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临床试验/NCT03839966
NCT03839966已完成不适用

Computerized Intervention for Loneliness

Florida State University2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2019年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
2
主要终点
UCLA Loneliness Scale (ULS)

研究概览

简要总结

This study assesses whether a month long computerized interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment.

详细描述

This study hopes to assess whether a month long interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment. Participants will be randomized into an active treatment condition or a control treatment that involves a healthy living and relaxation protocol. The investigators hypothesize that participants in the IBM condition will have lower levels of negative interpretation bias and loneliness than those in the healthy habits condition at post treatment and follow up. The investigators further hypothesize that the effects of IBM on loneliness will be accounted for by changes in interpretation bias.

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
Single (Participant)

盲法说明

Participants will not know if they are receiving the active or control treatment.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Score of >48 on the UCLA Loneliness Scale

排除标准

  • Concurrent psychotherapy for social anxiety or depression
  • Unstable psychotropic medication status (i.e. a change within the last month)
  • History of psychotic or (hypo)manic symptoms
  • Alcohol or other substance abuse or dependence within the last three months
  • Previous participation in a similar IBM study

结局指标

主要结局

UCLA Loneliness Scale (ULS)

时间窗: Change in loneliness from baseline to post treatment (4weeks) and three month follow up (16 weeks)

A 20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.

次要结局

  • Center for Epidemiological Studies Depression Scale (CES-D)(Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks))
  • Interpretations Questionnaire- Social Subscale (IQ-S)(Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks))
  • Multidimensional Scale of Perceived Social Support(Change in Perceived Social Support from baseline to post treatment (4weeks) and three month follow up (16 weeks))
  • State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)(Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks))
  • Social Phobia inventory(Change in social anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks))
  • Interpersonal Needs Questionnaire (INQ)(Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesse Cougle

Associate Professor

Florida State University

研究点 (2)

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