Mindfulness and Intercare Based Intervention for Medicine Students (MIIM)

Sponsor
University Diego Portales (Other)
Overall Status
Completed
CT.gov ID
NCT05011955
Collaborator
(none)
360
Enrollment
1
Location
3
Arms
4.2
Actual Duration (Months)
86.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The effects of Coronavirus Disease (COVID-19) pandemic on health, economy and social network has an impact on mental health, specially students. The aim of the study was to evaluate the effectiveness of a brief online mindfulness, compassion and intercare based intervention in medicine students in Santiago de Chile.

Randomized controlled trial was conducted. Enrolled participants were randomly assigned to 1) a mindfulness, compassion and intercare based intervention, 2) a psychoeducational intervention or 3) waiting list. Both intervention lasted 1 hour per week for 4 weeks. Academic flexibility, breaks and individual psychological help was offered to the whole group. An online assessment of well being, anxiety and depression symptoms was completed at the beginning, 1 month and 3 month.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Mindfulness, compassion and intercare based Intervention
  • Behavioral: Psychoeducational based intervention
  • Other: General curricular intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Brief Online Mindfulness and Intercare Based Intervention for Medicine Students (MIIM)
Actual Study Start Date :
May 18, 2020
Actual Primary Completion Date :
Sep 22, 2020
Actual Study Completion Date :
Sep 22, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Mindfulness, compassion and intercare based Intervention

Four week, one hour peer week, online group intervention plus home work based on mindfulness, compassion and intercare based programs.

Behavioral: Mindfulness, compassion and intercare based Intervention
The mindfulness based intervention was a short version of the Mindfulness based intercare program (IBAP). The intervention consists of four synchronic group sessions via ZOOM of one hour each, one peer week and home practice. A total of four groups were conducted of 15 students each. The IBAP program was inspired by first and second generation mindfulness based interventions, such as Mindfulness based cognitive training, Self-Compassion and Cognitive based Compassion training. Also compassionate communication, conservation of resource theory and habits theory. Each module consists in meditation practices, inquiry and self or group reflections on different topics such as mindfulness, automatic pilot, mind wandering , acceptance, gratitude and compassion, care resources and intercare.

Other: General curricular intervention
All participants were offered psychological sessions if a high score on depression or anxiety symptoms were detected. Psychological sessions consists of 4 to 8 sessions with specific objectives and then referral to continue the mental health process according to the student's welfare system. Participants also have academic breaks of two week per semester, apart from holidays, and academic flexibility in submitting work, attending practical activities and taking exams.

Active Comparator: Psychoeducational based intervention

Four week, one hour peer week, online group intervention plus home work based on psychoeducation about stress, anxiety, selfcare and effective communication.

Behavioral: Psychoeducational based intervention
Four week, one hour peer week, online group intervention plus home work base on psychoeducation about stress, anxiety, selfcare and effective communication. Plus general curricular intervention. Delivered by psychologist.

Other: General curricular intervention
All participants were offered psychological sessions if a high score on depression or anxiety symptoms were detected. Psychological sessions consists of 4 to 8 sessions with specific objectives and then referral to continue the mental health process according to the student's welfare system. Participants also have academic breaks of two week per semester, apart from holidays, and academic flexibility in submitting work, attending practical activities and taking exams.

Other: General curricular intervention

All participants were offered psychological sessions if a high score on depression or anxiety symptoms were detected. Participants also have academic breaks of two week per semester, apart from holidays, and academic flexibility in submitting work, attending practical activities and taking exams.

Other: General curricular intervention
All participants were offered psychological sessions if a high score on depression or anxiety symptoms were detected. Psychological sessions consists of 4 to 8 sessions with specific objectives and then referral to continue the mental health process according to the student's welfare system. Participants also have academic breaks of two week per semester, apart from holidays, and academic flexibility in submitting work, attending practical activities and taking exams.

Outcome Measures

Primary Outcome Measures

  1. Depression symptoms - Patient Health Questionnaire - 9 (PHQ9) [Baseline]

    Depression symptoms were evaluated using the Patient Health Questionnaire - 9 (PHQ9), which its used for depression screening with a sensibility and specificity of 88% y 92%. It contains 9 items on a 5-point Likert scale (0-4) to evaluate frequency of symptoms from "Never" to "Almost every day".

  2. Depression symptoms - Patient Health Questionnaire - 9 (PHQ9) [1 month - after intervention]

    Depression symptoms were evaluated using the Patient Health Questionnaire - 9 (PHQ9), which its used for depression screening with a sensibility and specificity of 88% y 92%. It contains 9 items on a 5-point Likert scale (0-4) to evaluate frequency of symptoms from "Never" to "Almost every day".

  3. Depression symptoms - Patient Health Questionnaire - 9 (PHQ9) [3 month]

    Depression symptoms were evaluated using the Patient Health Questionnaire - 9 (PHQ9), which its used for depression screening with a sensibility and specificity of 88% y 92%. It contains 9 items on a 5-point Likert scale (0-4) to evaluate frequency of symptoms from "Never" to "Almost every day".

  4. Anxiety symptoms - General Anxiety Disorder 7 (GAD-7) [Baseline]

    Anxiety symptoms were evaluated using the General Anxiety Disorder 7 (GAD-7) validated on Spanish population for anxiety disorder screening with a a sensibility and specificity of 86,8% and 93,4%. It contains 7 items on a 5-point Likert scale (0-3) to evaluate frequency of symptoms from "Never" to "Almost every day".

  5. Anxiety symptoms - General Anxiety Disorder 7 (GAD-7) [1 month - after intervention]

    Anxiety symptoms were evaluated using the General Anxiety Disorder 7 (GAD-7) validated on Spanish population for anxiety disorder screening with a a sensibility and specificity of 86,8% and 93,4%. It contains 7 items on a 5-point Likert scale (0-3) to evaluate frequency of symptoms from "Never" to "Almost every day".

  6. Anxiety symptoms - General Anxiety Disorder 7 (GAD-7) [3 month]

    Anxiety symptoms were evaluated using the General Anxiety Disorder 7 (GAD-7) validated on Spanish population for anxiety disorder screening with a a sensibility and specificity of 86,8% and 93,4%. It contains 7 items on a 5-point Likert scale (0-3) to evaluate frequency of symptoms from "Never" to "Almost every day".

Secondary Outcome Measures

  1. Mental Health - Mental Health Continuum Scale- Short Form (MHC-14) [Baseline]

    Mental health can be defined as a state in which an individual realizes his or her own abilities, can cope with the stresses of life, can work productively and can make a contribution,and is described by Corey L. Keyes in 3 main dimensions; emotional well being, psychological well being and social well being.

  2. Mental Health - Mental Health Continuum Scale- Short Form (MHC-14) [1 month - after intervention]

    Mental health can be defined as a state in which an individual realizes his or her own abilities, can cope with the stresses of life, can work productively and can make a contribution,and is described by Corey L. Keyes in 3 main dimensions; emotional well being, psychological well being and social well being.

  3. Mental Health - Mental Health Continuum Scale- Short Form (MHC-14) [3 month]

    Mental health can be defined as a state in which an individual realizes his or her own abilities, can cope with the stresses of life, can work productively and can make a contribution,and is described by Corey L. Keyes in 3 main dimensions; emotional well being, psychological well being and social well being.

  4. Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) [Baseline]

    Mindfulness is defined as the ability to pay attention to our own experiences without judging them. In 2006 Baer et al developed the FFMQ which consists of 39 questions that look for the 5 facets of mindfulness: observe, describe, act aware, non-judge and non-react.

  5. Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) [1 month - after intervention]

    Mindfulness is defined as the ability to pay attention to our own experiences without judging them. In 2006 Baer et al developed the FFMQ which consists of 39 questions that look for the 5 facets of mindfulness: observe, describe, act aware, non-judge and non-react.

  6. Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) [3 month]

    Mindfulness is defined as the ability to pay attention to our own experiences without judging them. In 2006 Baer et al developed the FFMQ which consists of 39 questions that look for the 5 facets of mindfulness: observe, describe, act aware, non-judge and non-react.

  7. Self compassion scale Short form (SCS-SF) [Baseline]

    Self compassion is understood as maintenance of full attention and opening without disconnecting from self's suffering with the desire to alleviate it in a non judgemental way, comprehending the own experience as a part of the human experience. A scale of 6 sub domains was developed and for the study, a translation of the "Self Compassion Scale Short Form - 12

  8. Self compassion scale Short form (SCS-SF) [1 month - after intervention]

    Self compassion is understood as maintenance of full attention and opening without disconnecting from self's suffering with the desire to alleviate it in a non judgemental way, comprehending the own experience as a part of the human experience. A scale of 6 sub domains was developed and for the study, a translation of the "Self Compassion Scale Short Form - 12

  9. Self compassion scale Short form (SCS-SF) [3 month]

    Self compassion is understood as maintenance of full attention and opening without disconnecting from self's suffering with the desire to alleviate it in a non judgemental way, comprehending the own experience as a part of the human experience. A scale of 6 sub domains was developed and for the study, a translation of the "Self Compassion Scale Short Form - 12

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Medicine Students

  • 1st to 7th class year

Exclusion Criteria:
  • Recent Grief

  • Severe acute depression disorder

  • Active suicidal ideation

  • Active Psychosis

  • Active addiction

  • Post Traumatic Stres Disorder

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University Diego PortalesSantiagoMetropolitanaChile7850345

Sponsors and Collaborators

  • University Diego Portales

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Francisco Javier Villalon Lopez, Principal Investigator, University Diego Portales
ClinicalTrials.gov Identifier:
NCT05011955
Other Study ID Numbers:
  • 06-2020
First Posted:
Aug 18, 2021
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021