Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06542029

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

Led by University of Helsinki · Updated on 2024-09-19

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Helsinki

Lead Sponsor

S

Strategic Research Council, Finland

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the feasibility, effectiveness, and cost-effectiveness of the Groups 4 Health (G4H) intervention among students at the University of Helsinki. G4H is a psychosocial group intervention designed to improve mental well-being by enhancing social connectedness and reducing loneliness. Previous studies in Australia showed G4H reduced loneliness and social anxiety and increased group memberships more than usual treatments and had sustained effects compared to cognitive behavioral therapy. This study also compares G4H to other active interventions and a no-intervention control group in Finland. The study includes four groups: the G4H group intervention consisting of five 90-minute sessions led by trained psychology students or psychologists; a group intervention facilitated by study psychologists focusing on study challenges and peer support; an online course promoting well-being and study skills over seven weeks based on Acceptance and Commitment Therapy; and a no-intervention control group. The interventions are free for University of Helsinki students and involve various session formats including face-to-face, remote, and online delivery. Participants complete questionnaires and provide registry data before, during, immediately after, and at one- and three-month follow-ups to assess loneliness, depression, group memberships, mental and general well-being, anxiety, social anxiety, quality of life, and use of social and health services. Facilitators' experiences and characteristics are also measured. Additionally, qualitative methods explore inclusion and equality issues within the G4H intervention through observations, interviews, and focus groups with minority youth. Participation may last up to three years for follow-up interviews.

CONDITIONS

Brief Title

Interventions for the Wellbeing of Students At the University of Helsinki

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (age 18 and above)
  • Student at the University of Helsinki, Finland
  • Able to speak or read Finnish, Swedish, or English
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or electronic)

Outpatient Treatment

Duration - 5 to 7 weeks depending on the intervention

Participants receive one of several group or online interventions focused on improving mental well-being, social connectedness, and study skills. These include the Groups 4 Health (G4H) intervention, study psychologists' group intervention, or an online course for well-being and studying.

Weekly group or online sessions (5 to 7 sessions)

Follow-up

Duration - 3 months

Participants complete follow-up assessments to monitor mental well-being and related outcomes at 1 and 3 months after the intervention ends. Participants in the no intervention group complete assessments at similar timepoints.

2 follow-up assessments via electronic questionnaires

Trial Site Locations

Total: 1 location

1

University of Helsinki

Helsinki, Uusimaa, Finland, 00014

Actively Recruiting

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Research Team

J

Jari M Lahti, PhD

S

Silja A Martikainen, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Published Research Related To This Trial

Development of a Web-Based Intervention Course to Promote Students' Well-Being and Studying in Universities: Protocol for an Experimental Study Design.

Henna Asikainen, Nina Katajavuori

https://pubmed.ncbi.nlm.nih.gov/33687336

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.

Tegan Cruwys, Catherine Haslam, Joanne A Rathbone...

https://pubmed.ncbi.nlm.nih.gov/35049477

Groups 4 Health: Evidence that a social-identity intervention that builds and strengthens social group membership improves mental health.

Catherine Haslam, Tegan Cruwys, S Alexander Haslam...

https://pubmed.ncbi.nlm.nih.gov/26828756

GROUPS 4 HEALTH reduces loneliness and social anxiety in adults with psychological distress: Findings from a randomized controlled trial.

Catherine Haslam, Tegan Cruwys, Melissa X-L Chang...

https://pubmed.ncbi.nlm.nih.gov/31403815

Psychometric evaluation of the Working Alliance Inventory-Therapist version: Current and new short forms.

Robert L Hatcher, Karin Lindqvist, Fredrik Falkenström

https://pubmed.ncbi.nlm.nih.gov/31621525

Measuring single constructs by single items: Constructing an even shorter version of the "Short Five" personality inventory.

Kenn Konstabel, Jan-Erik Lönnqvist, Sointu Leikas...

https://pubmed.ncbi.nlm.nih.gov/28800630