Clinical trial NCT05197595: Efficacy of a Compassion Program in University Students
Official title: Efficacy of a Compassion Program for the Reduction of Psychological Distress in University Students
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Wellness
Keywords: Attachment-based compassion therapy
Students
Psychological well-being
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Depression Anxiety and Stress Scale - 21 (DASS-21)
timeFrame: Baseline
measure: Depression Anxiety and Stress Scale - 21 (DASS-21)
timeFrame: Baseline
measure: Depression Anxiety and Stress Scale - 21 (DASS-21)
timeFrame: Post-treatment 6 weeks from baseline
measure: Depression Anxiety and Stress Scale - 21 (DASS-21)
timeFrame: Post-treatment 6 weeks from baseline
measure: Depression Anxiety and Stress Scale - 21 (DASS-21)
timeFrame: Six-months follow-up
measure: Depression Anxiety and Stress Scale - 21 (DASS-21)
timeFrame: Six-months follow-up
Secondary outcomes:
measure: Sociodemographic data Gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: Sociodemographic data Gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: Positive and negative affect (PANAS)
timeFrame: Baseline
measure: Positive and negative affect (PANAS)
timeFrame: Baseline
measure: Positive and negative affect (PANAS)
timeFrame: Post-treatment 6 weeks from baseline
measure: Positive and negative affect (PANAS)
timeFrame: Post-treatment 6 weeks from baseline
measure: Positive and negative affect (PANAS)
timeFrame: Six-months follow-up
measure: Positive and negative affect (PANAS)
timeFrame: Six-months follow-up
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Baseline
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Baseline
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Post-treatment 6 weeks from baseline
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Post-treatment 6 weeks from baseline
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Six-months follow-up
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Six-months follow-up
measure: Maslach Burnout Inventory Student Survey (MBI-SS)
timeFrame: Baseline
measure: Maslach Burnout Inventory Student Survey (MBI-SS)
timeFrame: Baseline
measure: Maslach Burnout Inventory Student Survey (MBI-SS)
timeFrame: Post-treatment 6 weeks from baseline
measure: Maslach Burnout Inventory Student Survey (MBI-SS)
timeFrame: Post-treatment 6 weeks from baseline
measure: Maslach Burnout Inventory Student Survey (MBI-SS)
timeFrame: Six-months follow-up
measure: Maslach Burnout Inventory Student Survey (MBI-SS)
timeFrame: Six-months follow-up
Other outcomes:
measure: The Relationship Questionnaire (RQ)
timeFrame: Baseline
measure: The Relationship Questionnaire (RQ)
timeFrame: Baseline
measure: The Relationship Questionnaire (RQ)
timeFrame: Post-treatment 6 weeks from baseline
measure: The Relationship Questionnaire (RQ)
timeFrame: Post-treatment 6 weeks from baseline
measure: The Relationship Questionnaire (RQ)
timeFrame: Six-months follow-up
measure: The Relationship Questionnaire (RQ)
timeFrame: Six-months follow-up
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Post-treatment 6 weeks from baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Post-treatment 6 weeks from baseline
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Six-months follow-up
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Six-months follow-up
measure: Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
timeFrame: Baseline
measure: Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
timeFrame: Baseline
measure: Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
timeFrame: Post-treatment 6 weeks from baseline
measure: Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
timeFrame: Post-treatment 6 weeks from baseline
measure: Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
timeFrame: Six-months follow-up
measure: Sussex-Oxford Compassion for Others Scale & SussexOxford Compassion for the Self Scale (SOCS)
timeFrame: Six-months follow-up
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Post-treatment 6 weeks from baseline
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Post-treatment 6 weeks from baseline
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Six-months follow-up
measure: Five Facets of Mindfulness Questionnaire (FFMQ)
timeFrame: Six-months follow-up
Locations:
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital
Study officials:
References: