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Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications

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ClinicalTrials.gov Identifier: NCT03633682
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Stephen Schueller, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Behavioral: Headspace - Meditation and Mindfulness App Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Text Message Engagement Support of Mindfulness Smartphone
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

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.

No Engagement Support
Participants in this group will receive no text message support.
Behavioral: 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.

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.




Primary Outcome Measures :
  1. Change in Depression and Anxiety at Week 2 and Week 4 [ Time Frame: Baseline, Week 2, 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).

  2. Change in Anxiety at Week 2 and Week 4 [ Time Frame: Baseline, Week 2, 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 :
  1. App Usage [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]
    App usage will be defined as how many minutes the participant meditated and how many meditations they listened to.

  2. App Satisfaction [ Time Frame: Week 1, Week 2, Week 3, Week 4 ]
    App satisfaction evaluates the participants satisfaction with the app on a scale ranging from 1 (Not At All) to 5 (Extremely).


Other Outcome Measures:
  1. Change in Mindfulness at Week 4 [ Time Frame: Baseline and Week 4 ]
    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").

  2. Change in Psychological Flexibility at Week 2 and Week 4 [ Time Frame: Baseline, Week 2, Week 4 ]
    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).

  3. Change in Depression, Anxiety, and Stress at Week 1, 2, 3, and 4 [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 4 ]
    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).

  4. Change in Rumination at Week 4 [ Time Frame: Baseline, Week 4 ]
    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).

  5. Change in Insomnia at Week 4 [ Time Frame: Baseline, Week 4 ]
    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)

  6. Change in Quality of Life at Week 4 [ Time Frame: Baseline, Week 4 ]
    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).

  7. Change in Stress at Week 4 [ Time Frame: Baseline, Week 4 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633682


Contacts
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Contact: Elizabeth C Adkins, MA 3125036576 elizabethkaiser2015@u.northwestern.edu
Contact: Stephen Schueller, PhD Schueller@northwestern.edu

Locations
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United States, Illinois
Northwester University, Feinberg School of Medicine, Center for Behavioral Intervention Technologies Recruiting
Chicago, Illinois, United States, 60611
Contact: Elizabeth Adkins, MA    312-503-6576    elizabethkaiser2015@u.northwestern.edu   
Contact: Stephen Schueller, PhD       schueller@northwestern.edu   
Sponsors and Collaborators
Northwestern University
  Study Documents (Full-Text)

Documents provided by Stephen Schueller, Northwestern University:
Study Protocol  [PDF] June 5, 2018
Statistical Analysis Plan  [PDF] March 3, 2020

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Responsible Party: Stephen Schueller, Adjunct Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03633682    
Other Study ID Numbers: STU00206204
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms