The Feasibility, Acceptability and Preliminary Efficacy of a Group Intervention Aimed at Reducing Social and Emotional Loneliness: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Weekly changes in social isolation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Weekly changes in social isolation
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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!").
次要结局
- 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.)
- 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.)
- 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))
研究者
Carmen van den Bulck
C.M.M. (Carmen) van den Bulck, MSc
University of Amsterdam