Clinical trial NCT04035304: Online and Mobile Mindfulness Intervention to Reduce Distress
Official title: Online and Mobile Mindfulness Intervention to Reduce Distress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2019-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test whether a mobile app can improve mindful awareness, attention, and psychological well-being in Veterans and cancer survivors with mild to moderate PTSD symptoms. Because many of those experiencing trauma symptoms do not receive evidence-based care for PTSD, it is important to identify effective means of delivering efficacious treatments, like mindfulness-based interventions, using technology-based channels. In the proposed study, Veterans with PTSD will be recruited using social media advertising and will be randomized to one of 2 groups: no treatment control group or Mindfulness Coach mobile app. Participants in each of the 2 groups will be asked to complete measures of mindfulness and psychological well- being at baseline (prior to randomization) and again at 8-weeks (immediately post-treatment) and 16-weeks (8 weeks after completing treatment).

Detailed description: In brief, 200 community-dwelling veterans with significant, untreated PTSD symptoms will be randomized to one of 2 groups: a no-treatment control group for one month/30-days, followed by receiving the phone app. And a treatment group that will receive the Mobile app or Mindfulness Coach mobile phone app. Potential participants will be identified from targeted Facebook and other social media outreach efforts.

Investigators at Stanford/VAPAHCS will be responsible for recruitment of the Veteran sample. Those who view an advertisement will be directed to the study website, hosted by Stanford's Qualtrics domain, where they will be provided with information about the study, screened for eligibility, and then provided with an informed consent document. Participants will then be randomized to one of the two groups and provided with an invitation and hyperlink that either a) provides them with information about when they will next be contacted (30-days after initial assessment) (control group), or b) a link that allows them to download the study app (Mindfulness Coach) onto their smart phone. Participants in Group 1 will then be encouraged to use the Mindfulness Coach app as often or as little as they like. Outcomes will be evaluated using objective measures of engagement with the intervention, changes in self-report measures of mindful awareness, attention, and psychological well-being, and qualitative experiences (phone interview) associated with use of each intervention. Barriers to implementation and identified strategies for overcoming barriers will be catalogued over the duration of the study.

Description of Each Condition:

GROUP 1. Mindfulness Coach Mobile App (n = 100). Participants in this condition will complete 3 assessments: initial, end of month two and end of month four. Each participant, following initial assessment will be provided with a link to download the Mindfulness Coach mobile app as well as with brief recommendations for how to use the app over the subsequent 16 weeks of the study. Mindfulness Coach is a mobile app for iPhone and Android, developed by the VA National Center for PTSD in collaboration with National Center for Telehealth and Technology (T2). Mindfulness Coach has been widely downloaded and is the 2nd most popular VA app available to the general public. Mindfulness Coach provides 4 primary treatment components: 1) psychoeducation about PTSD and Mindfulness (e.g., "What is Mindfulness?", "Why Practice Mindfulness?", "Mindfulness for Veterans", "Benefits of Mindfulness for PTSD", "Practice Challenges with PTSD", and "PTSD Symptoms During Practice"), 2) self-monitoring tools for tracking mindfulness practice, 3) 9 audio- guided mindfulness exercises (e.g., "Mindful Breathing", "Body Scan", "Clouds in the Sky", etc.), and 4) reminders to regularly practice mindfulness exercises.

GROUP 2. Will serve, initially, as a No Treatment Control Group (n = 100) for 60- days (one-month). Participants in this condition will initially be provided with links to resources for Veterans with PTSD (http://ptsd.va.gov) and will be told that they will be contacted again in 8 weeks (60 days) to complete a second assessment. Each participant will then be provided with a link to download the Mindfulness Coach mobile app and with brief recommendations for how to use the app over the subsequent 8 weeks of the study (see description above). Participants will participate in a final follow up survey 8 weeks after receiving the app.

Eligibility criteria: Inclusion Criteria:

* PTSD Diagnosis
* Veteran Status
* Must own personal smartphone/tablet with internet connection
* English fluency

Exclusion Criteria:

* Under 18

Primary outcomes:
measure: Mindfulness Questionnaire
timeFrame: 8 weeks
measure: PEG Pain Scale
timeFrame: 8 weeks
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a
timeFrame: 8 weeks
measure: Acceptance and Action Questionnaire (AAQ-II)
timeFrame: 8 weeks
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 8 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 8 weeks
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: 8 weeks
measure: The Brief Inventory of Psychosocial Functioning (B-IPF)
timeFrame: 8 weeks
measure: World Health Organization Quality of Life, abbreviated version (WHOQOL) - BREF
timeFrame: 8 weeks
measure: White Bear Suppression Inventory (WBSI)
timeFrame: 8 weeks
measure: Five Facet Mindfulness Questionnaire
timeFrame: 8 weeks
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: VA Palo Alto Health Care System Menlo Park Division
state: California
Study officials:
References: