NCT06436469

Brief Summary

The goal of this observational study is to evaluate the effectiveness of a mindfulness-based stress reduction (MBSR) program in reducing compassion fatigue among nurses. The main question it aims to answer is: Does participation in an MBSR program decrease levels of compassion fatigue among nurses? The primary hypothesis is that nurses who participate in the MBSR program will experience a significant reduction in compassion fatigue after implementing the interventions. Participants will include psychiatric nurse practitioners working in high-stress environments. Participants will: Attend a series of MBSR sessions over a specified period. Engage in mindfulness practices such as body scans, and deep breathing. Complete self-report measures to assess levels of compassion fatigue before and after the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

May 24, 2024

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compassion Fatigue Assessment

    The primary outcome measure involves assessing participants' levels of compassion fatigue using a validated instrument, such as the Professional Quality of Life (ProQOL) questionnaire. This questionnaire evaluates various dimensions of compassion fatigue, including emotional exhaustion, depersonalization, and reduced personal accomplishment.

    Participants will complete the compassion fatigue assessment at two time points: before starting the mindfulness-based stress reduction (MBSR) program (baseline/pretest) and after completing the program (follow-up/posttest) over a period of 4 weeks.

Study Arms (1)

Mindfulness interventions

OTHER

The intervention involves participation in a structured Mindfulness-Based Stress Reduction (MBSR) program. Participants engage in a series of sessions over a four week period. During these sessions, participants learn and practice mindfulness techniques such as deep breathing and body scans.

Behavioral: Mindfulness-Based Stress Reduction (MBSR) Program

Interventions

The intervention involves participation in a structured Mindfulness-Based Stress Reduction (MBSR) program. Participants engage in a series of sessions over a four week period. During these sessions, participants learn and practice mindfulness techniques such as deep breathing and body scans. The program is designed to enhance participants' awareness of their thoughts, emotions, and bodily sensations in the present moment, promoting a nonjudgmental acceptance of their experiences. By cultivating mindfulness skills, participants aim to reduce stress, enhance emotional regulation, and develop resilience in coping with the challenges of their work environment.

Mindfulness interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Psychiatric Nurse Practitioner
  • At least one year of nursing experience
  • Participants would need to be able to read and understand English.

You may not qualify if:

  • Is not a Psychiatric Nurse practitioner
  • Reservations against the program
  • Have \<1 yr. nursing experience

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Psychiatrist

Hollywood, Florida, 33024, United States

Location

MeSH Terms

Conditions

Compassion Fatigue

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorOccupational StressStress, Psychological

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Charmaine Coffman

    Nova Southeastern University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The model for this study is a single-group pretest-posttest design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2024

First Posted

May 31, 2024

Study Start

July 1, 2024

Primary Completion

August 11, 2024

Study Completion

August 11, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

The IPD sharing plan involves sharing anonymized participant data (demographics, baseline characteristics, outcome measures, intervention details) for collaboration, further analysis, or meta-analyses. Before sharing, informed consent will be obtained, and identifying information will be removed to protect confidentiality. Sharing will comply with institutional policies, ethical guidelines, and data sharing agreements, ensuring regulatory and privacy compliance.

Shared Documents
SAP
Time Frame
The data from this observational study will become available for sharing after completion of the study and publication of the primary study findings and will be available for up to 36 months after.
Access Criteria
Access criteria for obtaining anonymized IPD include: clear research purpose related to compassion fatigue, affiliation with recognized institutions, ethical approval evidence, compliance with data security protocols, signing data sharing agreements, and adherence to regulatory requirements.

Locations