Recruiting

Transdiagnostic Treatment

Sponsor:

UCLA

Code:

NCT05986604

Conditions

Sleep Disorder

Circadian Dysregulation

Memory Impairment

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

Memory Support Intervention

Transdiagnostic Intervention for Sleep and Circadian Dysfunction

Study Details

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

Study ID

NCT05986604

Start date

Jan 4, 2024

Status verified date

Nov, 2025

Completion date

Jul 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion criteria:

1. Aged 50 years and older;
2. English language fluency;
3. Experiencing a mobility impairment;
4. Low income;
5. 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.
6. 25-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment.
7. Able/willing to give informed consent.

Exclusion criteria:

1. 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);
2. 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);
3. Homelessness;
4. Night shift work >2 nights per week in the past 3 months;
5. Substance abuse/dependence only if it makes participation in the study unfeasible;
6. Suicide risk sufficient to preclude treatment on an outpatient basis.

Study Design

Enrollment

178 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TranS-C+MSI

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

active comparator: TranS-C alone

The Transdiagnostic Sleep and Circadian Intervention will be delivered alone

Interventions

Memory Support Intervention

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.

Transdiagnostic Intervention for Sleep and Circadian Dysfunction

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.

Primary outcome measure

  • Patient-Reported Outcomes Measurement Information System - Sleep Disturbance [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Locations

University of California, Berkeley

Recruiting

Berkeley, California, United States, 94720-1650

Contacts

More Information

Sponsor

University of California, Berkeley

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Berkeley on 2025-11-24.