Enhancing Social Connection, Health, and Aging in Older Persons: A Pilot Randomized Trial of the Hopeful and Healthy Living (HHL) Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure
研究概览
简要总结
The goal of this clinical trial is to learn if a novel psychosocial intervention is effective in helping adults over 50 with serious mental illness (SMI) increase their social connections and participate in more healthy lifestyle activities. The Hopeful and Healthy Living (HHL) intervention combines social skills training and training in cognitive self-management strategies in order to help older adults build healthy lifestyle and social routines. We predict that:
- Individuals who participate in the HHL intervention will improve more in perceived social support (i.e., what people get from relationships such as reliance, reassurance of worth, attachment) and loneliness at the 4-, 8-, and 12-month follow-up assessments than those who receive treatment as usual (TAU).
- Individuals who participate in the HHL intervention will improve more in overall psychosocial functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
- Individuals who participate in the HHL intervention will improve more in cognitive functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
- Individuals who participate in the HHL intervention will improve more in healthy behaviors (sleep, activity, diet) at the 4-, 8-, and 12-month follow-up assessments than those who receive TAU.
In this trial, participants will be either receive the HHL intervention or participate in their regular treatment activities (treatment as usual). HHL vs. TAU will be compared to see if there are any differences in social support, cognition, loneliness, psychosocial functioning, or healthy lifestyle activities including physical activity, sleep, and diet.
Participants will be asked to complete an interview-based assessment at baseline, 4-months, 8-months, and 12-months. After completing the baseline assessment, those who are in the experimental group will participate in the 16-week long HHL group intervention.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years or older, diagnosis of a serious mental illness, and a member of Center Club or Transitions of Boston
排除标准
- •Diagnosis of dementia or other progressive neurological disorder
研究组 & 干预措施
HHL group participants
Participants will complete the 16-week manualized HHL intervention. This group intervention will occur weekly for 90 minutes. These participants will also continue with treatment as usual.
干预措施: Hopeful and Healthy Living (HHL) (Behavioral)
Treatment as usual
Participants assigned to this arm will continue with treatment as usual.
结局指标
主要结局
The DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure
时间窗: Baseline, 4-, 8-, 12- month followup
Adult will be used to assess and statistically control for mental health symptom severity.
The UCLA Loneliness Scale-3-item instrument
时间窗: Baseline, 4-, 8-, 12- month followup
3-item screening tool for loneliness.
The Social Provisions Scale
时间窗: Baseline, 4-, 8-, 12- month followup
24-item instrument that will be used to measure various types of social supports.
The Physical Activity Scale for the Elderly (PASE)
时间窗: Baseline, 4-, 8-, 12- month followup
Standardized measurement of physical activity related to exercise, work, recreation, and daily living activities.
Starting the Conversation
时间窗: Baseline, 4-, 8-, 12- month followup
A brief standardized survey for assessing daily eating habits.
Pittsburg Sleep Quality Index (PSQI)
时间窗: Baseline, 4-, 8-, 12- month followup
An 11-item tool that is used to assess sleep quality and routines.
Montreal Cognitive Assessment (MOCA)
时间窗: Baseline, 4-, 8-, 12- month followup
Standardized screening tool used for assessing cognition.
The Cognitive Self-Efficacy Scale
时间窗: Baseline, 4-, 8-, 12- month followup
10-item measure that assesses confidence in everyday cognitive tasks.
次要结局
- HHL Group Satisfaction and Feedback Survey(4-month assessment only)