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临床试验/NCT02909387
NCT02909387已完成不适用

Adapting Evidence-Based Epilepsy Self-Management Programs for Blacks in Georgia

Morehouse School of Medicine2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2016年9月8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
82
试验地点
2
主要终点
Modified Beck Depression Inventory

研究概览

简要总结

Evaluate the efficacy of Project UPLIFT for reducing symptoms of depression and anxiety among African Americans at immediate posttest and after 3 months.

详细描述

Project UPLIFT is a manualized intervention that includes a script for use by the telephone facilitators in leading activities and discussions; use of a script is possible because the delivery is not face-to-face. Activities and discussions are designed to increase knowledge about epilepsy and mental health; monitoring, challenging, and changing of thoughts; coping and relaxing; attention and mindfulness; focusing on pleasure; the importance of reinforcement; and preventing relapse. Sessions are designed to last one hour by telephone, and are comprised of a check-in period, teaching on the topic of that week's session, group discussion, a skill-building exercise, and a recommended practice for the week. They are co-facilitated by a research staff and an UPLIFT trained adult with epilepsy. The same facilitators lead all eight sessions of a particular group. Facilitators will receive training in delivery of the program, including delivery of a practice session, from the Co-PI, a Georgia-licensed clinical psychologist. She will also supervise the facilitators throughout the program delivery. As noted above, spiritualism and religion; oral, interpersonal communication; and appreciation of intuition and experience are commonly held values in the African American community. This suggests that Project UPLIFT, with its activities based in experiential, meditative exercises, and oral, group discussion over the telephone may be a good fit.

Design. The outcome evaluation of the efficacy of the Project UPLIFT telephone intervention groups will be assessed using a cross-over design.

Participants/Procedure. A total of 60 participants will be recruited. Participants must self-identify as black or African American. All participants must be English-speaking, age 18 or older, mentally stable as assessed by the T-MMSE, have been diagnosed with epilepsy for at least three months, and screen positive for depression or anxiety on the Patient Health Questionnaire for Depression and Anxiety (PHQ-4). They must also have access to a telephone, be willing to attend eight hour-long telephone groups, and be willing to be audio-recorded. Individuals who are on antidepressant medication will not be excluded from this study, since CBT has been demonstrated to have a greater effect on relapse prevention than antidepressant medication. Once recruited, participants will be randomly assigned to one of two strata, each comprised of five 6-person groups. After each 12-participant cohort is recruited, they will be randomly assigned to Stratum 1 (intervention) or Stratum 2 (treatment-as-usual waitlist). During weeks 1-4, all participants will be pre-tested. During weeks 5-10, participants in Stratum 1 will receive Project UPLIFT, while participants in Stratum 2 are called weekly for a brief check-in. During weeks 11-14, all participants will receive interim testing. During weeks 15-22, participants in Stratum 2 will receive Project UPLIFT. During weeks 23-26, all participants will be post-tested. Five months after the completion of their final UPLIFT session, participants will be contacted for a follow-up assessment.

During the intervention in stratum 1, stratum 2 will serve as a control. In addition, the design allows a replication of the results in the initial intervention group (stratum 1) by the delayed intervention group (stratum 2). By the end of the intervention, all 10 6-person groups will have received the intervention.

Research Strategy Conferencing Methods. In order for the participants to communicate with one another as well as the facilitators, the telecommunicated group intervention sessions will use GoToMeeting. This conferencing method allows the moderator to not only record the call but also to screening participants waiting to join the call with the option to accept or reject those waiting, dismiss in-meeting participants, lock the meeting as well as dial out to participants. Use of this service is free of charge to MSM faculty.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • Identify as African American or Black;
  • Diagnosed by a healthcare provider with epilepsy or seizure disorder at least 3 months ago;
  • Is mildly to moderately depressed or mildly to moderately anxious as determined by the PHQ-4;
  • Willing to be audio-recorded during UPLIFT sessions

排除标准

  • Reports suicidal ideation within the past month

结局指标

主要结局

Modified Beck Depression Inventory

时间窗: Post intervention (8 weeks)

Measure of depressive symptoms over previous two weeks.

Beck Anxiety Inventory

时间窗: Post intervention (8 weeks)

Measure of anxiety symptoms over previous week.

次要结局

  • Modified Beck Depression Inventory(3-months Post Intervention)
  • Beck Anxiety Inventory(3-months Post intervention)

研究者

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

Rakale Collins Quarells

Associate Professor

Morehouse School of Medicine

研究点 (2)

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