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临床试验/NCT04010019
NCT04010019已完成不适用

The Impact of Facebook Support Groups for Adults With Chronic Pain: A Randomized Clinical Trial

Wayne State University2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2019年9月27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
119
试验地点
2
主要终点
Change in pain severity from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory

研究概览

简要总结

This randomized trial will create and compare two private Facebook conditions for patients with chronic pain. The control condition will be comprised of groups of patients who communicate without much clinician / moderator input, and the experimental condition will have a clinician moderating and teaching patients several techniques designed to facilitate social disclosure, validation, and emotional engagement with avoided activities.

详细描述

This study will investigate the effectiveness of a private Facebook group for individuals in chronic pain. Currently, more than 100,000 individuals with chronic pain (ICPs) participate in Facebook groups, seeking support from others in similar situations. There are currently some online self-management programs for ICPs; however, most lack a peer support aspect, as they are individualized, self-directed, and focus on instructing patients in how to manage their pain. The goals of the proposed online pain support group are: 1) to provide peer-to-peer social support for individuals with chronic pain; and 2) to disseminate psychosocial pain management techniques using a social media platform. Screened participants will be assigned to one of two conditions: a Facebook group similar to the groups that are occurring naturally (control condition) or an enhanced Facebook group that is moderated by clinicians and offers psychosocial pain management techniques (experimental condition). Both conditions involve peer-to-peer healthcare and support, but the experimental group additionally includes components such as psychoeducation about pain neuroscience, emotional validation training, guided emotional disclosure, and activities to overcome emotional and behavioral avoidance. Findings from this study will offer important information about the impact of Facebook support groups on pain outcomes, and test whether psychosocial pain interventions can be disseminated using a social media platform.

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

入选标准

  • Must have chronic pain (i.e., pain that persists for greater than 3 months)
  • Must be fluent at reading and writing in English
  • Must have an active Facebook account and check Facebook at least 3 times a week

排除标准

  • Terminal illness such as cancer
  • Active psychosis (e.g., hallucinations, delusions)

结局指标

主要结局

Change in pain severity from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory

时间窗: Pain severity will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)

Brief Pain Inventory (Cleeland, 1991): Pain severity items: 1) Worst pain (0 \[no pain\] - 10 \[pain as bad as you can imagine\]), 2) Average pain (0 \[no pain\] - 10 \[pain as bad as you can imagine\]), 3) A composite of the 4 pain items (a mean pain severity score) will also be computed (0 \[no pain\] - 10 \[pain as bad as you can imagine\])

Change in pain interference from baseline to post-intervention to 1-month follow-up: Brief Pain Inventory

时间窗: Pain interference will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends)

Brief Pain Inventory (Cleeland, 1991): Pain interference items: A composite of the 7 interference items (a mean interference score) will be computed (0 \[does not interfere\] - 10 \[completely interferes\])

次要结局

  • Change in self-efficacy for managing pain: PROMIS Self-Efficacy for Managing Symptoms v1.0(Self-efficacy for managing pain will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in depression from baseline to post-intervention to 1-month follow-up(Depression will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in anxiety from baseline to post-intervention to 1-month follow-up(Anxiety will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in helplessness(Helplessness will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in pain catastrophizing: Pain Catastrophizing Scale(Pain catastrophizing will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in anger from baseline to post-intervention to 1-month follow-up(Anger will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in self-efficacy for managing emotions: PROMIS Self-Efficacy for Managing Emotions - Short Form 4a v1.0(Self-efficacy for managing emotions will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in perceived chronic pain social support from baseline to post-intervention to 1-month follow-up(Perceived chronic pain social support will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in social isolation(Social isolation will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in alexithymia(Alexithymia will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Change in substance use(Substance use will be assessed at 3 timepoints: 1) baseline (i.e., at the start of the intervention), 2. post-intervention (i.e., immediately after the intervention), and 3. 1-month follow-up (30 days after the intervention ends))
  • Perceived emotional support within the Facebook group(Perceived emotional support within the Facebook group will be assessed at post-intervention (i.e., immediately after the intervention))

研究者

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

Mark A. Lumley

Distinguished Professor and Director of Clinical Psychology Training

Wayne State University

研究点 (2)

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