Recruiting

Mindfulness Intervention

Sponsor:

VA Palo Alto Health Care System

Code:

NCT04035304

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness Coach

Study Details

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).

Conditions

PTSD

Study ID

NCT04035304

Start date

Jul 24, 2019

Status verified date

Aug, 2019

Completion date

Aug 1, 2020

Anticipated

Primary completion date

Aug 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Mindfulness Coach Mobile App

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).

no intervention: No Treatment Control Group

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.

Interventions

Mindfulness Coach

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.

Primary outcome measure

  • Mindfulness Questionnaire [ Time Frame: 8 weeks ]
  • PEG Pain Scale [ Time Frame: 8 weeks ]
  • PROMIS (Patient-Reported Outcomes Measurement Information System) Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a [ Time Frame: 8 weeks ]
  • Acceptance and Action Questionnaire (AAQ-II) [ Time Frame: 8 weeks ]
  • PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 8 weeks ]
  • Patient Health Questionnaire (PHQ-9) [ Time Frame: 8 weeks ]
  • Generalized Anxiety Disorder 7 (GAD-7) [ Time Frame: 8 weeks ]
  • The Brief Inventory of Psychosocial Functioning (B-IPF) [ Time Frame: 8 weeks ]
  • World Health Organization Quality of Life, abbreviated version (WHOQOL) - BREF [ Time Frame: 8 weeks ]
  • White Bear Suppression Inventory (WBSI) [ Time Frame: 8 weeks ]
  • Five Facet Mindfulness Questionnaire [ Time Frame: 8 weeks ]
  • Multidimensional Assessment of Interoceptive Awareness (MAIA) [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Jason Owen, PhD

(650) 493-5000jason.owen@va.gov

Andrew Chang, MA

(650) 493-5000andrew.chang9@va.gov

Locations

VA Palo Alto Health Care System Menlo Park Division

Recruiting

Menlo Park, California, United States, 94025

Contacts

Jason Owen, PhD

650-493-5000jason.owen@va.gov

More Information

Sponsor

VA Palo Alto Health Care System

Last update posted

Aug 20, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Palo Alto Health Care System on 2019-08-20.