Interventions for the Wellbeing of Students At the University of Helsinki

NCT06542029 | Recruiting

• 1 other identifier: SRC 352700
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The psychological, social, and health consequences of psychological ill-being, particularly loneliness, are well-documented among students, which underlines the importance of providing adequate support. Groups 4 Health (G4H) is a promising psychosocial group intervention focused on improving well-being by supporting social connectedness and belonging. In earlier Australian studies G4H has decreased loneliness and social anxiety and increased group memberships significantly more than treatment as usual. When compared to cognitive behavioral therapy G4H has showed continued reduction in the participants' loneliness at the end of the intervention period and in the follow-up. Research on the G4H intervention's effectiveness outside Australia and research on the intervention's cost-effectiveness is lacking. Therefore, this clinical study investigates the feasibility, effectiveness, and cost-effectiveness of the G4H among the University of Helsinki students in Finland. The effectiveness and cost-effectiveness of the G4H will be compared to two other active intervention groups: the well-being groups facilitated by the study psychologists at the University of Helsinki and an online course for students' well-being. Effectiveness will also be compared to students who do not participate in any well-being courses or interventions. The investigators hypothesize that all the active intervention groups promote student well-being. Questionnaires and University of Helsinki registry data will be gathered before and after the interventions to evaluate the effectiveness and cost-effectiveness of the interventions. The factors that influence the intervention's effectiveness and cost-effectiveness will also be studied. In addition to these research questions, qualitative methods are used to explore the challenges and possibilities identified in the G4H-intervention regarding inclusion and equality.

Conditions

Well-Being, Psychological

Keywords

University Students; Group Intervention; Mental Health; Loneliness; Social Isolation; Anxiety; Depression; Social Anxiety; Social Cohesion; Equality; Inclusion; Motivation; Controlled study; Groups 4 Health; Adherence; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (2)

• Loneliness

  Loneliness is measured with the 4 and 8-item short forms of the revised University of California, Los Angeles Loneliness Scale (ULS-4 and ULS-8, response options: 1=never, 2=rarely, 3=sometimes, 4=often, lower score means better outcome).

  1) Before the intervention, 2) During the intervention (week 3), 3) immediately after the intervention, 4) one month follow-up, 5) three months follow-up

• Depression

  Symptoms of depression are assessed with the 9-item Patient Health Questionnaire (response options: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day, lower score means better outcome).

  1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up

Secondary Outcomes (11)

• Active group memberships

  1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up

• Mental well-being

  1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up

• General well-being

  1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up

• Anxiety

  1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-up

• Social anxiety

  1) Before the intervention, 3) immediately after the intervention 4) one month follow-up, 5) three months follow-u

Other Outcomes (6)

• Mood

  1) Before the intervention, 2) During the intervention (week 3), 3) immediately after the intervention, 4) one month follow-up, 5) three months follow-up

• Identification with the intervention

  During intervention (week 3)

• Participant adherence

  Immediately after each intervention session, during 8 weeks

Study Arms (4)

Groups 4 Health (G4H)

EXPERIMENTAL

Groups 4 Health (G4H, "Ryhmät kuntoon") intervention is administered in this arm.

Behavioral: Groups 4 Health (G4H)

The study psychologists' group intervention

ACTIVE COMPARATOR

The study psychologists' group intervention is administered in this arm.

Behavioral: The study psychologists' group intervention

Towards better well-being and studying -online course

ACTIVE COMPARATOR

Online course for students' well-being and studying ("Kohti parempaa opiskelua") is administered in this arm.

Behavioral: Towards better well-being and studying -online course

No intervention control group

NO INTERVENTION

The no intervention control group consists of students who are not attending any active interventions for mental well-being or promotion of studying skills.

Interventions

Groups 4 Health (G4H) BEHAVIORAL

Groups 4 Health, G4H, ("Ryhmät kuntoon") at the University of Helsinki is a manualized group intervention for the students that focuses on social connectedness and aims at improving general health and life satisfaction. G4H groups are facilitated by two psychology MA students (or licensed psychologists) carefully trained for the intervention and mentored by experienced clinical psychologists. G4H consists of five 90 minutes sessions that aim to give participants the knowledge and skills they need to effectively manage their social group memberships and identities. Each session contains exercises and discussions described in the G4H workbook that target different aspects of group life identified within the social identity model of identity change and put the Social Identity Approach to Health -model to practice. Students earn 2 ECTS (European Credit Transfer and Accumulation System) credits for completing the intervention.

Also known as: Ryhmät kuntoon

Groups 4 Health (G4H)

The study psychologists' group intervention BEHAVIORAL

University of Helsinki study psychology team organizes group interventions for various challenges of studying for bachelor's and master's students. These groups offer client-centered peer support facilitated by one to two study psychologists. Recurring themes in the groups include: challenges in attentiveness, independent studying, and scientific writing, as well as support for re-entering the studies after a break. The approach in the different thematic groups is largely similar: short presentations, group discussions and practices. These groups have been implemented as both face-to-face and remote meetings. One group typically lasts for a study period and comprises five to six 90 minutes sessions. Typical group size is six to 12 students.

The study psychologists' group intervention

Towards better well-being and studying -online course BEHAVIORAL

Towards better well-being and studying -online course ("Kohti parempaa opiskelua") is an optional, seven-week online course that aims to foster university students' well-being and study skills. It is available for all University of Helsinki students. The course is based on principles of Acceptance and Commitment therapy and aims to support the development of psychological flexibility. The course takes place in Moodle platform and the students earn 3 ECTS credits for completing it. This course progresses week by week and has six central themes which include individual work in practicing psychological flexibility skills as well as study skills on a weekly basis and weekly group discussion.

Towards better well-being and studying -online course

Eligibility Criteria

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

You may qualify if:

• Adult (age 18 and above)
• Student in the University of Helsinki, Finland
• Able to speak/read Finnish, Swedish, or English

You may not qualify if:

• \- None

Sponsors & Collaborators

• University of Helsinki: lead
• Strategic Research Council, Finland: collaborator
• University of Eastern Finland: collaborator
• Finnish Institute for Health and Welfare: collaborator

Study Sites (1)

University of Helsinki

Helsinki, Uusimaa, 00014, Finland

RECRUITING

Related Publications (25)

• Asikainen H, Katajavuori N. Development of a Web-Based Intervention Course to Promote Students' Well-Being and Studying in Universities: Protocol for an Experimental Study Design. JMIR Res Protoc. 2021 Mar 9;10(3):e23613. doi: 10.2196/23613.

  PMID: 33687336 BACKGROUND

• Connor KM, Kobak KA, Churchill LE, Katzelnick D, Davidson JR. Mini-SPIN: A brief screening assessment for generalized social anxiety disorder. Depress Anxiety. 2001;14(2):137-40. doi: 10.1002/da.1055.

  PMID: 11668666 BACKGROUND

• Cruwys T, Haslam C, Rathbone JA, Williams E, Haslam SA, Walter ZC. Groups 4 Health versus cognitive-behavioural therapy for depression and loneliness in young people: randomised phase 3 non-inferiority trial with 12-month follow-up. Br J Psychiatry. 2022 Mar;220(3):140-147. doi: 10.1192/bjp.2021.128.

  PMID: 35049477 BACKGROUND

• Haslam C, Holme A, Haslam SA, Iyer A, Jetten J, Williams WH. Maintaining group memberships: social identity continuity predicts well-being after stroke. Neuropsychol Rehabil. 2008 Oct-Dec;18(5-6):671-91. doi: 10.1080/09602010701643449.

  PMID: 18924001 BACKGROUND

• Haslam C, Cruwys T, Haslam SA, Dingle G, Chang MX. Groups 4 Health: Evidence that a social-identity intervention that builds and strengthens social group membership improves mental health. J Affect Disord. 2016 Apr;194:188-95. doi: 10.1016/j.jad.2016.01.010. Epub 2016 Jan 21.

  PMID: 26828756 BACKGROUND

• Haslam C, Cruwys T, Chang MX, Bentley SV, Haslam SA, Dingle GA, Jetten J. GROUPS 4 HEALTH reduces loneliness and social anxiety in adults with psychological distress: Findings from a randomized controlled trial. J Consult Clin Psychol. 2019 Sep;87(9):787-801. doi: 10.1037/ccp0000427.

  PMID: 31403815 BACKGROUND

• Hatcher RL, Lindqvist K, Falkenstrom F. Psychometric evaluation of the Working Alliance Inventory-Therapist version: Current and new short forms. Psychother Res. 2020 Jul;30(6):706-717. doi: 10.1080/10503307.2019.1677964. Epub 2019 Oct 17.

  PMID: 31621525 BACKGROUND

• Hays RD, DiMatteo MR. A short-form measure of loneliness. J Pers Assess. 1987 Spring;51(1):69-81. doi: 10.1207/s15327752jpa5101_6.

  PMID: 3572711 BACKGROUND

• Heinonen E, Orlinsky DE, Willutzki U, Ronnestad MH, Schroder T, Messina I, Loffler-Stastka H, Hartmann A. Psychotherapist Trainees' Quality of Life: Patterns and Correlates. Front Psychol. 2022 Mar 24;13:864691. doi: 10.3389/fpsyg.2022.864691. eCollection 2022.

  PMID: 35401345 BACKGROUND

• Konstabel K, Lonnqvist JE, Leikas S, Garcia Velazquez R, Qin H, Verkasalo M, Walkowitz G. Measuring single constructs by single items: Constructing an even shorter version of the "Short Five" personality inventory. PLoS One. 2017 Aug 11;12(8):e0182714. doi: 10.1371/journal.pone.0182714. eCollection 2017.

  PMID: 28800630 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• McKay MT, Andretta JR. Evidence for the Psychometric Validity, Internal Consistency and Measurement Invariance of Warwick Edinburgh Mental Well-being Scale Scores in Scottish and Irish Adolescents. Psychiatry Res. 2017 Sep;255:382-386. doi: 10.1016/j.psychres.2017.06.071. Epub 2017 Jun 21.

  PMID: 28666244 BACKGROUND

• Postmes T, Haslam SA, Jans L. A single-item measure of social identification: reliability, validity, and utility. Br J Soc Psychol. 2013 Dec;52(4):597-617. doi: 10.1111/bjso.12006. Epub 2012 Nov 4.

  PMID: 23121468 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Wei M, Russell DW, Mallinckrodt B, Vogel DL. The Experiences in Close Relationship Scale (ECR)-short form: reliability, validity, and factor structure. J Pers Assess. 2007 Apr;88(2):187-204. doi: 10.1080/00223890701268041.

  PMID: 17437384 BACKGROUND

• Evans C, Connell J, Audin K, Sinclair A, Barkham M. Rationale and development of a general population well-being measure: Psychometric status of the GP-CORE in a student sample. Br J Guid Counc. 2005;33(2):153-73

  BACKGROUND

• Guay F, Vallerand RJ, Blanchard C. On the assessment of situational intrinsic and extrinsic motivation: The Situational Motivation Scale (SIMS). Motiv Emot. 2000;24:175-213.

  BACKGROUND

• Haslam C, Jetten J, Cruwys T, Dingle G, Haslam SA. The new psychology of health: Unlocking the social cure. Routledge; 2018.

  BACKGROUND

• Hatcher RL, Gillaspy JA. Development and validation of a revised short version of the Working Alliance Inventory. Psychotherapy research. 2006;16(1):12-25.

  BACKGROUND

• Iyer A, Jetten J, Tsivrikos D. Torn Between Identities: Predictors of Adjustment to Identity Change Self Continuity: Individual And Collective Perspectives. Psychology Press, New York, NY, US; 2008.

  BACKGROUND

• Orlinsky DE, Strauss B, Rønnestad MH, Hill C, Castonguay L, Willutzki U, et al. A collaborative study of development in psychotherapy trainees. Psychotherapy Bulletin. 2015;50(4):21-5.

  BACKGROUND

• Parpala A, Lindblom-Ylänne S. Using a research instrument for developing quality at the university. Quality in Higher Education. 2012;18(3):313-28.

  BACKGROUND

• Sarason IG, Sarason BR, Shearin EN, Pierce GR. A brief measure of social support: Practical and theoretical implications. J Soc Pers Relat. 1987;4(4):497-510.

  BACKGROUND

• Roberts RE, Lewinsohn PM, Seeley JR. A brief measure of loneliness suitable for use with adolescents. Psychol Rep. 1993 Jun;72(3 Pt 2):1379-91. doi: 10.2466/pr0.1993.72.3c.1379.

  PMID: 8337350 BACKGROUND

• Russell D, Peplau LA, Cutrona CE. The revised UCLA Loneliness Scale: concurrent and discriminant validity evidence. J Pers Soc Psychol. 1980 Sep;39(3):472-80. doi: 10.1037//0022-3514.39.3.472.

  PMID: 7431205 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Social Isolation; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Social Behavior; Mental Disorders; Behavioral Symptoms

Study Officials

• Jari M Lahti, PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jari M Lahti, PhD

CONTACT

040 571 2297; jari.lahti@helsinki.fi

Silja A Martikainen, PhD

CONTACT

044 353 1984; silja.martikainen@helsinki.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a parallel-arm non-randomized controlled clinical trial. The participants are assigned to the different intervention arms based on their preference (the students can sign up for an intervention of their choosing).

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: August 7, 2024
• Study Start: March 20, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)