Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications

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Northwestern University

Status

Completed

Conditions

Depression
Anxiety

Treatments

Behavioral: Headspace - Meditation and Mindfulness App
Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App

Study type

Interventional

Funder types

Other

Identifiers

NCT03633682
STU00206204

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Engagement Support
Experimental group
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.
Treatment:
Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App
Behavioral: Headspace - Meditation and Mindfulness App
No Engagement Support
Other group
Description:
Participants in this group will receive no text message support.
Treatment:
Behavioral: Stop, Breathe, & Think - Meditation and Mindfulness App
Behavioral: Headspace - Meditation and Mindfulness App

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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