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临床试验/NCT06222346
NCT06222346已完成不适用

Online Peer Support in Long-term Conditions: a Feasibility Randomised Controlled Trial

King's College London1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Incidence of probable Major Depressive Disorder (MDD)

研究概览

简要总结

Over 15 million people in England live with a long-term physical health condition. Low mood, loneliness and worry related to chronic illness are very common. In partnership with people with long-term conditions we have co-designed an online peer support platform to help people with health problems connect, support others, share experiences, and receive evidence-based information and advice on self-management.

This study explores if the platform is feasible to implement and acceptable for people with long-term conditions experiencing mild depressive symptoms. Those allocated to the intervention arm will be invited to try out an online peer support platform with psychoeducational resources named "CommonGround". Those in the control arm will be guided to use the National Health Service NHS "Mental Health" webpages.

详细描述

Approximately 20% of people with a long-term conditions (LTC) experience subthreshold depression (SUBD), which is also a key risk factor for developing more significant depression. There is currently no targeted psychological support for people with LTC also experiencing SUBD. This work offers a potentially novel way of addressing this gap through the delivery of an online peer support and psychoeducation platform. This project builds on previously funded work, which has enabled the co-production of a platform curated through cross-collaborations of people with LTC, clinicians, academics, and web design experts.

Study Design:

This is a mixed method, two-arm, parallel group, unblinded randomised controlled feasibility trial, with nested qualitative interviews evaluating participant experiences.

Population, Study Setting and Recruitment:

People living with long-term conditions who are experiencing subthreshold depression will take part in the randomised controlled trial. All participants will be recruited in the United Kingdom by King's College London (KCL). Both treatment arms will be delivered online. Participants will be randomly allocated to receive either the intervention (peer support and psychoeducation platform) or a control condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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
否

入选标准

  • •Probable SUBD (scoring 5-9 on the PHQ-8).
  • •Currently living with one or more LTCs. A long-term condition is a diagnosed physical medical condition with a duration of ≥6 months that demonstrates recurrence or deterioration and is typically associated with a poor prognosis. There are no restrictions on the type of LTCs. Please see list below.
  • •Aged ≥18 years old.
  • •Access to the internet (via phone, desktop, or laptop).
  • •Sufficient English to engage with the platform (assessed via self-report during screening).
  • •Ability to give informed consent (i.e., no known circumstances/conditions that may affect capacity to consent, e.g., dementia, memory loss or awaiting diagnosis).

排除标准

  • •Have ever received a clinical diagnosis of severe mental illness of bipolar, psychosis, post-traumatic stress disorder (PTSD), and/or schizophrenia, and/or a diagnosis of dementia.

研究组 & 干预措施

CommonGround Platform

Experimental

Online Peer Support and Psychoeducational Platform

干预措施: CommonGround (Behavioral)

Control

Active Comparator

National Health Service (NHS) "Mental Health" webpage(s)

干预措施: NHS Mental Health (Behavioral)

结局指标

主要结局

Incidence of probable Major Depressive Disorder (MDD)

时间窗: 3 months

Measured by the Patient Health Questionnaire (PHQ)-8 (PHQ-8 \>9 = 1; PHQ-8 ≤9 = 0).

次要结局

  • Social connectedness(3 months)
  • Symptoms of depression(Mid-intervention (Week 6) and 3 months)
  • Symptoms of anxiety(3 months)
  • Well-being(3 months)
  • Health-related quality of life(3 months)
  • Self-efficacy(3 months)
  • Entitativity(3 months)
  • Sense of virtual community(3 months)
  • Client Services Receipt Inventory (CSRI)(3 months)
  • Health Economics(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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