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

Posttraumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05157035
• Other study ID #: 1760618-3
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: January 1, 2022
• Est. completion date: October 14, 2022

Study information

• Verified date: December 2021
• Source: University of Nevada, Las Vegas
• Contact: Andrew Thomas Reyes, PhD
• Phone: 7028955094
• Email: andrewthomas.reyes[@]unlv.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 14, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (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)

Exclusion Criteria:

• (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

Related Conditions & MeSH terms

• COVID-19
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Mindfulness/Acceptance-Based Smartphone App (MABSA)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

References & Publications (4)

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. — View Citation

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. 2021 May 20. doi: 10.1111/ppc.12848. [Epub ahead of print] — View Citation

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. — View Citation

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. 2021 Aug 4:1-10. doi: 10.1080/01612840.2021.1953652. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intervention Satisfaction (Intervention Satisfaction Survey or also called ISS).	The Intervention Satisfaction Survey (ISS) will be used to determine the degree of acceptability of the intervention (e.g., overall satisfaction, perceived helpfulness, comprehension, intentions to use, and perceived fit). There are 8 items in the ISS. The minimum value for the ISS is 8, and the maximum value is 48. Higher scores mean a better outcomes (indicating higher level of satisfaction with the app).	The investigator will measure intervention satisfaction at mid-intervention (Week 3) and post-intervention (Week 6)
Other	Usability of the App (System Usability Scale or also called SUS)	The perceived usability of the app will be measured using the System Usability Scale (SUS). There are 10 items in the SUS. The minimum value of the SUS is 10, and the maximum value is 50. Higher scores mean a better outcome (i.e., that the app is perceived to be useful and relevant for the participants).	The investigator will measure perceived usability of the app at mid-intervention (Week 3) and post-intervention (Week 6)
Primary	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).	The investigator will measure PTSD at baseline, mid-intervention (Week 3), post-intervention (Week 6), and at one-month follow-up
Primary	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).	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
Primary	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).	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
Primary	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).	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
Primary	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)	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	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).	The investigator will measure posttraumatic stress disorder symptoms daily using the app (ecological momentary assessment).
Secondary	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).	The investigator will measure resilience daily using the app (ecological momentary assessment)