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CompletedNCT03296254Updated Jan 14, 2021

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

An interventional study of Sitting Mindfulness Exercises. and Body Mindfulness Exercises in Mental Health Wellness 1, sponsored by Universidad Nacional de Educación a Distancia. Completed at 1 site in Cuba. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Universidad Nacional de Educación a Distancia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mental Health Wellness 1

Keywords

  • mindfulness
  • meditation
  • stress
  • burn-out
  • personality
  • randomized controlled trial
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • To suffer a pathology that discourages participation in the study.
  • Previous training in mindfulness
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
127 participants (actual)

Study arms

  • 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. · Behavioral: Body Mindfulness Exercises

  • 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. · Behavioral: Body Mindfulness Exercises

Interventions

  • BehavioralSitting Mindfulness Exercises.

    5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation

  • BehavioralBody Mindfulness Exercises

    5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements

05

What researchers measure

Primary outcomes

  1. Change from Baseline Stress at 5 weeks

    Stress measured using Seppo Aro Symptomatic Stress Scale

    Time frame: Baseline, Post- treatment 5 weeks from baseline

  2. Change from Baseline Burnout at 5 weeks

    Burnout measured using Moreno Short Questionnaire of Burnout.

    Time frame: Baseline, Post- treatment 5 weeks from baseline

  3. Change from Baseline Stress at 10 weeks

    Stress measured using Seppo Aro Symptomatic Stress Scale

    Time frame: Baseline, Post- treatment 10 weeks

  4. Change from Baseline Stress at three-months follow-up

    Stress measured using Seppo Aro Symptomatic Stress Scale

    Time frame: Baseline, Three-months follow-up

  5. Change from Baseline Burnout at 10 weeks

    Burnout measured using Moreno Short Questionnaire of Burnout.

    Time frame: Baseline, Post- treatment 10 weeks

  6. Change from Baseline Burnout at at three-months follow-up

    Burnout measured using Moreno Short Questionnaire of Burnout.

    Time frame: Baseline, Three-months follow-up

  7. Change from Baseline State Anxiety at 5 weeks

    State anxiety measured using State Anxiety Inventary IDARE

    Time frame: Baseline, Post- treatment 5 weeks from baseline

  8. Change from Baseline State Anxiety at 10 weeks

    State anxiety measured using State Anxiety Inventary IDARE

    Time frame: Baseline, Post- treatment 10 weeks

  9. Change from Baseline State Anxiety at three-months follow-up

    State anxiety measured using State Anxiety Inventary IDARE

    Time frame: Baseline, Three-months follow-up

Secondary outcomes

  1. Sociodemographic data

    Gender, age, marital status, professional status, years of mental health work, workplace, previous experience in related techniques.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

06

Study locations

1 site
  • Justo Reinalod Fabelo Roche
    La Habana, Cuba
07

References and documents

Publications

  • 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. PubMed 25798208 ↗
  • 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. PubMed 22849035 ↗
  • 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. PubMed 24395196 ↗
  • 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. PubMed 28379084 ↗
  • 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. PubMed 19341981 ↗
  • 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. PubMed 21533847 ↗
  • 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. PubMed 34206446 ↗

Individual participant data

Plan to share: Yes — The data that support the findings of this study are available from the corresponding author, \[Miguel A. Santed\], upon reasonable request.

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT03296254
Lead sponsor
Universidad Nacional de Educación a Distancia
Collaborators
Universidad de Ciencias Médicas de La Habana
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Jan 22, 2018
Primary completion
May 22, 2018
Completion
Jan 7, 2019
Last update
Jan 14, 2021

Study contacts

Miguel Angel Santed Germán, PhD
study director · Universidad Nacional a Distancia (España)
Justo R Fabelo Roche, PhD
study chair · Universidad de Ciencias Médicas de La Habana (Cuba)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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