Mental Health WellnessNCT05197595
Efficacy of a Compassion Program in University Students
A study testing Attachment-based compassion therapy and Relaxation program in people with Mental Health Wellness, run by Hospital Miguel Servet at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness
- What is being tested?
- Attachment-based compassion therapy and Relaxation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 6 Nov 2021to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Compassion Program for the Reduction of Psychological Distress 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.
- Conditions
- Mental Health Wellness
- Being tested
- Attachment-based compassion therapy, Relaxation program
- Keywords
- Attachment-based compassion therapy, Students, Psychological well-being
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment-based compassion therapyBehavioural
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 programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Relaxation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety and Stress Scale - 21 (DASS-21)
In the compassion program group
Measured: Baseline
Depression Anxiety and Stress Scale - 21 (DASS-21)
In the relaxation program group
Measured: Baseline
Depression Anxiety and Stress Scale - 21 (DASS-21)
In the compassion condition group
Measured: Post-treatment 6 weeks from baseline
Depression Anxiety and Stress Scale - 21 (DASS-21)
In the relaxation program group
Measured: Post-treatment 6 weeks from baseline
Depression Anxiety and Stress Scale - 21 (DASS-21)
In the compassion condition group
Measured: Six-months follow-up
Depression Anxiety and Stress Scale - 21 (DASS-21)
In the relaxation program group
Measured: Six-months follow-up
Secondary outcomes (20)
Sociodemographic data Gender, age, marital status, education, occupation, economical level
In the compassion condition group
Measured: Baseline
Sociodemographic data Gender, age, marital status, education, occupation, economical level
In the relaxation program group
Measured: Baseline
Positive and negative affect (PANAS)
In the compassion condition group
Measured: Baseline
Positive and negative affect (PANAS)
In the relaxation program group
Measured: Baseline
Positive and negative affect (PANAS)
In the compassion condition group
Measured: Post-treatment 6 weeks from baseline
Positive and negative affect (PANAS)
In the relaxation program group
Measured: Post-treatment 6 weeks from baseline
Positive and negative affect (PANAS)
In the compassion condition group
Measured: Six-months follow-up
Positive and negative affect (PANAS)
In the relaxation program group
Measured: Six-months follow-up
Emotional Regulation Questionnaire (ERQ)
In the compassion condition group
Measured: Baseline
Emotional Regulation Questionnaire (ERQ)
In the relaxation program group
Measured: Baseline
Emotional Regulation Questionnaire (ERQ)
In the compassion condition group
Measured: Post-treatment 6 weeks from baseline
Emotional Regulation Questionnaire (ERQ)
In the relaxation program group
Measured: Post-treatment 6 weeks from baseline
Emotional Regulation Questionnaire (ERQ)
In the compassion condition group
Measured: Six-months follow-up
Emotional Regulation Questionnaire (ERQ)
In the relaxation program group
Measured: Six-months follow-up
Maslach Burnout Inventory Student Survey (MBI-SS)
In the compassion condition group
Measured: Baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
In the relaxation program group
Measured: Baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
In the compassion condition group
Measured: Post-treatment 6 weeks from baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
In the relaxation program group
Measured: Post-treatment 6 weeks from baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
In the compassion condition group
Measured: Six-months follow-up
Maslach Burnout Inventory Student Survey (MBI-SS)
In the relaxation program group
Measured: Six-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start6 Nov 2021
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Garcia Campayo, Hospital Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197595
- Sponsor's protocol ID
- 18/2021
- Status last verified
- Jul 2026
- First submitted
- 5 Jan 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37691796
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Compassion Program for the Reduction of Psychological Distress in University Students
- ClinicalTrials.gov ID
- NCT05197595
- Acronym / sponsor ID
- 18/2021
- Conditions
- Mental Health Wellness
- Keywords
- Attachment-based compassion therapy, Students, Psychological well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hospital Miguel ServetUniversity, hospital or other
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compassion condition | Experimental | Behavioral: Attachment-based compassion therapy90-minute group sessions, held once a week over a space of 6 weeks, and is offered as an extra-curricular activity. |
| Relaxation condition | Active comparator | Behavioral: Relaxation program90-minute group sessions, held once a week over a space of 6 weeks, and will be offered as an extracurricular activity. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attachment-based compassion therapyCompassion 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 | Behavioural | Compassion condition |
| Relaxation programRelaxation 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 | Behavioural | Relaxation condition |
Primary outcome
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time frame: Baseline
In the compassion program group
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time frame: Baseline
In the relaxation program group
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time frame: Post-treatment 6 weeks from baseline
In the compassion condition group
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time frame: Post-treatment 6 weeks from baseline
In the relaxation program group
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time frame: Six-months follow-up
In the compassion condition group
Depression Anxiety and Stress Scale - 21 (DASS-21)
Time frame: Six-months follow-up
In the relaxation program group
20 secondary outcomes
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time frame: Baseline
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time frame: Baseline
Positive and negative affect (PANAS)
Time frame: Baseline
Positive and negative affect (PANAS)
Time frame: Baseline
Positive and negative affect (PANAS)
Time frame: Post-treatment 6 weeks from baseline
Positive and negative affect (PANAS)
Time frame: Post-treatment 6 weeks from baseline
Positive and negative affect (PANAS)
Time frame: Six-months follow-up
Positive and negative affect (PANAS)
Time frame: Six-months follow-up
Emotional Regulation Questionnaire (ERQ)
Time frame: Baseline
Emotional Regulation Questionnaire (ERQ)
Time frame: Baseline
Emotional Regulation Questionnaire (ERQ)
Time frame: Post-treatment 6 weeks from baseline
Emotional Regulation Questionnaire (ERQ)
Time frame: Post-treatment 6 weeks from baseline
Emotional Regulation Questionnaire (ERQ)
Time frame: Six-months follow-up
Emotional Regulation Questionnaire (ERQ)
Time frame: Six-months follow-up
Maslach Burnout Inventory Student Survey (MBI-SS)
Time frame: Baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
Time frame: Baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
Time frame: Post-treatment 6 weeks from baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
Time frame: Post-treatment 6 weeks from baseline
Maslach Burnout Inventory Student Survey (MBI-SS)
Time frame: Six-months follow-up
Maslach Burnout Inventory Student Survey (MBI-SS)
Time frame: Six-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Derived from this study: PubMed 37691796Beltran-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment-based compassion therapy and Relaxation program in people with Mental Health Wellness, run by Hospital Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety and Stress Scale - 21 (DASS-21) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 4 Nov 2026.