Psychosocial Blended Group Intervention RCT

NCT05867758 | Unknown

• 1 other identifier: 18-11-22
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

social isolation; international college students; loneliness; psychosocial group intervention; blended intervention

Outcome Measures

Primary Outcomes (9)

• Baseline before the group intervention (ULS-6)

  Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: Loneliness will be assessed with ULS-6, short-form UCLA Loneliness Scale

  the first week of intervention (T0)

• Baseline before the group intervention (MSPSS)

  Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: Perceived social support will be assessed with MSPSS, Multidimensional Scale of Perceived Social Support

  the first week of intervention (T0)

• Baseline before the group intervention (GAD-7)

  Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: General Anxiety will be assessed with GAD-7, General Anxiety Disorder-7

  the first week of intervention (T0)

• Baseline before the group intervention (PHQ-9)

  Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: General well-being will be assessed with PHQ-9, Patient Health Questionnaire-9

  the first week of intervention (T0)

• Baseline before the group intervention (SWLS)

  Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: Psychological well-being will be assessed with SWLS, Satisfaction With Life Scale

  the first week of intervention (T0)

• Baseline before the group intervention (MLQ)

  Participants of both groups (EG and CG) will fulfill the following measures to assess their baselines before the starting of the group intervention, objectives and clinical tools are the following: Perception of personal well-being will be assessed with MLQ, Meaning in Life Questionnaire

  the first week of intervention (T0)

• Post intervention effect (from baseline to the last week of intervention)

  Evaluation of change from the baseline (T0) to the last week of intervention (T1) in all the measures presented for (T0) baseline evaluation. Participants of both groups (EG and CG), at the end of the intervention (T1), will fulfill previously presented measures to assess changes from baseline (T0).

  the last week of the intervention (T1)

• Follow up intervention effect (from baseline to follow up)

  Evaluation of change from the baseline (T0) to the follow up measurement 2 months after the end of the intervention (T2) in all the measures presented for (T0) baseline evaluation. Participants of both groups (EG and CG), at the follow up measurement 2 months after the end of the intervention (T2), will fulfill previously presented measures to assess changes from baseline (T0).

  two months after the last week of the intervention (T2)

• Follow up intervention effect (from last week of intervention to follow up)

  Evaluation of change from the post intervention (T1) to the follow up measurement 2 months after the end of the intervention (T2) in all the measures presented for (T0) baseline evaluation. Participants of both groups (EG and CG), at the follow up measurement 2 months after the end of the intervention (T2), will fulfill previously presented measures to assess changes from post intervention (T1).

  two months after the last week of the intervention (T2)

Study Arms (2)

intervention group

EXPERIMENTAL

Group of participants (9 to 12) participating in the psychosocial group intervention (8 sessions, one per week) and receiving the self-help digital materials each week.

Other: Psychosocial group intervention

Control group - waiting list

NO INTERVENTION

Group of participants (9 to 12) receiving the self-help digital materials each week, who will take part in the psychosocial group intervention once the data collection will be over

Interventions

Psychosocial group intervention OTHER

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).

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years,
• being an international student enrolled to a full university course at the University of Padua
• living in Padua
• Being able to communicate in English

You may not qualify if:

• Participants were excluded if they were Erasmus students
• not resident in Padua at the time of the intervention
• not responding to the invitation to participate in the group activities

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

SCUP - Servizi Clinici Universitari Psicologici

Padua, PD, 35135, Italy

Location

Related Publications (7)

• Bu F, Steptoe A, Fancourt D. Who is lonely in lockdown? Cross-cohort analyses of predictors of loneliness before and during the COVID-19 pandemic. Public Health. 2020 Sep;186:31-34. doi: 10.1016/j.puhe.2020.06.036. Epub 2020 Aug 5.

  PMID: 32768621 BACKGROUND

• Cipolletta S, Gris F. Older People's Lived Perspectives of Social Isolation during the First Wave of the COVID-19 Pandemic in Italy. Int J Environ Res Public Health. 2021 Nov 11;18(22):11832. doi: 10.3390/ijerph182211832.

  PMID: 34831586 BACKGROUND

• Cipolletta, S., Mercurio, A., & Pezzetta, R. (2022). Perceived Social Support and Well-Being of International Students at an Italian University, Journal of International Students, 12(3). https://doi.org/10.32674/jis.v12i3.3954

  BACKGROUND

• Cuijpers P, Auerbach RP, Benjet C, Bruffaerts R, Ebert D, Karyotaki E, Kessler RC. The World Health Organization World Mental Health International College Student initiative: An overview. Int J Methods Psychiatr Res. 2019 Jun;28(2):e1761. doi: 10.1002/mpr.1761. Epub 2019 Jan 6.

  PMID: 30614123 BACKGROUND

• Haikalis M, Doucette H, Meisel MK, Birch K, Barnett NP. Changes in College Student Anxiety and Depression From Pre- to During-COVID-19: Perceived Stress, Academic Challenges, Loneliness, and Positive Perceptions. Emerg Adulthood. 2022 Apr;10(2):534-545. doi: 10.1177/21676968211058516.

  PMID: 35382515 BACKGROUND

• Karyotaki E, Cuijpers P, Albor Y, Alonso J, Auerbach RP, Bantjes J, Bruffaerts R, Ebert DD, Hasking P, Kiekens G, Lee S, McLafferty M, Mak A, Mortier P, Sampson NA, Stein DJ, Vilagut G, Kessler RC. Sources of Stress and Their Associations With Mental Disorders Among College Students: Results of the World Health Organization World Mental Health Surveys International College Student Initiative. Front Psychol. 2020 Jul 30;11:1759. doi: 10.3389/fpsyg.2020.01759. eCollection 2020.

  PMID: 32849042 BACKGROUND

• Song B, Zhao Y, Zhu J. COVID-19-related Traumatic Effects and Psychological Reactions among International Students. J Epidemiol Glob Health. 2021 Mar;11(1):117-123. doi: 10.2991/jegh.k.201016.001. Epub 2020 Oct 24.

  PMID: 33605116 BACKGROUND

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Sabrina Cipolletta, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial of a Group intervention with international college students

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: May 22, 2023
• Study Start: November 9, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: May 22, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)