NCT07147712

Brief Summary

This study evaluates the impact of a psychological group intervention aimed at promoting well-being and social connectedness among university students. The intervention is part of the UNIST-HEALTH (PRO-BEN) initiative and targets students enrolled at the University of Padua. Participants will be randomly assigned to either an intervention group or a waitlist control group. The intervention consists of six weekly group sessions focused on psychoeducation and experiential activities designed to enhance the quality of social relationships, reduce loneliness, and improve psychological well-being. Assessments will be conducted at baseline, post-intervention, and at a four-week follow-up.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 29, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

July 18, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

university studentswell beingsocial relationshipssocialization

Outcome Measures

Primary Outcomes (4)

  • Between group differences (experimental vs control group) in wellbeing levels

    Psychological Well-Being Scale (PWS; min=18, max=108; higher scores indicate greater wellbeing)

    baseline, 6-weeks, 4-weeks follow-up

  • Between group differences (experimental vs control group) in loneliness levels

    UCLA Loneliness Scale - 3-item version (min=3, max=9; higher scores indicate higher levels of loneliness)

    baseline, 6-weeks, 4-weeks follow-up

  • Adherence to the intervention

    Participants' attendance rates to the sessions

    6-weeks, 4-weeks follow-up

  • Acceptability of the intervention

    Participants' rates to the satisfaction questionnaire, developed ad hoc for the present study (min=8, max= 56; higher scores indicate higher satisfaction)

    6-weeks

Secondary Outcomes (2)

  • Between group differences (experimental vs control group) in symptoms of anxiety

    baseline, 6-weeks, 4-weeks follow-up

  • Between group differences (experimental vs control group) in symptoms of depression

    baseline, 6-weeks, 4-weeks follow-up

Study Arms (2)

Experimental - Psychological Group Intervention

EXPERIMENTAL

Intervention Group (receives the program immediately)

Behavioral: Psychological Group Intervention

Control group - waitlist

NO INTERVENTION

Participants in the waitlist control group will not take part in the intervention during the initial phase of the study. They will complete all assessments at the same time points as the experimental group (pre, post, and follow-up) and will be offered the same 6-session intervention after the follow-up data collection is complete.

Interventions

6-session psychological group intervention, delivered once per week over six weeks. The intervention is designed to promote well-being and improve the quality of social relationships. It includes psychoeducational content, experiential exercises, and guided group discussions focused on emotional expression, social connection, and mutual support. A follow-up session will be offered after 4 weeks. Sessions will be led by trained psychologists and conducted in a university setting.

Experimental - Psychological Group Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • University students regularly enrolled at the University of Padua
  • Aged 18 years or older
  • Able to understand and complete the questionnaires in Italian or English
  • Residing in Padova or its province during the study period
  • Providing informed consent for participation

You may not qualify if:

  • Presence of severe psychological conditions requiring immediate or specialized clinical care, as identified during the initial screening interview
  • Inability or unavailability to attend group sessions for the full 6-week duration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi di Padova

Padua, Padova, 35131, Italy

RECRUITING

Related Publications (1)

  • Cipolletta S, Tedoldi I, Tomaino SCM. A blended group intervention to promote social connectedness and wellbeing among international university students: an exploratory study. Front Psychol. 2024 Nov 27;15:1497544. doi: 10.3389/fpsyg.2024.1497544. eCollection 2024.

    PMID: 39664633BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Central Study Contacts

Sabrina Cipolletta, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will use a randomized controlled design to test the impact of a brief psychological group intervention on university students' psychological well-being and social connectedness. Participants will be randomly assigned to either the intervention group (immediate participation in the 6-session program) or the control group (waitlist, intervention after follow-up).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2025

First Posted

August 29, 2025

Study Start

May 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

August 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

A plan will be established by the research team for data sharing following publication of the first manuscript

Locations