Depressive SymptomsMIIMNCT05011955
Mindfulness and Intercare Based Intervention for Medicine Students (MIIM)
A study testing Mindfulness, compassion and intercare based Intervention, Psychoeducational based intervention and General curricular intervention in people with Depressive Symptoms and Mental Health Wellness 1, run by University Diego Portales at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Mental Health Wellness 1, Anxiety
- What is being tested?
- Mindfulness, compassion and intercare based Intervention, Psychoeducational based intervention and General curricular intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChile
- Study dates
- 18 May 2020to 22 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medicine Students
- 1st to 7th class year
Who cannot join
- Recent Grief
- Severe acute depression disorder
- Active suicidal ideation
- Active Psychosis
- Active addiction
- Post Traumatic Stres Disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Online 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.
- Conditions
- Depressive Symptoms, Mental Health Wellness 1, Anxiety
- Being tested
- Mindfulness, compassion and intercare based Intervention, Psychoeducational based intervention, General curricular intervention
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness, compassion and intercare based InterventionBehavioural
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 interventionBehavioural
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: General curricular intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 3 month
Secondary outcomes (9)
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.
Measured: Baseline
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.
Measured: 1 month - after intervention
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.
Measured: 3 month
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.
Measured: Baseline
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.
Measured: 1 month - after intervention
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.
Measured: 3 month
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
Measured: Baseline
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
Measured: 1 month - after intervention
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
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start18 May 2020
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Diego Portales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier Villalon Lopez, University Diego Portales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011955
- Sponsor's protocol ID
- 06-2020
- Acronym
- MIIM
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Online Mindfulness and Intercare Based Intervention for Medicine Students (MIIM)
- ClinicalTrials.gov ID
- NCT05011955
- Acronym / sponsor ID
- MIIM / 06-2020
- Conditions
- Depressive Symptoms, Mental Health Wellness 1, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University Diego PortalesUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness, compassion and intercare based Intervention | Experimental | Behavioral: Mindfulness, compassion and intercare based Intervention, Other: General curricular interventionFour week, one hour peer week, online group intervention plus home work based on mindfulness, compassion and intercare based programs. |
| Psychoeducational based intervention | Active comparator | Behavioral: Psychoeducational based intervention, Other: General curricular interventionFour week, one hour peer week, online group intervention plus home work based on psychoeducation about stress, anxiety, selfcare and effective communication. |
| General curricular intervention | Other | Other: General curricular interventionAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medicine Students
- 1st to 7th class year
Key exclusion criteria (6 listed)
- Recent Grief
- Severe acute depression disorder
- Active suicidal ideation
- Active Psychosis
- Active addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness, compassion and intercare based InterventionThe 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. | Behavioural | Mindfulness, compassion and intercare based Intervention |
| Psychoeducational based interventionFour 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. | Behavioural | Psychoeducational based intervention |
| General curricular interventionAll 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, Mindfulness, compassion and intercare based Intervention, Psychoeducational based intervention |
Primary outcome
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".
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".
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".
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".
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".
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".
9 secondary outcomes
Mental Health - Mental Health Continuum Scale- Short Form (MHC-14)
Time frame: Baseline
Mental Health - Mental Health Continuum Scale- Short Form (MHC-14)
Time frame: 1 month - after intervention
Mental Health - Mental Health Continuum Scale- Short Form (MHC-14)
Time frame: 3 month
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Time frame: Baseline
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Time frame: 1 month - after intervention
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Time frame: 3 month
Self compassion scale Short form (SCS-SF)
Time frame: Baseline
Self compassion scale Short form (SCS-SF)
Time frame: 1 month - after intervention
Self compassion scale Short form (SCS-SF)
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness, compassion and intercare based Intervention, Psychoeducational based intervention and General curricular intervention in people with Depressive Symptoms and Mental Health Wellness 1, run by University Diego Portales at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms - Patient Health Questionnaire - 9 (PHQ9) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.