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Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Headspace - Meditation and Mindfulness App
Stop, Breathe, & Think - Meditation and Mindfulness App
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Engagement Support

No Engagement Support

Arm Description

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

Participants in this group will receive no text message support.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

App Usage
App usage will be defined as how many minutes the participant meditated and how many meditations they listened to.
App Satisfaction
App satisfaction evaluates the participants satisfaction with the app on a scale ranging from 1 (Not At All) to 5 (Extremely).

Full Information

First Posted
June 26, 2018
Last Updated
July 1, 2021
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03633682
Brief Title
Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications
Official Title
Evaluation of Text Message Engagement Support of Mindfulness Smartphone
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Engagement Support
Arm Type
Experimental
Arm Description
In the engagement support group, participants will be sent text messages that will encourage use of the app through tips, reminders, and encouraging messages.
Arm Title
No Engagement Support
Arm Type
Other
Arm Description
Participants in this group will receive no text message support.
Intervention Type
Behavioral
Intervention Name(s)
Headspace - Meditation and Mindfulness App
Intervention Description
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
Intervention Name(s)
Stop, Breathe, & Think - Meditation and Mindfulness App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Depression and Anxiety at Week 2 and Week 4
Description
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).
Time Frame
Baseline, Week 2, Week 4
Title
Change in Anxiety at Week 2 and Week 4
Description
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).
Time Frame
Baseline, Week 2, Week 4
Secondary Outcome Measure Information:
Title
App Usage
Description
App usage will be defined as how many minutes the participant meditated and how many meditations they listened to.
Time Frame
Week 1, Week 2, Week 3, Week 4
Title
App Satisfaction
Description
App satisfaction evaluates the participants satisfaction with the app on a scale ranging from 1 (Not At All) to 5 (Extremely).
Time Frame
Week 1, Week 2, Week 3, Week 4
Other Pre-specified Outcome Measures:
Title
Change in Mindfulness at Week 4
Description
Five Facet Mindfulness Questionnaire. A self-report measure of five facets of mindfulness: observing, describing, acting with awareness, being nonjudgmental, and nonreactivity. The FFMQ is a 39-item questionnaire, and each FFMQ item is rated on a 5-point scale ranging from 1 ("never or very rarely true") to 5 ("very often or always true").
Time Frame
Baseline and Week 4
Title
Change in Psychological Flexibility at Week 2 and Week 4
Description
Acceptance and Action Questionnaire (AAQ-II). The AAQ-II is a 7-item self-report questionnaire designed to measure psychological flexibility. Scores on this measure range from 1 (never true) to 7 (always true).
Time Frame
Baseline, Week 2, Week 4
Title
Change in Depression, Anxiety, and Stress at Week 1, 2, 3, and 4
Description
Depression, Anxiety, and Stress Scale (DASS). The DASS-21 is a 21-item self-report measure consisting of three subscales (depression, anxiety and stress). Answers range from 0 (did not apply to me at all) to 3 (applied to me very much).
Time Frame
Baseline, Week 1, Week 2, Week 3, Week 4
Title
Change in Rumination at Week 4
Description
The Rumination-Reflection Questionnaire (RRQ). The RRQ is a 24-item self-reported questionnaire assessing both self-rumination and self-reflection, with 12 items corresponding to each subscale. Participants rate the degree to which they engage in self- rumination (e.g. "sometimes it is hard for me to shut off thoughts about myself") and self-reflective thoughts (e.g. "I love to meditate on the nature and meaning of things") on a Likert scale ranging from one (strongly disagree) to five (strongly agree).
Time Frame
Baseline, Week 4
Title
Change in Insomnia at Week 4
Description
Insomnia Severity Scale (ISI). The ISI is a 7-item self-report measure of insomnia. Total ISI scale scores range from a low of 0 (least insomnia) to a high of 28 (worst insomnia)
Time Frame
Baseline, Week 4
Title
Change in Quality of Life at Week 4
Description
Quality of Life Scale (QOLS). The QOLS is a 16-item self-report measure of quality of life. The QOLS accesses five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation. The scale ranges from 1 (terrible) to 7 (delighted).
Time Frame
Baseline, Week 4
Title
Change in Stress at Week 4
Description
Perceived Stress Scale (PSS). The PSS is a 10-item self-report measure of stress, with scores ranging from 10-40 and a higher score indicates a worse outcome.
Time Frame
Baseline, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Northwester University, Feinberg School of Medicine, Center for Behavioral Intervention Technologies
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

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Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications

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