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Cognitive Behavioral Therapy
Digital CBT + Psychoeducation for Generalized Anxiety Disorder (GATE Trial)
N/A
Waitlist Available
Research Sponsored by Big Health Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 10 and 24 post-randomization
Awards & highlights
GATE Trial Summary
This trial will compare two ways to treat anxiety in people with Generalized Anxiety Disorder.
Who is the study for?
This trial is for adults over 22 in the USA with Generalized Anxiety Disorder (GAD), who score at least 15 on the GAD-7 questionnaire, speak English, and have regular internet access via a modern mobile device. Excluded are those with certain mental health conditions like psychosis or bipolar disorder, recent CBT/ACT therapy for anxiety, unstable medication use, substance abuse issues within the last year, or sensory impairments affecting digital content use.Check my eligibility
What is being tested?
The study compares two methods to treat anxiety: digital Cognitive Behavioral Therapy (CBT) and psychoeducation. Participants will be randomly assigned to one of these treatments to see which is more effective at reducing symptoms of generalized anxiety.See study design
What are the potential side effects?
While not typical for psychological interventions like digital CBT and psychoeducation, some participants might experience discomfort discussing personal issues or temporary increases in anxiety when confronting anxious thoughts or behaviors during treatment.
GATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 10 and 24 post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 10 and 24 post-randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Clinical Global Impression - Severity (CGI-S)
Generalized Anxiety Disorder Questionnaire (GAD-7)
Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)
+2 moreGATE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital CBTExperimental Treatment1 Intervention
digitally-delivered CBT for anxiety accessed via mobile app
Group II: PsychoeducationActive Control1 Intervention
psychoeducation delivered via digital written materials
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
digital CBT
2023
N/A
~360
Find a Location
Who is running the clinical trial?
Big Health Inc.Lead Sponsor
11 Previous Clinical Trials
138,980 Total Patients Enrolled
Boston UniversityOTHER
454 Previous Clinical Trials
9,941,219 Total Patients Enrolled
1 Trials studying Generalized Anxiety Disorder
600 Patients Enrolled for Generalized Anxiety Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had or currently have mental health conditions like psychosis, schizophrenia, bipolar disorder, or obsessive-compulsive disorder (OCD).You need to have a smartphone or tablet with internet access using Android 8 or higher or iOS 13 or higher.You have a condition that affects your ability to think or learn, which would make it difficult for you to understand and follow the study instructions.You have had a significant problem with alcohol or drugs in the past year.You have a high risk of wanting to hurt yourself or commit suicide.You have trouble hearing or seeing, which makes it difficult for you to understand and use the audio and visual materials in the therapy or educational content.You have been diagnosed with generalized anxiety disorder (GAD).You have a score of 15 or higher on a questionnaire that measures generalized anxiety disorder symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Digital CBT
- Group 2: Psychoeducation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Generalized Anxiety Disorder Patient Testimony for trial: Trial Name: NCT05748652 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still open positions in this clinical experiment?
"According to clinicaltrials.gov, this trial is not in search of participants anymore as the last update was posted on February 17th 2023. Although it has closed its doors for recruitment, there are 404 other medical trials that individuals can join at present."
Answered by AI
Who else is applying?
What state do they live in?
New Hampshire
What site did they apply to?
Boston University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Because I want to feel better.
PatientReceived 1 prior treatment
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