Efficacy of a Compassion Program in University Students

Study Overview
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Brief Summary
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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.

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

Conditions
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Mental Health Wellness

Intervention / Treatment
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* Behavioral: Attachment-based compassion therapy
* Behavioral: Relaxation program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compassion condition<br>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<br>* 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<br>|
| Active Comparator: Relaxation condition<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Anxiety and Stress Scale - 21 (DASS-21) | In the compassion program group | Baseline | 
| Depression Anxiety and Stress Scale - 21 (DASS-21) | In the relaxation program group | Baseline | 
| Depression Anxiety and Stress Scale - 21 (DASS-21) | In the compassion condition group | Post-treatment 6 weeks from baseline | 
| Depression Anxiety and Stress Scale - 21 (DASS-21) | In the relaxation program group | Post-treatment 6 weeks from baseline | 
| Depression Anxiety and Stress Scale - 21 (DASS-21) | In the compassion condition group | Six-months follow-up | 
| Depression Anxiety and Stress Scale - 21 (DASS-21) | 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 | In the compassion condition group | Baseline | 
| Sociodemographic data Gender, age, marital status, education, occupation, economical level | In the relaxation program group | Baseline | 
| Positive and negative affect (PANAS) | In the compassion condition group | Baseline | 
| Positive and negative affect (PANAS) | In the relaxation program group | Baseline | 
| Positive and negative affect (PANAS) | In the compassion condition group | Post-treatment 6 weeks from baseline | 
| Positive and negative affect (PANAS) | In the relaxation program group | Post-treatment 6 weeks from baseline | 
| Positive and negative affect (PANAS) | In the compassion condition group | Six-months follow-up | 
| Positive and negative affect (PANAS) | In the relaxation program group | Six-months follow-up | 
| Emotional Regulation Questionnaire (ERQ) | In the compassion condition group | Baseline | 
| Emotional Regulation Questionnaire (ERQ) | In the relaxation program group | Baseline | 
| Emotional Regulation Questionnaire (ERQ) | In the compassion condition group | Post-treatment 6 weeks from baseline | 
| Emotional Regulation Questionnaire (ERQ) | In the relaxation program group | Post-treatment 6 weeks from baseline | 
| Emotional Regulation Questionnaire (ERQ) | In the compassion condition group | Six-months follow-up | 
| Emotional Regulation Questionnaire (ERQ) | In the relaxation program group | Six-months follow-up | 
| Maslach Burnout Inventory Student Survey (MBI-SS) | In the compassion condition group | Baseline | 
| Maslach Burnout Inventory Student Survey (MBI-SS) | In the relaxation program group | Baseline | 
| Maslach Burnout Inventory Student Survey (MBI-SS) | In the compassion condition group | Post-treatment 6 weeks from baseline | 
| Maslach Burnout Inventory Student Survey (MBI-SS) | In the relaxation program group | Post-treatment 6 weeks from baseline | 
| Maslach Burnout Inventory Student Survey (MBI-SS) | In the compassion condition group | Six-months follow-up | 
| Maslach Burnout Inventory Student Survey (MBI-SS) | In the relaxation program group | Six-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attachment-based compassion therapy, Students, Psychological well-being