Investigating How the Brain Processes Different Experiences

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

App-Delivered Mindfulness Training (MT)

App-Delivered Coloring

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Mindfulness, MRI, Cell Phone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 - 65 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 Exclusion Criteria: 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)

Sites / Locations

Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

App-Delivered Mindfulness Training (MT)

App-Delivered Coloring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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

Secondary Outcome Measures

Penn State Worry Questionnaire (PSWQ)

The PSWQ is a validated 16-item self-report measure of worry with items presented on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me).

Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale

The non-reactivity scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 7 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).

Full Information

NCT ID

NCT06051084

First Posted

September 18, 2023

Last Updated

September 21, 2023

Sponsor

Brown University

Collaborators

Dartmouth College, Tiny Blue Dot Foundation

1. Study Identification

Unique Protocol Identification Number

NCT06051084

Brief Title

Investigating How the Brain Processes Different Experiences

Official Title

Advancing Our Understanding and Treatment of Anxiety Through Bringing Together Facets of Conscious Experience and Brain Mechanisms: Open/Closed Meets the Default Mode Network

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 31, 2023 (Anticipated)

Primary Completion Date

January 31, 2025 (Anticipated)

Study Completion Date

March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brown University

Collaborators

Dartmouth College, Tiny Blue Dot Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

Detailed Description

The main question[s] it aims to answer are: PRIMARY AIM: Confirm that the conscious experience of open/closed correlates with P/PCC activation/deactivation. SECONDARY AIM: Determine if changes in P/PCC activity predict clinical outcomes (GAD-7 scores) in individuals with moderate to severe anxiety after using an app. Participants may be asked to: Complete a Zoom interview Complete online surveys at baseline and 2 months post-treatment initiation Complete MRIs at baseline and 2 months post-treatment initiation Wear a smartwatch and answer daily questions about their anxiety Use an app daily

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety

Keywords

Anxiety, Mindfulness, MRI, Cell Phone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

App-Delivered Mindfulness Training (MT)

Arm Type

Experimental

Arm Description

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.

Arm Title

App-Delivered Coloring

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

App-Delivered Mindfulness Training (MT)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

App-Delivered Coloring

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in GAD - 7

Description

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).

Time Frame

collected at baseline and 2 month follow up apt

Title

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

Description

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

Time Frame

collected at baseline and 2 month follow up apt

Secondary Outcome Measure Information:

Title

Penn State Worry Questionnaire (PSWQ)

Description

The PSWQ is a validated 16-item self-report measure of worry with items presented on a 5-point Likert scale ranging from 1 (not at all typical of me) to 5 (very typical of me).

Time Frame

collected at baseline and 2 month follow up apt

Title

Five Facet Mindfulness Questionnaire (FFMQ) non-reactivity scale

Description

The non-reactivity scale is a validated subscale of the 39-item FFMQ which is a self-report psychological measure of mindfulness skills. This subscale contains 7 items which are presented on a 6-point Likert scale ranging from 1 (almost always) to 6 (almost never).

Time Frame

collected at baseline and 2 month follow up apt

Other Pre-specified Outcome Measures:

Title

Multidimensional Assessment of Interoceptive Awareness (MAIA)

Description

The MAIA is a validated 32-item self-report questionnaire comprised of 8 subscales including: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Items are rated on a 6-point Likert scale ranging from 0 (never) to 5 (always).

Time Frame

collected at baseline and 2 month follow up apt

Title

Anxiety Sensitivity Index (ASI)

Description

The ASI is a validated 16-item self-report measure of the fear of anxiety sensations. Items are rated on a 5-point Likert scale ranging from 0 (Very little) to 4 (Very much).

Time Frame

collected at baseline and 2 month follow up apt

Title

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

Description

The I/D scale is a validated 10-item self-report measure of curiosity. Items are rated on a 4-point Likert scale ranging from 1 (Almost never) to 4 (Almost always).

Time Frame

collected at baseline and 2 month follow up apt

Title

Acceptance & Action questionnaire (AAQ-II)

Description

The AAQ-II is a validated 7-item self-report measure of experiential avoidance. Items are rated on a 7-point Likert scale ranging from 1 (Never true) to 7 (Always true).

Time Frame

collected at baseline and 2 month follow up apt

Title

Intolerance of Uncertainty 12-item scale (IUS-12)

Description

The IUS-12 is a validated 12-item self-report measure of intolerance of uncertainty. Items are rated on a 5-point Likert scale ranging from 1 (Not at all characteristic of me) to 5 (Entirely characteristic of me).

Time Frame

collected at baseline and 2 month follow up apt

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 - 65 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 Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joseph Casamassima, MA

Phone

(401) 484-1087

Email

joseph_casamassima@brown.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Judson Brewer, MD, PhD

Organizational Affiliation

Brown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brown University

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joseph Casamassima, MA

Phone

401-484-1087

Email

joseph_casamassima@brown.edu

12. IPD Sharing Statement

Plan to Share IPD

No

Anxiety

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial