The Feasibility, Acceptability and Preliminary Efficacy of a Group Intervention to Reduce Loneliness

Study Overview
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Brief Summary
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Severe loneliness is a large and growing clinical and societal problem. Although there are interventions for loneliness, elevated levels often remain. This pilot study evaluates the feasibility and acceptability of an intervention to alleviate social and emotional loneliness among students. The second aim is to obtain effect sizes that inform sample size calculations of a subsequent randomized controlled trial (RCT). The goal of this clinical trial is to learn about the feasibility and acceptability of a group intervention aimed at reducing social and emotional loneliness and social isolation in students. In addition, we want to obtain effect sizes that can inform the sample size calculation of a subsequent randomized controlled trial (RCT). The hypotheses are that: Participants after completing the intervention have reduced levels of social and emotional loneliness and social isolation compared to baseline (primary outcomes). Participants after completing the intervention have reduced levels of social anxiety, depressive symptoms, and better daily functioning compared to baseline (secondary outcomes). Before the group intervention starts, participants will first follow a baseline period, ranging between 1 and 7 weeks. The length of the baseline period is based on the date of enrolment and therefore not random. Following the baseline period, all participants will start in the group intervention. This intervention aims to encourage social behavioural activation tailored to the values of the participant and teach skills that make negative emotions and thoughts less bothersome and reduce feelings of loneliness. This intervention consists of seven weekly group sessions and a booster session. The intervention is offered in a group format to maximize possibilities for interpersonal therapeutic practice and is framed as a psycho-educational course to increase its acceptability. Data are collected at screening, pre-intervention, post-intervention, one-month follow-up and three-month follow-up, as well as during weekly measurements during the baseline period and the course period. Primary outcome measures are social and emotional loneliness and social isolation. Secondary outcome measures are social anxiety, depression, and daily functioning. Other outcome measures are interpersonal problems and assessment of the sessions. Participants will be recruited via posters at the University of Amsterdam.

Official Title
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The Feasibility, Acceptability and Preliminary Efficacy of a Group Intervention Aimed at Reducing Social and Emotional Loneliness: a Pilot Study

Conditions
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Loneliness, Social Isolation

Intervention / Treatment
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* Behavioral: Goal-Based Cognitive Behavioural Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Being at least 16 years old Exhibiting at least moderate levels of loneliness as assessed by the De Jong Gierveld Loneliness Scale 11-item version (DJGLS; de Jong-Gierveld & Kamphuls, 1985) Possessing sufficient proficiency in the English language. Exclusion criteria: - The presence of severe (psychiatric) problems that hinder participation in the study or require other forms of immediate care, as indicated by the Mini International Neuropsychiatric Interview 7.0.2 (MINI; Sheehan et al., 1998). If participants were already receiving psychological or pharmacological treatment for psychiatric problems, this treatment had to be temporarily interrupted for the duration of the study in consultation with the participant's clinician.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Before the intervention starts, participants will first follow a baseline period, ranging between 1 and 7 weeks. The length of the baseline period is based on the date of enrolment and therefore not random. Following the baseline period, all participants will start in the group intervention. Data are collected at screening, pre-intervention, post-intervention, one-month follow-up and three-month follow-up, as well as during weekly measurements during the waiting list period and the course.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal-Based Cognitive Behavioural Intervention<br>Participants start with a 1 to 7 weeks baseline period. The duration is based on the enrolment date and therefore not random. Afterward, all participants enter the intervention, which promotes social behavioural activation aligned with personal values and teaches skills that make negative emotions and thoughts less bothersome and reduce feelings of loneliness. The intervention comprises seven weekly sessions and a follow-up, conducted in a group format to facilitate interpersonal practice and is presented as a course for enhanced acceptability. Please note: The original design involved an RCT with a Goal-Based Cognitive Behavioral Intervention as the experimental arm and a waitlist arm. Participants in the waitlist arm would enter the intervention after a waitlist period. Due to limited enrollments, the design was modified to a single arm resembling the waitlist arm of the initial RCT design. | Behavioral: Goal-Based Cognitive Behavioural Intervention<br>* A goal-based cognitive behavioural intervention in a group format that addresses negative social cognitions and focuses on social approach processes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in social loneliness | Loneliness Scale (LS; de Jong Gierveld & van Tilburg, 1999). The 11-item Loneliness Scale was used to measure emotional and social loneliness. Participants score the items on a 5-point Likert scale (yes!, yes, more or less, no, no!). | Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. | 
| Weekly changes in social loneliness | Loneliness Scale (LS; de Jong Gierveld & van Tilburg, 2006) The 6-item Loneliness Scale was used to measure emotional and social loneliness. Participants score the items on a 5-point Likert scale (yes!, yes, more or less, no, no!). | Assessed in weekly measurements in the baseline period (up to 7 weeks before pretest) and in weekly measurements in the intervention period (up to 7 weeks after pretest) | 
| Changes in emotional loneliness | Measured by the Loneliness Scale (LS; de Jong Gierveld & van Tilburg, 1999). The 11-item Loneliness Scale was used to measure emotional and social loneliness. Participants score the items on a 5-point Likert scale (yes!, yes, more or less, no, no!). | Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. | 
| Weekly changes in emotional loneliness | Loneliness Scale (LS; de Jong Gierveld & van Tilburg, 2006) The 6-item Loneliness Scale was used to measure emotional and social loneliness. Participants score the items on a 5-point Likert scale (yes!, yes, more or less, no, no!). | Assessed in weekly measurements in the baseline period (up to 7 weeks before pretest) and in weekly measurements in the intervention period (up to 7 weeks after pretest) | 
| Changes in social isolation | Lubben Social Network Scale (LSNS; Lubben, 1998). The 12-item LSNS-R quantifies social isolation from family and friends. Participants score the items on a 6-point Likert scale. | Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. | 
| Weekly changes in social isolation | Lubben Social Network Scale (LSNS; Lubben, 2006). The 6-item LSNS quantifies social isolation from family and friends. Participants score the items on a 6-point Likert scale (0 ≥ 9 relatives/friends to 5 = no relatives/friends). | Assessed in weekly measurements in the baseline period (up to 7 weeks before pretest) and in weekly measurements in the intervention period (up to 7 weeks after pretest) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depressive symptoms | Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977). The 20-item CES-D was used to measure feelings of depression. Participants score the items on a 4-point scale, from Rarely or none of the time (Less than 1 Day) to Most or all of the time (5-7 days). | Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. | 
| Changes in social anxiety | Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998). The SIAS is a 20-item questionnaire to assess social anxiety symptoms, specifically from the perspective of the individual when engaging in social interactions. Items are rated on a 5-point Likert scale (0 = not at all, 4 = very much). | Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. | 
| Changes in daytime functioning | Daytime functioning (Hawkley et al.,2010) To measure daily functioning, the questionnaire 5-item questionnaire from Hawkley et al. (2010) rates the extent of sleepiness, exhaustion, liveliness, energy, and fatigue over the last seven days on a 5-point scale (Not at all to Very much). | Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month and three-month follow-up, in weekly measurements in baseline period and intervention period (up to 7 weeks before and after pretest respectively) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loneliness, Social Isolation