Physiological, Hormonal, and DNA-based Mechanisms of Psychosocial Stress and Therapeutic Effect

NCT07152652 | Recruiting

• 1 other identifier: 60/2025
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to learn if the Groups 4 Health (G4H) intervention is effective in supporting student well-being at the University of Helsinki. It will also learn about the factors that may influence the efficacy of the intervention (such as facilitators characteristics, stress physiology and changes in gene expression). The main questions it aims to answer are:

• Facilitate the G4H intervention.
• Fill in questionnaires and provide physiological and molecular measurements before, during, and after the G4H intervention. The G4H participants will:
• Participate in the G4H intervention.
• Fill in questionnaires and provide physiological, hormonal and molecular measurements before, during, and after the G4H intervention.

Conditions

Well-Being, Psychological; Loneliness

Keywords

University Students; Group Intervention; Mental Health; Loneliness; Social Isolation; Anxiety; Depression; Social Anxiety; Social Cohesion; Groups 4 Health; Stress system functioning; Genetics; Epigenetics; Experience Sampling Method; Stress physiology

Outcome Measures

Primary Outcomes (7)

• 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, 6) 12 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, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up

• 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).

  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, 6) 12-months follow-up

• 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).

  1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up

• 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).

  1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up

• 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).

  1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up

• 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).

  1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up

Secondary Outcomes (16)

• Perceived Stress

  1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up

• Self- and other-compassion

  1) Before the intervention, 2) immediately after the intervention 3) one month follow-up, 4) three months follow-up, 5) 12-months follow-up

• Health-related quality of life

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

• Use of social and health care services

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

• Time used by facilitators

  Immediately after each intervention session, during 8 weeks

Other Outcomes (12)

• 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, 6) 12-months follow-up

• Identification with the intervention

  During intervention (week 3)

• Participant adherence

  Immediately after each intervention session, during 8 weeks

Study Arms (2)

Groups 4 Health Intervention

EXPERIMENTAL

This group will receive the G4H intervention immediately after randomization

Behavioral: Groups 4 health

Waitlist Control Group

NO INTERVENTION

This group will receive the G4H intervention after the 19 weeks waitlist period

Interventions

Groups 4 health BEHAVIORAL

Groups 4 Health (G4H) 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 master's 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 European Credit Transfer and Accumulation System (ECTS) credits for completing the intervention.

Also known as: G4H, Ryhmät kuntoon

Groups 4 Health Intervention

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), 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
• Finnish Cultural Foundation: collaborator

Study Sites (1)

University of Helsinki

Helsinki, Uusimaa, 00014, Finland

RECRUITING

Related Publications (4)

• 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

• 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, 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

• 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

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jari Lahti, PhD

CONTACT

040 571 2297; jari.lahti@helsinki.fi

Study Design

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

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)