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

Sleep Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04373538
• Other study ID #: TranS-C and MSI
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: June 25, 2021

Study information

• Verified date: September 2021
• Source: University of California, Berkeley
• Contact: n/a
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 25, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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.

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	STOP-BANG Questionnaire	Scores range from 0-8 with higher scores associated with higher risk of experiencing sleep apnea	Baseline only
Other	Screen for periodic limb movement disorder	Restless Leg Syndrome Questions	Baseline only
Other	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
Other	Medication Type		Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Other	Medication Use Frequency		Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Other	Change in Medications		Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Other	Semi-structured interview	Assess patient perceptions of treatment	Only at post-treatment which is 8-10 weeks after the beginning of treatment
Primary	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
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
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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
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
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
Secondary	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
Secondary	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
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
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
Secondary	Memory for Treatment	Recall on the Patient Treatment Recall Task	At post-treatment, which is 8-10 weeks after the beginning of treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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