Posttraumatic Stress DisorderPhase 1NCT04861311
Testing the Efficacy of a Mindfulness- and Acceptance-Based Smartphone App for PTSD: A Randomized Controlled Trial
A Phase 1 study testing Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention in people with Posttraumatic Stress Disorder, run by University of Nevada, Las Vegas.
Trial summary
The purpose of the study is to test the feasibility and acceptability of a mindfulness- and acceptance-based smartphone app (MABSA) intervention for college student veterans with posttraumatic stress disorder (PTSD) symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) aged 18 years old or older, (2) currently registered as an undergraduate or graduate student, (3) has previous active military service from any U.S. military service branch, (4) has at least daily access to their own Apple iPhone (version 5 or later) or Android phone, and (5) have posttraumatic stress disorder (PTSD) symptoms (must have a score of 33 or above on the PTSD Checklist for DSM-5)
Who cannot join
- (1) Those who have a score of 32 or below on the PTSD Checklist for DSM-5 and (2) Those who have a cognitive impairment such as dementia-related disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Testing the Efficacy of a Mindfulness- and Acceptance-Based Smartphone App Intervention for College Student Veterans With Posttraumatic Stress Disorder (PTSD): A Randomized Controlled Trial
The purpose of the study is to test the feasibility and acceptability of a mindfulness- and acceptance-based smartphone app (MABSA) intervention for college student veterans with posttraumatic stress disorder (PTSD) symptoms. The study will use a randomized controlled trial design of two groups: intervention group of about 30 participants with PTSD and wait-list control group of about 30 participants. The duration of the MABSA intervention is 6 weeks. The following are the outcomes to be measured: resilience, PTSD, mindfulness, experiential avoidance, and rumination.
Read the detailed description
The objective of the proposed study is to evaluate the feasibility of the Mindfulness/Acceptance-Based Smartphone App (MABSA) intervention in a randomized controlled trial (RCT) environment and to obtain generalized information (i.e., initial efficacy, recruitment, retention, adherence, satisfaction, and usability of the refined intervention). The expected results will provide the foundation for a prospective, fully powered, larger-scale RCT study. We previously developed the MABSA and pilot tested it in a single-arm study. Our central hypothesis is that the refined MABSA intervention would improve intervention satisfaction, app usability, and adherence and positively affect resilience, PTSD, mindfulness, experiential avoidance, and rumination. The specific aims of the proposed study are outlined below.
AIM 1: To refine the previously developed MABSA intervention. The 6-week smartphone-delivered program will involve (1) daily audio-guided meditations on various mindfulness and acceptance exercises constructed based on the principles of acceptance and commitment therapy; (2) weekly support and feedback through phone calls and/or texting the intervention facilitators; and (3) ecological momentary assessment (daily monitoring of PTSD and resilience) to monitor the progression of treatment response (i.e., the trajectory of resilience and PTSD recovery). We will obtain qualitative feedback on program content and format through a pilot test of the prototype with a group of eligible college student veterans (N = 4). Upon revising the intervention based on participants' feedback, we will develop the intervention protocol manual for the RCT.
AIM 2: To test the feasibility and acceptability of the refined MABSA intervention in a small-scale RCT for a prospective, fully powered, larger-scale RCT study. The small-scale RCT study will involve the following two groups of college student veterans: (1) the MABSA intervention group (N = 30) and the waitlist control group (N = 30). Upon collecting the data on recruitment, retention, adherence, intervention satisfaction, and app usability, we will determine the preliminary efficacy based on the following five outcomes: resilience, PTSD, mindfulness, experiential avoidance, and rumination. Qualitative feedback on the facilitators of and challenges to recruitment, retention, and adherence will be collected via exit interviews.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention
- Keywords
- Posttraumatic Stress Disorder, mindfulness, acceptance, resilience
- 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/Acceptance-Based Smartphone App (MABSA) InterventionBehavioural
The intervention is based on the principles of Acceptance and Commitment Therapy (ACT). Therefore, the intervention is an ACT-based smartphone app delivered for 6 weeks in which participants will be applying the mindfulness and acceptance exercises embedded in the app. The mindfulness and acceptance exercises are audio-guided mindfulness meditations and video lessons about ACT.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group | Experimental | The intervention is 6 weeks in duration. Participants will be asked to listen daily to at least one audio-guided mindfulness meditation embedded in the app. They will also be asked to watch a weekly video lesson on mindfulness and acceptance and will be asked to write a reflection about the video. They will also receive weekly emotional and technical support during the duration of the intervention. Receives: Behavioral: Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention |
| Wait-List Control Group | No intervention | The control group is a wait-list control group. Participants in the control group will be offered to use the app after 10 weeks of being in the study. The control group participants once they opted to use the app after 10 weeks will only have access to the app for 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD
Changes in posttraumatic stress disorder (PTSD) symptoms based on the PTSD Checklist for DSM-5 (PCL-5)
Measured: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Resilience
Changes in resilience based on the Connor-Davidson Resilience Scale 25
Measured: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Mindfulness
Changes in mindfulness based on the Mindfulness Attention and Awareness Scale
Measured: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Experiential Avoidance
Changes in experiential avoidance based on the Acceptance and Action Questionnaire
Measured: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Rumination
Changes in rumination based on the Rumination Scale
Measured: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Secondary outcomes (2)
PTSD Recovery
Daily measures of PTSD using the abbreviated PTSD Checklist for DSM-5
Measured: We will measure PTSD daily using the app (ecological momentary assessment)
Resilience Progression
Daily measures of resilience using the abbreviate Connor-Davidson Resilience Scale 10
Measured: We will measure resilience daily using the app (ecological momentary assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Jan 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group will use the smartphone app which comprises of audio-guided mindfulness meditations and video lessons. Participants are asked to listen to at least one guided meditation daily and watch one video lesson each week. Participants will also receive a weekly phone call for emotional and technical support. The wait-list control group will have the option to use the app-based intervention after 10 weeks of being in the control group.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Thomas Reyes, University of Nevada, Las Vegas
- Investigators
- Andrew T Reyes, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861311
- Sponsor's protocol ID
- 1603895-3
- Status last verified
- Dec 2021
- First submitted
- 22 Apr 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reyes AT, Bhatta TR, Muthukumar V, Gangozo WJ. Testing the acceptability and initial efficacy of a smartphone-app mindfulness intervention for college student veterans with PTSD. Arch Psychiatr Nurs. 2020 Apr;34(2):58-66. doi: 10.1016/j.apnu.2020.02.004. Epub 2020 Feb 18.
PubMed 32248935Reyes AT, Serafica R, Sojobi A. College student veterans' experience with a mindfulness- and acceptance-based mobile app intervention for PTSD: A qualitative study. Arch Psychiatr Nurs. 2020 Dec;34(6):497-506. doi: 10.1016/j.apnu.2020.09.005. Epub 2020 Sep 11.
PubMed 33280672
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of a Mindfulness- and Acceptance-Based Smartphone App Intervention for College Student Veterans With Posttraumatic Stress Disorder (PTSD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04861311
- Acronym / sponsor ID
- 1603895-3
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, mindfulness, acceptance, resilience
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 27 Apr 2021 (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.
The purpose of the study is to test the feasibility and acceptability of a mindfulness- and acceptance-based smartphone app (MABSA) intervention for college student veterans with posttraumatic stress disorder (PTSD) symptoms. The study will use a randomized controlled trial design of two groups: intervention group of about 30 participants with PTSD and wait-list control group of about 30 participants. The duration of the MABSA intervention is 6 weeks. The following are the outcomes to be measured: resilience, PTSD, mindfulness, experiential avoidance, and rumination.
Detailed description
The objective of the proposed study is to evaluate the feasibility of the Mindfulness/Acceptance-Based Smartphone App (MABSA) intervention in a randomized controlled trial (RCT) environment and to obtain generalized information (i.e., initial efficacy, recruitment, retention, adherence, satisfaction, and usability of the refined intervention). The expected results will provide the foundation for a prospective, fully powered, larger-scale RCT study. We previously developed the MABSA and pilot tested it in a single-arm study. Our central hypothesis is that the refined MABSA intervention would improve intervention satisfaction, app usability, and adherence and positively affect resilience, PTSD, mindfulness, experiential avoidance, and rumination. The specific aims of the proposed study are outlined below.
AIM 1: To refine the previously developed MABSA intervention. The 6-week smartphone-delivered program will involve (1) daily audio-guided meditations on various mindfulness and acceptance exercises constructed based on the principles of acceptance and commitment therapy; (2) weekly support and feedback through phone calls and/or texting the intervention facilitators; and (3) ecological momentary assessment (daily monitoring of PTSD and resilience) to monitor the progression of treatment response (i.e., the trajectory of resilience and PTSD recovery). We will obtain qualitative feedback on program content and format through a pilot test of the prototype with a group of eligible college student veterans (N = 4). Upon revising the intervention based on participants' feedback, we will develop the intervention protocol manual for the RCT.
AIM 2: To test the feasibility and acceptability of the refined MABSA intervention in a small-scale RCT for a prospective, fully powered, larger-scale RCT study. The small-scale RCT study will involve the following two groups of college student veterans: (1) the MABSA intervention group (N = 30) and the waitlist control group (N = 30). Upon collecting the data on recruitment, retention, adherence, intervention satisfaction, and app usability, we will determine the preliminary efficacy based on the following five outcomes: resilience, PTSD, mindfulness, experiential avoidance, and rumination. Qualitative feedback on the facilitators of and challenges to recruitment, retention, and adherence will be collected via exit interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group will use the smartphone app which comprises of audio-guided mindfulness meditations and video lessons. Participants are asked to listen to at least one guided meditation daily and watch one video lesson each week. Participants will also receive a weekly phone call for emotional and technical support. The wait-list control group will have the option to use the app-based intervention after 10 weeks of being in the control group.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group | Experimental | Behavioral: Mindfulness/Acceptance-Based Smartphone App (MABSA) InterventionThe intervention is 6 weeks in duration. Participants will be asked to listen daily to at least one audio-guided mindfulness meditation embedded in the app. They will also be asked to watch a weekly video lesson on mindfulness and acceptance and will be asked to write a reflection about the video. They will also receive weekly emotional and technical support during the duration of the intervention. |
| Wait-List Control Group | No intervention | –The control group is a wait-list control group. Participants in the control group will be offered to use the app after 10 weeks of being in the study. The control group participants once they opted to use the app after 10 weeks will only have access to the app for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) aged 18 years old or older, (2) currently registered as an undergraduate or graduate student, (3) has previous active military service from any U.S. military service branch, (4) has at least daily access to their own Apple iPhone (version 5 or later) or Android phone, and (5) have posttraumatic stress disorder (PTSD) symptoms (must have a score of 33 or above on the PTSD Checklist for DSM-5)
Key exclusion criteria (1 listed)
- (1) Those who have a score of 32 or below on the PTSD Checklist for DSM-5 and (2) Those who have a cognitive impairment such as dementia-related disorders.
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/Acceptance-Based Smartphone App (MABSA) InterventionThe intervention is based on the principles of Acceptance and Commitment Therapy (ACT). Therefore, the intervention is an ACT-based smartphone app delivered for 6 weeks in which participants will be applying the mindfulness and acceptance exercises embedded in the app. The mindfulness and acceptance exercises are audio-guided mindfulness meditations and video lessons about ACT. | Behavioural | Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group |
Primary outcome
PTSD
Time frame: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in posttraumatic stress disorder (PTSD) symptoms based on the PTSD Checklist for DSM-5 (PCL-5)
Resilience
Time frame: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in resilience based on the Connor-Davidson Resilience Scale 25
Mindfulness
Time frame: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in mindfulness based on the Mindfulness Attention and Awareness Scale
Experiential Avoidance
Time frame: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in experiential avoidance based on the Acceptance and Action Questionnaire
Rumination
Time frame: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Changes in rumination based on the Rumination Scale
2 secondary outcomes
PTSD Recovery
Time frame: We will measure PTSD daily using the app (ecological momentary assessment)
Resilience Progression
Time frame: We will measure resilience daily using the app (ecological momentary assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Background: PubMed 32248935Reyes AT, Bhatta TR, Muthukumar V, Gangozo WJ. Testing the acceptability and initial efficacy of a smartphone-app mindfulness intervention for college student veterans with PTSD. Arch Psychiatr Nurs. 2020 Apr;34(2):58-66. doi: 10.1016/j.apnu.2020.02.004. Epub 2020 Feb 18.
- Background: PubMed 33280672Reyes AT, Serafica R, Sojobi A. College student veterans' experience with a mindfulness- and acceptance-based mobile app intervention for PTSD: A qualitative study. Arch Psychiatr Nurs. 2020 Dec;34(6):497-506. doi: 10.1016/j.apnu.2020.09.005. Epub 2020 Sep 11.
- Individual participant dataSharing planned: No
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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.
Andrew T Reyes, PhD principal investigator
University of Nevada, Las Vegas
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention in people with Posttraumatic Stress Disorder, run by University of Nevada, Las Vegas.
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 1 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 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Andrew T Reyes, PhD (702-895-5094, andrewthomas.reyes@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD (time frame: We will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up). The study lists 5 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 NCT04861311, which also lists 2 linked publications.
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 13 Dec 2021.