Clinical trial NCT05748652: Generalized Anxiety Therapy Effectiveness
Official title: Clinical Effectiveness of Digital CBT for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
GAD
anxiety
digital CBT
Lead sponsor: Big Health Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boston University
First posted: 2023-03-01
Enrollment: 351
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: 10 weeks post-randomization
measure: Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)
timeFrame: 10 weeks post-randomization
Secondary outcomes:
measure: Generalized Anxiety Disorder Questionnaire (GAD-7)
timeFrame: 6 and 24 weeks post-randomization
measure: Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)
timeFrame: 24 weeks post-randomization
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: Weeks 10 and 24 post-randomization
measure: Sleep Condition Indicator (SCI-8)
timeFrame: Weeks 10 and 24 post-randomization
measure: Clinical Global Impression - Severity (CGI-S)
timeFrame: Weeks 10 and 24 post-randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References: