HEPPI: A Randomized Controlled Trial of the Efficacy of a Cognitive-Emotional Intervention for Homebound Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Changes in Episodic Memory
研究概览
简要总结
The main goal of this research is to assess the efficacy of a 10-week home-delivered cognitive-emotional intervention program for homebound older adults presenting Mild Cognitive Impairment (MCI) and depressive and/or anxiety symptoms. The Homebound Elderly People Psychotherapeutic Intervention (HEPPI) combines cognitive training, psychotherapeutic techniques, and compensatory strategy training, and was designed to optimize memory function and to reduce depressive or anxious symptomatology of these older adults.
A two-arm randomized controlled trial (RCT) is conducted to investigate the efficacy of the HEPPI among the homebound older population.
详细描述
The present study aims to assess the efficacy of a cognitive-emotional intervention (the HEPPI program) for homebound older adults with MCI and depressive and/or anxious symptomatology.
The research design of the trial followed the methodological recommendations for conducting goropsychoterapy research. Moreover, a pilot RCT was conducted prior to the present RCT, in order to assess the feasibility, acceptability, and preliminary efficacy of the HEPPI. Appropriate adjustments to the HEPPI protocol were carried out considering the results.
The present study is a two-arm RCT comparing the intervention condition (HEPPI) to a treatment as usual (TAU) control group. The sample includes community-dwelling older adults who do not leave home more often than once a week. Homebound older adults are recruited from the community through contact with their health care networks. A minimum number of 79 participants per condition will be required (N=158). Accounting for an expected 20% attrition rate, an anticipated sample of 198 participants will be enrolled in the study. Participants who demonstrate interest in the study are informed of the goals and procedures of the research and asked to provide informed consent before eligibility assessment. Eligible participants are randomly assigned to the HEPPI or the TAU group.
Homebound older adults are asked to complete baseline, post-intervention, and 3-month follow-up assessments. Assessments include neuropsychological tests to assess cognition function, psychological health, subjective memory complaints, quality of life, functional status, perceived loneliness, and personality. The study procedures take place at the participants' homes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Homebound older adults aged 65 years and older;
- •MoCA score 1 to 1.5 standard deviation below the mean for age- and education- adjusted norms;
- •FCSRT total immediate and delayed recall scores ≤ 35 and ≤ 12, respectively;
- •Presence of subjective memory complaints (SMCS score ≥ 3);
- •Presence of depressive symptomatology (GDS-30 score ≥ 11);
- •Presence of anxious symptomatology (GAI score ≥ 8);
- •No significant impact from cognitive impairment on daily functional capacity;
- •Residence in mainland Portugal;
排除标准
- •Presence or history of significant neurological conditions;
- •Presence of severe psychiatric illnesses;
- •Presence of comorbid medical conditions associated with cognition decline;
- •Use of psychotropic medication for less than three months;
- •Presence of alcoholism or toxicomania;
- •Significant impairment of vision, hearing, communication, or manual dexterity.
研究组 & 干预措施
HEPPI
The HEPPI group attends weekly 90-minute intervention sessions at the participants' homes.
干预措施: HEPPI (Behavioral)
Treatment as Usual (TAU)
The TAU group receives access to HEPPI at the end of the study.
结局指标
主要结局
Changes in Episodic Memory
时间窗: Baseline, post-intervention, and 3-month follow-up
Logical Memory of the Wechsler Memory Scale-III (LM) \| Higher scores indicate a better outcome
Changes in Depressive Symptomatology
时间窗: Baseline, post-intervention, and 3-month follow-up
Measured by Geriatric Depression Scale-30 (GDS-30) \| Lower scores indicate a better outcome
Changes in Anxious Symptomatology
时间窗: Baseline, post-intervention, and 3-month follow-up
Measured by Geriatric Anxiety Inventory (GAI) \| Lower scores indicate a better outcome
次要结局
- Changes in General Cognitive Function(Baseline, post-intervention, and 3-month follow-up)
- Changes in Attentional Control(Baseline, post-intervention, and 3-month follow-up)
- Changes in Perceived Quality of Life(Baseline, post-intervention, and 3-month follow-up)
- Changes in Functional Status(Baseline, post-intervention, and 3-month follow-up)
- Changes in Loneliness(Baseline, post-intervention, and 3-month follow-up)
- Changes in Subjective Memory Complaints(Baseline, post-intervention, and 3-month follow-up)
研究者
Andreia Jesus
Principal Investigator
University of Coimbra