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Well-Being, PsychologicalINSIGHTNCT06542029

Interventions for the Wellbeing of Students At the University of Helsinki

A study testing Groups 4 Health (G4H), The study psychologists' group intervention and Towards better well-being and studying -online course in people with Well-Being, Psychological, run by University of Helsinki at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Well-Being, Psychological
What is being tested?
Groups 4 Health (G4H), The study psychologists' group intervention and Towards better well-being and studying -online course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteFinland
Study dates
20 Mar 2022to 31 Jul 2026
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Finland1 site, 1 recruiting
  • University of Helsinki

    Helsinki, Uusimaa, 00014

    Jari M Lahti, PhD, 040 571 2297 ext. +358, jari.lahti@helsinki.fi

    Recruiting

Other trials in Finland

About this study

Official title: Groups 4 Health (Ryhmät Kuntoon) for Mental Well-being: a Feasibility and Controlled Effectiveness Study At the University of Helsinki

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.

Read more

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.

Read the detailed description

Groups for health (G4H) is a manualized brief intervention based on social identity theory aiming to improve mental well-being by promoting social connectedness and belonging as well as reducing loneliness by building the participants' social identity capital in the context of group experience.

The Effectiveness of the G4H intervention has been studied in two Australian randomized controlled trials (RCT) as well as in one Australian controlled experiment. The RCT studies showed that G4H decreased loneliness and social anxiety and increased group memberships significantly more than treatment as usual and that in comparison with cognitive-behavioral therapy (CBT), both interventions reduced loneliness as effectively in the beginning of the intervention period, but the G4H group showed continued reduction in loneliness at the end of the intervention period and in the follow-up. Both interventions reduced depressive symptoms significantly and there were no differences between G4H and CBT. In all three controlled studies on the effects of G4H, inclusion criteria for the study were low mood and loneliness.

At present research on the effectiveness of G4H outside Australia is lacking and the cost-effectiveness of the G4H intervention or determinants of intervention effectiveness have not been evaluated. Consequently, this study focuses on the feasibility, effectiveness, and cost-effectiveness of the G4H among the University of Helsinki (UH) students in Finland. Moreover, students will not be excluded based on lack of loneliness or symptoms of depression.

The participants are students at the UH who have either; A) applied for three brief interventions for students' well-being: "Ryhmät kuntoon" -course (G4H at the UH), groups facilitated by the study psychologists, or online course for students' well-being (active intervention groups), or B) students who are not attending to any active interventions for mental well-being or promotion of studying skills (no-intervention control group). The students will be recruited for the active intervention groups and no-intervention group by email, website, and social media advertisements circulated by the UH media and communications services, communications services at the faculties, student health services, and student organizations. The interventions will be organized at the UH and are free for the UH students.

Data on the outcome measures is collected before and during the intervention as well as in 1- and 3-months follow-ups. Appropriate statistical methods including linear mixed model analyses will be used to study the effectiveness of the G4H intervention.

In addition to the outcome measures, data on the participants' and facilitators' background will be collected. The participant background questionnaire is filled out before the intervention and it consists of information on age, gender, birth date, mother tongue, marital status, household composition, residential situation, employment status, education, income, subjective health, readiness to attend to the intervention, social support, academic skills, and situational intrinsic and extrinsic motivation. Data gathered from UH registries include information on study rights (faculty, degree programs, fields of study) and their starting years, on active and passive registration, completed degrees, and information on learning and studies, such as approaches to learning, experiences of the teaching-learning environment, stress, and experiences of study-related burnout during studies and work during studies (HowULearn and HowUStudy questionnaires). This data is gathered to account for these factors in the statistical analyses and to analyze if these factors influence the effectiveness and cost-effectiveness of the intervention.

To investigate how facilitators' individual professional and personal characteristics may predict intervention process and effectiveness, G4H facilitators will fill self-report measures both before and during the interventions. Before initiating the intervention, facilitators will fill questionnaires related to personality traits (Extra-Short Five questionnaire), attachment style (Experiences in Close Relationships -questionnaire), and self-experiences in close personal relationships (Trainee Background Information Form). After the week 3 session, the facilitators' experiences of their current skillfulness, difficulties, and emotions in group work is measured based on an abbreviated version of the self-reported Trainee Current Practice Report. In addition, the facilitators' experiences of the group working alliance will be surveyed, based on a modified version of the Therapist Working Alliance Inventory Short Form.

In the collection of the quantitative data, both paper-and-pencil and electronic versions of the questionnaires will be used. Those in the active intervention groups will fill in the data as part of the sessions during the interventions or in the frequency of the sessions if the questionnaires are provided electronically and those in the no-intervention group will fill-in the questionnaires based on the email reminders of the electronic data collection system (time interval between reminders resembling interval between sessions in the active intervention groups). Data is collected before the intervention, during the intervention (week 3), immediately after the intervention and in one- and three-months follow-ups.

In addition to the quantitative data collection the investigators will explore the challenges and possibilities identified in the G4H-intervention regarding inclusion and equality. Three methods of data collection are used: 1) participant observations, 2) interviews with G4H participants and facilitators and 3) focus groups with young people who belong to minorities. In this sub-study, the aim is to examine challenges and possibilities identified in the G4H-intervention regarding inclusion and equality and whether G4H promotes long-term inclusion and equality among the participants.

Participant observations are conducted in the meetings of the G4H group and interviews are conducted with a subset of facilitators and intervention participants in the end of the intervention period. The follow-up interviews will be conducted 6 months, 12 months and 3 years after the first interview. The facilitators and participants of G4H will be mailed information about the study and an informed consent will be acquired before the first session. The participant observation focuses on the interaction in the groups and the experiences of facilitators and participants, in order to gain knowledge about how the groups work, what kinds of issues they deal with and especially how inclusion and equality are accomplished in the groups (are there minority participants, can participants influence the themes dealt with in the groups, or is inclusion and equality taken into account in some other ways in the groups). Following the ethnographic research tradition, the researcher takes part in the activities of the groups instead of observing them from the outside. Depending on their preferences, the study participants (both facilitators and participants in the groups) will be interviewed in a group, in pairs or individually, in facilities located outside the university (for example in a study room of a local library).

In addition, focus groups are arranged with young people belonging to minority groups with increased risk of marginalization or mental health problems. In the focus groups, young people are asked to comment on the design/description of G4H in terms of equality and inclusion, with the goal of enhancing inclusivity by listening to their views on the interventions and accumulation knowledge on the fit between the interventions and their specific needs. The focus groups target young people belonging to sexual and/or gender minorities, young people with immigrant background and young people with disabilities. These groups represent youth minorities with a high risk of loneliness. To date, research on their experiences of different services is lacking. All the interviews will be tape-recorded and later transcribed.

Written informed consent is gathered from all participants. The participants who have given their consent have the option to withdraw from the study at any point. Students who are currently undergoing other (mental health) treatment will not be interviewed to avoid causing them further stress.

Being tested
Groups 4 Health (G4H), The study psychologists' group intervention, Towards better well-being and studying -online course
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
Medical subject headings
Psychological Well-Being, Social Isolation, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Groups 4 Health (G4H)Behavioural

    Also called Ryhmät kuntoon

    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.

  • The study psychologists' group interventionBehavioural

    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.

  • Towards better well-being and studying -online courseBehavioural

    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.

Study groups in NCT06542029
Study groupRoleWhat they receive
Groups 4 Health (G4H)ExperimentalGroups 4 Health (G4H, "Ryhmät kuntoon") intervention is administered in this arm.
Receives: Behavioral: Groups 4 Health (G4H)
The study psychologists' group interventionActive comparatorThe study psychologists' group intervention is administered in this arm.
Receives: Behavioral: The study psychologists' group intervention
Towards better well-being and studying -online courseActive comparatorOnline course for students' well-being and studying ("Kohti parempaa opiskelua") is administered in this arm.
Receives: Behavioral: Towards better well-being and studying -online course
No intervention control groupNo interventionThe no intervention control group consists of students who are not attending any active interventions for mental well-being or promotion of studying skills.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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

  2. 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).

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

Secondary outcomes (11)
  1. Active group memberships

    Multiple group memberships are assessed with the 4-item Exeter Identity Transition Scale (response options: 1 = strongly disagree, 7 = strongly agree, higher score means better outcome).

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

  2. Mental well-being

    Mental well-being is assessed with the 7-item Short Warwick-Edinburgh Mental Wellbeing Scale (response options: 1=not at all, 2=rarely, 3=occasionally, 4=often, 5=all the time, higher score means better outcome).

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

  3. General well-being

    General well-being is assessed with the 14-item General Population version of the Clinical Outcomes in Routine Evaluation (response options: 0=not at all, 1=only occasionally, 2=sometimes, 3=often, 4=most of/all of the time, lower score means better outcome).

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

  4. Anxiety

    Symptoms of anxiety are assessed with the 7-item Generalized Anxiety Disorder 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).

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

  5. Social anxiety

    Social anxiety is assessed with the 3-item Mini Social Phobia Inventory (response options: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day, lower score means better outcome).

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

  6. Health-related quality of life

    Health-related quality of life is measured with the Euro Quality of Life - 5 dimension - 5 level questionnaire (EQ-5D-5L). The measure has 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) comprising of five statements of which the respondent can choose the option that best describes their situation. Higher score means better outcome. This measure is used to calculate the cost-effectiveness of the interventions.

    Measured: 1) Before the intervention, 2) immediately after the intervention, 3) three months follow-up

  7. Use of social and health care services

    The use of social and health care services for mental health is measured with a self-report questionnaire (medications, health care appointments, hospitalization, counseling). The use of health care services will be monetarized by using Finnish national unit costs. This measure is used to calculate the cost-effectiveness of the interventions.

    Measured: 1) Before the intervention, 2) immediately after the intervention, 3) three months follow-up

  8. Time used by facilitators

    The time used for planning, executing, and assessing the G4H sessions is reported by the facilitators. This measure is used to calculate the cost-effectiveness of the interventions.

    Measured: Immediately after each intervention session, during 8 weeks

  9. Study credits

    Overall accumulated study credit data is gathered from the UH registries. These data will be used both as measures of effectiveness of the interventions and to account for the confounders in the statistical analyses.

    Measured: 1 year before the intervention, 1 year after the intervention

  10. Grade point average

    One year grade point average is gathered from the UH registries. These data will be used both as measures of effectiveness of the interventions and to account for the confounders in the statistical analyses.

    Measured: 1 year before the intervention, 1 year after the intervention

  11. Weighted grade point average

    Weighted grade point average is determined by the grades of each course weighted by the number of credits gained for it.

    Measured: 1 year before the intervention, 1 year after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2024
  2. Study start20 Mar 2022
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06542029
Sponsor's protocol ID
SRC 352700
Acronym
INSIGHT
Status last verified
Sep 2024
First submitted
2 Feb 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33687336
  • 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.

    PubMed 11668666
  • 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.

    PubMed 35049477
  • 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.

    PubMed 18924001
  • 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.

    PubMed 26828756
  • 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.

    PubMed 31403815
  • 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.

    PubMed 31621525
  • Hays RD, DiMatteo MR. A short-form measure of loneliness. J Pers Assess. 1987 Spring;51(1):69-81. doi: 10.1207/s15327752jpa5101_6.

    PubMed 3572711
  • 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.

    PubMed 35401345
  • 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.

    PubMed 28800630
  • 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.

    PubMed 11556941
  • 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.

    PubMed 28666244
  • 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.

    PubMed 23121468
  • 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.

    PubMed 16717171
  • 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.

    PubMed 17437384

Questions about this trial

What is this clinical trial studying?

A study testing Groups 4 Health (G4H), The study psychologists' group intervention and Towards better well-being and studying -online course in people with Well-Being, Psychological, run by University of Helsinki at 1 site in Finland.

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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Finland. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jari M Lahti, PhD (040 571 2297 ext. +358, jari.lahti@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loneliness (time frame: 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). The study lists 2 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 NCT06542029, which also lists 26 linked publications.

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 19 Sep 2024.

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