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

NCT04373538 | Completed

• 1 other identifier: TranS-C and MSI
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder; Circadian Dysregulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Positive and Negative Affect Scale

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

• Perceived Stress Scale

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

• Satisfaction with Life Scale

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

• Credibility Expectancy Questionnaire

  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)

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

Other Outcomes (7)

• STOP-BANG Questionnaire

  Baseline only

• Screen for periodic limb movement disorder

  Baseline only

• Medication Dosage

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment

Study Arms (1)

Memory Support Intervention

EXPERIMENTAL

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

Interventions

Trans-C for sleep and circadian function + Memory Support BEHAVIORAL

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.

Memory Support Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720-1650, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Chronobiology Disorders

Interventions

Sleep

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Allison Harvey, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 4, 2020
• Study Start: May 1, 2020
• Primary Completion: January 15, 2021
• Study Completion: June 25, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

US (1)