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Completed

NCT Number: NCT05011955

Mindfulness and Intercare Based Intervention for Medicine Students (MIIM)

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.

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Key information

Conditions

Depressive Symptoms Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Mental Health Wellness 1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Diego Portales

Santiago, Santiago Metropolitan, 7850345, Chile

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness, compassion and intercare based Intervention

Behavioral

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.

Psychoeducational based intervention

Behavioral

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.

General curricular intervention

Other

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.

Primary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Diego Portales

Other

Registry information

Official study title

Brief Online Mindfulness and Intercare Based Intervention for Medicine Students (MIIM)

Acronym: MIIM

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 18, 2021
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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