An interventional study of Memory Support Intervention and Transdiagnostic Intervention for Sleep and Circadian Dysfunction in Sleep Disorder, Circadian Dysregulation and Memory Impairment, sponsored by University of California, Berkeley. Recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of California, Berkeley · Not applicable, Interventional, and Treatment
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.
Life expectancy has increased drastically in the United States. Longer life is too often associated with illness, discomfort, disability, and dependency. Progress toward promoting health and well-being as we age must include the identification of novel treatment targets that are safe, powerful, inexpensive, and deployable. The proposed research will test one such target-patient memory for the contents of treatment.
Over 5 years, we will recruit adults who are 50 years and older and who are experiencing sleep and circadian problems (n = 178, including 20% for attrition). Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone via eight 50-minute, weekly, individual sessions. Assessments will be conducted at baseline, post-treatment, and at 6- and 12-month follow-up (6FU and 12FU).
Specific Aim 1: To evaluate if adding the MSI to TranS-C (a) improves sleep and circadian functioning, (b) improves daytime functioning, (c) improves well-being and (d) improves patient memory by comparing the effects of TranS-C+MSI vs. TranS-C alone. Hypothesis 1. Compared to TranS-C alone, people who receive TranS-C+MSI will improve more on all outcomes at post-treatment, 6FU and 12FU.
Specific Aim 2: To evaluate if patient memory for treatment mediates the relation between treatment condition and sleep and circadian functioning. Hypothesis 2. TranS-C+MSI will be associated with better memory for treatment relative to TranS-C alone, and in turn, better memory for treatment will be associated with better sleep and circadian functioning immediately following treatment and at 6FU and 12FU.
Specific Aim 3: To evaluate if subgroups hypothesized to derive added benefit from memory support moderate (a) patient memory for treatment and (b) treatment outcome. Hypothesis 3. Treatment effects for TranS-C+MSI will be larger at post-treatment for those who are older, have fewer years of education, poorer baseline cognitive functioning and more severe baseline sleep disruption and sleep-related impairment.
Exploratory analyses will compare the treatments on (a) patient adherence as well as patient-rated treatment credibility and utilization of treatment elements and (b) provider-rated acceptability, appropriateness, and feasibility.
747 studies on the registry are indexed under Sleep Wake Disorders; 182 are open to participants now.
This study's planned enrollment of 178 is above the median of 66 across 531 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →University of California, Berkeley is the lead sponsor of 111 studies on the registry; 20 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The Transdiagnostic Sleep and Circadian Intervention will be delivered alone
Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction
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 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
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).
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
Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment
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
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.
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
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).
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
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
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
WHODAS 2.0
A measure of functional impairment
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
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.
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
Epworth Sleepiness Scale
Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
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
Memory for Treatment: Cumulative recall
Recall on the Patient Treatment Recall Task
Time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
Thoughts and Applications Task
Measures how treatment points have generalized to the participant's thinking and functioning during every day life
Time frame: Week 4 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 8-10 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up]
Adapted Utilization Scale
19-item; 0-4 scale. Scores can range from 0 to 76 (Higher score means more utilization).
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
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).
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
Mean sleep efficiency (Daily Sleep Diary)
Daily Sleep Diary mean for sleep efficiency (total sleep time/time in bed X 100)
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
Mean total wake time (Daily Sleep Diary)
Daily Sleep Diary mean for total wake time defined as sleep onset latency + wake after sleep onset + Early morning awakening
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
Mean for total sleep time (Daily Sleep Diary)
Daily Sleep Diary mean for total sleep time
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
Mean for total wake time (Actigraphy)
Actigraphy mean for total wake time defined as sleep onset latency + wake after sleep onset + early morning awakening
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Mean for total sleep time (Actigraphy)
Actigraphy mean for total sleep time
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Mean for daytime activity (Actigraphy)
Actigraphy mean for daytime activity
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Provider level: Acceptability of Intervention Measure
Assess provider perceptions of the acceptability of the treatment intervention using a self-report questionnaire
Time frame: Through therapy completion, an average of 8 weeks following baseline
Provider level: Appropriateness Intervention Measure
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire
Time frame: Through therapy completion, an average of 8 weeks following baseline
Provider level: Feasibility of Intervention Measure
Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire
Time frame: Through therapy completion, an average of 8 weeks following baseline
Provider level: Provider-rated TranS-C Checklist
A measure of the TranS-C elements that are delivered. This is completed by the therapist at the end of every treatment session
Time frame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
Provider level: Memory Support Treatment Provider Checklist
A measure of memory support delivered. This is completed by the therapist at the end of every treatment session
Time frame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
Provider level: Patient adherence via the TARS
A measure of patient treatment adherence completed by the therapist at the end of every treatment session
Time frame: Every treatment session which is 8 sessions, spaced one week apart for approximately 8-10 weeks
Provider level: Memory Support Rating Scale, total amount
Assesses the total amount of memory support used by a provider via coding of session tapes
Time frame: Randomly selected therapy tapes
Provider level: Memory Support Rating Scale, number of types
Assesses the number of types of memory support used by a provider via coding of session tapes
Time frame: Randomly selected therapy tapes
WatchPAT One
For participants who screen positive for obstructive sleep apnea, WatchPAT One will be offered to determine eligibility
Time frame: Baseline only
Side effects checklist
To assess any side effects experienced as a result of participating in the study
Time frame: Only at post-treatment which is 8-10 weeks after the beginning of treatment
Montreal Cognitive Assessment (MoCA)
A measure of cognitive functioning/cognitive impairments to determine eligibility
Time frame: Baseline only
Adapted Credibility Expectancy Questionnaire
Measures the credibility and expectation of improvement from the treatment.
Time frame: At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment
Structured Clinical Interview for Sleep Disorders
Measures sleep and circadian diagnoses according to DSM-5
Time frame: Baseline only
Adapted Brief Disability Questionnaire
A measure of functional impairment
Time frame: Baseline only
Started Jan 2024 (actual). Primary completion is estimated for Feb 2028, 49 months after the start.
Of 208 non-industry interventional studies with no phase under Sleep Wake Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 40. This study's planned 49 months is above that.
Counting every sponsor, half of 243 studies reached it within 19 months; a quarter within 6 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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