Mental Health Wellness 1NCT03296254
Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals
A study testing Sitting Mindfulness Exercises. and Body Mindfulness Exercises in people with Mental Health Wellness 1, run by Universidad Nacional de Educación a Distancia at 1 site in Cuba.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Sitting Mindfulness Exercises. and Body Mindfulness Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteCuba
- Study dates
- 22 Jan 2018to 7 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be a full time mental health professional
- To be 18 years or older
- To be able to attend weekly sessions
Who cannot join
- To suffer a pathology that discourages participation in the study.
- Previous training in mindfulness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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-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.
Read the 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- Sitting Mindfulness Exercises., Body Mindfulness Exercises
- Keywords
- mindfulness, meditation, stress, burn-out, personality, randomized controlled trial
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting Mindfulness Exercises.Behavioural
5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation
Body Mindfulness ExercisesBehavioural
5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements
| Study group | Role | What they receive |
|---|---|---|
| Course A | Experimental | Body Mindfulness Exercised followed by Sitting Mindfulness Exercises. Written material and sound recordings will be offered as support elements. Receives: 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. Receives: Behavioral: Sitting Mindfulness Exercises.; Behavioral: Body Mindfulness Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Stress at 5 weeks
Stress measured using Seppo Aro Symptomatic Stress Scale
Measured: Baseline, Post- treatment 5 weeks from baseline
Change from Baseline Burnout at 5 weeks
Burnout measured using Moreno Short Questionnaire of Burnout.
Measured: Baseline, Post- treatment 5 weeks from baseline
Change from Baseline Stress at 10 weeks
Stress measured using Seppo Aro Symptomatic Stress Scale
Measured: Baseline, Post- treatment 10 weeks
Change from Baseline Stress at three-months follow-up
Stress measured using Seppo Aro Symptomatic Stress Scale
Measured: Baseline, Three-months follow-up
Change from Baseline Burnout at 10 weeks
Burnout measured using Moreno Short Questionnaire of Burnout.
Measured: Baseline, Post- treatment 10 weeks
Change from Baseline Burnout at at three-months follow-up
Burnout measured using Moreno Short Questionnaire of Burnout.
Measured: Baseline, Three-months follow-up
Change from Baseline State Anxiety at 5 weeks
State anxiety measured using State Anxiety Inventary IDARE
Measured: Baseline, Post- treatment 5 weeks from baseline
Change from Baseline State Anxiety at 10 weeks
State anxiety measured using State Anxiety Inventary IDARE
Measured: Baseline, Post- treatment 10 weeks
Change from Baseline State Anxiety at three-months follow-up
State anxiety measured using State Anxiety Inventary IDARE
Measured: Baseline, Three-months follow-up
Secondary outcomes (2)
Sociodemographic data
Gender, age, marital status, professional status, years of mental health work, workplace, previous experience in related techniques.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start22 Jan 2018
- Primary completion22 May 2018
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Educación a Distancia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Ciencias Médicas de La Habana
- Responsible party
- Sponsor
- Investigators
- Miguel Angel Santed Germán, PhD, Study director, Universidad Nacional a Distancia (España)Justo R Fabelo Roche, PhD, Study chair, Universidad de Ciencias Médicas de La Habana (Cuba)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296254
- Sponsor's protocol ID
- 48817036RRI
- Status last verified
- Jan 2021
- First submitted
- 18 Sep 2017
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author, \[Miguel A. Santed\], upon reasonable request.
Publications
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.
PubMed 25798208Goodman 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.
PubMed 22849035Goyal 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.
PubMed 24395196Ireland 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.
PubMed 28379084Irving 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.
PubMed 19341981Morse 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.
PubMed 21533847Ruiz-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.
PubMed 37251062Ruiz-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.
PubMed 34206446
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Brief Mindfulness Intervention for Stress, Anxiety and Burnout in Mental Health Professionals: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03296254
- Acronym / sponsor ID
- 48817036RRI
- Conditions
- Mental Health Wellness 1
- Keywords
- mindfulness, meditation, stress, burn-out, personality, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Universidad Nacional de Educación a DistanciaUniversity, hospital or other
- Collaborators
- Universidad de Ciencias Médicas de La Habana
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a 2-sequence, 2-period, 2-treatment crossover design with sequences AB and BA
| Arm | Type | Receives |
|---|---|---|
| Course A | Experimental | Behavioral: Sitting Mindfulness Exercises., Behavioral: Body Mindfulness ExercisesBody Mindfulness Exercised followed by Sitting Mindfulness Exercises. Written material and sound recordings will be offered as support elements. |
| Course B | Experimental | Behavioral: Sitting Mindfulness Exercises., Behavioral: Body Mindfulness ExercisesSitting Mindfulness Exercises followed by Body Mindfulness Exercises. Written material and sound recordings will be offered as support elements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be a full time mental health professional
- To be 18 years or older
- To be able to attend weekly sessions
Key exclusion criteria (2 listed)
- To suffer a pathology that discourages participation in the study.
- Previous training in mindfulness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitting Mindfulness Exercises.5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation | Behavioural | Course A, Course B |
| Body Mindfulness Exercises5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements | Behavioural | Course A, Course B |
Primary outcome
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
2 secondary outcomes
Sociodemographic data
Time frame: Baseline
The sixteen personality factor questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Background: PubMed 25798208de 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.
- Background: PubMed 22849035Goodman 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.
- Background: PubMed 24395196Goyal 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.
- Background: PubMed 28379084Ireland 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.
- Background: PubMed 19341981Irving 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.
- Background: PubMed 21533847Morse 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.
- Derived from this study: PubMed 37251062Ruiz-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.
- Derived from this study: PubMed 34206446Ruiz-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.
- Investigations at the National Distance Education UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author, [Miguel A. Santed], upon reasonable request.
Related trials for Mental Health Wellness 1
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Recruiting
GUT-FEELINGS: Using Citizen Science for Large-Scale Prebiotic Clinical Trials for Mental Wellness in Adults
Sleep Disturbance, Stress
Not yet recruitingPhase 1
A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults
Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel Angel Santed Germán, PhD study director
Universidad Nacional a Distancia (España)
Justo R Fabelo Roche, PhD study chair
Universidad de Ciencias Médicas de La Habana (Cuba)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting Mindfulness Exercises. and Body Mindfulness Exercises in people with Mental Health Wellness 1, run by Universidad Nacional de Educación a Distancia at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Stress at 5 weeks (time frame: Baseline, Post- treatment 5 weeks from baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03296254, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.