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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05011955
Other study ID # 06-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 18, 2020
Est. completion date September 22, 2020

Study information

Verified date August 2021
Source University Diego Portales
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date September 22, 2020
Est. primary completion date September 22, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
Chile University Diego Portales Santiago Metropolitana

Sponsors (1)

Lead Sponsor Collaborator
University Diego Portales

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Mental Health - Mental Health Continuum Scale- Short Form (MHC-14) 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. Baseline
Secondary Mental Health - Mental Health Continuum Scale- Short Form (MHC-14) 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. 1 month - after intervention
Secondary Mental Health - Mental Health Continuum Scale- Short Form (MHC-14) 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 month
Secondary Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) 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. Baseline
Secondary Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) 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. 1 month - after intervention
Secondary Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF) 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. 3 month
Secondary Self compassion scale Short form (SCS-SF) 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 Baseline
Secondary Self compassion scale Short form (SCS-SF) 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 1 month - after intervention
Secondary Self compassion scale Short form (SCS-SF) 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 3 month
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