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

Sleep Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05986604
• Other study ID #: TranS-C+MSI vs. TranS-C Alone
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2024
• Est. completion date: July 28, 2028

Study information

• Verified date: June 2024
• Source: University of California, Berkeley
• Contact: Allison Harvey, PhD
• Phone: 5106427138
• Email: aharvey[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: July 28, 2028
• Est. primary completion date: February 28, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation
• Memory Impairment
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	WatchPAT One	For participants who screen positive for obstructive sleep apnea, WatchPAT One will be offered to determine eligibility	Baseline only
Other	Adverse events checklist	To assess any adverse events experienced as a result of participating in the study	Only at post-treatment which is 8-10 weeks after the beginning of treatment
Other	Montreal Cognitive Assessment (MoCA)	A measure of cognitive functioning/cognitive impairments to determine eligibility	Baseline only
Other	Adapted Credibility Expectancy Questionnaire	Measures the credibility and expectation of improvement from the treatment.	At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment
Other	Structured Clinical Interview for Sleep Disorders	Measures sleep and circadian diagnoses according to DSM-5	Baseline only
Other	Adapted Brief Disability Questionnaire	A measure of functional impairment	Baseline only
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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]
Secondary	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]
Secondary	Adapted Utilization Scale	19-item; 0-4 scale. Scores can range from 0 to 76 (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
Secondary	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
Secondary	Mean sleep efficiency (Daily Sleep Diary)	Daily Sleep Diary mean for sleep efficiency (total sleep time/time in bed X 100)	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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