Online and Mobile Mindfulness Intervention to Reduce Distress

NCT04035304 | Unknown

• 1 other identifier: 35540
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (12)

• Mindfulness Questionnaire

  This is a 7-item questionnaire which asks participants to rate their ability to practice, and attitude towards mindfulness meditation practices. Mindfulness meditation in the clinical context is defined as nonjudgmental attention to present-moment experiences. Originally stemming from Buddhist tradition, it guides users to the regulation of their attention to maintain their focus on immediate experiences such as thoughts, emotions, body posture and sensations, and the ability to approach one's experiences with openness and acceptance. The minimum score on this scale is 7, maximum 35. Some items are reverse-coded, and possible responses include "Strongly disagree", "Somewhat disagree", "Neither agree nor disagree", "Somewhat agree", or "Strongly agree". Higher scores indicate an increased mindfulness practice capability, which is the better outcome. Responses are summed.

  8 weeks

• PEG Pain Scale

  PEG is a 3-item questionnaire assessing Pain Intensity and Interference. Pain is measured on a 0 to 10 scale by asking participants to rate their pain over the past week. Responding 0 to any item indicates "No pain", whereas 10 is "Pain as bad as you can imagine". It also asks how much pain interferes with their enjoyment of life and general activity. The minimum score is 0, and maximum is 30. Lower score is the better outcome. Responses are summed.

  8 weeks

• PROMIS (Patient-Reported Outcomes Measurement Information System) Item Bank v. 1.0 - Sleep-Related Impairment - Short Form 8a

  PROMIS is an 8-item questionnaire which assesses sleep quality, such as if they feel rested after sleeping, or still feel tired after they wake up, and if that impacts their quality of life. Some items are reverse-coded, and possible responses include "Not at all", "A little bit", "Somewhat", "Quite a bit", or "Very much". The minimum score is 8, and the maximum is 40. Lower score is the better outcome. Responses are summed.

  8 weeks

• Acceptance and Action Questionnaire (AAQ-II)

  AAQ-II is a 10-item questionnaire on how personal memories effect feelings of anxiety and control over one's life. The Acceptance and Action Questionnaire measures experiential avoidance and psychological inflexibility, such as the avoidance of thoughts and feelings, ability to distinguish negative thoughts from objective facts about the situation, and behavioral adjustment in the presence of difficult thoughts or feelings. It is used to predict a wide-range of quality of life outcomes (e.g., depression, anxiety, general mental health, job satisfaction, future work absence, and future job performance. Some items are reverse-coded, and possible responses include "Never true", "Very seldom true", "Seldom true", "Sometimes true", "Frequently true", "Almost always true", or "Always true". The minimum score is 10, and the maximum is 70. Lower score is the better outcome. Responses are summed.

  8 weeks

• PTSD Checklist for DSM-5 (PCL-5)

  The PCL-5 is a 20-item questionnaire that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including: Monitoring symptom change during and after treatment, Screening individuals for PTSD, Making a provisional PTSD diagnosis. Possible responses include "Not at all", "A little bit", "Moderately", "Quite a bit", or "Extremely". The minimum score is 0, and the maximum is 80. Lower score is the better outcome. Responses are summed.

  8 weeks

• Patient Health Questionnaire (PHQ-9)

  PHQ-9 is a 10-item questionnaire that assesses the DSM-5 symptoms of Major Depression over the past two weeks. These are operationalized in the amount of impact on respondents daily functioning the symptoms have with possible responses include "Not at all", "Several days", "More than half the days", "Nearly every day". The minimum score is 0, and the maximum is 36. Lower score is the better outcome. Responses are summed.

  8 weeks

• Generalized Anxiety Disorder 7 (GAD-7)

  GAD-7 is a 7-item questionnaire that assesses the DSM-5 symptoms of Generalized Anxiety Disorder symptoms over the past two weeks. These are operationalized in the amount of impact on respondents daily functioning the symptoms have with possible responses include "Not at all", "Several days", "More than half the days", "Nearly every day". The minimum score is 0, and the maximum is 28. Lower score is the better outcome. Responses are summed.

  8 weeks

• The Brief Inventory of Psychosocial Functioning (B-IPF)

  B-IPF is a 7-item questionnaire that assesses posttraumatic stress disorder (PTSD)-related psychosocial functional impairment over the past month. These are operationalized in the amount of difficulty participants have in their social relationships because of their PTSD symptoms. Possible responses include "0 Not at all", "1", "2", "3 Somewhat", "4", "5", "6 Always", or "N/A". The minimum score is 0, and the maximum is 42. Lower score is the better outcome. Responses are summed.

  8 weeks

• World Health Organization Quality of Life, abbreviated version (WHOQOL) - BREF

  WHOQOL - BREF is a 27-item questionnaire that assesses overall quality of life across 4 subscales over the past two weeks. The first is Physical Health, such as Activities of daily living, Dependence on medicinal substances and medical aids. Second is Psychological, such as Bodily image and appearance, memory and concentration. Third is Social relationships, such as Social support and Sexual activity. And fourth is Environment, such as Financial Resources and Physical safety and security. These subgroups are analyzed separately and not summed. Possible responses include "Very dissatisfied", "Dissatisfied", "Neither satisfied nor dissatisfied", "Satisfied", and "Very satisfied" or "Not at all", "A little", "Moderately", "Mostly", "Completely". Some items are reverse-coded. The minimum score is 27, and the maximum is 135. Higher score is the better outcome. Responses are summed.

  8 weeks

• White Bear Suppression Inventory (WBSI)

  WBSI is a 15-item questionnaire that is designed to measure thought suppression. Chronic thoughts suppression is a variable that is related to obsessive thinking and negative affect associated with depression and anxiety. The WBSI can help to identify individuals who are more prone to develop chronic thought suppression as well as individuals who express wishing they were not depressed, but are in fact depressed. Possible responses include "Strongly disagree", "Disagree", "Neutral or don't know", "Agree", and "Strongly agree". The minimum score is 15, and the maximum is 75. Lower score is the better outcome. Responses are summed.

  8 weeks

• Five Facet Mindfulness Questionnaire

  Five Facet Mindfulness is a 39-item questionnaire which assesses the participant's awareness of their thoughts, emotions, and physical state at the current moment and in general. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. These subgroups can be analyzed separately or summed. Possible responses include "never or very rarely true", "rarely true", "sometimes true", "often true", or "often true or always true". Some items are reverse-coded. The minimum score is 39, and the maximum is 195. Lower score is the better outcome. Responses are summed.

  8 weeks

• Multidimensional Assessment of Interoceptive Awareness (MAIA)

  Multidimensional Assessment of Interoceptive Awareness is a 32-item questionnaire, of which 17 were selected, which assesses the participant's bodily awareness. It allows a more differentiated assessment of essential psychological aspects of the perception and evaluation of body sensations. The four subscales evaluated are Noticing, Not-Distracting, Not-Worrying, and Attention Regulation. Possible responses include "0 Never", "1", "2", "3", "4" or "5 Always". Higher total scores and subscale scores indicate higher levels of positive awareness, the better outcome. The minimum score is 0, and the maximum is 85. Some items are reverse coded, and subscales are averaged separately, then summed.

  8 weeks

Study Arms (2)

Mindfulness Coach Mobile App

EXPERIMENTAL

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).

Other: Mindfulness Coach

No Treatment Control Group

NO INTERVENTION

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 OTHER

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.

Mindfulness Coach Mobile App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Under 18

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead

Study Sites (1)

VA Palo Alto Health Care System Menlo Park Division

Menlo Park, California, 94025, United States

RECRUITING

Related Publications (1)

• Wielgosz J, Walser RD, Kuhn E, Chang A, Bantum EO, Pagano I, Jaworski BK, Taylor K, Ramsey KM, Owen JE. Clinical benefits of self-guided mindfulness coach mobile app use for veterans with posttraumatic stress disorder: A pilot randomized control trial. Psychol Trauma. 2025 Jul;17(5):1117-1126. doi: 10.1037/tra0001736. Epub 2024 Aug 26.

  PMID: 39190441 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Jason Owen, PhD

CONTACT

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

Andrew Chang, MA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Waitlist control group, which will receive same intervention 8 weeks after baseline.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: July 24, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)