NCT05986604

NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment

NIA_Improving Sleep and Circadian Functioning, Daytime Functioning, and Well-being for Midlife and Older Adults by Improving Patient Memory for a Transdiagnostic Sleep and Circadian Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: University of California, Berkeley · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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 50 years and older to assess if a novel version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.

Detailed description

Life expectancy has increased drastically in the United States. Longer life is too often associated with illness, discomfort, disability, and dependency. Progress toward promoting health and well-being as we age must include the identification of novel treatment targets that are safe, powerful, inexpensive, and deployable. The proposed research will test one such target-patient memory for the contents of treatment. Over 5 years, we will recruit adults who are 50 years and older and who are experiencing sleep and circadian problems (n = 178, including 20% for attrition). Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone via eight 50-minute, weekly, individual sessions. Assessments will be conducted at baseline, post-treatment, and at 6- and 12-month follow-up (6FU and 12FU). Specific Aim 1: To evaluate if adding the MSI to TranS-C (a) improves sleep and circadian functioning, (b) improves daytime functioning, (c) improves well-being and (d) improves patient memory by comparing the effects of TranS-C+MSI vs. TranS-C alone. Hypothesis 1. Compared to TranS-C alone, people who receive TranS-C+MSI will improve more on all outcomes at post-treatment, 6FU and 12FU. Specific Aim 2: To evaluate if patient memory for treatment mediates the relation between treatment condition and sleep and circadian functioning. Hypothesis 2. TranS-C+MSI will be associated with better memory for treatment relative to TranS-C alone, and in turn, better memory for treatment will be associated with better sleep and circadian functioning immediately following treatment and at 6FU and 12FU. Specific Aim 3: To evaluate if subgroups hypothesized to derive added benefit from memory support moderate (a) patient memory for treatment and (b) treatment outcome. Hypothesis 3. Treatment effects for TranS-C+MSI will be larger at post-treatment for those who are older, have fewer years of education, poorer baseline cognitive functioning and more severe baseline sleep disruption and sleep-related impairment. Exploratory analyses will compare the treatments on (a) patient adherence as well as patient-rated treatment credibility and utilization of treatment elements and (b) provider-rated acceptability, appropriateness, and feasibility.

Conditions

• Sleep Disorder
• Circadian Dysregulation
• Memory Impairment

Interventions

Type	Name	Description
BEHAVIORAL	Memory Support Intervention	The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. The memory support strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.
BEHAVIORAL	Transdiagnostic Intervention for Sleep and Circadian Dysfunction	TranS-C aims to provide one protocol to treat a range of sleep and circadian problems because sleep and circadian problems are often not so neatly categorized and because the existing research provides few guidelines to treat more complex patients.

Timeline

• Start date: 2024-01-04
• Primary completion: 2028-02-28
• Completion: 2028-07-28
• First posted: 2023-08-14
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States