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

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ClinicalTrials.gov Identifier: NCT03296254
Recruitment Status : Active, not recruiting
First Posted : September 28, 2017
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
Universidad de Ciencias Médicas de La Habana
Information provided by (Responsible Party):
Universidad Nacional de Educación a Distancia

September 18, 2017
September 28, 2017
February 20, 2018
January 22, 2018
May 2018   (Final data collection date for primary outcome measure)
  • Change from Baseline Stress at 5 weeks [ Time Frame: Baseline, Post- treatment 5 weeks from baseline ]
    Stress measured using Seppo Aro Symptomatic Stress Scale
  • Change from Baseline Burnout at 5 weeks [ Time Frame: Baseline, Post- treatment 5 weeks from baseline ]
    Burnout measured using Moreno Short Questionnaire of Burnout.
  • Change from Baseline Stress at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    Stress measured using Seppo Aro Symptomatic Stress Scale
  • Change from Baseline Stress at three-months follow-up [ Time Frame: Baseline, Three-months follow-up ]
    Stress measured using Seppo Aro Symptomatic Stress Scale
  • Change from Baseline Burnout at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    Burnout measured using Moreno Short Questionnaire of Burnout.
  • Change from Baseline Burnout at at three-months follow-up [ Time Frame: Baseline, Three-months follow-up ]
    Burnout measured using Moreno Short Questionnaire of Burnout.
  • Change from Baseline State Anxiety at 5 weeks [ Time Frame: Baseline, Post- treatment 5 weeks from baseline ]
    State anxiety measured using State Anxiety Inventary IDARE
  • Change from Baseline State Anxiety at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    State anxiety measured using State Anxiety Inventary IDARE
  • Change from Baseline State Anxiety at three-months follow-up [ Time Frame: Baseline, Three-months follow-up ]
    State anxiety measured using State Anxiety Inventary IDARE
  • Change from Baseline Stress at 5 weeks [ Time Frame: Baseline, Post- treatment 5 weeks from baseline ]
    Stress measured using Seppo Aro Symptomatic Stress Scale
  • Change from Baseline Burnout at 5 weeks [ Time Frame: Baseline, Post- treatment 5 weeks from baseline ]
    Burnout measured using Moreno Short Questionnaire of Burnout.
  • Change from Baseline Stress at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    Stress measured using Seppo Aro Symptomatic Stress Scale
  • Change from Baseline Stress at three-months follow-up [ Time Frame: Baseline, Three-months follow-up ]
    Stress measured using Seppo Aro Symptomatic Stress Scale
  • Change from Baseline Burnout at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    Burnout measured using Moreno Short Questionnaire of Burnout.
  • Change from Baseline Burnout at at three-months follow-up [ Time Frame: Baseline, Three-months follow-up ]
    Burnout measured using Moreno Short Questionnaire of Burnout.
Complete list of historical versions of study NCT03296254 on ClinicalTrials.gov Archive Site
  • Sociodemographic data [ Time Frame: Baseline ]
    Gender, age, marital status, professional status, hours of work, years of mental health work
  • The sixteen personality factor questionnaire [ Time Frame: Baseline ]
    Cattell's 16 personality factors. This test uses a public domain scales from the Internation Personality Item Pool to measure the same traits.
  • Expectations [ Time Frame: Baseline ]
    One item question. "Do you expect the practice of mindfulness to improve your stress and burnout levels?" Five possible responses on a Likert scale from 1 to 5, where 1 is "Nothing", 2 "Little", 3 "Something", 4 "Quite" and 5 is "Much".
  • Change from Baseline State Depression at 5 weeks [ Time Frame: Baseline, Post- treatment 5 weeks from baseline ]
    State anxiety measured using State Depression Inventary IDERE
  • Change from Baseline State Depression at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    State depression measured using State Depression Inventary IDERE
  • Change from Baseline State Depression at three-months follow-up [ Time Frame: Baseline, Three-months follow-up ]
    State depression measured using State Depression Inventary IDERE
  • Trait anxiety [ Time Frame: Baseline ]
    Trait anxiety measured using State Anxiety Inventary IDARE
  • Trait depression [ Time Frame: Baseline ]
    Trait depression measured using State Depression Inventary IDERE
  • Sociodemographic data [ Time Frame: Baseline ]
    Gender, age, marital status, professional status, hours of work, years of mental health work
  • The sixteen personality factor questionnaire [ Time Frame: Baseline ]
    Cattell's 16 personality factors. This test uses a public domain scales from the Internation Personality Item Pool to measure the same traits.
  • Expectations [ Time Frame: Baseline ]
    One item question. "Do you expect the practice of mindfulness to improve your stress and burnout levels?" Five possible responses on a Likert scale from 1 to 5, where 1 is "Nothing", 2 "Little", 3 "Something", 4 "Quite" and 5 is "Much".
Not Provided
Not Provided
 
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 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 exercises being at least as effective as mindfulness meditations.
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 body mindfulness 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 30 participants with a total sample of 60. The principal hypothesis is that both interventions will decrease stress and anxiety levels and professional burnout, with mindfulness body exercises being at least as effective as mindfulness sitting meditations. Secondarily, the personality type will be analyzed as a moderating variable in the effectiveness of the interventions. Te investigators will also study the role of daily practices and previous expectations in the results of this intervention. Finally, a qualitative study will be conducted in order to analyze the the acceptability and use-effectiveness in mental health professionals who are beginner meditators. This study will allow to understand what types of personality may benefit most from different types of meditation interventions.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Mental Health Wellness 1
  • 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 A
    Body Mindfulness Exercised followed by Sitting Mindfulness Exercises. Written material and sound recordings will be offered as support elements.
    Interventions:
    • 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.
    Interventions:
    • Behavioral: Sitting Mindfulness Exercises.
    • Behavioral: Body Mindfulness Exercises

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
127
60
September 2019
May 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Cuba
 
 
NCT03296254
48817036RRI
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Universidad Nacional de Educación a Distancia
Universidad Nacional de Educación a Distancia
Universidad de Ciencias Médicas de La Habana
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)
Universidad Nacional de Educación a Distancia
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP