Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542029
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-02
Brief Title:
Interventions for the Wellbeing of Students At the University of Helsinki
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Groups 4 Health Ryhmät Kuntoon for Mental Well-being a Feasibility and Controlled Effectiveness Study At the University of Helsinki
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSIGHT
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 interventions effectiveness outside Australia and research on the interventions 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 interventions 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
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 interventions effectiveness outside Australia and research on the interventions 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 interventions 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
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 designdescription 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 andor 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
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 designdescription 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None