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Clinical Trials/NCT05986604
NCT05986604
Recruiting
Not Applicable

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

University of California, Berkeley1 site in 1 country178 target enrollmentJanuary 4, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disorder
Sponsor
University of California, Berkeley
Enrollment
178
Locations
1
Primary Endpoint
Satisfaction with Life Scale
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2024
End Date
July 28, 2028
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Allison Harvey

Professor

University of California, Berkeley

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Satisfaction with Life Scale

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

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.

Patient-Reported Outcomes Measurement Information System - Sleep Disturbance

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

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

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

Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment

Secondary Outcomes

  • Mean for total wake time (Actigraphy)(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
  • Provider level: Appropriateness Intervention Measure(Through therapy completion, an average of 8 weeks following baseline)
  • Provider level: Memory Support Rating Scale, number of types(Randomly selected therapy tapes)
  • Mean for daytime activity (Actigraphy)(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
  • Provider level: Acceptability of Intervention Measure(Through therapy completion, an average of 8 weeks following baseline)
  • Provider level: Provider-rated TranS-C Checklist(Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks)
  • Provider level: Memory Support Rating Scale, total amount(Randomly selected therapy tapes)
  • Positive and Negative Affect Scale(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(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])
  • Provider level: Memory Support Treatment Provider Checklist(Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks)
  • Provider level: Patient adherence via the TARS(Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks)
  • WHODAS 2.0(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(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)
  • Thoughts and Applications 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])
  • Mean total wake time (Daily Sleep Diary)(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)(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 (Actigraphy)(Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment)
  • Provider level: Feasibility of Intervention Measure(Through therapy completion, an average of 8 weeks following baseline)
  • Patient-Reported Outcomes Measurement Information System - Sleep Related 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(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(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 Utilization Scale(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)(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)

Study Sites (1)

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