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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03296254
Other study ID # 48817036RRI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2018
Est. completion date January 7, 2019

Study information

Verified date January 2021
Source Universidad Nacional de Educación a Distancia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date January 7, 2019
Est. primary completion date May 22, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sitting Mindfulness Exercises.
5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation
Body Mindfulness Exercises
5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements

Locations

Country Name City State
Cuba Justo Reinalod Fabelo Roche La Habana

Sponsors (2)

Lead Sponsor Collaborator
Universidad Nacional de Educación a Distancia Universidad de Ciencias Médicas de La Habana

Country where clinical trial is conducted

Cuba, 

References & Publications (6)

de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sørlie T, Halland E, Bjørndal A. Does Personality Moderate the Effects of Mindfulness Training for Medical and Psychology Students? Mindfulness (N Y). 2015;6(2):281-289. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Stress at 5 weeks Stress measured using Seppo Aro Symptomatic Stress Scale Baseline, Post- treatment 5 weeks from baseline
Primary Change from Baseline Burnout at 5 weeks Burnout measured using Moreno Short Questionnaire of Burnout. Baseline, Post- treatment 5 weeks from baseline
Primary Change from Baseline Stress at 10 weeks Stress measured using Seppo Aro Symptomatic Stress Scale Baseline, Post- treatment 10 weeks
Primary Change from Baseline Stress at three-months follow-up Stress measured using Seppo Aro Symptomatic Stress Scale Baseline, Three-months follow-up
Primary Change from Baseline Burnout at 10 weeks Burnout measured using Moreno Short Questionnaire of Burnout. Baseline, Post- treatment 10 weeks
Primary Change from Baseline Burnout at at three-months follow-up Burnout measured using Moreno Short Questionnaire of Burnout. Baseline, Three-months follow-up
Primary Change from Baseline State Anxiety at 5 weeks State anxiety measured using State Anxiety Inventary IDARE Baseline, Post- treatment 5 weeks from baseline
Primary Change from Baseline State Anxiety at 10 weeks State anxiety measured using State Anxiety Inventary IDARE Baseline, Post- treatment 10 weeks
Primary Change from Baseline State Anxiety at three-months follow-up State anxiety measured using State Anxiety Inventary IDARE Baseline, Three-months follow-up
Secondary Sociodemographic data Gender, age, marital status, professional status, years of mental health work, workplace, previous experience in related techniques. Baseline
Secondary 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
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