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

NCT ID: NCT04373538

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2021-06-25

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.

Conditions

Sleep Disorder; Circadian Dysregulation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Memory Support Intervention

Group Type: EXPERIMENTAL

Trans-C for sleep and circadian function + Memory Support

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Allison Harvey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Harvey, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

University of California, Berkeley

Berkeley, California, United States

Countries

United States

Other Identifiers

TranS-C and MSI

Identifier Type: -

Identifier Source: org_study_id