Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals
Primary Purpose
Mental Health Wellness 1
Status
Completed
Phase
Not Applicable
Locations
Cuba
Study Type
Interventional
Intervention
Sitting Mindfulness Exercises.
Body Mindfulness Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Wellness 1 focused on measuring mindfulness, meditation, stress, burn-out, personality, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- To be a full time mental health professional
- To be 18 years or older
- To be able to attend weekly sessions
Exclusion Criteria:
- To suffer a pathology that discourages participation in the study.
- Previous training in mindfulness
Sites / Locations
- Justo Reinalod Fabelo Roche
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Course A
Course B
Arm Description
Body Mindfulness Exercised followed by Sitting Mindfulness Exercises. Written material and sound recordings will be offered as support elements.
Sitting Mindfulness Exercises followed by Body Mindfulness Exercises. Written material and sound recordings will be offered as support elements.
Outcomes
Primary Outcome Measures
Change from Baseline Stress at 5 weeks
Stress measured using Seppo Aro Symptomatic Stress Scale
Change from Baseline Burnout at 5 weeks
Burnout measured using Moreno Short Questionnaire of Burnout.
Change from Baseline Stress at 10 weeks
Stress measured using Seppo Aro Symptomatic Stress Scale
Change from Baseline Stress at three-months follow-up
Stress measured using Seppo Aro Symptomatic Stress Scale
Change from Baseline Burnout at 10 weeks
Burnout measured using Moreno Short Questionnaire of Burnout.
Change from Baseline Burnout at at three-months follow-up
Burnout measured using Moreno Short Questionnaire of Burnout.
Change from Baseline State Anxiety at 5 weeks
State anxiety measured using State Anxiety Inventary IDARE
Change from Baseline State Anxiety at 10 weeks
State anxiety measured using State Anxiety Inventary IDARE
Change from Baseline State Anxiety at three-months follow-up
State anxiety measured using State Anxiety Inventary IDARE
Secondary Outcome Measures
Sociodemographic data
Gender, age, marital status, professional status, years of mental health work, workplace, previous experience in related techniques.
The sixteen personality factor questionnaire
Cattell's 16 personality factors. This test uses a public domain scales from the Internation Personality Item Pool to measure the same traits.
Full Information
NCT ID
NCT03296254
First Posted
September 18, 2017
Last Updated
January 11, 2021
Sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Universidad de Ciencias Médicas de La Habana
1. Study Identification
Unique Protocol Identification Number
NCT03296254
Brief Title
Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals
Official Title
Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
May 22, 2018 (Actual)
Study Completion Date
January 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Universidad de Ciencias Médicas de La Habana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to examine the effectiveness of two mindfulness interventions for stress, anxiety and burnout in mental health professionals. Participants will receive the treatments in reverse order: a brief intervention based on body-centered exercises and another brief intervention based on sitting meditation. It is hypothesized that both interventions will decrease stress and anxiety levels and professional burnout, with mindfulness body-centered exercises being at least as effective as mindfulness meditations.
Detailed Description
The aim of this study is to examine the effectiveness of two mindfulness interventions for stress, anxiety and burnout in mental health professionals. It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA. Treatment A consists of a block of five sessions of bodyfulness exercises, whereas experimental treatment B consists of a block of five sessions of sitting mindfulness meditation exercises. In the sixth session, the exercise blocks will be exchanged. Each group will be composed of half the sample, with a initial sample of 130. The principal hypothesis is that both interventions will decrease stress and anxiety levels and professional burnout, with body-centered exercises being at least as effective as mindfulness sitting meditations. Secondarily, the personality type will be analyzed as a moderating variable in those variables in which the interventions will be effective. Third, a qualitative study will be conducted in order to analyze the perceptions of change and experiences in Cuban mental health professionals who are beginner meditators. This study will allow to understand the differential effectiveness of bodyfulness and midfulness and what types of personality may benefit most from different types of meditation interventions. Also, it will hell to get a deeper understanding of mindfulness practice in a new cultural context (i.e., Cuba). A previous pilot study will be conduct to investigate the acceptability and effectiveness of a culturally-adapted mindfulness-based intervention in Cuba.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1
Keywords
mindfulness, meditation, stress, burn-out, personality, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Course A
Arm Type
Experimental
Arm Description
Body Mindfulness Exercised followed by Sitting Mindfulness Exercises. Written material and sound recordings will be offered as support elements.
Arm Title
Course B
Arm Type
Experimental
Arm Description
Sitting Mindfulness Exercises followed by Body Mindfulness Exercises. Written material and sound recordings will be offered as support elements.
Intervention Type
Behavioral
Intervention Name(s)
Sitting Mindfulness Exercises.
Intervention Description
5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation
Intervention Type
Behavioral
Intervention Name(s)
Body Mindfulness Exercises
Intervention Description
5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements
Primary Outcome Measure Information:
Title
Change from Baseline Stress at 5 weeks
Description
Stress measured using Seppo Aro Symptomatic Stress Scale
Time Frame
Baseline, Post- treatment 5 weeks from baseline
Title
Change from Baseline Burnout at 5 weeks
Description
Burnout measured using Moreno Short Questionnaire of Burnout.
Time Frame
Baseline, Post- treatment 5 weeks from baseline
Title
Change from Baseline Stress at 10 weeks
Description
Stress measured using Seppo Aro Symptomatic Stress Scale
Time Frame
Baseline, Post- treatment 10 weeks
Title
Change from Baseline Stress at three-months follow-up
Description
Stress measured using Seppo Aro Symptomatic Stress Scale
Time Frame
Baseline, Three-months follow-up
Title
Change from Baseline Burnout at 10 weeks
Description
Burnout measured using Moreno Short Questionnaire of Burnout.
Time Frame
Baseline, Post- treatment 10 weeks
Title
Change from Baseline Burnout at at three-months follow-up
Description
Burnout measured using Moreno Short Questionnaire of Burnout.
Time Frame
Baseline, Three-months follow-up
Title
Change from Baseline State Anxiety at 5 weeks
Description
State anxiety measured using State Anxiety Inventary IDARE
Time Frame
Baseline, Post- treatment 5 weeks from baseline
Title
Change from Baseline State Anxiety at 10 weeks
Description
State anxiety measured using State Anxiety Inventary IDARE
Time Frame
Baseline, Post- treatment 10 weeks
Title
Change from Baseline State Anxiety at three-months follow-up
Description
State anxiety measured using State Anxiety Inventary IDARE
Time Frame
Baseline, Three-months follow-up
Secondary Outcome Measure Information:
Title
Sociodemographic data
Description
Gender, age, marital status, professional status, years of mental health work, workplace, previous experience in related techniques.
Time Frame
Baseline
Title
The sixteen personality factor questionnaire
Description
Cattell's 16 personality factors. This test uses a public domain scales from the Internation Personality Item Pool to measure the same traits.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
To be a full time mental health professional
To be 18 years or older
To be able to attend weekly sessions
Exclusion Criteria:
To suffer a pathology that discourages participation in the study.
Previous training in mindfulness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Angel Santed Germán, PhD
Organizational Affiliation
Universidad Nacional a Distancia (España)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Justo R Fabelo Roche, PhD
Organizational Affiliation
Universidad de Ciencias Médicas de La Habana (Cuba)
Official's Role
Study Chair
Facility Information:
Facility Name
Justo Reinalod Fabelo Roche
City
La Habana
Country
Cuba
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that support the findings of this study are available from the corresponding author, [Miguel A. Santed], upon reasonable request.
Citations:
PubMed Identifier
25798208
Citation
de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sorlie T, Halland E, Bjorndal A. Does Personality Moderate the Effects of Mindfulness Training for Medical and Psychology Students? Mindfulness (N Y). 2015;6(2):281-289. doi: 10.1007/s12671-013-0258-y.
Results Reference
background
PubMed Identifier
22849035
Citation
Goodman MJ, Schorling JB. A mindfulness course decreases burnout and improves well-being among healthcare providers. Int J Psychiatry Med. 2012;43(2):119-28. doi: 10.2190/PM.43.2.b.
Results Reference
background
PubMed Identifier
24395196
Citation
Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.
Results Reference
background
PubMed Identifier
28379084
Citation
Ireland MJ, Clough B, Gill K, Langan F, O'Connor A, Spencer L. A randomized controlled trial of mindfulness to reduce stress and burnout among intern medical practitioners. Med Teach. 2017 Apr;39(4):409-414. doi: 10.1080/0142159X.2017.1294749. Epub 2017 Feb 28.
Results Reference
background
PubMed Identifier
19341981
Citation
Irving JA, Dobkin PL, Park J. Cultivating mindfulness in health care professionals: a review of empirical studies of mindfulness-based stress reduction (MBSR). Complement Ther Clin Pract. 2009 May;15(2):61-6. doi: 10.1016/j.ctcp.2009.01.002. Epub 2009 Feb 28.
Results Reference
background
PubMed Identifier
21533847
Citation
Morse G, Salyers MP, Rollins AL, Monroe-DeVita M, Pfahler C. Burnout in mental health services: a review of the problem and its remediation. Adm Policy Ment Health. 2012 Sep;39(5):341-52. doi: 10.1007/s10488-011-0352-1.
Results Reference
background
PubMed Identifier
34206446
Citation
Ruiz-Iniguez R, Carralero Montero A, Burgos-Julian FA, Fabelo Roche JR, Santed MA. Interactions between Personality and Types of Mindfulness Practice in Reducing Burnout in Mental Health Professionals. Int J Environ Res Public Health. 2021 Jun 22;18(13):6721. doi: 10.3390/ijerph18136721.
Results Reference
derived
Links:
URL
http://portal.uned.es/portal/page?_pageid=93,25453043&_dad=portal&_schema=PORTAL
Description
Investigations at the National Distance Education University
Learn more about this trial
Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals
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