A Pilot Study for Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
研究概览
简要总结
Mental illness is often chronic, severe, and difficult to treat. Though there has been significant progress towards establishing effective and efficient interventions for psychological health problems, many individuals do not gain lasting benefits from these treatments. The Memory Support Intervention (MSI) was developed utilizing existing findings from the cognitive science literature to improve treatment outcomes. In this study, the investigators aim to conduct an open trial that includes individuals 55 years and older to assess if a simplified version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.
详细描述
Given the huge burden associated with mental illness, a major challenge ahead is to hasten progress toward developing and testing highly efficient and effective interventions for psychological health problems. Progress toward establishing evidence-based psychosocial treatments for most types of mental illness has been excellent, particularly the cognitive and behavioral treatments (CBT). However, much work remains. The effect sizes are moderate, gains may not persist, and there are patients who derive little or no benefit. Even under optimal conditions, treatment failure is too common. Hence, the challenge is to improve outcomes. Seminal progress toward meeting this challenge must include innovations that are safe, powerful, inexpensive and simple (for fast and effective dissemination).
The proposed research seeks to extend the investigators' program of research on one such innovation. With an R34 and an R01 from NIMH, the investigators have been seeking to improve outcome by improving memory for the content of therapy sessions. To achieve this goal, the investigators have developed and adapted existing findings from the education and cognitive science literatures. The resulting Memory Support Intervention (MSI) involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory.
This line of research arises from several lines of evidence: (a) memory for the content of therapy sessions is poor and (b) memory impairment is modifiable. Although the outcomes will be relevant to psychosocial treatments for a broad range of problems, the focus of this proposal is one treatment for sleep and circadian dysfunction because (a) sleep problems are one of the most prevalent psychological health problems, (b) there is substantial and promising evidence for the efficacy of the transdiagnostic sleep and circadian (TranS-C), yet there is also room for improvement in outcome and (c) sleep problems are associated with memory impairment.
This pilot study will be conducted in order to collect data on individuals who are 55 years and older because memory functioning can decline over this phase of the lifespan. Sleep and circadian problems are also common.
The aim is: To conduct an open trial that includes n = 40 individuals 55 years and older to assess if the Memory Support Intervention (a) improves sleep and circadian functioning, (b) reduces functional impairment and (c) improves patient memory for treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 55 years and older
- •English language fluency
- •Exhibit a sleep or circadian disturbance as determined by endorsing 4 "quite a bit" or 5 "very much" (or the equivalent for reverse scored items) on one or more PROMIS-SD questions
排除标准
- •Presence of an active and progressive mental or physical illness or neurological degenerative disease
- •Night shift work >2 nights per week in the past 3 months
- •Not able and willing to participate in and/or complete the assessments and participate in the treatment
- •Current suicide risk sufficient to preclude treatment on an outpatient basis
研究组 & 干预措施
Memory Support Intervention
干预措施: Trans-C for sleep and circadian function + Memory Support (Behavioral)
结局指标
主要结局
Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
时间窗: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).
Sheehan Disability Scale
时间窗: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment
次要结局
- Positive and Negative Affect Scale(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Perceived Stress Scale(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Satisfaction with Life Scale(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Credibility Expectancy Questionnaire(At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment)
- Means and Variability of sleep efficiency (Daily Sleep Diary)(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Composite Sleep Health Score(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- British Columbia Complaints Inventory(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Mutlidimensional Fatigue Inventory(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Cognitive Failures Questionnaire(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Epworth Sleepiness Scale(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Memory for Treatment(At post-treatment, which is 8-10 weeks after the beginning of treatment)
- Generalization Task Questionnaire(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
- Acceptability Intervention Measure(Through therapy completion, an average of 8 weeks)
- Intervention Appropriateness Measure(Through therapy completion, an average of 8 weeks)
- Feasibility of Intervention Measure(Through therapy completion, an average of 8 weeks)
研究者
Allison Harvey
Professor
University of California, Berkeley