Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals

Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness 1
• Intervention / Treatment: Behavioral: Sitting Mindfulness Exercises.; Behavioral: Body Mindfulness Exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cuba
  • La Habana, Cuba
    • Justo Reinalod Fabelo Roche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Course A; Body Mindfulness Exercised followed by Sitting Mindfulness Exercises. Written material and sound recordings will be offered as support elements.	Behavioral: Sitting Mindfulness Exercises.; 5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation; Behavioral: Body Mindfulness Exercises; 5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements
Experimental: Course B; Sitting Mindfulness Exercises followed by Body Mindfulness Exercises. Written material and sound recordings will be offered as support elements.	Behavioral: Sitting Mindfulness Exercises.; 5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation; Behavioral: Body Mindfulness Exercises; 5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Stress at 5 weeks	Stress measured using Seppo Aro Symptomatic Stress Scale	Baseline, Post- treatment 5 weeks from baseline
Change from Baseline Burnout at 5 weeks	Burnout measured using Moreno Short Questionnaire of Burnout.	Baseline, Post- treatment 5 weeks from baseline
Change from Baseline Stress at 10 weeks	Stress measured using Seppo Aro Symptomatic Stress Scale	Baseline, Post- treatment 10 weeks
Change from Baseline Stress at three-months follow-up	Stress measured using Seppo Aro Symptomatic Stress Scale	Baseline, Three-months follow-up
Change from Baseline Burnout at 10 weeks	Burnout measured using Moreno Short Questionnaire of Burnout.	Baseline, Post- treatment 10 weeks
Change from Baseline Burnout at at three-months follow-up	Burnout measured using Moreno Short Questionnaire of Burnout.	Baseline, Three-months follow-up
Change from Baseline State Anxiety at 5 weeks	State anxiety measured using State Anxiety Inventary IDARE	Baseline, Post- treatment 5 weeks from baseline
Change from Baseline State Anxiety at 10 weeks	State anxiety measured using State Anxiety Inventary IDARE	Baseline, Post- treatment 10 weeks
Change from Baseline State Anxiety at three-months follow-up	State anxiety measured using State Anxiety Inventary IDARE	Baseline, Three-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic data	Gender, age, marital status, professional status, years of mental health work, workplace, previous experience in related techniques.	Baseline
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.	Baseline

Collaborators and Investigators

• Sponsor: Universidad Nacional de Educación a Distancia
• Collaborators: Universidad de Ciencias Médicas de La Habana
• Investigators: Study Director: Miguel Angel Santed Germán, PhD, Universidad Nacional a Distancia (España); Study Chair: Justo R Fabelo Roche, PhD, Universidad de Ciencias Médicas de La Habana (Cuba)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Investigations at the National Distance Education University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): May 22, 2018
• Study Completion (Actual): January 7, 2019

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): September 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: randomized controlled trial; mindfulness; meditation; stress; personality; burn-out
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: 48817036RRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study are available from the corresponding author, [Miguel A. Santed], upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No