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Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction

Primary Purpose

Sleep Disorder, Circadian Dysregulation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trans-C for sleep and circadian function + Memory Support
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sleep Disorder

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 55 years and older
  • English language fluency
  • 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

Exclusion Criteria:

  • Presence of an active and progressive mental or physical illness or neurological degenerative disease
  • Night shift work >2 nights per week in the past 3 months
  • Not able and willing to participate in and/or complete the assessments and participate in the treatment
  • Current suicide risk sufficient to preclude treatment on an outpatient basis

Sites / Locations

  • University of California, Berkeley

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Memory Support Intervention

Arm Description

Outcomes

Primary Outcome Measures

Patient-level outcome: 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

Secondary Outcome Measures

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
Perceived Stress Scale
Individual scores on the Perceived Stress Scale can range from 0-40 with higher scores indicating higher perceived stress
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.
Credibility Expectancy Questionnaire
Measures the credibility and expectation of improvement from the treatment. Scores can range from 9- 81 with higher scores indicating higher treatment satisfaction.
Means and Variability of sleep efficiency (Daily Sleep Diary)
Daily Sleep Diary means and variability for sleep efficiency (total sleep time/time in bed X 100), Total sleep time (TST), Total wake time (TWT), bedtime, waketime.
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).
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).
British Columbia Complaints Inventory
Assessed perceived cognitive difficulties, scale consists of 6 items. Scores can range from 0-18 with higher scores indicating higher levels of perceived cognitive difficulties
Mutlidimensional Fatigue Inventory
20-item scale designed to evaluate five dimensions of fatigue. Scores can range from 20-100 with higher total scores corresponding with more acute levels of fatigue
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
Recall on the Patient Treatment Recall Task
Generalization Task Questionnaire
Measures how treatment gains sustained during therapy have generalized to the participant's thinking and functioning during every day life
Acceptability Intervention Measure
Assess provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire
Intervention Appropriateness Measure
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire
Feasibility of Intervention Measure
Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire

Full Information

First Posted
April 24, 2020
Last Updated
September 27, 2021
Sponsor
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT04373538
Brief Title
Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction
Official Title
A Pilot Study for Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)

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 55 years and older to assess if a simplified version of the Memory Support Intervention improves sleep and circadian functioning, reduces functional impairment, and improves patient memory for treatment.
Detailed Description
Given the huge burden associated with mental illness, a major challenge ahead is to hasten progress toward developing and testing highly efficient and effective interventions for psychological health problems. Progress toward establishing evidence-based psychosocial treatments for most types of mental illness has been excellent, particularly the cognitive and behavioral treatments (CBT). However, much work remains. The effect sizes are moderate, gains may not persist, and there are patients who derive little or no benefit. Even under optimal conditions, treatment failure is too common. Hence, the challenge is to improve outcomes. Seminal progress toward meeting this challenge must include innovations that are safe, powerful, inexpensive and simple (for fast and effective dissemination). The proposed research seeks to extend the investigators' program of research on one such innovation. With an R34 and an R01 from NIMH, the investigators have been seeking to improve outcome by improving memory for the content of therapy sessions. To achieve this goal, the investigators have developed and adapted existing findings from the education and cognitive science literatures. The resulting Memory Support Intervention (MSI) involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory. This line of research arises from several lines of evidence: (a) memory for the content of therapy sessions is poor and (b) memory impairment is modifiable. Although the outcomes will be relevant to psychosocial treatments for a broad range of problems, the focus of this proposal is one treatment for sleep and circadian dysfunction because (a) sleep problems are one of the most prevalent psychological health problems, (b) there is substantial and promising evidence for the efficacy of the transdiagnostic sleep and circadian (TranS-C), yet there is also room for improvement in outcome and (c) sleep problems are associated with memory impairment. This pilot study will be conducted in order to collect data on individuals who are 55 years and older because memory functioning can decline over this phase of the lifespan. Sleep and circadian problems are also common. The aim is: To conduct an open trial that includes n = 40 individuals 55 years and older to assess if the Memory Support Intervention (a) improves sleep and circadian functioning, (b) reduces functional impairment and (c) improves patient memory for treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Support Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Trans-C for sleep and circadian function + Memory Support
Intervention Description
The Memory Support Intervention will be delivered interwoven with Trans-C. 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.
Primary Outcome Measure Information:
Title
Patient-level outcome: 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
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
Secondary Outcome Measure Information:
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
Title
Perceived Stress Scale
Description
Individual scores on the Perceived Stress Scale can range from 0-40 with higher scores indicating higher perceived stress
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
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
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
Means and Variability of sleep efficiency (Daily Sleep Diary)
Description
Daily Sleep Diary means and variability 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
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
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
Title
British Columbia Complaints Inventory
Description
Assessed perceived cognitive difficulties, scale consists of 6 items. Scores can range from 0-18 with higher scores indicating higher levels of perceived cognitive difficulties
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Mutlidimensional Fatigue Inventory
Description
20-item scale designed to evaluate five dimensions of fatigue. Scores can range from 20-100 with higher total scores corresponding with more acute levels of fatigue
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
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
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
Title
Memory for Treatment
Description
Recall on the Patient Treatment Recall Task
Time Frame
At post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Generalization Task Questionnaire
Description
Measures how treatment gains sustained during therapy have generalized to the participant's thinking and functioning during every day life
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Acceptability Intervention Measure
Description
Assess provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire
Time Frame
Through therapy completion, an average of 8 weeks
Title
Intervention Appropriateness 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
Title
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
Other Pre-specified Outcome Measures:
Title
STOP-BANG Questionnaire
Description
Scores range from 0-8 with higher scores associated with higher risk of experiencing sleep apnea
Time Frame
Baseline only
Title
Screen for periodic limb movement disorder
Description
Restless Leg Syndrome Questions
Time Frame
Baseline only
Title
Medication Dosage
Description
Collect dose, type, frequency and changes in medications
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Medication Type
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Medication Use Frequency
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Change in Medications
Time Frame
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Title
Semi-structured interview
Description
Assess patient perceptions of treatment
Time Frame
Only at post-treatment which is 8-10 weeks after the beginning of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 55 years and older English language fluency 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 Exclusion Criteria: Presence of an active and progressive mental or physical illness or neurological degenerative disease Night shift work >2 nights per week in the past 3 months Not able and willing to participate in and/or complete the assessments and participate in the treatment Current suicide risk sufficient to preclude treatment on an outpatient basis
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

12. IPD Sharing Statement

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Improving Well-being by Improving Memory for Treatment for Sleep and Circadian Dysfunction

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