Clinical trial NCT03633682: Evaluation of Text Message Engagement Support of Mindfulness Smartphone Applications
Official title: Evaluation of Text Message Engagement Support of Mindfulness Smartphone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in Depression and Anxiety at Week 2 and Week 4
timeFrame: Baseline, Week 2, Week 4
measure: Change in Anxiety at Week 2 and Week 4
timeFrame: Baseline, Week 2, Week 4
Secondary outcomes:
measure: App Usage
timeFrame: Week 1, Week 2, Week 3, Week 4
measure: App Satisfaction
timeFrame: Week 1, Week 2, Week 3, Week 4
Other outcomes:
measure: Change in Mindfulness at Week 4
timeFrame: Baseline and Week 4
measure: Change in Psychological Flexibility at Week 2 and Week 4
timeFrame: Baseline, Week 2, Week 4
measure: Change in Depression, Anxiety, and Stress at Week 1, 2, 3, and 4
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4
measure: Change in Rumination at Week 4
timeFrame: Baseline, Week 4
measure: Change in Insomnia at Week 4
timeFrame: Baseline, Week 4
measure: Change in Quality of Life at Week 4
timeFrame: Baseline, Week 4
measure: Change in Stress at Week 4
timeFrame: Baseline, Week 4
Locations:
city: Chicago
country: United States
facility: Northwester University, Feinberg School of Medicine, Center for Behavioral Intervention Technologies
state: Illinois
Study officials:
References: