Efficacy of a Compassion Program in University Students

October 17, 2023 updated by: Javier Garcia Campayo, Hospital Miguel Servet

Efficacy of a Compassion Program for the Reduction of Psychological Distress in University Students

University life is a challenging period. College students are exposed to a large number of stressors such as increased workload, multitasking, new responsibilities, changes in sleep and eating habits, social stressors, financial concerns and future employability, unlimited access to technology, etc. The participation of some of them in unhealthy activities should also be noted.

There is sufficient evidence to affirm that high levels of stress cause different alterations in students, such as attention and concentration deficits, difficulties in memorizing and solving problems, low productivity and poor academic performance. Due to this, in addition to the psychological and social impact of said mental health problems, the academic functioning of the students decreases and the dropout rates increase, which represents a problem for themselves and for the institutions. On the other hand, students and future professionals in training run the risk of suffering burnout as a consequence of the chronic stress to which they are subjected, with the consequent negative effects on their future professional practice.

The main objective of the present research is to evaluate the efficacy of a six-week compassion program for the reduction of psychological distress in university students compared to an active control condition based on relaxation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50009
        • Miguel Servet University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 18-30 years old.
  • Study undergraduate or master's degrees at the University of Zaragoza.
  • Understand perfectly spoken and written Spanish.
  • Grant informed consent.

Exclusion Criteria:

  • Any diagnose of disease that may affect central nervous system (brain pathology traumatic brain injury, dementia, etc.).
  • Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.) except for anxious pathology or personality disorders.
  • Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Compassion condition
90-minute group sessions, held once a week over a space of 6 weeks, and is offered as an extra-curricular activity.
Behavioral: Attachment-based compassion therapy
Compassion program consists of 6 sessions of 90 minutes/session (15-20 people) Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months
Active Comparator: Relaxation condition
90-minute group sessions, held once a week over a space of 6 weeks, and will be offered as an extracurricular activity.
Behavioral: Relaxation program
Relaxation program consists of 6 sessions of 90 minutes/session (15-20 people) Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time Frame: Baseline
In the compassion program group
Baseline
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time Frame: Baseline
In the relaxation program group
Baseline
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time Frame: Post-treatment 6 weeks from baseline
In the compassion condition group
Post-treatment 6 weeks from baseline
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time Frame: Post-treatment 6 weeks from baseline
In the relaxation program group
Post-treatment 6 weeks from baseline
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time Frame: Six-months follow-up
In the compassion condition group
Six-months follow-up
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time Frame: Six-months follow-up
In the relaxation program group
Six-months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time Frame: Baseline
In the compassion condition group
Baseline
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time Frame: Baseline
In the relaxation program group
Baseline
Positive and negative affect (PANAS)
Time Frame: Baseline
In the compassion condition group
Baseline
Positive and negative affect (PANAS)
Time Frame: Baseline
In the relaxation program group
Baseline
Positive and negative affect (PANAS)
Time Frame: Post-treatment 6 weeks from baseline
In the compassion condition group
Post-treatment 6 weeks from baseline
Positive and negative affect (PANAS)
Time Frame: Post-treatment 6 weeks from baseline
In the relaxation program group
Post-treatment 6 weeks from baseline
Positive and negative affect (PANAS)
Time Frame: Six-months follow-up
In the compassion condition group
Six-months follow-up
Positive and negative affect (PANAS)
Time Frame: Six-months follow-up
In the relaxation program group
Six-months follow-up
Emotional Regulation Questionnaire (ERQ)
Time Frame: Baseline
In the compassion condition group
Baseline
Emotional Regulation Questionnaire (ERQ)
Time Frame: Baseline
In the relaxation program group
Baseline
Emotional Regulation Questionnaire (ERQ)
Time Frame: Post-treatment 6 weeks from baseline
In the compassion condition group
Post-treatment 6 weeks from baseline
Emotional Regulation Questionnaire (ERQ)
Time Frame: Post-treatment 6 weeks from baseline
In the relaxation program group
Post-treatment 6 weeks from baseline
Emotional Regulation Questionnaire (ERQ)
Time Frame: Six-months follow-up
In the compassion condition group
Six-months follow-up
Emotional Regulation Questionnaire (ERQ)
Time Frame: Six-months follow-up
In the relaxation program group
Six-months follow-up
Maslach Burnout Inventory Student Survey (MBI-SS)
Time Frame: Baseline
In the compassion condition group
Baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
Time Frame: Baseline
In the relaxation program group
Baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
Time Frame: Post-treatment 6 weeks from baseline
In the compassion condition group
Post-treatment 6 weeks from baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
Time Frame: Post-treatment 6 weeks from baseline
In the relaxation program group
Post-treatment 6 weeks from baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
Time Frame: Six-months follow-up
In the compassion condition group
Six-months follow-up
Maslach Burnout Inventory Student Survey (MBI-SS)
Time Frame: Six-months follow-up
In the relaxation program group
Six-months follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Relationship Questionnaire (RQ)
Time Frame: Baseline
In the compassion condition group
Baseline
The Relationship Questionnaire (RQ)
Time Frame: Baseline
In the relaxation program group
Baseline
The Relationship Questionnaire (RQ)
Time Frame: Post-treatment 6 weeks from baseline
In the compassion condition group
Post-treatment 6 weeks from baseline
The Relationship Questionnaire (RQ)
Time Frame: Post-treatment 6 weeks from baseline
In the relaxation program group
Post-treatment 6 weeks from baseline
The Relationship Questionnaire (RQ)
Time Frame: Six-months follow-up
In the compassion condition group
Six-months follow-up
The Relationship Questionnaire (RQ)
Time Frame: Six-months follow-up
In the relaxation program group
Six-months follow-up
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Baseline
In the compassion condition group
Baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Baseline
In the relaxation program group
Baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Post-treatment 6 weeks from baseline
In the compassion condition group
Post-treatment 6 weeks from baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Post-treatment 6 weeks from baseline
In the relaxation program group
Post-treatment 6 weeks from baseline
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Six-months follow-up
In the compassion condition group
Six-months follow-up
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Six-months follow-up
In the relaxation program group
Six-months follow-up
Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
Time Frame: Baseline
In the compassion condition group
Baseline
Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
Time Frame: Baseline
In the relaxation program group
Baseline
Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
Time Frame: Post-treatment 6 weeks from baseline
In the compassion condition group
Post-treatment 6 weeks from baseline
Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
Time Frame: Post-treatment 6 weeks from baseline
In the relaxation program group
Post-treatment 6 weeks from baseline
Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
Time Frame: Six-months follow-up
In the compassion condition group
Six-months follow-up
Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
Time Frame: Six-months follow-up
In the relaxation program group
Six-months follow-up
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline
In the compassion condition group
Baseline
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline
In the relaxation program group
Baseline
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Post-treatment 6 weeks from baseline
In the compassion condition group
Post-treatment 6 weeks from baseline
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Post-treatment 6 weeks from baseline
In the relaxation program group
Post-treatment 6 weeks from baseline
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Six-months follow-up
In the compassion condition group
Six-months follow-up
Five Facets of Mindfulness Questionnaire (FFMQ)
Time Frame: Six-months follow-up
In the relaxation program group
Six-months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Miguel Servet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2021

Primary Completion (Actual)

May 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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