Efficacy of a Compassion Program in University Students

Mental Health Wellness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05197595
• Other study ID #: 18/2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 6, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2023
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Wellness

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Miguel Servet University Hospital	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Miguel Servet

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Relationship Questionnaire (RQ)	In the compassion condition group	Baseline
Other	The Relationship Questionnaire (RQ)	In the relaxation program group	Baseline
Other	The Relationship Questionnaire (RQ)	In the compassion condition group	Post-treatment 6 weeks from baseline
Other	The Relationship Questionnaire (RQ)	In the relaxation program group	Post-treatment 6 weeks from baseline
Other	The Relationship Questionnaire (RQ)	In the compassion condition group	Six-months follow-up
Other	The Relationship Questionnaire (RQ)	In the relaxation program group	Six-months follow-up
Other	Acceptance and Action Questionnaire-II (AAQ-II)	In the compassion condition group	Baseline
Other	Acceptance and Action Questionnaire-II (AAQ-II)	In the relaxation program group	Baseline
Other	Acceptance and Action Questionnaire-II (AAQ-II)	In the compassion condition group	Post-treatment 6 weeks from baseline
Other	Acceptance and Action Questionnaire-II (AAQ-II)	In the relaxation program group	Post-treatment 6 weeks from baseline
Other	Acceptance and Action Questionnaire-II (AAQ-II)	In the compassion condition group	Six-months follow-up
Other	Acceptance and Action Questionnaire-II (AAQ-II)	In the relaxation program group	Six-months follow-up
Other	Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)	In the compassion condition group	Baseline
Other	Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)	In the relaxation program group	Baseline
Other	Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)	In the compassion condition group	Post-treatment 6 weeks from baseline
Other	Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)	In the relaxation program group	Post-treatment 6 weeks from baseline
Other	Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)	In the compassion condition group	Six-months follow-up
Other	Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)	In the relaxation program group	Six-months follow-up
Other	Five Facets of Mindfulness Questionnaire (FFMQ)	In the compassion condition group	Baseline
Other	Five Facets of Mindfulness Questionnaire (FFMQ)	In the relaxation program group	Baseline
Other	Five Facets of Mindfulness Questionnaire (FFMQ)	In the compassion condition group	Post-treatment 6 weeks from baseline
Other	Five Facets of Mindfulness Questionnaire (FFMQ)	In the relaxation program group	Post-treatment 6 weeks from baseline
Other	Five Facets of Mindfulness Questionnaire (FFMQ)	In the compassion condition group	Six-months follow-up
Other	Five Facets of Mindfulness Questionnaire (FFMQ)	In the relaxation program group	Six-months follow-up
Primary	Depression Anxiety and Stress Scale - 21 (DASS-21)	In the compassion program group	Baseline
Primary	Depression Anxiety and Stress Scale - 21 (DASS-21)	In the relaxation program group	Baseline
Primary	Depression Anxiety and Stress Scale - 21 (DASS-21)	In the compassion condition group	Post-treatment 6 weeks from baseline
Primary	Depression Anxiety and Stress Scale - 21 (DASS-21)	In the relaxation program group	Post-treatment 6 weeks from baseline
Primary	Depression Anxiety and Stress Scale - 21 (DASS-21)	In the compassion condition group	Six-months follow-up
Primary	Depression Anxiety and Stress Scale - 21 (DASS-21)	In the relaxation program group	Six-months follow-up
Secondary	Sociodemographic data Gender, age, marital status, education, occupation, economical level	In the compassion condition group	Baseline
Secondary	Sociodemographic data Gender, age, marital status, education, occupation, economical level	In the relaxation program group	Baseline
Secondary	Positive and negative affect (PANAS)	In the compassion condition group	Baseline
Secondary	Positive and negative affect (PANAS)	In the relaxation program group	Baseline
Secondary	Positive and negative affect (PANAS)	In the compassion condition group	Post-treatment 6 weeks from baseline
Secondary	Positive and negative affect (PANAS)	In the relaxation program group	Post-treatment 6 weeks from baseline
Secondary	Positive and negative affect (PANAS)	In the compassion condition group	Six-months follow-up
Secondary	Positive and negative affect (PANAS)	In the relaxation program group	Six-months follow-up
Secondary	Emotional Regulation Questionnaire (ERQ)	In the compassion condition group	Baseline
Secondary	Emotional Regulation Questionnaire (ERQ)	In the relaxation program group	Baseline
Secondary	Emotional Regulation Questionnaire (ERQ)	In the compassion condition group	Post-treatment 6 weeks from baseline
Secondary	Emotional Regulation Questionnaire (ERQ)	In the relaxation program group	Post-treatment 6 weeks from baseline
Secondary	Emotional Regulation Questionnaire (ERQ)	In the compassion condition group	Six-months follow-up
Secondary	Emotional Regulation Questionnaire (ERQ)	In the relaxation program group	Six-months follow-up
Secondary	Maslach Burnout Inventory Student Survey (MBI-SS)	In the compassion condition group	Baseline
Secondary	Maslach Burnout Inventory Student Survey (MBI-SS)	In the relaxation program group	Baseline
Secondary	Maslach Burnout Inventory Student Survey (MBI-SS)	In the compassion condition group	Post-treatment 6 weeks from baseline
Secondary	Maslach Burnout Inventory Student Survey (MBI-SS)	In the relaxation program group	Post-treatment 6 weeks from baseline
Secondary	Maslach Burnout Inventory Student Survey (MBI-SS)	In the compassion condition group	Six-months follow-up
Secondary	Maslach Burnout Inventory Student Survey (MBI-SS)	In the relaxation program group	Six-months follow-up