Mindfulness and Intercare Based Intervention for Medicine Students (MIIM)

NCT05011955 | Completed

• 1 other identifier: 06-2020
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Mental Health Wellness 1; Anxiety

Outcome Measures

Primary Outcomes (6)

• Depression symptoms - Patient Health Questionnaire - 9 (PHQ9)

  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".

  Baseline

• Depression symptoms - Patient Health Questionnaire - 9 (PHQ9)

  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".

  1 month - after intervention

• Depression symptoms - Patient Health Questionnaire - 9 (PHQ9)

  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 month

• Anxiety symptoms - General Anxiety Disorder 7 (GAD-7)

  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".

  Baseline

• Anxiety symptoms - General Anxiety Disorder 7 (GAD-7)

  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".

  1 month - after intervention

• Anxiety symptoms - General Anxiety Disorder 7 (GAD-7)

  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".

  3 month

Secondary Outcomes (9)

• Mental Health - Mental Health Continuum Scale- Short Form (MHC-14)

  Baseline

• Mental Health - Mental Health Continuum Scale- Short Form (MHC-14)

  1 month - after intervention

• Mental Health - Mental Health Continuum Scale- Short Form (MHC-14)

  3 month

• Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)

  Baseline

• Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)

  1 month - after intervention

Study Arms (3)

Mindfulness, compassion and intercare based Intervention

EXPERIMENTAL

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; Other: General curricular intervention

Psychoeducational based intervention

ACTIVE COMPARATOR

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; Other: General curricular intervention

General curricular intervention

OTHER

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

Interventions

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.

Mindfulness, compassion and intercare based Intervention

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.

Psychoeducational based intervention

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.

General curricular intervention; Mindfulness, compassion and intercare based Intervention; Psychoeducational based intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male, Female, Non Binary, Other
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medicine Students
• st to 7th class year

You may not qualify if:

• Recent Grief
• Severe acute depression disorder
• Active suicidal ideation
• Active Psychosis
• Active addiction
• Post Traumatic Stres Disorder

Sponsors & Collaborators

• University Diego Portales: lead

Study Sites (1)

University Diego Portales

Santiago, Santiago Metropolitan, 7850345, Chile

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 18, 2021
• Study Start: May 18, 2020
• Primary Completion: September 22, 2020
• Study Completion: September 22, 2020
• Last Updated: August 18, 2021

Record last verified: 2021-08

Locations

CL (1)