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Completed

NCT Number: NCT05748652

Generalized Anxiety Therapy Effectiveness

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

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

digital CBT

Device

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

Psychoeducation

Other

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

Primary outcomes

  1. Generalized Anxiety Disorder Questionnaire (GAD-7)

    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

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

    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

Secondary outcomes

  1. Generalized Anxiety Disorder Questionnaire (GAD-7)

    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

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

    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

  3. Patient Health Questionnaire (PHQ-8)

    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

  4. Sleep Condition Indicator (SCI-8)

    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

  5. Clinical Global Impression - Severity (CGI-S)

    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

Sponsors and collaborators

Lead sponsor

Big Health Inc.

Industry

Collaborators

  • Boston University

Registry information

Official study title

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

Acronym: GATE

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 1, 2023
Registry last updated
Apr 5, 2024

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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