The Feasibility, Acceptability and Preliminary Efficacy of a Group Intervention to Reduce Loneliness
- Conditions
- LonelinessSocial Isolation
- Interventions
- Behavioral: Goal-Based Cognitive Behavioural Intervention
- Registration Number
- NCT05831813
- Lead Sponsor
- University of Amsterdam
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Goal-Based Cognitive Behavioural Intervention Goal-Based Cognitive Behavioural Intervention 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.
- Primary Outcome Measures
Name Time Method Weekly changes in social isolation 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) 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).
Changes in social loneliness Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. 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!").
Weekly changes in social loneliness 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) 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!").
Changes in social isolation Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. 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.
Changes in emotional loneliness Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. 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!").
Weekly changes in emotional loneliness 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) 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!").
- Secondary Outcome Measures
Name Time Method Changes in depressive symptoms Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. 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)".
Changes in social anxiety Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up. 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).
Changes in daytime functioning 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) 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").
Trial Locations
- Locations (1)
University of Amsterdam
🇳🇱Amsterdam, Noord Holland, Netherlands