Anxiety DisordersNCT03683472
Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
A study testing Unwinding Anxiety Phone App in people with Anxiety Disorders, run by MindSciences, Inc. at 1 site in United States.
Trial summary
The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Unwinding Anxiety Phone App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 17 Oct 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Owns a smart phone
- GAD - 7 is equal to or greater than 10
Who cannot join
- If using psychotropic medication - not on a stable dosage for at least 6 weeks
- Medical disorder of the severity that would interfere with ability to participate
- Not being fluent in English (due to instructions provided in English)
- As needed use (i.e. prn) of benzodiazepines
- Psychotic disorder,
- Previous MT (e.g. MBSR, other Claritas MindSciences training programs).
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder.
Read the detailed description
The study aims are to (1) develop and refine Unwinding Anxiety for individuals with generalized anxiety disorder, (2) determine user engagement and acceptability as well as measure effect sizes of the program vs. treatment as usual, and (3) preliminarily test mechanisms of action. The knowledge gained will set the stage for a number of future studies related to further elucidating the mechanisms of mindfulness, and the clinical efficacy and utility of this type of training delivered via digital therapeutics in general. Specifically, this study will provide necessary variances for powering larger phase 2 studies.
- Conditions
- Anxiety Disorders
- Being tested
- Unwinding Anxiety Phone App
- Keywords
- Anxiety, worry, mindfulness, meditation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unwinding Anxiety Phone AppBehavioural
The Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry "habit loops" and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and "ride out" habitual mind states that perpetuate and reinforce anxiety
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | No intervention | Individuals will receive treatment as usual |
| TAU and Unwinding Anxiety Phone App | Active comparator | The Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry "habit loops" and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and "ride out" habitual mind states that perpetuate and reinforce anxiety. Together, these help individuals "unlearn"/extinguish worry at a core mechanistic level. Receives: Behavioral: Unwinding Anxiety Phone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
UA Program engagement
Number of modules completed
Measured: Two months
Change in worry
Penn State Worry Questionnaire (PSWQ)
Measured: Baseline, two months
Secondary outcomes (2)
Change in non-reactivity & awareness
Five Facet Mindfulness Questionnaire - Non-Reactivity subscale (FFMQ)
Measured: Baseline, two months
UA Program Acceptability
Net Promoter Score (NPS)
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start20 May 2019
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- MindSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Judson Brewer, Brown University
- Investigators
- Judson Brewer, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683472
- Sponsor's protocol ID
- 1R41MH118130-01
- Status last verified
- May 2020
- First submitted
- 11 Jun 2018
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taylor VA, Roy A, Brewer JA. Cluster-based psychological phenotyping and differences in anxiety treatment outcomes. Sci Rep. 2023 Feb 21;13(1):3055. doi: 10.1038/s41598-023-28660-7.
PubMed 36810609Roy A, Hoge EA, Abrante P, Druker S, Liu T, Brewer JA. Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial. J Med Internet Res. 2021 Dec 2;23(12):e26987. doi: 10.2196/26987.
PubMed 34860673
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT03683472
- Acronym / sponsor ID
- 1R41MH118130-01
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety, worry, mindfulness, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- MindSciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Brown University
- Study start
- 20 May 2019 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 25 Sep 2018 (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.
The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder.
Detailed description
The study aims are to (1) develop and refine Unwinding Anxiety for individuals with generalized anxiety disorder, (2) determine user engagement and acceptability as well as measure effect sizes of the program vs. treatment as usual, and (3) preliminarily test mechanisms of action. The knowledge gained will set the stage for a number of future studies related to further elucidating the mechanisms of mindfulness, and the clinical efficacy and utility of this type of training delivered via digital therapeutics in general. Specifically, this study will provide necessary variances for powering larger phase 2 studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | No intervention | –Individuals will receive treatment as usual |
| TAU and Unwinding Anxiety Phone App | Active comparator | Behavioral: Unwinding Anxiety Phone AppThe Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry "habit loops" and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and "ride out" habitual mind states that perpetuate and reinforce anxiety. Together, these help individuals "unlearn"/extinguish worry at a core mechanistic level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Owns a smart phone
- GAD - 7 is equal to or greater than 10
Key exclusion criteria (6 listed)
- If using psychotropic medication - not on a stable dosage for at least 6 weeks
- Medical disorder of the severity that would interfere with ability to participate
- Not being fluent in English (due to instructions provided in English)
- As needed use (i.e. prn) of benzodiazepines
- Psychotic disorder,
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 |
|---|---|---|
| Unwinding Anxiety Phone AppThe Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry "habit loops" and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and "ride out" habitual mind states that perpetuate and reinforce anxiety | Behavioural | TAU and Unwinding Anxiety Phone App |
Primary outcome
UA Program engagement
Time frame: Two months
Number of modules completed
Change in worry
Time frame: Baseline, two months
Penn State Worry Questionnaire (PSWQ)
2 secondary outcomes
Change in non-reactivity & awareness
Time frame: Baseline, two months
UA Program Acceptability
Time frame: Two months
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 18 May 2020.
- Derived from this study: PubMed 36810609Taylor VA, Roy A, Brewer JA. Cluster-based psychological phenotyping and differences in anxiety treatment outcomes. Sci Rep. 2023 Feb 21;13(1):3055. doi: 10.1038/s41598-023-28660-7.
- Derived from this study: PubMed 34860673Roy A, Hoge EA, Abrante P, Druker S, Liu T, Brewer JA. Clinical Efficacy and Psychological Mechanisms of an App-Based Digital Therapeutic for Generalized Anxiety Disorder: Randomized Controlled Trial. J Med Internet Res. 2021 Dec 2;23(12):e26987. doi: 10.2196/26987.
- 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.
Judson Brewer principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unwinding Anxiety Phone App in people with Anxiety Disorders, run by MindSciences, 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 2 inclusion and 6 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 18 May 2020. 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?
UA Program engagement (time frame: Two months). 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 NCT03683472, which also lists 2 linked publications.
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 18 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.