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Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unwinding Anxiety Phone App
Sponsored by
MindSciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Anxiety, worry, mindfulness, meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Owns a smart phone
  • GAD - 7 is equal to or greater than 10

Exclusion Criteria:

  • 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).

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Treatment as usual (TAU)

TAU and Unwinding Anxiety Phone App

Arm Description

Individuals will receive treatment as usual

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.

Outcomes

Primary Outcome Measures

UA Program engagement
Number of modules completed
Change in worry
Penn State Worry Questionnaire (PSWQ)

Secondary Outcome Measures

Change in non-reactivity & awareness
Five Facet Mindfulness Questionnaire - Non-Reactivity subscale (FFMQ)
UA Program Acceptability
Net Promoter Score (NPS)

Full Information

First Posted
June 11, 2018
Last Updated
May 14, 2020
Sponsor
MindSciences, Inc.
Collaborators
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT03683472
Brief Title
Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
Official Title
Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
October 17, 2019 (Actual)
Study Completion Date
October 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MindSciences, Inc.
Collaborators
Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Anxiety, worry, mindfulness, meditation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual (TAU)
Arm Type
No Intervention
Arm Description
Individuals will receive treatment as usual
Arm Title
TAU and Unwinding Anxiety Phone App
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Unwinding Anxiety Phone App
Intervention Description
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
Primary Outcome Measure Information:
Title
UA Program engagement
Description
Number of modules completed
Time Frame
Two months
Title
Change in worry
Description
Penn State Worry Questionnaire (PSWQ)
Time Frame
Baseline, two months
Secondary Outcome Measure Information:
Title
Change in non-reactivity & awareness
Description
Five Facet Mindfulness Questionnaire - Non-Reactivity subscale (FFMQ)
Time Frame
Baseline, two months
Title
UA Program Acceptability
Description
Net Promoter Score (NPS)
Time Frame
Two months
Other Pre-specified Outcome Measures:
Title
Change in anxiety
Description
Generalized Anxiety Disorder - 7 items (GAD-7)
Time Frame
Baseline, two months
Title
Change in self-regulation
Description
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time Frame
Baseline, two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Owns a smart phone GAD - 7 is equal to or greater than 10 Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judson Brewer
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34860673
Citation
Roy 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.
Results Reference
derived

Learn more about this trial

Developing a Novel Digital Therapeutic for the Treatment of Generalized Anxiety Disorder

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