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Psychosocial Blended Group Intervention RCT

NCT05867758 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-05-22

No results posted yet for this study

Summary

Extensive literature on social isolation and loneliness in young people points out that those conditions can negatively influence physical and psychological health, increasing the risks of loneliness-related health problems later in life. To date, especially after two years of the COVID-19 pandemic, the situation regarding loneliness and psychological frailties in young people has become even more urgent to address especially in populations at higher risks as for international students. This population in fact report to face greater social exclusion, discrimination, stigma, difficulties in cultural adaptation and more, compared to their peers, that can exacerbate loneliness and negatively impact on their psychological and physical health.

The pandemic delineated future directions for the development and implementation of digital interventions in the everyday clinical practice, many studies are starting to evaluate the efficacy and usability of blended (digital and in presence) psychological interventions within different populations. Thus, this study aims to assess the usability and efficacy of a blended psychosocial group intervention to tackle social isolation, loneliness and promoting well-being in this population.

Conditions

  • Social Isolation

Interventions

OTHER

Psychosocial group intervention

The psychosocial group intervention is composed of 8 weekly sessions of 90 minutes each and the receiving of self-help digital materials. Both organized as following: 2 on isolation, loneliness and social connection, 2 on well-being, 2 on the use of digital tools, 2 on the fostering of socialization with peers. To evaluate the effects of the blended intervention and of the two conditions we will ask participants to fulfill the following clinical questionnaires: ULS-6 (Russell et al. 1980), MSPSS (Zimet et al., 1988), GAD-7 (Spitzer et al., 2006), PHQ-9 (Kroenke, Spitzer \& Williams, 2001), SWLS (Diener et al., 1985), MLQ (Steger et al., 2006) before starting the intervention in presence and online (T0), at the end of that period (T1) and 2 months after (T2).

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Sabrina Cipolletta, PhD · University of Padova

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05867758 on ClinicalTrials.gov