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Completed

NCT Number: NCT05197595

Efficacy of a Compassion Program 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.

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Key information

Conditions

Mental Health Wellness Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miguel Servet University Hospital

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Attachment-based compassion therapy

Behavioral

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

Relaxation program

Behavioral

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

Primary outcomes

  1. Depression Anxiety and Stress Scale - 21 (DASS-21)

    Time frame: Baseline

    In the compassion program group

  2. Depression Anxiety and Stress Scale - 21 (DASS-21)

    Time frame: Baseline

    In the relaxation program group

  3. Depression Anxiety and Stress Scale - 21 (DASS-21)

    Time frame: Post-treatment 6 weeks from baseline

    In the compassion condition group

  4. Depression Anxiety and Stress Scale - 21 (DASS-21)

    Time frame: Post-treatment 6 weeks from baseline

    In the relaxation program group

  5. Depression Anxiety and Stress Scale - 21 (DASS-21)

    Time frame: Six-months follow-up

    In the compassion condition group

  6. Depression Anxiety and Stress Scale - 21 (DASS-21)

    Time frame: Six-months follow-up

    In the relaxation program group

Secondary outcomes

  1. Sociodemographic data Gender, age, marital status, education, occupation, economical level

    Time frame: Baseline

    In the compassion condition group

  2. Sociodemographic data Gender, age, marital status, education, occupation, economical level

    Time frame: Baseline

    In the relaxation program group

  3. Positive and negative affect (PANAS)

    Time frame: Baseline

    In the compassion condition group

  4. Positive and negative affect (PANAS)

    Time frame: Baseline

    In the relaxation program group

  5. Positive and negative affect (PANAS)

    Time frame: Post-treatment 6 weeks from baseline

    In the compassion condition group

  6. Positive and negative affect (PANAS)

    Time frame: Post-treatment 6 weeks from baseline

    In the relaxation program group

  7. Positive and negative affect (PANAS)

    Time frame: Six-months follow-up

    In the compassion condition group

  8. Positive and negative affect (PANAS)

    Time frame: Six-months follow-up

    In the relaxation program group

  9. Emotional Regulation Questionnaire (ERQ)

    Time frame: Baseline

    In the compassion condition group

  10. Emotional Regulation Questionnaire (ERQ)

    Time frame: Baseline

    In the relaxation program group

  11. Emotional Regulation Questionnaire (ERQ)

    Time frame: Post-treatment 6 weeks from baseline

    In the compassion condition group

  12. Emotional Regulation Questionnaire (ERQ)

    Time frame: Post-treatment 6 weeks from baseline

    In the relaxation program group

  13. Emotional Regulation Questionnaire (ERQ)

    Time frame: Six-months follow-up

    In the compassion condition group

  14. Emotional Regulation Questionnaire (ERQ)

    Time frame: Six-months follow-up

    In the relaxation program group

  15. Maslach Burnout Inventory Student Survey (MBI-SS)

    Time frame: Baseline

    In the compassion condition group

  16. Maslach Burnout Inventory Student Survey (MBI-SS)

    Time frame: Baseline

    In the relaxation program group

  17. Maslach Burnout Inventory Student Survey (MBI-SS)

    Time frame: Post-treatment 6 weeks from baseline

    In the compassion condition group

  18. Maslach Burnout Inventory Student Survey (MBI-SS)

    Time frame: Post-treatment 6 weeks from baseline

    In the relaxation program group

  19. Maslach Burnout Inventory Student Survey (MBI-SS)

    Time frame: Six-months follow-up

    In the compassion condition group

  20. Maslach Burnout Inventory Student Survey (MBI-SS)

    Time frame: Six-months follow-up

    In the relaxation program group

Other outcomes

  1. The Relationship Questionnaire (RQ)

    Time frame: Baseline

    In the compassion condition group

  2. The Relationship Questionnaire (RQ)

    Time frame: Baseline

    In the relaxation program group

  3. The Relationship Questionnaire (RQ)

    Time frame: Post-treatment 6 weeks from baseline

    In the compassion condition group

  4. The Relationship Questionnaire (RQ)

    Time frame: Post-treatment 6 weeks from baseline

    In the relaxation program group

  5. The Relationship Questionnaire (RQ)

    Time frame: Six-months follow-up

    In the compassion condition group

  6. The Relationship Questionnaire (RQ)

    Time frame: Six-months follow-up

    In the relaxation program group

  7. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Baseline

    In the compassion condition group

  8. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Baseline

    In the relaxation program group

  9. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Post-treatment 6 weeks from baseline

    In the compassion condition group

  10. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Post-treatment 6 weeks from baseline

    In the relaxation program group

  11. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Six-months follow-up

    In the compassion condition group

  12. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: Six-months follow-up

    In the relaxation program group

  13. Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)

    Time frame: Baseline

    In the compassion condition group

  14. Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)

    Time frame: Baseline

    In the relaxation program group

  15. 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

  16. 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

  17. Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)

    Time frame: Six-months follow-up

    In the compassion condition group

  18. Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)

    Time frame: Six-months follow-up

    In the relaxation program group

  19. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Baseline

    In the compassion condition group

  20. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Baseline

    In the relaxation program group

  21. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Post-treatment 6 weeks from baseline

    In the compassion condition group

  22. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Post-treatment 6 weeks from baseline

    In the relaxation program group

  23. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Six-months follow-up

    In the compassion condition group

  24. Five Facets of Mindfulness Questionnaire (FFMQ)

    Time frame: Six-months follow-up

    In the relaxation program group

Sponsors and collaborators

Lead sponsor

Hospital Miguel Servet

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2022
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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