Clinical trial NCT03296254: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: mindfulness
meditation
stress
burn-out
personality
randomized controlled trial
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Universidad de Ciencias Médicas de La Habana
First posted: 2017-09-28
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Stress at 5 weeks
timeFrame: Baseline, Post- treatment 5 weeks from baseline
measure: Change from Baseline Burnout at 5 weeks
timeFrame: Baseline, Post- treatment 5 weeks from baseline
measure: Change from Baseline Stress at 10 weeks
timeFrame: Baseline, Post- treatment 10 weeks
measure: Change from Baseline Stress at three-months follow-up
timeFrame: Baseline, Three-months follow-up
measure: Change from Baseline Burnout at 10 weeks
timeFrame: Baseline, Post- treatment 10 weeks
measure: Change from Baseline Burnout at at three-months follow-up
timeFrame: Baseline, Three-months follow-up
measure: Change from Baseline State Anxiety at 5 weeks
timeFrame: Baseline, Post- treatment 5 weeks from baseline
measure: Change from Baseline State Anxiety at 10 weeks
timeFrame: Baseline, Post- treatment 10 weeks
measure: Change from Baseline State Anxiety at three-months follow-up
timeFrame: Baseline, Three-months follow-up
Secondary outcomes:
measure: Sociodemographic data
timeFrame: Baseline
measure: The sixteen personality factor questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: La Habana
country: Cuba
facility: Justo Reinalod Fabelo Roche
Study officials:
affiliation: Universidad Nacional a Distancia (España)
name: Miguel Angel Santed Germán, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Ciencias Médicas de La Habana (Cuba)
name: Justo R Fabelo Roche, PhD
role: STUDY_CHAIR
References:
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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.
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.
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.
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.