NCT03296254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

September 18, 2017

Last Update Submit

January 11, 2021

Conditions

Keywords

mindfulnessmeditationstressburn-outpersonalityrandomized controlled trial

Outcome Measures

Primary Outcomes (9)

  • Change from Baseline Stress at 5 weeks

    Stress measured using Seppo Aro Symptomatic Stress Scale

    Baseline, Post- treatment 5 weeks from baseline

  • Change from Baseline Burnout at 5 weeks

    Burnout measured using Moreno Short Questionnaire of Burnout.

    Baseline, Post- treatment 5 weeks from baseline

  • Change from Baseline Stress at 10 weeks

    Stress measured using Seppo Aro Symptomatic Stress Scale

    Baseline, Post- treatment 10 weeks

  • Change from Baseline Stress at three-months follow-up

    Stress measured using Seppo Aro Symptomatic Stress Scale

    Baseline, Three-months follow-up

  • Change from Baseline Burnout at 10 weeks

    Burnout measured using Moreno Short Questionnaire of Burnout.

    Baseline, Post- treatment 10 weeks

  • Change from Baseline Burnout at at three-months follow-up

    Burnout measured using Moreno Short Questionnaire of Burnout.

    Baseline, Three-months follow-up

  • Change from Baseline State Anxiety at 5 weeks

    State anxiety measured using State Anxiety Inventary IDARE

    Baseline, Post- treatment 5 weeks from baseline

  • Change from Baseline State Anxiety at 10 weeks

    State anxiety measured using State Anxiety Inventary IDARE

    Baseline, Post- treatment 10 weeks

  • Change from Baseline State Anxiety at three-months follow-up

    State anxiety measured using State Anxiety Inventary IDARE

    Baseline, Three-months follow-up

Secondary Outcomes (2)

  • Sociodemographic data

    Baseline

  • The sixteen personality factor questionnaire

    Baseline

Study Arms (2)

Course A

EXPERIMENTAL

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

Course B

EXPERIMENTAL

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

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

Course ACourse B

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

Course ACourse B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be a full time mental health professional
  • To be 18 years or older
  • To be able to attend weekly sessions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Justo Reinalod Fabelo Roche

La Habana, Cuba

Location

Related Publications (8)

  • 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.

    PMID: 25798208BACKGROUND
  • 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.

    PMID: 22849035BACKGROUND
  • 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.

    PMID: 24395196BACKGROUND
  • 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.

    PMID: 28379084BACKGROUND
  • 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.

    PMID: 19341981BACKGROUND
  • 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.

    PMID: 21533847BACKGROUND
  • Ruiz-Iniguez R, Carralero Montero A, Burgos-Julian FA, Fabelo Roche JR, Santed MA. Comparison of two brief mindfulness interventions for anxiety, stress and burnout in mental health professionals: a randomised crossover trial. Front Psychol. 2023 May 12;14:1160714. doi: 10.3389/fpsyg.2023.1160714. eCollection 2023.

  • 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.

Related Links

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Miguel Angel Santed Germán, PhD

    Universidad Nacional a Distancia (España)

    STUDY DIRECTOR
  • Justo R Fabelo Roche, PhD

    Universidad de Ciencias Médicas de La Habana (Cuba)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 28, 2017

Study Start

January 22, 2018

Primary Completion

May 22, 2018

Study Completion

January 7, 2019

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations