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Completed

NCT Number: NCT03633682

Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications

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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Headspace - Meditation and Mindfulness App

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

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Evaluation of Text Message Engagement Support of Mindfulness Smartphone

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 16, 2018
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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