NCT06051084

Brief Summary

The goal of this clinical trial is to test the efficacy of an app-based program in reducing anxiety and exploring associated changes in brain activity.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

September 18, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

September 18, 2023

Last Update Submit

March 13, 2024

Conditions

Anxiety

Keywords

AnxietyMindfulnessMRICell Phone

Outcome Measures

Primary Outcomes (2)

  • Change in GAD - 7

    Generalized Anxiety Disorder 7-items (GAD-7). The GAD-7 is a validated 7-item measure of anxiety rated on a 4-point Likert scale ranging from 0 (Not at all sure) to 3 (Nearly every day).

    collected at baseline and 2 month follow up apt

  • Change From Baseline in Posterior Cingulate Cortex (PCC) Blood Oxygen Level Dependent (BOLD) Signal

    BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping

    collected at baseline and 2 month follow up apt

Secondary Outcomes (2)

  • Penn State Worry Questionnaire (PSWQ)

    collected at baseline and 2 month follow up apt

  • Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale

    collected at baseline and 2 month follow up apt

Other Outcomes (5)

  • Multidimensional Assessment of Interoceptive Awareness (MAIA)

    collected at baseline and 2 month follow up apt

  • Anxiety Sensitivity Index (ASI)

    collected at baseline and 2 month follow up apt

  • Interest (I) Type and Deprivation (D) Type scale (I/D)

    collected at baseline and 2 month follow up apt

  • +2 more other outcomes

Study Arms (2)

App-Delivered Mindfulness Training (MT)

EXPERIMENTAL

The program is delivered via a smartphone-based platform, which includes a progression through 30+ daily modules of brief didactic and experience-based mindfulness training (videos and animations), app-triggered check-ins to encourage engagement, and user-initiated guided mindfulness exercises to help disrupt worry cycles in the moment.

Behavioral: App-Delivered Mindfulness Training (MT)

App-Delivered Coloring

ACTIVE COMPARATOR

An app-based coloring book with a variety of designs to choose from including mandalas, animal patterns, and florals. It is designed to help individuals relax and reduce stress and anxiety based on the benefits found in past research studies.

Behavioral: App-Delivered Coloring

Interventions

App-Delivered Mindfulness Training (MT)BEHAVIORAL

The program is delivered via a smartphone-based platform, which includes a progression through 30+ daily modules of brief didactic and experience-based mindfulness training (videos and animations), app-triggered check-ins to encourage engagement, and user-initiated guided mindfulness exercises to help disrupt worry cycles in the moment.

App-Delivered Mindfulness Training (MT)
App-Delivered ColoringBEHAVIORAL

An app-based coloring book with a variety of designs to choose from including mandalas, animal patterns, and florals. It is designed to help individuals relax and reduce stress and anxiety based on the benefits found in past research studies.

App-Delivered Coloring

Eligibility Criteria

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

You may qualify if:

  • years
  • Able to travel to Brown University for research assessment
  • Able to speak English because all study activities will be conducted in English.
  • GAD-7 ≥ 10
  • Owns a smartphone

You may not qualify if:

  • If using psychotropic medication - not on a stable dosage at least 6 weeks
  • As needed (i.e., prn) benzodiazepine use
  • Psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis)
  • MRI contraindications
  • Claustrophobia
  • Recreational drug use past 2 weeks
  • Alcohol abuse
  • Pregnancy or plans to become pregnant
  • Cohabiting with a study participant
  • Weight ≥ 300 lbs (due to inability to fit in scanner)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Judson Brewer, MD, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

September 22, 2023

Study Start

October 5, 2023

Primary Completion

January 31, 2025

Study Completion

March 31, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)