Generalized Anxiety DisorderGATENCT05748652
Generalized Anxiety Therapy Effectiveness
A study testing digital CBT and Psychoeducation in people with Generalized Anxiety Disorder, run by Big Health Inc. at 1 site in United States.
Trial summary
This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- digital CBT and Psychoeducation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Effectiveness of Digital CBT for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial
This study will examine the effectiveness of digital CBT versus psychoeducation in improving anxiety for those with Generalized Anxiety Disorder.
Read the 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- digital CBT, Psychoeducation
- Keywords
- Generalized Anxiety Disorder, GAD, anxiety, digital CBT
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital CBTDevice
An app-based intervention based on principles from cognitive behavioral therapy for anxiety.
PsychoeducationOther
Participants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm.
| Study group | Role | What they receive |
|---|---|---|
| Digital CBT | Experimental | digitally-delivered CBT for anxiety accessed via mobile app Receives: Device: digital CBT |
| Psychoeducation | Active comparator | psychoeducation delivered via digital written materials Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 10 weeks post-randomization
Secondary outcomes (5)
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
Measured: 6 and 24 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
Measured: 24 weeks post-randomization
Patient Health Questionnaire (PHQ-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 24 where higher scores indicate greater severity
Measured: Weeks 10 and 24 post-randomization
Sleep Condition Indicator (SCI-8)
Validated questionnaire; an 8-item scale with total scores between 0 and 32 where higher scores indicate better sleep
Measured: Weeks 10 and 24 post-randomization
Clinical Global Impression - Severity (CGI-S)
A single-item measure scored between 1 and 7 where higher scores indicate greater severity of Generalized Anxiety Disorder Symptoms
Measured: Weeks 10 and 24 post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start6 Mar 2023
- Primary completion15 Nov 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Big Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748652
- Sponsor's protocol ID
- BH-D-01
- Acronym
- GATE
- Status last verified
- Dec 2023
- First submitted
- 17 Feb 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41396602
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Digital CBT for the Treatment of Generalized Anxiety Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05748652
- Acronym / sponsor ID
- GATE / BH-D-01
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, GAD, anxiety, digital CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Big Health Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boston University
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital CBT | Experimental | Device: digital CBTdigitally-delivered CBT for anxiety accessed via mobile app |
| Psychoeducation | Active comparator | Other: Psychoeducationpsychoeducation delivered via digital written materials |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital CBTAn app-based intervention based on principles from cognitive behavioral therapy for anxiety. | Device | Digital CBT |
| PsychoeducationParticipants will be provided with psychoeducation which will be delivered digitally upon allocation to the psychoeducation arm. | Other | Psychoeducation |
Primary outcome
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
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
5 secondary outcomes
Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: 6 and 24 weeks post-randomization
Generalized Anxiety Disorder remission (score 1 or 2) on the the Clinical Global Impression Scale - Improvement (CGI-I)
Time frame: 24 weeks post-randomization
Patient Health Questionnaire (PHQ-8)
Time frame: Weeks 10 and 24 post-randomization
Sleep Condition Indicator (SCI-8)
Time frame: Weeks 10 and 24 post-randomization
Clinical Global Impression - Severity (CGI-S)
Time frame: Weeks 10 and 24 post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 41396602Parsons 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital CBT and Psychoeducation in people with Generalized Anxiety Disorder, run by Big Health Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generalized Anxiety Disorder Questionnaire (GAD-7) (time frame: 10 weeks post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05748652, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.