A Randomized Controlled Trial to Evaluate the Efficacy of Two Internet-based Self-help Interventions for Loneliness.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Loneliness
研究概览
简要总结
In this study, people who suffer from loneliness will be randomized to three study conditions. The first and second group get an account to an internet-based self-help intervention. The first group also receives weekly feedback from a coach and the second group receives an automated email on a weekly basis. The third group is a waiting control group. In all three conditions additional care or treatment is allowed. The aim of the study is to investigate the efficacy of an internet-based self-help intervention to reduce feelings of loneliness compared to a waiting list and the effect of support during the intervention. Assessments are at baseline, 5-week, 10-week, 6-months and 12-months post-randomization. Participants in the waiting control group get also access to the intervention and fill out questionnaires at baseline, 5-week and 10-week post-randomization and get also access to the intervention 10 weeks after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sumscore ≥ 18 on the UCLA Loneliness Scale
- •Signed Informed Consent
- •Contact information provided in case of emergency
- •Internet connection and device to use it (Smartphone, Computer, Tablet)
- •Fluent in german language
排除标准
- •Acute suicidality
- •A current diagnose of substance dependence, a current or previous diagnose of psychotic disorder or bipolar disorder
- •A current diagnosis of severe depression (PHQ-9 > 14)
研究组 & 干预措施
Internet-based self-help + weekly feedback by a coach
Internet-based self-help on the basis of CBT-interventions, mindfulness and self-compassion to address cognitions, emotions and behavior related to loneliness. The self-help program consists of nine text, audio and video-based sessions, various exercises (e.g., breathing meditation, diaries) and tasks. Participants receive weekly feedback by a coach.
干预措施: SOLUS-D + weekly feedback by a coach (Other)
Internet-based self-help + weekly automated messages
Internet-based self-help on the basis of CBT-interventions, mindfulness and self-compassion to address cognitions, emotions and behavior related to loneliness. The self-help program consists of nine text-, audio- and video-based sessions, various exercises (e.g., breathing meditation, diaries) and tasks. Participants receive weekly automated messages in order to increase motivation.
干预措施: SOLUS-D + weekly automated messages (Other)
Waiting control group
结局指标
主要结局
Loneliness
时间窗: 10-week
Measured with the UCLA Loneliness Scale, 9-Item Version (UCLA-9). Total score ranging from 1-4 (representing the mean score of all 9 items). Lower scores represent less loneliness and a more favourable outcome.
次要结局
- Misanthropy(Baseline, 10-week, 6-months, 12-months)
- Depressive Symptoms(Baseline, 5-week, 10-week, 6-months, 12-months)
- Interpretation and Judgmental Bias(Baseline, 5-week, 10-week, 6-months, 12-months)
- Behavioral-social Avoidance(Baseline, 5-week, 10-week, 6-months, 12-months)
- System Usability(10-week)
- Satisfaction with Life(Baseline, 5-week, 10-week, 6-months, 12-months)
- Rejection Sensitivity(Baseline, 5-week, 10-week, 6-months, 12-months)
- Negative Effects(10-week)
- Self-Stigma in Loneliness(Baseline, 10-week, 6-months, 12-months)
- Social Interaction Anxiety(Baseline, 10-week, 6-months, 12-months)
- Self-Compassion(Baseline, 10-week, 6-months, 12-months)
- Diagnostic Interview for Mental Disorders, short-version (Mini-DIPS)(Baseline, 6-months)
- Authenticity(Baseline, 5-week, 10-week, 6-months, 12-months)
- Social Network(Baseline, 10-week, 6-months, 12-months)
- Distress Disclosure(Baseline, 5-week, 10-week, 6-months, 12-months)
- Client Satisfaction(10-week)
- Self-esteem(Baseline, 10-week)
- Self-determined motivation for solitude(Baseline, 10-week)
- Social Phobia(Baseline, 10-week, 6-months, 12-months)