Adapting the "Do More, Feel Better" Intervention for Older People Living With HIV
More than half of people living with HIV (PWH) in the United States are 50 years of age or older. Older PWH have a 2.3-fold increased risk of depression compared to their peers without HIV. The investigator team has developed a streamlined lay-delivered behavioral activation intervention called "Do More, Feel Better" that has been shown to decrease depressive symptoms among older adults obtaining services in community senior centers. The investigators propose to (1) identify barriers and facilitators to improving mental health among older PWH by using this intervention in the context of Ryan White case management services, (2) adapt and enhance the intervention to meet the needs of older PWH, and (3) conduct a pilot randomized controlled trial to determine the acceptability, feasibility, and appropriateness of the adapted DMFB intervention.
研究概览
详细说明
More than half of people living with HIV (PWH) in the United States (US) are 50 years of age or older. Compared with those without HIV, older PWH have 2.3-fold increased risk of depression. The impact of unmitigated mental health symptoms and related conditions among this growing population is significant and includes social isolation, loss of independence, and poor engagement with healthcare, undermining progress towards ending the HIV epidemic. Due to a shortage behavioral health providers, there is growing interest in innovative interventions using community-based, peer-led approaches to improve access to effective mental health services. Behavioral activation is an evidence-based intervention that has shown promise for reducing depressive symptoms among older adults. The investigator team has developed a streamlined lay-delivered behavioral activation intervention called "Do More, Feel Better" (DMFB) that has been shown to decrease depressive symptoms among depressed (PHQ-9 ≥10) older adults obtaining services in community senior centers. Delivery of an adapted version of the DMFB intervention for older PWH with poor access to professional counseling could be relatively straightforward within the existing Ryan White HIV/AIDS program, supported by organizations that provide essential services such as non-medical case management to low-income PWH. Because the intervention is tailored to individual preferences and needs, it promises to be acceptable, especially after careful adaptation using input from community members and stakeholders. This study's aims are therefore: (1) to understand the impact of mental health issues on HIV care, functioning, and quality of life and identify multi-level barriers and facilitators that could influence participation in and delivery of an adapted DMFB intervention; (2) to adapt and enhance the DMFB intervention for delivery by case management program staff or volunteers to older PWH, following the ADAPT-ITT model in collaboration with community partners; and (3) to determine the acceptability, feasibility, and appropriateness of the adapted DMFB intervention compared to clinician-delivered Behavioral Activation therapy over 3 months in a pilot randomized controlled trial. Results of this research will have high impact by adapting an effective lay-delivered behavioral activation intervention for older PWH that is low-cost, scalable, and easily tailored to individual preferences and needs. Ongoing work on the DMFB intervention indicates that this lay-delivered intervention has great potential to produce concrete improvements in mental health and quality of life. The study's multidisciplinary team has a strong record of research on HIV care, geriatric mental health, HIV and aging, behavioral health and implementation science, and the experience with mixed methods approaches, intervention adaptation, and clinical trials necessary to successfully carry out this work. Adaptation of the DMFB intervention has the potential to be acceptable, feasible, effective and scalable when delivered within case management organizations, improving the lives and HIV outcomes of older PWH.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Susan M Graham, MD MPH PhD
- 电话号码:206-351-0414
- 邮箱:grahamsm@uw.edu
研究联系人备份
- 姓名:Isabell Griffith Fillipo, BA
- 电话号码:206-685-4585
- 邮箱:irgf@uw.edu
学习地点
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Washington
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Seattle、Washington、美国、98195
- University of Washington
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ≥50 years of age
- living with HIV
- English-speaking
- elevated depressive symptoms (PHQ-9 ≥10)
- resident in Washington for ≥1 year
- assigned to a Ryan White case manager
- willing to undergo all study procedures
Exclusion Criteria: Participants in the Aim 1 and 2 work (interviews and theater testing) and those who serve as certification participants (for interventionist training) will be excluded from the trial. Other exclusion criteria include:
- active suicidal ideation
- a diagnosis of bipolar disorder, schizophrenia or psychosis
- dementia or Telephone Interview for Cognitive Status-modified (TICS-M) scores <21
- current regular psychotherapy
- antidepressant use, unless at stable doses for 12 weeks
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Usual care
The control condition will be usual care, which will likely involve some period waiting for an intake followed by supportive counseling sessions for treating depressive symptoms. Receipt of counseling and other supportive services during the trial for both the intervention and usual care groups will be closely tracked. |
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实验性的:Adapted "Do More, Feel Better" Intervention
Lay-delivered behavioral activation intervention, adapted based on interviews and theater testing with the target audience |
The adapted behavioral activation intervention will be delivered by trained lay interventionists and provided over 9 weekly sessions lasting 45-60 minutes in person, by telephone, or by Zoom. This intervention currently consists of an initial meeting for psychoeducation and compilation of a tailored list of enjoyable and rewarding activities the client will draw from and schedule, followed by 8 weekly sessions to monitor symptoms, review homework, and continue daily activity scheduling. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
大体时间:week 3 and 9
|
4-item scale with response options ranging from 1-5 per item, with a summed scale score ranging from 4-20 and mean scale score ranging from 1-5. Higher scores indicate greater acceptability of the intervention. |
week 3 and 9
|
|
Intervention Appropriateness Measure (IAM)
大体时间:week 3 and 9
|
4-item scale with response options ranging from 1-5 per item, with a summed scale score ranging from 4-20 and mean scale score ranging from 1-5. Higher scores indicate greater perceived appropriateness of the intervention. |
week 3 and 9
|
|
Feasibility of Intervention Measure (FIM)
大体时间:week 3 and 9
|
4-item scale with response options ranging from 1-5 per item, with a summed scale score ranging from 4-20 and mean scale score ranging from 1-5. Higher scores indicate greater perceived feasibility of the intervention. |
week 3 and 9
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Session attendance
大体时间:week 9
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Session attendance will be calculated as the proportion of intervention sessions attended out of nine possible sessions. |
week 9
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Exit interview
大体时间:week 9
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Qualitative feedback on the adapted DMFB intervention and clinician-delivered BA therapy will be collected in exit interviews with a sample of participants from each arm |
week 9
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hamilton Rating Scale for Depression (Ham-D)
大体时间:Baseline, week 3, week 6, week 9, week 12
|
The Ham-D 24-item scale is a semi-structured clinical interview that assesses depression severity. Scores range from 0 to 76, with higher scores indicating greater depressive-symptom severity. Scores 0-7 represent transient to no depressive symptoms; 8-13 mild depression; 14-18 moderate depression; 19-22 severe depression and above 22 very severe depression. |
Baseline, week 3, week 6, week 9, week 12
|
|
Behavioral activation for depression scale (BADS)
大体时间:Baseline, week 3, week 6, week 9, week 12
|
The BADS is a 25-item scale assessing overall activity level based on four factors: activation, avoidance/rumination, work/school impairment and social impairment. Each item ranges from 0 ('not at all') to 6 ('completely'); total scores range from 0 to 150. Higher total scores indicate better behavioral activation and fewer depressive-avoidance behaviors. |
Baseline, week 3, week 6, week 9, week 12
|
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Three-item self-report measure for medication adherence
大体时间:Baseline, week 9, week 12
|
Wilson's three-item self-report measure for medication adherence assesses missed days during the past 30 days, frequency of taking medication as prescribed, and the person's rating of how well they took it. Scores range from 0-100 for the raw summary score, calculated as the mean of the three item scores. Higher scores indicate better medication adherence. |
Baseline, week 9, week 12
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Index of engagement in HIV care
大体时间:Baseline, week 9, week 12
|
The CFAR Network of Integrated Clinical Systems 10-item index of engagement in HIV care includes 10 items rated on a 5-point Likert scale. The range of summed scores is from 10-50 and mean scores range from 1-5. Higher scores indicate better HIV care engagement. |
Baseline, week 9, week 12
|
|
HIV-1 RNA viral load
大体时间:Baseline, week 12
|
Dried blood spots will be collected for viral load testing through the University of Washington Department of Laboratory Medicine. Any viral load <200 copies/mL will be considered suppressed. |
Baseline, week 12
|
|
Date of last clinic visit
大体时间:Baseline, week 24
|
Provider-reported date of last clinic visit, obtained for participants who grant permission for release of this information. |
Baseline, week 24
|
|
Most recent viral load
大体时间:Baseline, week 24
|
Provider-reported most recent viral load, obtained for participants who grant permission for release of this information. |
Baseline, week 24
|
|
Most recent CD4 count
大体时间:Baseline, week 24
|
Provider-reported most recent CD4 count, obtained for participants who grant permission for release of this information. |
Baseline, week 24
|
合作者和调查者
调查人员
- 首席研究员:Susan M Graham, MD MPH PhD、University of Washington
出版物和有用的链接
一般刊物
- Raue PJ, Hawrilenko M, Corey M, Lin J, Chen S, Mosser BA. "Do More, Feel Better": Pilot RCT of Lay-Delivered Behavioral Activation for Depressed Senior Center Clients. Behav Ther. 2022 May;53(3):458-468. doi: 10.1016/j.beth.2021.11.005. Epub 2021 Nov 26.
- Raue PJ, Dawson A, Hoeft T, Russo J, Ferguson D, Green L, Petersky C, Kaplan C. Acceptability of a lay-delivered intervention for depression in senior centers. Aging Ment Health. 2021 Mar;25(3):445-452. doi: 10.1080/13607863.2019.1698515. Epub 2019 Dec 4.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- R34MH143573 (美国 NIH 拨款/合同)
- 1R34MH143573-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IDP will be shared with the NIMH Data Archive.
IPD 共享时间框架
The protocol, statistical analysis plan, and ICF will be uploaded to ClinicalTrials.gov as soon as they are approved. The clinical study report and analytic code will be uploaded upon completion of the trial and its analysis.
IPD 共享访问标准
Deidentified data on arm, primary and secondary outcomes, and basic demographic characteristics will be available through the NIMH Data Archives.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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