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Posttraumatic Stress DisorderEarly Phase 1NCT05157035

Testing a Mindfulness/Acceptance-Based Smartphone App for Nurses Impacted by the COVID-19 Pandemic

A Early Phase 1 study testing Mindfulness/Acceptance-Based Smartphone App (MABSA) in people with Posttraumatic Stress Disorder, run by University of Nevada, Las Vegas.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 frontline nurses emotionally and psychologically impacted by the COVID-19 pandemic. 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)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Jan 2022to 14 Oct 2022
Phase
Early 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) frontline registered nurse or licensed practical nurse practising in the United States, (3) has at least daily access to their own Apple iPhone (version 5 or later) or Android phone, and (4) 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) healthcare workers that are not RNs or LPNs

Trial locations and contacts

No sites are listed yet.

Andrew Thomas Reyes, PhD contact

7028955094

andrewthomas.reyes@unlv.edu

About this study

Official title: Testing a Mindfulness/Acceptance-Based Smartphone App Intervention to Develop Resilience Among Nurses Traumatized From the Effects of the COVID-19 Pandemic: 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 frontline nurses emotionally and psychologically impacted by the COVID-19 pandemic. The study will use a randomized controlled trial design of two groups: an intervention group of about 30 participants with posttraumatic stress symptoms and a 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. The investigator previously developed the MABSA and pilot-tested it in a single-arm study among veterans, and the study will be testing the app among nurses who have been emotionally and psychologically impacted by the COVID-19 pandemic. 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). The investigator will obtain qualitative feedback on program content and format through a pilot test of the prototype with a group of eligible nurses (N = 4). Upon revising the intervention based on participants' feedback, the investigator 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 frontline nurses: (1) the MABSA intervention group (N = 30) and the wait-list control group (N = 30). Upon collecting the data on recruitment, retention, adherence, intervention satisfaction, and app usability, the study 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.

Being tested
Mindfulness/Acceptance-Based Smartphone App (MABSA)
Keywords
posttraumatic stress disorder, mindfulness, COVID-19, mindfulness app
Medical subject headings
Stress Disorders, Post-Traumatic, COVID-19

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)Behavioural

    This is a mindfulness- and acceptance-based smartphone app. The mindfulness and acceptance exercises embedded in the app are based on the principles of Acceptance and Commitment Therapy. Participants in the intervention group will be using the app for 6 weeks. They are expected to access the meditations and mindfulness exercises within the app on a daily basis.

Study groups in NCT05157035
Study groupRoleWhat they receive
Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention GroupExperimentalThe 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)
Wait-List Control GroupNo interventionThe 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.

  1. Posttraumatic Stress Disorder Symptoms (PTSD Checklist for DSM-5 or also called PCL-20)

    Changes in posttraumatic stress disorder (PTSD) symptoms based on the PTSD Checklist for DSM-5 (PCL-20). There are 20 items in the PCL-20. The minimum value of PCL-20 is 0, and the maximum value is 80. Higher scores mean a worse outcome (more severe symptoms of Posttraumatic Stress Disorder).

    Measured: The investigator will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

  2. Resilience (Connor-Davidson Resilience Scale or also called CD-RISC-25)

    Changes in resilience based on the Connor-Davidson Resilience Scale (CD-RISC-25). There are 25 items in the CD-RISC-25. The minimum value of CD-RISC-25 is 0, and the maximum value is 100. Higher scores mean a better outcome (higher level of resilience).

    Measured: The investigator will measure resilience (Connor-Davidson Resilience Scale, CD-RISC-25) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

  3. Mindfulness (Mindfulness Attention and Awareness Scale or also called MAAS)

    Changes in mindfulness based on the Mindfulness Attention and Awareness Scale (MAAS). There are 15 items in the MAAS. The minimum value of MAAS is 15, and the maximum value is 90. Higher scores mean a better outcome (higher level of mindfulness).

    Measured: The investigator will measure mindfulness (Mindfulness Attention and Awareness Scale, MAAS) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

  4. Experiential Avoidance (Acceptance and Action Questionnaire or also called AAQ)

    Changes in experiential avoidance based on the Acceptance and Action Questionnaire (AAQ). There are 7 items in the AAQ. The minimum value of the AAQ is 7, and the maximum value is 49. Higher scores mean a worse outcome (higher level of experiential avoidance or the unwillingness to be present with difficult emotions and thoughts).

    Measured: The investigator will measure experiential avoidance (Acceptance and Action Questionnaire, AAQ) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

  5. Rumination (Rumination Response Scale or also called RRS)

    Changes in rumination based on the Rumination Response Scale (RRS). The RRS has 22 items. The minimum value of the RRS is 22, and the maximum value is 88. Higher scores mean a worse outcome (higher level of rumination or perseverative and passive focus on symptoms and the possible causes and outcomes of psychological distress)

    Measured: The investigator will measure rumination (Rumination Response Scale, RRS) at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up

Secondary outcomes (2)

  1. Posttraumatic Stress Disorder Recovery (Abbreviated Version of the Posttraumatic Stress Disorder Checklist or also called PCL-8)

    Daily measures of posttraumatic stress disorder (PTSD) using the abbreviated PTSD Checklist for DSM-5 (PCL-8). The PCL-8 is a shortened version of the PCL-20. There are 8 items in the PCL-8. The minimum value is 0, and the maximum value is 32. Higher scores mean a worse outcome (greater severity of Posttraumatic Stress Disorder symptoms).

    Measured: The investigator will measure posttraumatic stress disorder symptoms daily using the app (ecological momentary assessment).

  2. Resilience Progression (Abbreviated Version of the Connor-Davidson Resilience Scale or also called CD-RISC-10)

    Daily measures of resilience using the abbreviate Connor-Davidson Resilience Scale 10 (CD-RISC-10). There are 10 items in the CD-RISC-10. The minimum value of the CD-RISC-10 is 0, and the maximum value is 40. Higher scores mean a better outcome (higher level of resilience).

    Measured: The investigator 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.

  1. First posted14 Dec 2021
  2. Study start1 Jan 2022 (estimated)
  3. Primary completion14 Oct 2022 (estimated)
  4. Study completion14 Oct 2022 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Early 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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05157035
Sponsor's protocol ID
1760618-3
Status last verified
Dec 2021
First submitted
9 Dec 2021
Last updated
5 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Reyes AT. The Process of Learning Mindfulness and Acceptance through the Use of a Mobile App Based on Acceptance and Commitment Therapy: A Grounded Theory Analysis. Issues Ment Health Nurs. 2022 Jan;43(1):3-12. doi: 10.1080/01612840.2021.1953652. Epub 2021 Aug 4.

    PubMed 34346278

  • Reyes AT, Song H, Bhatta TR, Kearney CA. Exploring the relationships between resilience, mindfulness, and experiential avoidance after the use of a mindfulness- and acceptance-based mobile app for posttraumatic stress disorder. Perspect Psychiatr Care. 2022 Apr;58(2):776-784. doi: 10.1111/ppc.12848. Epub 2021 May 20.

    PubMed 34018197

  • Reyes AT. A Mindfulness Mobile App for Traumatized COVID-19 Healthcare Workers and Recovered Patients: A Response to "The Use of Digital Applications and COVID-19". Community Ment Health J. 2020 Oct;56(7):1204-1205. doi: 10.1007/s10597-020-00690-9. Epub 2020 Aug 9. No abstract available.

    PubMed 32772205

  • 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 32248935

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Mindfulness/Acceptance-Based Smartphone App (MABSA) 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 5 Jan 2022. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Thomas Reyes, PhD (7028955094, andrewthomas.reyes@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Posttraumatic Stress Disorder Symptoms (PTSD Checklist for DSM-5 or also called PCL-20) (time frame: The investigator 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 NCT05157035, which also lists 4 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 5 Jan 2022.

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