Sleep DisorderNCT05986604
NIA_Improving Function and Well-being by Improving Patient Memory: Transdiagnostic Sleep and Circadian Treatment
A study testing Memory Support Intervention and Transdiagnostic Intervention for Sleep and Circadian Dysfunction in people with Sleep Disorder and Circadian Dysregulation, run by University of California, Berkeley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Circadian Dysregulation, Memory Impairment
- What is being tested?
- Memory Support Intervention and Transdiagnostic Intervention for Sleep and Circadian Dysfunction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2024to 28 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 25-30 on the Montreal Cognitive Assessment, as a negative screen for cognitive impairment.
- Able/willing to give informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Berkeley
Berkeley, California, 94720-1650
Allison Harvey, PhD, 510-642-7138, aharvey@berkeley.edu
Nena Salazar, (925) 421-0083, n.salazar@berkeley.edu
About this study
Official title: NIA_Improving Sleep and Circadian Functioning, Daytime Functioning, and Well-being for Midlife and Older Adults by Improving Patient Memory for a Transdiagnostic Sleep and Circadian 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.
Read the detailed description
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.
- Conditions
- Sleep Disorder, Circadian Dysregulation, Memory Impairment
- Being tested
- Memory Support Intervention, Transdiagnostic Intervention for Sleep and Circadian Dysfunction
- Medical subject headings
- Sleep Wake Disorders, Chronobiology Disorders, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory Support InterventionBehavioural
Also called MSI
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 DysfunctionBehavioural
Also called TranS-C
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.
| Study group | Role | What they receive |
|---|---|---|
| TranS-C+MSI | Experimental | Transdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention Receives: 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 Receives: Behavioral: Transdiagnostic Intervention for Sleep and Circadian Dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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
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).
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Randomly selected therapy tapes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start4 Jan 2024
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Harvey, University of California, Berkeley
- Investigators
- Allison Harvey, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986604
- Sponsor's protocol ID
- TranS-C+MSI vs. TranS-C Alone
- Status last verified
- Nov 2025
- First submitted
- 2 Aug 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39363383
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIA_Improving Sleep and Circadian Functioning, Daytime Functioning, and Well-being for Midlife and Older Adults by Improving Patient Memory for a Transdiagnostic Sleep and Circadian Treatment
- ClinicalTrials.gov ID
- NCT05986604
- Acronym / sponsor ID
- TranS-C+MSI vs. TranS-C Alone
- Conditions
- Sleep Disorder, Circadian Dysregulation, Memory Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Jul 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to TranS-C plus the MSI ("TranS-C+MSI") or TranS-C alone
| Arm | Type | Receives |
|---|---|---|
| TranS-C+MSI | Experimental | Behavioral: Memory Support Intervention, Behavioral: Transdiagnostic Intervention for Sleep and Circadian DysfunctionTransdiagnostic Intervention for Sleep and Circadian Dysfunction will be combined with the Memory Support Intervention |
| TranS-C alone | Active comparator | Behavioral: Transdiagnostic Intervention for Sleep and Circadian DysfunctionThe Transdiagnostic Sleep and Circadian Intervention will be delivered alone |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory Support InterventionAlso: MSIThe 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. | Behavioural | TranS-C+MSI |
| Transdiagnostic Intervention for Sleep and Circadian DysfunctionAlso: TranS-CTranS-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. | Behavioural | TranS-C alone, TranS-C+MSI |
Primary outcome
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
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).
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
Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment
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
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.
23 secondary outcomes
Patient-Reported Outcomes Measurement Information System - Sleep Related 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
Positive and Negative Affect 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
WHODAS 2.0
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
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
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
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
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
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
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)
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)
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)
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)
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Mean for total sleep time (Actigraphy)
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Mean for daytime activity (Actigraphy)
Time frame: Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment
Provider level: Acceptability of Intervention Measure
Time frame: Through therapy completion, an average of 8 weeks following baseline
Provider level: Appropriateness Intervention Measure
Time frame: Through therapy completion, an average of 8 weeks following baseline
Provider level: Feasibility of Intervention Measure
Time frame: Through therapy completion, an average of 8 weeks following baseline
Provider level: Provider-rated TranS-C Checklist
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
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
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
Time frame: Randomly selected therapy tapes
Provider level: Memory Support Rating Scale, number of types
Time frame: Randomly selected therapy tapes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 39363383Milner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Harvey, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory Support Intervention and Transdiagnostic Intervention for Sleep and Circadian Dysfunction in people with Sleep Disorder and Circadian Dysregulation, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Harvey, PhD (5106427138, aharvey@berkeley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05986604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.