducation delivered via digital written materials

Other: Psychoeducation

Interventions

digital CBT DEVICE

An app-based intervention based on principles from cognitive behavioral therapy for anxiety.

Digital CBT

Psychoeducation OTHER

Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.

Psychoeducation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Big Health Inc.: lead
• Boston University: collaborator

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Parsons EM, Ball T, Carl J, Henry AL, Emsley R, Miller CB, Wong EY, Coombs E, Collins D, Long LJ, Ster AC, Smits JAJ, Otto MW. Digital Cognitive Behavioral Treatment for Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2548884. doi: 10.1001/jamanetworkopen.2025.48884.

  PMID: 41396602 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 1, 2023
• Study Start: March 6, 2023
• Primary Completion: November 15, 2023
• Study Completion: February 28, 2024
• Last Updated: April 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)