Mindfulness and Intercare Based Intervention for Medicine Students (MIIM)

NCT ID: NCT05011955

Last Updated: 2021-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2020-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Symptoms Mental Health Wellness 1 Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness, compassion and intercare based Intervention

Intervention Type 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.

General curricular intervention

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Psychoeducational based intervention

Intervention Type 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

Intervention Type 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.

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.

Group Type OTHER

General curricular intervention

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Diego Portales

OTHER

Sponsor Role lead

Responsible Party

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Francisco Javier Villalon Lopez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Diego Portales

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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06-2020

Identifier Type: -

Identifier Source: org_study_id

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