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

Study Overview
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Brief Summary
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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
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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 and (c) improves well-being, 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.

Official Title
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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

Conditions
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Sleep Disorder, Circadian Dysregulation, Memory Impairment

Intervention / Treatment
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* Behavioral: Memory Support Intervention
* Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Aged 50 years and older; English language fluency; Experiencing a mobility impairment; Low income; 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. 25-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment. Consent to regular communications between the research team and the patient's medical provider/s; Able/willing to give informed consent. Exclusion criteria: 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); 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); Homelessness; Night shift work >2 nights per week in the past 3 months; Substance abuse/dependence only if it makes participation in the study unfeasible; Suicide risk sufficient to preclude treatment on an outpatient basis.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly allocated to TranS-C plus the MSI (TranS-C+MSI) or TranS-C alone
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TranS-C+MSI<br>Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention | Behavioral: Memory Support Intervention<br>* 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.<br>* Other names: MSI;Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction<br>* 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.<br>* Other names: TranS-C;|
| Active Comparator: TranS-C alone<br>The Transdiagnostic Sleep and Circadian Intervention will be delivered alone | Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction<br>* 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.<br>* Other names: TranS-C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | 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). | 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 | 
| Sheehan Disability Scale | Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment | 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 | 
| Satisfaction with Life Scale | 5-item instrument designed to measure global cognitive judgements of satisfaction with one's life. Scores can range from 5-35 with higher scores indicating higher levels of satisfaction with life. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Assesses perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep related problems (worse outcome). | 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 | 
| Positive and Negative Affect Scale | Positive affect scores can range from 10-15, with higher scores representing higher levels of positive affect. Negative affect scores can range from 10-50, with lower scores representing lower levels of negative affect | 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 | 
| WHODAS 2.0 | A measure of functional impairment | 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 | 
| Adapted Brief Disability Scale | A measure of functional impairment | 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 | 
| Cognitive Failures Questionnaire | Used to assess the frequency with which people experienced cognitive failures. Scores range from 0-100, with higher scores indicating higher levels of cognitive failures. | 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 | 
| Epworth Sleepiness Scale | Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness. | 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 | 
| Memory for Treatment: Cumulative recall | Recall on the Patient Treatment Recall Task | 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] | 
| Thoughts and Applications Task | Measures how treatment points have generalized to the participant's thinking and functioning during every day life | 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] | 
| Utilization Scale | 16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more utilization). | 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 | 
| Composite Sleep Health Score | Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time). | 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 | 
| Mean sleep efficiency (Daily Sleep Diary) | Daily Sleep Diary mean for sleep efficiency (total sleep time/time in bed X 100), Total sleep time (TST), Total wake time (TWT), bedtime, waketime. | 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 | 
| Mean total wake time (Daily Sleep Diary) | Daily Sleep Diary mean for total wake time defined as sleep onset latency + wake after sleep onset + Early morning awakening | 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 | 
| Mean for total sleep time (Daily Sleep Diary) | Daily Sleep Diary mean for total sleep time | 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 | 
| Mean for total wake time (Actigraphy) | Actigraphy mean for total wake time defined as sleep onset latency + wake after sleep onset + early morning awakening | Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment | 
| Mean for total sleep time (Actigraphy) | Actigraphy mean for total sleep time | Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment | 
| Mean for daytime activity (Actigraphy) | Actigraphy mean for daytime activity | Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment | 
| Provider level: Acceptability of Intervention Measure | Assess provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire | Through therapy completion, an average of 8 weeks following baseline | 
| Provider level: Appropriateness Intervention Measure | Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire | Through therapy completion, an average of 8 weeks following baseline | 
| Provider level: Feasibility of Intervention Measure | Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire | Through therapy completion, an average of 8 weeks following baseline | 
| Provider level: Provider-rated TranS-C Checklist | A measure of the TranS-C elements that are delivered. This is completed by the therapist at the end of every treatment session | Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks | 
| Provider level: Memory Support Treatment Provider Checklist | A measure of memory support delivered. This is completed by the therapist at the end of every treatment session | Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks | 
| Provider level: Patient adherence via the TARS | A measure of patient treatment adherence completed by the therapist at the end of every treatment session | Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks | 
| Provider level: Memory Support Rating Scale, total amount | Assesses the total amount of memory support used by a provider via coding of session tapes | Randomly selected therapy tapes | 
| Provider level: Memory Support Rating Scale, number of types | Assesses the number of types of memory support used by a provider via coding of session tapes | Randomly selected therapy tapes |