VA Palo Alto Health Care System Menlo Park Division
Menlo Park, California, 94025
Jason Owen, PhD, 650-493-5000 ext. 23478, jason.owen@va.gov
Recruiting

Other trials in United States

About this study

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).

Read the 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.

Conditions: PTSD
Being tested: Mindfulness Coach
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness CoachOther
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.

Study groups in NCT04035304
Study group	Role	What they receive
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). Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 20191 Aug 2020

First posted29 Jul 2019
Study start24 Jul 2019
Primary completion1 Aug 2020 (estimated)
Study completion1 Aug 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PTSDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04035304
Sponsor's protocol ID: 35540
Status last verified: Aug 2019
First submitted: 24 Jul 2019
Last updated: 20 Aug 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39190441

Want to know more?

Jason Owen, PhD

(650) 493-5000 ext. 27358

jason.owen@va.gov

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder

All PTSD trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Online and Mobile Mindfulness Intervention to Reduce Distress
ClinicalTrials.gov ID: NCT04035304
Acronym / sponsor ID: 35540
Conditions: PTSD
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 200 participants (estimated)
Lead sponsor: VA Palo Alto Health Care SystemUS federal agency
Study start: 24 Jul 2019 (actual)
Primary completion: 1 Aug 2020 (estimated)
Study completion: 1 Aug 2020 (estimated)
First posted: 29 Jul 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Description of Each Condition:

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mindfulness Coach Mobile App	Experimental	Other: Mindfulness CoachParticipants 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 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

Under 18

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness CoachMindfulness 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.	Other	Mindfulness Coach Mobile App

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
Derived from this study: PubMed 39190441Wielgosz 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.
Individual participant dataSharing planned: No

Related trials for PTSD

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jason Owen, PhD contact

(650) 493-5000 ext. 27358

jason.owen@va.gov

Andrew Chang, MA contact

(650) 493-5000 ext. 26328

andrew.chang9@va.gov

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Coach in people with PTSD, run by VA Palo Alto Health Care System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jason Owen, PhD ((650) 493-5000 ext. 27358, jason.owen@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mindfulness Questionnaire (time frame: 8 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04035304, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.