Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications

NCT ID: NCT03633682

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-26
• Study Completion Date: 2020-08-01

Brief Summary

The aim of this study is to assess the usability of two mindfulness smartphone applications (apps) and to evaluate whether text message support can promote engagement with those apps through a 4-week trial comparing support vs. no support.

Detailed Description

Part one of this study is to conduct usability testing to understand more about the acceptability and usability of these existing mindfulness apps in a population with depression and anxiety. The goal of usability testing is to identify any usability problems, provide information for future app development, and determine the participant's satisfaction with the apps. Participants will then be randomized to receive either engagement support or no support which will be delivered via text messaging, and will be randomized to use one of the two mindfulness applications for the 4 week period. Specific Aim 2.1 is to evaluate any differences on outcome measures between the two mindfulness apps. Specific Aim 2.2 is to evaluate the differences of outcome measures between text message engagement support versus no support, regardless of the mindfulness app. For Aim 2.1, the investigators predict that all mindfulness apps will be capable of leading to improvements on outcome measures. For Aim 2.2, the investigators predict that the text message engagement support arm will engage more with the mindfulness app and will see greater improvements in outcome measures regardless of the mindfulness app.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Engagement Support

In the engagement support group, participants will be sent text messages that will encourage use of the app through tips, reminders, and encouraging messages.

Group Type: EXPERIMENTAL

Headspace - Meditation and Mindfulness App

Intervention Type: BEHAVIORAL

Participants randomized to this arm will receive 1-month full access to the Headspace meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.

Stop, Breathe, & Think - Meditation and Mindfulness App

Intervention Type: BEHAVIORAL

Participants randomized to this arm will receive 1-month full access to the Stop, Breathe, \& Think meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.

No Engagement Support

Participants in this group will receive no text message support.

Group Type: OTHER

Headspace - Meditation and Mindfulness App

Intervention Type: BEHAVIORAL

Participants randomized to this arm will receive 1-month full access to the Headspace meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.

Stop, Breathe, & Think - Meditation and Mindfulness App

Intervention Type: BEHAVIORAL

Participants randomized to this arm will receive 1-month full access to the Stop, Breathe, \& Think meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.

Interventions

Headspace - Meditation and Mindfulness App

Participants randomized to this arm will receive 1-month full access to the Headspace meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.

Intervention Type: BEHAVIORAL

Stop, Breathe, & Think - Meditation and Mindfulness App

Participants randomized to this arm will receive 1-month full access to the Stop, Breathe, \& Think meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. meet criteria for clinically significant distress caused by anxiety defined by a Generalized Anxiety Disorder-7 (GAD-7) greater than a 10 or clinically significant distress caused my depression defined by a Patient Health Questionnaire (PHQ-9) greater than 10

2. 18 years of age or older;

3. fluent in English;

4. lives in the Chicago area and are able to attend and in person session;

5. own an internet ready smartphone with data and text plans.

Exclusion Criteria

1. have visual, hearing, voice, or motor impairment that would prevent completion treatment procedures;

2. past or current diagnosis of a psychotic disorder, bipolar disorder, dissociative disorder, substance or alcohol abuse dependence, or other diagnosis for which participation in the trial would be dangerous;

3. suicidal, defined as a 1 or higher on item 9 of the Patient Health Questionnaire (PHQ-9);

4. adults unable to consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Stephen Schueller

Adjunct Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Northwester University, Feinberg School of Medicine, Center for Behavioral Intervention Technologies

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

STU00206204

Identifier Type: -

Identifier Source: org_study_id