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临床试验/NCT04267289
NCT04267289已完成不适用

Happy@Home: Delivering Internet-based Cognitive Behavioral Therapy With Homecare Workers to At-Home Seniors

University of Michigan2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年5月30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
28
试验地点
2
主要终点
Satisfaction with the treatment program

研究概览

简要总结

Depression is one of the most common and debilitating conditions among older adults. At-home seniors, also called homebound seniors, are older adults who are confined to a bed or chair and are unable to get about outdoors. Internet-based CBT (iCBT) delivers CBT via websites or dedicated apps on mobile devices or tablets. iCBT can be self-administered or guided by a therapist. Its strengths include low-cost, accessibility, and ability to tailor to individual needs while maintaining fidelity. Despite its potential, iCBT trials have rarely included older adults. Those that included older adults showed that they tended to report more technological challenges but they benefited from the intervention as much as younger adults did. As far as we know, studies have not yet tested the feasibility and preliminary effects of iCBT with a diverse group of at-home seniors receiving non-skilled home care. This study explores the feasibility and acceptability of delivering iCBT to a sample of at-home seniors who receive non-skilled home care. Home care workers who care for these seniors are recruited to provide assistance for completing iCBT. We hypothesize that iCBT is an acceptable and feasible intervention for treating depression among at-home seniors.

详细描述

Depression is one of the most common and debilitating conditions among older adults. At-home seniors, also called homebound seniors, are older adults who are confined to a bed or chair and are unable to get about outdoors. Medical morbidity, disability, cognitive impairment, pain, and social isolation are known risk factors for depression that are prevalent among at-home seniors. Epidemiological and community-based studies have consistently documented a high prevalence of depression among at-home seniors. However, depression treatment is often inaccessible to at-home seniors. The majority of at-home seniors with depression do not receive adequate treatment, with the dominant treatment modality being medication. Successfully treating late-life depression requires a multi-component treatment program beyond medication. Besides, medication non-adherence is common due to concerns of side effects and preferences for other treatment modalities such as counseling. However, office-based psychotherapy is out of reach for at-home seniors who often require assistance for transportation. In addition, older adults prefer home-based treatment and counseling, and consideration of their preference may lead to better treatment outcomes.

Online therapy (iCBT) is an evidence-based approach for treating depression. Cognitive-behavioral therapy (CBT) is the gold standard of psychotherapy for depression in both young and older adults. Internet-based CBT (iCBT) delivers CBT via d websites or dedicated apps on mobile devices or tablets. iCBT can be self-administered or guided by a therapist. Its strengths include low-cost, accessibility, and ability to tailor to individual needs while maintaining fidelity. Meta-analyses have shown that iCBT is equivalent to face-to-face CBT in its effectiveness for treating depression. Emerging evidence suggests that iCBT may actually be more effective for older adults, because they are more likely to adhere to treatment than their younger counterparts. Despite the benefits of iCBT, most older adults do not use iCBT, possibly due to limited opportunities accessing iCBT programs and technological challenges.

This project explores the feasibility of implementing iCBT in non-skilled home care. Home care workers provide personal care and companionship to older adults in need of assistance with daily activities, housekeeping, medication management, and transportation. Home care is provided full-time, part-time, intermittently, or even around the clock to address the recipient's long-term care needs. Home-based care provides a naturalized and accessible setting, and frequent home visits over an extended period offer opportunities for prolonged engagement and symptom monitoring. Research shows that iCBT programs with human support are more effective than self-guided programs. For at-home seniors, home care workers represent an untapped resource of human support and can be trained to provide technical assistance for at-home seniors with limited computer literacy, addressing technological challenges associated with iCBT use. Moreover, home care workers can facilitate the completion of behavioral activation activities (e.g., drive a client to attend a social activity), which is critical in realizing the effectiveness of CBT. In addition, participation in training and intervention may also benefit the home care workers themselves by improving job satisfaction, pride, and retention. However, Studies have not tested iCBT with at-home seniors receiving home care. Protocols for implementing iCBT in home care also do not exist. Issues regarding screening, supervision, and referrals need to be addressed and standardized. In addition, we need to develop strategies to address implementation barriers at the patient, provider, and organization levels to achieve sustained impact.

This pilot feasibility study is a pragmatic trial of iCBT among a sample of diverse at-home seniors receiving non-skilled home care. Guided by the Replicating Effective Programs framework, this study aims to develop materials to package an existing, evidence-based iCBT program called Beating the Blues for testing in a sample of at-home seniors receiving home care. The primary aim of the study is to test whether iCBT is an acceptable treatment modality for at-home seniors with varying levels of technology competency. An exploratory aim is to examine whether it is feasible to train home care workers to assist seniors with iCBT completion. Findings from this pilot study will gather information regarding barriers to implement iCBT in non-skilled home care at the provider- (home care workers) and the patient- (at-home seniors) levels. If the results from this study are promising, subsequent efforts will be devoted to address implementation barriers at the organizational (home care agencies) level.

The study is a single-group open trial. Study materials (measurements, participant workbook) will be piloted tested with 2 subjects, who will not participate in the full trial. The targeted sample size for the full trial is 28. A sample size of 23 provides a power of 0.95 to detect a significant effect size of d=.8 from paired-sample t-test (G*Power, 3.1 version). A proposed sample size of 28 therefore has sufficient power to detect the projected effect size.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 60 years of age
  • have received home care for ≥ 1 month and anticipate continued care for ≥ 3 months
  • have at least mild depressive symptoms (PHQ-9≥5)
  • speak English.

排除标准

  • Currently receiving psychotherapy
  • Have a psychotic disorder (BPRS)
  • Have active suicidal ideation based on endorsement of PHQ-9 item 9 (other than not at all)
  • Severe cognitive impairment, assessed as having ≥ 3 errors on the 6-item Mini mental state exam
  • Have a planned hospital admission in the next 3 months of enrollment

结局指标

主要结局

Satisfaction with the treatment program

时间窗: Up to 3 months after the start the treatment

self rated satisfaction with the program, score ranges from 1 to 10. Higher score indicates higher satisfaction.

Patient Health Questionnaire-9 Items (PHQ-9)

时间窗: Change from baseline PHQ9 at end of treatment (3 months after the start of treatment)

PHQ-9 for depressive symptoms, total score ranges from 0 to 27, higher scores indicate worse depressive symptoms

# of sessions completed

时间窗: Up to 3 months after the start the treatment

# of Beating the Blues sessions completed at the end of 3 months

Acceptability

时间窗: Up to 3 months after the start the treatment

Treatment acceptability scale, has a total of 10 questions, total score ranges from 10 to 50, higher scores indicate higher acceptability

次要结局

  • EQ5D-5L(Change from baseline EQ5D at end of treatment (3 months after the start of treatment))
  • Generalized Anxiety Disorder-7 (GAD-7)(Change from baseline GAD7 at end of treatment (3 months after the start of treatment))
  • Montreal Cognitive Assessment (MoCA)(Change from baseline MoCA at end of treatment (3 months after the start of treatment))

研究者

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

Xiaoling Xiang

Assistant Professor

University of Michigan

研究点 (2)

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