NCT03683472

Brief Summary

The investigators propose to develop and adapt Unwinding Anxiety phone app specifically for individuals with generalized anxiety disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

June 11, 2018

Last Update Submit

May 14, 2020

Conditions

Anxiety Disorders

Keywords

Anxiety, worry, mindfulness, meditation

Outcome Measures

Primary Outcomes (2)

  • UA Program engagement

    Number of modules completed

    Two months

  • Change in worry

    Penn State Worry Questionnaire (PSWQ)

    Baseline, two months

Secondary Outcomes (2)

  • Change in non-reactivity & awareness

    Baseline, two months

  • UA Program Acceptability

    Two months

Other Outcomes (2)

  • Change in anxiety

    Baseline, two months

  • Change in self-regulation

    Baseline, two months

Study Arms (2)

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.

Behavioral: Unwinding Anxiety Phone App

Interventions

Unwinding Anxiety Phone AppBEHAVIORAL

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

TAU and Unwinding Anxiety Phone App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Publications (2)

  • 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.

    PMID: 36810609DERIVED

  • 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.

    PMID: 34860673DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Judson Brewer

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research & Innovation

Study Record Dates

First Submitted

June 11, 2018

First Posted

September 25, 2018

Study Start

May 20, 2019

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

May 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)