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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Circadian Dysregulation
• Intervention / Treatment: Behavioral: Trans-C for sleep and circadian function + Memory Support

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720-1650
      • University of California, Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Memory Support Intervention

Behavioral: Trans-C for sleep and circadian function + Memory Support; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Perceived Stress Scale	Individual scores on the Perceived Stress Scale can range from 0-40 with higher scores indicating higher perceived stress	Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
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
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.	At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment
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.	Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
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
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
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	Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
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	Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
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
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
Memory for Treatment	Recall on the Patient Treatment Recall Task	At post-treatment, which is 8-10 weeks after the beginning of treatment
Generalization Task Questionnaire	Measures how treatment gains sustained during therapy have generalized to the participant's thinking and functioning during every day life	Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Acceptability Intervention Measure	Assess provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire	Through therapy completion, an average of 8 weeks
Intervention Appropriateness Measure	Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire	Through therapy completion, an average of 8 weeks
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
STOP-BANG Questionnaire	Scores range from 0-8 with higher scores associated with higher risk of experiencing sleep apnea	Baseline only
Screen for periodic limb movement disorder	Restless Leg Syndrome Questions	Baseline only
Medication Dosage	Collect dose, type, frequency and changes in medications	Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Medication Type		Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Medication Use Frequency		Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Change in Medications		Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Semi-structured interview	Assess patient perceptions of treatment	Only at post-treatment which is 8-10 weeks after the beginning of treatment

Collaborators and Investigators

• Sponsor: University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ACTUAL): January 15, 2021
• Study Completion (ACTUAL): June 25, 2021

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (ACTUAL): May 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Chronobiology Disorders
• Other Study ID Numbers: TranS-C and MSI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No