Physiological, Hormonal, and DNA-based Mechanisms of Psychosocial Stress and Therapeutic Effect
NCT ID: NCT07152652
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
148 participants
INTERVENTIONAL
2025-09-12
2028-12-31
Brief Summary
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1. Is the G4H intervention effective and cost-effective in supporting student well-being?
2. To what extent participants' physiological, hormonal, or molecular characteristics mediate the therapeutic effect of the G4H
3. To what extent participants' genotype moderates the effect of the G4H
4. To what extent facilitators' characteristics mediate or moderate the effect of the G4H
Data is collected from both the intervention participants and the facilitators.
The G4H facilitators will:
* 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.
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Detailed Description
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This trial will investigate:
1. The efficacy and cost-efficacy of the G4H in a wait-list randomized controlled trial (RCT)
2. To what extent participants' physiological, hormonal or molecular measures of ANS, cortisol, alpha amylase, and Deoxyribonucleic Acid methylation (DNAm) mediate the therapeutic effect of the G4H.
3. To what extent participants' genotype moderates the effects of the G4H.
4. To what extent facilitators' characteristics mediates or moderates the effect of the G4H.
The participants will be randomized to start the G4H immediately after randomization or after the waitlist-period of 19 weeks (7 weeks active G4H + 3 months follow-up). The G4H includes five facilitated group sessions and will be delivered over a 7-week period. Data is collected before, during, and after the intervention, as well as in 1-, 3-, and 12-month follow-ups. The waitlist control group does not provide 12-months follow-up data, as they receive the intervention after the 19 weeks waitlist-period.
METHODS:
The study's outcome measures are described in the outcome measures -section. In addition, the following measures are used to answer the research questions.
Experience Sampling Method (ESM):
ESM is used to measure frequent, real-time assessments of participants self-reported mood, and stress appraisals at multiple times throughout the day. ESM is applied to explore the variation and changes in participants daily subjective well-being and loneliness in concurrence with G4H group facilitators stress appraisals before and after facilitation of G4H sessions. The ESM data will be collected using General Data Protection Regulation compliant experience-sampling software program that runs on smartphones (e.g. m-Path).
The daily ESM protocol consists of a morning and evening prompts in which participants are asked to rate their momentarily affect, and daily satisfaction with life. In the morning prompt, participants are also asked to assess daily physiological correlates such as sleep, amount of caffeine, and alcohol consumption, and exercise during the last 24h.
Intervention participants are also asked to answer questions about momentarily appraisal of social company, and loneliness (see outcome measures). Facilitators' event-based sampling takes place before and after the group facilitation and consists of self-report on the appraisals and experiences related to situation with single items derived from widely used questionnaires.
Experiences related to the pre-group situation are assessed from the facilitators during the intervention with items related to momentarily affect: "When thinking about the upcoming group session I feel: calm; happy; determined; enthusiastic; tired; stressed; worried; anxious" (response options: 0 =not at all - 6 = very much), and expectations: "I have prepared well for the session; I trust in my ability to manage the upcoming group session; I expect the session to go well." (response options: 0 = strongly disagree - 6 = strongly agree). Experiences related to the post-group situation are assessed with items related to the group situation: "I feel that the group session went well; I felt competent in facilitating the session; I was present during the session; It was easy for me to feel compassion towards participants" (response options: 0 = strongly disagree - 6 = strongly agree).
Salivary cortisol and alpha amylase:
Saliva samples with Cortisol Salivette synthetic swabs (Sarsted) are collected for cortisol and alpha-amylase measurements from both the intervention participants (see outcomes) and facilitators. These samples are collected by placing a synthetic swab in mouth for 2 minutes and returning it to a plastic tube thereafter.
The cortisol and alpha-amylase samples are provided by the participating facilitators during the first, third, and last intervention sessions. The sampling times are -45, -10, 45, 90, 110, and 135 minutes from the start of the session (6 samples per session).
Covariates related to the stress measurements:
Information on the following potential covariates related to stress physiology is also collected from the intervention participants and facilitators on the same day as the saliva samples are given: situational stress, sleep, physical activity, smoking, alcohol and coffee consumption, menstrual cycle, medication, chronic illness.
Deoxyribonucleic Acid (DNA) measures:
Omnigene saliva Oragene OG-600 DNA (or equivalent) is used for the DNAm and genotype sampling. Both the intervention participants and the facilitators will provide these samples before and immediately after the intervention.
Autonomic nervous system functioning:
A self-developed bra-integrated solution is used to collect non-medical electrocardiogram (ECG)-signal and accelerometer data from the facilitators. Data is collected by wearing a bra during times, when user regularly would use it, but especially on days when there is activity of G4H study. ECG signal is analysed by time- and frequency-based Hearth rate variability analysis (HRV). Accelerometer data is used to estimate physical activity and used for control high movement effects on HRV. HRV is used to assess daily levels of sympathetic and parasympathetic function of the ANS and to estimate cognitive load effects of facilitating G4H sessions.
Participants' background:
Participants' background information is collected from the intervention participants as potential covariates: gender, birth date, mother tongue, marital status, household composition, residential situation, employment status, education, income, subjective financial situation, subjective health, subjective loneliness, subjective minority status and willingness to participate in the intervention and academic skills (4-item organized studying scale, from Learn -questionnaire).
Facilitators' characteristics:
Information is collected at pre-intervention on the facilitator's background (gender, birth date, marital status, household composition, residential situation, employment status, education, work experience, income, subjective financial situation), and professional (12-item Experiences in Close Relationships Short form) and individual (30-item Extra-Short Five -questionnaire) characteristics.
The facilitators will also answer questionnaires during the intervention on study burnout risk (9-item Study Burnout Inventory, at pre-intervention and last session), perceived stress (10-item Perceived Stress Scale, at pre-intervention, 3rd, and last session), self and other compassion (4-item Process Based Assessment Tool, at pre-intervention, 3rd, and last session), and self-assessed skillfulness, difficulties, and feelings (36-item Therapist Work Involvement Scales, at 3rd and last session) as potential mediators or moderators of the intervention's effectiveness.
SAMPLE SIZE AND ANALYSES:
The minimum sample size is 148 intervention participants. Appropriate statistical methods including linear mixed model analyses will be used to study the effectiveness of the G4H intervention and the mediating and moderating factors. Appropriate imputation methods such as multiple imputation by chained equations will be used if necessary.
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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Groups 4 Health Intervention
This group will receive the G4H intervention immediately after randomization
Groups 4 health
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.
Waitlist Control Group
This group will receive the G4H intervention after the 19 weeks waitlist period
No interventions assigned to this group
Interventions
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Groups 4 health
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Student in the University of Helsinki, Finland
* Able to speak/read Finnish, Swedish, or English
Exclusion Criteria
18 Months
ALL
Yes
Sponsors
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Strategic Research Council, Finland
UNKNOWN
University of Eastern Finland
OTHER
Finnish Institute for Health and Welfare
OTHER_GOV
Finnish Cultural Foundation
OTHER
University of Helsinki
OTHER
Responsible Party
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Jari Lahti
Professor
Locations
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University of Helsinki
Helsinki, Uusimaa, Finland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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60/2025
Identifier Type: -
Identifier Source: org_study_id
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