Description

This study is a randomized waitlist-controlled trial for investigating the efficacy and cost-efficacy of Groups 4 Health (G4H) brief psychosocial intervention for loneliness among the students at the University of Helsinki. Furthermore, several biological and psychosocial mechanisms that may exert the effects of psychosocial stress and therapeutic change are studied. In addition to various psychosocial factors, the mechanisms include genetic factors and epigenetic alterations, hypothalamic-pituitary axis (HPA) activity (cortisol), and parasympathetic (heart rate variability) and sympathetic (alpha amylase) function of the autonomic nervous system (ANS).

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.