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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

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 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.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Behavioral: Sitting Mindfulness Exercises. Behavioral: Body Mindfulness Exercises Not Applicable

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
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
Official Title: Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals: a Randomized Controlled Trial
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from Baseline Stress at 5 weeks [ Time Frame: Baseline, Post- treatment 5 weeks from baseline ]
    Stress measured using Seppo Aro Symptomatic Stress Scale

  2. Change from Baseline Burnout at 5 weeks [ Time Frame: Baseline, Post- treatment 5 weeks from baseline ]
    Burnout measured using Moreno Short Questionnaire of Burnout.

  3. Change from Baseline Stress at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    Stress measured using Seppo Aro Symptomatic Stress Scale

  4. Change from Baseline Stress at three-months follow-up [ Time Frame: Baseline, Three-months follow-up ]
    Stress measured using Seppo Aro Symptomatic Stress Scale

  5. Change from Baseline Burnout at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    Burnout measured using Moreno Short Questionnaire of Burnout.

  6. 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.

  7. 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

  8. Change from Baseline State Anxiety at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    State anxiety measured using State Anxiety Inventary IDARE

  9. 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


Secondary Outcome Measures :
  1. Sociodemographic data [ Time Frame: Baseline ]
    Gender, age, marital status, professional status, hours of work, years of mental health work

  2. 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.

  3. 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".

  4. 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

  5. Change from Baseline State Depression at 10 weeks [ Time Frame: Baseline, Post- treatment 10 weeks ]
    State depression measured using State Depression Inventary IDERE

  6. 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

  7. Trait anxiety [ Time Frame: Baseline ]
    Trait anxiety measured using State Anxiety Inventary IDARE

  8. Trait depression [ Time Frame: Baseline ]
    Trait depression measured using State Depression Inventary IDERE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296254


Locations
Cuba
Justo Reinalod Fabelo Roche
La Habana, Cuba
Sponsors and Collaborators
Universidad Nacional de Educación a Distancia
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)

Additional Information:
Publications:
Responsible Party: Universidad Nacional de Educación a Distancia
ClinicalTrials.gov Identifier: NCT03296254     History of Changes
Other Study ID Numbers: 48817036RRI
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universidad Nacional de Educación a Distancia:
mindfulness
meditation
stress
burn-out
personality
randomized controlled trial