NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment

NCT05986604 | Recruiting

• 1 other identifier: TranS-C+MSI vs. TranS-C Alone
• Study Type: interventional
• Target: 178
• 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 50 years and older to assess if a novel 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; Memory Impairment

Outcome Measures

Primary Outcomes (3)

• 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 to 6-month follow-up to 12-month follow-up

• 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 to 6-month follow-up to 12-month follow-up

• 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 to 6-month follow-up to 12-month follow-up

Secondary Outcomes (23)

• Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

• Positive and Negative Affect Scale

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

• WHODAS 2.0

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

• Cognitive Failures Questionnaire

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

• Epworth Sleepiness Scale

  Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment to 6-month follow-up to 12-month follow-up

Other Outcomes (6)

• WatchPAT One

  Baseline only

• Adverse events checklist

  Only at post-treatment which is 8-10 weeks after the beginning of treatment

• Montreal Cognitive Assessment (MoCA)

  Baseline only

Study Arms (2)

TranS-C+MSI

EXPERIMENTAL

Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention

Behavioral: Memory Support Intervention; Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction

TranS-C alone

ACTIVE COMPARATOR

The Transdiagnostic Sleep and Circadian Intervention will be delivered alone

Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction

Interventions

Memory Support Intervention BEHAVIORAL

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.

Also known as: MSI

TranS-C+MSI

Transdiagnostic Intervention for Sleep and Circadian Dysfunction BEHAVIORAL

TranS-C aims to provide one protocol to treat a range of sleep and circadian problems because sleep and circadian problems are often not so neatly categorized and because the existing research provides few guidelines to treat more complex patients.

Also known as: TranS-C

TranS-C alone; TranS-C+MSI

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50 years and older;
• English language fluency;
• Experiencing a mobility impairment;
• Low income;
• 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.
• on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment.
• Able/willing to give informed consent.

You may not qualify if:

• Severe untreated sleep disordered breathing (AHI\>30) or moderate untreated sleep disordered breathing with severe daytime sleepiness (AHI of 15-30 and Epworth Sleepiness Scale \>10);
• Medical conditions that prevent a participant from comprehending and following the basic tenants of treatment (e.g., dementia) or that interfere with sleep in a manner that can't be addressed by a cognitive behavioral treatment (e.g., the Structured Clinical Interview for Sleep Disorders will be used to screen for narcolepsy, REM sleep behavior disorder) or that may preclude full participation (e.g., receipt of end of life care);
• Homelessness;
• Night shift work \>2 nights per week in the past 3 months;
• Substance abuse/dependence only if it makes participation in the study unfeasible;
• 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

RECRUITING

Related Publications (1)

• Milner AE, Hache RE, Oliver S, Sarfan LD, Spencer JM, Cogan A, Jiang Y, Agnew ER, Zieve GG, Martin JL, Zeidler MR, Dong L, Carpenter JK, Varghese J, Bol K, Bajwa Z, Tighe CA, Harvey AG. Integrating the Memory Support Intervention into the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): can improving memory for treatment in midlife and older adults improve patient outcomes? Study protocol for a randomized controlled trial. Trials. 2024 Oct 3;25(1):650. doi: 10.1186/s13063-024-08468-0.

  PMID: 39363383 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Chronobiology Disorders; Memory Disorders

Interventions

Sleep

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Allison Harvey, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Harvey, PhD

CONTACT

5106427138; aharvey@berkeley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: January 4, 2024
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): July 28, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)