Clinical trial NCT05986604: NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disorder
Circadian Dysregulation
Memory Impairment
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 178
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion 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.

Exclusion criteria:

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.

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Sheehan Disability Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Satisfaction with Life Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Positive and Negative Affect Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: WHODAS 2.0
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Cognitive Failures Questionnaire
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Epworth Sleepiness Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Memory for Treatment: Cumulative recall
timeFrame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
measure: Thoughts and Applications Task
timeFrame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
measure: Adapted Utilization Scale
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Composite Sleep Health Score
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Mean sleep efficiency (Daily Sleep Diary)
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Mean total wake time (Daily Sleep Diary)
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Mean for total sleep time (Daily Sleep Diary)
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up
measure: Mean for total wake time (Actigraphy)
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Mean for total sleep time (Actigraphy)
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Mean for daytime activity (Actigraphy)
timeFrame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
measure: Provider level: Acceptability of Intervention Measure
timeFrame: Through therapy completion, an average of 8 weeks following baseline
measure: Provider level: Appropriateness Intervention Measure
timeFrame: Through therapy completion, an average of 8 weeks following baseline
measure: Provider level: Feasibility of Intervention Measure
timeFrame: Through therapy completion, an average of 8 weeks following baseline
measure: Provider level: Provider-rated TranS-C Checklist
timeFrame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
measure: Provider level: Memory Support Treatment Provider Checklist
timeFrame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
measure: Provider level: Patient adherence via the TARS
timeFrame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
measure: Provider level: Memory Support Rating Scale, total amount
timeFrame: Randomly selected therapy tapes
measure: Provider level: Memory Support Rating Scale, number of types
timeFrame: Randomly selected therapy tapes
Other outcomes:
measure: WatchPAT One
timeFrame: Baseline only
measure: Adverse events checklist
timeFrame: Only at post-treatment which is 8-10 weeks after the beginning of treatment
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline only
measure: Adapted Credibility Expectancy Questionnaire
timeFrame: At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment
measure: Structured Clinical Interview for Sleep Disorders
timeFrame: Baseline only
measure: Adapted Brief Disability Questionnaire
timeFrame: Baseline only
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References: