NCT02936310

Brief Summary

The primary objective of this proposed one-year (January 01, 2017 to December 31,2017) project is to assess whether a mindfulness based intervention('Mindful Living With Stress') will be effective at helping nurses caring for HIV/AIDS patients in China to reduce stress. Based on the efficacy of previous studies in stress reduction, it is hypothesized that 'Mindful Living With Stress' will be an effective, feasible and affordable stress reduction program in China.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

October 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

October 13, 2016

Last Update Submit

August 27, 2017

Conditions

Keywords

stressmindfulnessMindful Living With Stress InterventionnurseHIV/AIDS

Outcome Measures

Primary Outcomes (2)

  • stress assessed with a self-administrated questionnaire (Chinese Version of Perceived Stress Scale)

    At the pre- and post-intervention assessment, participants will complete self-administrated questionnaire on stress.

    nine month

  • stress assessed with an in-depth interview

    At the post-intervention assessment,participants will be invited to attend an in-depth interview to give the feedback on the influence of MLWS intervention on living with stress.

    nine month

Secondary Outcomes (4)

  • burnout assessed with a self-administrated questionnaire (Chinese Version of Maslach Burnout Inventory)

    nine month

  • mindfulness assessed with a self-administrated questionnaire (Chinese Version of Five Facets Mindfulness Questionnaire)

    nine month

  • anxiety assessed with a self-administrated questionnaire (State-Trait Anxiety Inventory)

    nine month

  • depression assessed with a self-administrated questionnaire (Beck Depression Inventory)

    nine month

Study Arms (1)

mindfulness intervention

EXPERIMENTAL

The proposed Mindful Living With Stress Intervention will be conducted weekly, 2 hours per session, 4-6 sessions, group based program in mindfulness.The proposed topics include: 1) mindfulness: dealing with stress in a new way, 2) mindful awareness of stress: listening to our body, 3) mindful working with thoughts, 4) mindful working with emotions, 5) mindful interactions, and 6) dealing with obstacles of mindful practices and wrap-up. Mindfulness practices embedded in the program will include mindfulness breathing meditation, sitting meditation, standing meditation, walking meditation, movement meditation (Taichi or Yoga), body scan meditation and daily life meditation. Data will be collected at pre-intervention (one week before the first session) and post-intervention (one week after the last session) to assess stress, burnout, mindfulness, anxiety,depression,the feedback on the MLWS intervention and the feedback on the influence of MLWS intervention.

Behavioral: Mindful Living With Stress

Interventions

The proposed Mindful Living With Stress Intervention will be conducted weekly, 2 hours per session, 4-6 sessions, group based program in mindfulness.

mindfulness intervention

Eligibility Criteria

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

You may qualify if:

  • having a license to practice as a nurse in the People's Republic of China.
  • being employed as a nurse in the AIDS department of the First Hospital of Changsha for at least 1 year.
  • Chinese speaking.
  • being at least 18 years old.

You may not qualify if:

  • being other types of health care providers such as doctors, pharmacists, social workers.
  • being a nursing supervisor or manager.
  • The second step of the study: mindfulness intervention
  • having a license to practice as a nurse in the People's Republic of China.
  • being employed as a nurse in the AIDS department of the First Hospital of Changsha for at least 1 year.
  • Chinese speaking.
  • being at least 18 years old.
  • being other types of health care providers such as doctors, pharmacists, social workers.
  • being a nursing supervisor or manager.
  • having attended in the focus group of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Changsha

Changsha, Hunan, 410005, China

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Chen Pan, M.D., Ph.D.

    Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 13, 2016

First Posted

October 18, 2016

Study Start

January 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

data will be made available within 6 months of study completion

Locations