search
Back to results

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

Primary Purpose

Sleep Disorder, Circadian Dysregulation, Memory Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memory Support Intervention
Transdiagnostic Intervention for Sleep and Circadian Dysfunction
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. 26-30 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 (AHI>30) or moderate (AHI of 15-30) untreated OSA; 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.

Sites / Locations

  • University of California, BerkeleyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TranS-C+MSI

TranS-C alone

Arm Description

Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention

The Transdiagnostic Sleep and Circadian Intervention will be delivered alone

Outcomes

Primary Outcome Measures

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).
Sheehan Disability Scale
Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment
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.

Secondary Outcome Measures

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).
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
WHODAS 2.0
A measure of functional impairment
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.
Epworth Sleepiness Scale
Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
Memory for Treatment: Cumulative recall
Recall on the Patient Treatment Recall Task
Thoughts and Applications Task
Measures how treatment points have generalized to the participant's thinking and functioning during every day life
Utilization Scale
16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more utilization).
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).
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.
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
Mean for total sleep time (Daily Sleep Diary)
Daily Sleep Diary mean for total sleep time
Mean for total wake time (Actigraphy)
Actigraphy mean for total wake time defined as sleep onset latency + wake after sleep onset + early morning awakening
Mean for total sleep time (Actigraphy)
Actigraphy mean for total sleep time
Mean for daytime activity (Actigraphy)
Actigraphy mean for daytime activity
Provider level: Acceptability of Intervention Measure
Assess provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire
Provider level: Appropriateness Intervention Measure
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire
Provider level: Feasibility of Intervention Measure
Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire
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
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
Provider level: Patient adherence via the TARS
A measure of patient treatment adherence completed by the therapist at the end of every treatment session
Provider level: Memory Support Rating Scale, total amount
Assesses the total amount of memory support used by a provider via coding of session 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

Full Information

First Posted
August 2, 2023
Last Updated
October 6, 2023
Sponsor
University of California, Berkeley
search

1. Study Identification

Unique Protocol Identification Number
NCT05986604
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 15, 2027 (Anticipated)
Study Completion Date
November 25, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder, Circadian Dysregulation, Memory Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TranS-C+MSI
Arm Type
Experimental
Arm Description
Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention
Arm Title
TranS-C alone
Arm Type
Active Comparator
Arm Description
The Transdiagnostic Sleep and Circadian Intervention will be delivered alone
Intervention Type
Behavioral
Intervention Name(s)
Memory Support Intervention
Other Intervention Name(s)
MSI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Transdiagnostic Intervention for Sleep and Circadian Dysfunction
Other Intervention Name(s)
TranS-C
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
Description
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).
Time Frame
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
Title
Sheehan Disability Scale
Description
Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment
Time Frame
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
Title
Satisfaction with Life Scale
Description
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.
Time Frame
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 Measure Information:
Title
Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
Description
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).
Time Frame
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
Title
Positive and Negative Affect Scale
Description
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
Time Frame
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
Title
WHODAS 2.0
Description
A measure of functional impairment
Time Frame
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
Title
Cognitive Failures Questionnaire
Description
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.
Time Frame
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
Title
Epworth Sleepiness Scale
Description
Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
Time Frame
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
Title
Memory for Treatment: Cumulative recall
Description
Recall on the Patient Treatment Recall Task
Time Frame
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]
Title
Thoughts and Applications Task
Description
Measures how treatment points have generalized to the participant's thinking and functioning during every day life
Time Frame
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]
Title
Utilization Scale
Description
16-item; 0-4 scale. Scores can range from 0 to 64 (Higher score means more utilization).
Time Frame
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
Title
Composite Sleep Health Score
Description
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).
Time Frame
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
Title
Mean sleep efficiency (Daily Sleep Diary)
Description
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.
Time Frame
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
Title
Mean total wake time (Daily Sleep Diary)
Description
Daily Sleep Diary mean for total wake time defined as sleep onset latency + wake after sleep onset + Early morning awakening
Time Frame
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
Title
Mean for total sleep time (Daily Sleep Diary)
Description
Daily Sleep Diary mean for total sleep time
Time Frame
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
Title
Mean for total wake time (Actigraphy)
Description
Actigraphy mean for total wake time defined as sleep onset latency + wake after sleep onset + early morning awakening
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Mean for total sleep time (Actigraphy)
Description
Actigraphy mean for total sleep time
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Mean for daytime activity (Actigraphy)
Description
Actigraphy mean for daytime activity
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Provider level: Acceptability of Intervention Measure
Description
Assess provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire
Time Frame
Through therapy completion, an average of 8 weeks following baseline
Title
Provider level: Appropriateness Intervention Measure
Description
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire
Time Frame
Through therapy completion, an average of 8 weeks following baseline
Title
Provider level: Feasibility of Intervention Measure
Description
Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire
Time Frame
Through therapy completion, an average of 8 weeks following baseline
Title
Provider level: Provider-rated TranS-C Checklist
Description
A measure of the TranS-C elements that are delivered. This is completed by the therapist at the end of every treatment session
Time Frame
Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
Title
Provider level: Memory Support Treatment Provider Checklist
Description
A measure of memory support delivered. This is completed by the therapist at the end of every treatment session
Time Frame
Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
Title
Provider level: Patient adherence via the TARS
Description
A measure of patient treatment adherence completed by the therapist at the end of every treatment session
Time Frame
Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
Title
Provider level: Memory Support Rating Scale, total amount
Description
Assesses the total amount of memory support used by a provider via coding of session tapes
Time Frame
Randomly selected therapy tapes
Title
Provider level: Memory Support Rating Scale, number of types
Description
Assesses the number of types of memory support used by a provider via coding of session tapes
Time Frame
Randomly selected therapy tapes
Other Pre-specified Outcome Measures:
Title
WatchPAT One
Description
For participants who screen positive for obstructive sleep apnea, WatchPAT One will be offered to determine eligibility
Time Frame
Baseline only
Title
Adverse events checklist
Description
To assess any adverse events experienced as a result of participating in the study
Time Frame
Only at post-treatment which is 8-10 weeks after the beginning of treatment
Title
Montreal Cognitive Assessment (MoCA)
Description
A measure of cognitive functioning/cognitive impairments to determine eligibility
Time Frame
Baseline only
Title
Credibility Expectancy Questionnaire
Description
Measures the credibility and expectation of improvement from the treatment. Scores can range from 9- 81 with higher scores indicating higher treatment satisfaction.
Time Frame
At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment
Title
Structured Clinical Interview for Sleep Disorders
Description
Measures sleep and circadian diagnoses according to DSM-5
Time Frame
Baseline only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. 26-30 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 (AHI>30) or moderate (AHI of 15-30) untreated OSA; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison Harvey, PhD
Phone
5106427138
Email
aharvey@berkeley.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Harvey, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-1650
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Harvey, PhD
Phone
510-642-7138
Email
aharvey@berkeley.edu
First Name & Middle Initial & Last Name & Degree
Nena Salazar
Phone
‪(925) 421-0083‬
Email
n.salazar@berkeley.edu

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs