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

NCT05157035 | Unknown Early Phase 1

• 1 other identifier: 1760618-3
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Posttraumatic Stress Disorder

Keywords

posttraumatic stress disorder; mindfulness; COVID-19; mindfulness app

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

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

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

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

  The investigator will measure resilience daily using the app (ecological momentary assessment)

Other Outcomes (2)

• Intervention Satisfaction (Intervention Satisfaction Survey or also called ISS).

  The investigator will measure intervention satisfaction at mid-intervention (Week 3) and post-intervention (Week 6)

• Usability of the App (System Usability Scale or also called SUS)

  The investigator will measure perceived usability of the app at mid-intervention (Week 3) and post-intervention (Week 6)

Study Arms (2)

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.

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

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.

Interventions

Mindfulness/Acceptance-Based Smartphone App (MABSA) BEHAVIORAL

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.

Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention Group

Eligibility Criteria

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

You may qualify if:

• (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)

You may not qualify if:

• (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

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Related Publications (4)

• 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.

  PMID: 34346278 BACKGROUND

• 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.

  PMID: 34018197 BACKGROUND

• 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.

  PMID: 32772205 BACKGROUND

• 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.

  PMID: 32248935 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; COVID-19

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Andrew Thomas Reyes, PhD

CONTACT

7028955094; andrewthomas.reyes@unlv.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 14, 2021
• Study Start: January 1, 2022
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share