Efficacy of a Compassion Program in University Students

NCT05197595 | Unknown

• 1 other identifier: 18/2021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness

Keywords

Attachment-based compassion therapy; Students; Psychological well-being

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (20)

• Sociodemographic data Gender, age, marital status, education, occupation, economical level

  Baseline

• Sociodemographic data Gender, age, marital status, education, occupation, economical level

  Baseline

• Positive and negative affect (PANAS)

  Baseline

• Positive and negative affect (PANAS)

  Baseline

• Positive and negative affect (PANAS)

  Post-treatment 6 weeks from baseline

Other Outcomes (24)

• The Relationship Questionnaire (RQ)

  Baseline

• The Relationship Questionnaire (RQ)

  Baseline

• The Relationship Questionnaire (RQ)

  Post-treatment 6 weeks from baseline

Study Arms (2)

Compassion condition

EXPERIMENTAL

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

Relaxation condition

ACTIVE COMPARATOR

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

Interventions

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

Compassion condition

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

Relaxation condition

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Miguel Servet: lead

Study Sites (1)

Miguel Servet University Hospital

Zaragoza, 50009, Spain

Location

Related Publications (1)

• Beltran-Ruiz M, Fernandez S, Garcia-Campayo J, Puebla-Guedea M, Lopez-Del-Hoyo Y, Navarro-Gil M, Montero-Marin J. Effectiveness of attachment-based compassion therapy to reduce psychological distress in university students: a randomised controlled trial protocol. Front Psychol. 2023 Aug 24;14:1185445. doi: 10.3389/fpsyg.2023.1185445. eCollection 2023.

  PMID: 37691796 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: November 6, 2021
• Primary Completion: May 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

ES (1)