Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Text Message Engagement Support of Mindfulness Smartphone

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Behavioral: Headspace - Meditation and Mindfulness App
* Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 18 years of age or older; fluent in English; lives in the Chicago area and are able to attend and in person session; own an internet ready smartphone with data and text plans. Exclusion Criteria: have visual, hearing, voice, or motor impairment that would prevent completion treatment procedures; 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; suicidal, defined as a 1 or higher on item 9 of the Patient Health Questionnaire (PHQ-9); adults unable to consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Engagement Support<br>In the engagement support group, participants will be sent text messages that will encourage use of the app through tips, reminders, and encouraging messages. | Behavioral: Headspace - Meditation and Mindfulness App<br>* 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.<br>Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App<br>* 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.<br>|
| Other: No Engagement Support<br>Participants in this group will receive no text message support. | Behavioral: Headspace - Meditation and Mindfulness App<br>* 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.<br>Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression and Anxiety at Week 2 and Week 4 | Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depression. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day). | Baseline, Week 2, Week 4 | 
| Change in Anxiety at Week 2 and Week 4 | Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety. Scores on this measure range from 0 (Not At All) to 3 (Nearly Every Day). | Baseline, Week 2, Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| App Usage | App usage will be defined as how many minutes the participant meditated and how many meditations they listened to. | Week 1, Week 2, Week 3, Week 4 | 
| App Satisfaction | App satisfaction evaluates the participants satisfaction with the app on a scale ranging from 1 (Not At All) to 5 (Extremely). | Week 1, Week 2, Week 3, Week 4 |