Anxiety Disorders
Conditions
Keywords
Anxiety, worry, mindfulness, meditation
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.
Interventions
BEHAVIORALUnwinding Anxiety Phone App
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
Sponsors
Brown University
MindSciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UA Program engagement | Two months | Number of modules completed |
| Change in worry | Baseline, two months | Penn State Worry Questionnaire (PSWQ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in non-reactivity & awareness | Baseline, two months | Five Facet Mindfulness Questionnaire - Non-Reactivity subscale (FFMQ) |
| UA Program Acceptability | Two months | Net Promoter Score (NPS) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety | Baseline, two months | Generalized Anxiety Disorder - 7 items (GAD-7) |
| Change in self-regulation | Baseline, two months | Multidimensional Assessment of Interoceptive Awareness (MAIA) |
Countries
United States
Outcome results
None listed