RECRUITING

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

Conditions

Sleep Disorder Circadian Dysregulation Memory Impairment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-04

Study Completion:2028-07-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05986604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Aged 50 years and older; 2. English language fluency; 3. Experiencing a mobility impairment; 4. Low income; 5. 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. 6. 25-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment. 7. Able/willing to give informed consent.	1. Severe untreated sleep disordered breathing (AHI\>30) or moderate untreated sleep disordered breathing with severe daytime sleepiness (AHI of 15-30 and Epworth Sleepiness Scale \>10); 2. Medical conditions that prevent a participant from comprehending and following the basic tenants of treatment (e.g., dementia) or that interfere with sleep in a manner that can't be addressed by a cognitive behavioral treatment (e.g., the Structured Clinical Interview for Sleep Disorders will be used to screen for narcolepsy, REM sleep behavior disorder) or that may preclude full participation (e.g., receipt of end of life care); 3. Homelessness; 4. Night shift work \>2 nights per week in the past 3 months; 5. Substance abuse/dependence only if it makes participation in the study unfeasible; 6. Suicide risk sufficient to preclude treatment on an outpatient basis.

Inclusion Criteria

Exclusion Criteria

1. Aged 50 years and older;
2. English language fluency;
3. Experiencing a mobility impairment;
4. Low income;
5. 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.
6. 25-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment.
7. Able/willing to give informed consent.

1. Severe untreated sleep disordered breathing (AHI\>30) or moderate untreated sleep disordered breathing with severe daytime sleepiness (AHI of 15-30 and Epworth Sleepiness Scale \>10);
2. Medical conditions that prevent a participant from comprehending and following the basic tenants of treatment (e.g., dementia) or that interfere with sleep in a manner that can't be addressed by a cognitive behavioral treatment (e.g., the Structured Clinical Interview for Sleep Disorders will be used to screen for narcolepsy, REM sleep behavior disorder) or that may preclude full participation (e.g., receipt of end of life care);
3. Homelessness;
4. Night shift work \>2 nights per week in the past 3 months;
5. Substance abuse/dependence only if it makes participation in the study unfeasible;
6. Suicide risk sufficient to preclude treatment on an outpatient basis.

Contacts and Locations

Study Contact

Allison Harvey, PhD

CONTACT

5106427138

aharvey@berkeley.edu

Principal Investigator

Allison Harvey, PhD

PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Study Locations (Sites)

University of California, Berkeley

Berkeley, California, 94720-1650

United States

Collaborators and Investigators

Sponsor: University of California, Berkeley

Allison Harvey, PhD, PRINCIPAL_INVESTIGATOR, University of California, Berkeley

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-04

Study Completion Date2028-07-28

Study Record Updates

Study Start Date2024-01-04

Study Completion Date2028-07-28

Terms related to this study

Additional Relevant MeSH Terms

Sleep Disorder
Circadian Dysregulation
Memory Impairment