Memory ImpairmentNCT05668481
Improving Patient Memory for Treatment for Mild Cognitive Impairment
A study testing Transdiagnostic sleep and circadian intervention (TranS-C) in people with Memory Impairment and Sleep Disorder, run by University of California, Berkeley at 1 site in United States.
Trial summary
The main empirical question to be addressed is: What types of memory support are most potent for patients who are experiencing a mild cognitive impairment (MCI) relative to non-MCI patients? Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Memory Impairment, Sleep Disorder
- What is being tested?
- Transdiagnostic sleep and circadian intervention (TranS-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants 60 years and older will be recruited.
- Fluent in English.
- Experiencing some difficulties relating to sleep and circadian functioning and (d) a score of 19-25 on the Montreal Cognitive Assessment (for the MCI group) and score 26-30 on the Montreal Cognitive Assessment (for the non-MCI group) (e) Have a computer to use and an internet connection and (f) be able to attend sessions weekly and on the same day each week.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720-1650
About this study
Official title: Improving Memory for Treatment for Patients Experiencing Mild Cognitive Impairment: Are Constructive or Non-constructive Memory Supports More Helpful?
The main empirical question to be addressed is: What types of memory support are most potent for patients who are experiencing a mild cognitive impairment (MCI) relative to non-MCI patients?
Read the detailed description
People experiencing mild cognitive impairment (MCI) may benefit from adding memory support to treatment-as-usual. Adding memory support may be an innovative way to improve patient memory for treatment, adherence to treatment and outcome.
The key question is: What types of memory support are most potent for MCI patients relative to non-MCI patients?
The aim of the proposed research is to assess patient memory for treatment and the impact of adding memory support for people who are and are not experiencing MCI. The investigators will also compare the effectiveness of constructive vs. non-constructive memory supports for people who are experiencing MCI compared to people who are not experiencing MCI.
Hypotheses:
- Recall of the content of treatment will be lower in the MCI group relative to the non-MCI group.
- Constructive memory support will be more effective for the non-MCI group relative to the MCI group.
- Non-constructive memory support will be more effective for the MCI group relative to the non-MCI group.
The outcomes are: (1) patient memory for the content of treatment session and (2) the number and accuracy of thoughts and applications of the therapy points delivered. The investigators will also collect ratings of the acceptability of the treatment and the memory supports that are delivered.
This dataset will also be used to better understand the sleep and circadian challenges that people with and without MCI report via the SCID for sleep disorders and the PROMIS scales.
- Conditions
- Memory Impairment, Sleep Disorder
- Being tested
- Transdiagnostic sleep and circadian intervention (TranS-C)
- Keywords
- mild cognitive impairment, sleep and circadian functioning, improving treatment outcome
- Medical subject headings
- Memory Disorders, Sleep Wake Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic sleep and circadian intervention (TranS-C)Behavioural
TranS-C is a psychosocial treatment that helps people who have sleep and circadian problems to improve their sleep health.
| Study group | Role | What they receive |
|---|---|---|
| Constructive memory support | Active comparator | Participants will watch videos of a sleep expert delivering treatment components from the Transdiagnostic Sleep and Circadian Intervention (TranS-C). After each video, a team member will deliver constructive memory supports. Receives: Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C) |
| Non-constructive memory support | Active comparator | Participants will watch videos of a sleep expert delivering treatment components from the Transdiagnostic Sleep and Circadian Intervention (TranS-C). After each video, a team member will deliver non-constructive memory supports. Receives: Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of items recalled on the free recall task to assess outcome for constructive memory support
Assesses patient memory for treatment
Measured: Delivered two times: At the session in which constructive memory supports were used (baseline) and 1 week later.
Number of items recalled on the free recall task to assess outcome for non-constructive memory support
Assesses patient memory for treatment
Measured: Delivered two times: At the end of the session in which non-constructive memory supports were used (baseline) and 1 week later.
Number and accuracy of thoughts about the material covered in the prior treatment session in which constructive memory supports were delivered
To assess if the participant thought about the therapy session and if the thoughts accurately reflected the prior treatment session
Measured: Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports
Number and accuracy of thoughts about the material covered in the prior treatment session in which non-constructive memory supports were delivered
To assess if the participant thought about the therapy session and if the thoughts accurately reflected the prior treatment session
Measured: Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports
Number and accuracy of applications of the material covered in the prior treatment session in which constructive memory supports were delivered
To assess if the participant applied the material covered in the therapy session and if the participant accurately applied the material prior treatment session
Measured: Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports
Number and accuracy of applications of the material covered in the prior treatment session in which non-constructive memory supports were delivered
To assess if the participant applied the material covered in the therapy session and if the participant accurately applied the material prior treatment session
Measured: Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports
Secondary outcomes (1)
Acceptability of constructive memory support
Participants will be asked to rate the "How acceptable were the memory supports we asked you through this session?" The participant will then provide a rating from "1" Not at all acceptable to "9" Very acceptable.
Measured: One time point: At the end of the treatment session in which constructive memory support was delivered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start19 May 2023
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ImpairmentStudies 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
- Crossover
- Model description
- Participants will be randomized to receive constructive memory supports in Session 1 OR to receive non-constructive memory supports in Session 1. In Session 2, participants will receive the type of memory support they did not receive in Session 1. In other words, if a participant received constructive memory support in Session 1, in Session 2 they will receive non-constructive memory support. And if a participant received non-constructive memory support in Session 1, in Session 2 they will receive constructive memory support. This cross-over design was adopted to increase the number of observations of the constructive and non-constructive memory support.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668481
- Sponsor's protocol ID
- Protocol 2022-12-15881
- Status last verified
- Jul 2025
- First submitted
- 12 Dec 2022
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Memory for Treatment for Patients Experiencing Mild Cognitive Impairment: Are Constructive or Non-constructive Memory Supports More Helpful?
- ClinicalTrials.gov ID
- NCT05668481
- Acronym / sponsor ID
- Protocol 2022-12-15881
- Conditions
- Memory Impairment, Sleep Disorder
- Keywords
- mild cognitive impairment, sleep and circadian functioning, improving treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 19 May 2023 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 29 Dec 2022 (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.
The main empirical question to be addressed is: What types of memory support are most potent for patients who are experiencing a mild cognitive impairment (MCI) relative to non-MCI patients?
Detailed description
People experiencing mild cognitive impairment (MCI) may benefit from adding memory support to treatment-as-usual. Adding memory support may be an innovative way to improve patient memory for treatment, adherence to treatment and outcome.
The key question is: What types of memory support are most potent for MCI patients relative to non-MCI patients?
The aim of the proposed research is to assess patient memory for treatment and the impact of adding memory support for people who are and are not experiencing MCI. The investigators will also compare the effectiveness of constructive vs. non-constructive memory supports for people who are experiencing MCI compared to people who are not experiencing MCI.
Hypotheses:
- Recall of the content of treatment will be lower in the MCI group relative to the non-MCI group.
- Constructive memory support will be more effective for the non-MCI group relative to the MCI group.
- Non-constructive memory support will be more effective for the MCI group relative to the non-MCI group.
The outcomes are: (1) patient memory for the content of treatment session and (2) the number and accuracy of thoughts and applications of the therapy points delivered. The investigators will also collect ratings of the acceptability of the treatment and the memory supports that are delivered.
This dataset will also be used to better understand the sleep and circadian challenges that people with and without MCI report via the SCID for sleep disorders and the PROMIS scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive constructive memory supports in Session 1 OR to receive non-constructive memory supports in Session 1. In Session 2, participants will receive the type of memory support they did not receive in Session 1. In other words, if a participant received constructive memory support in Session 1, in Session 2 they will receive non-constructive memory support. And if a participant received non-constructive memory support in Session 1, in Session 2 they will receive constructive memory support. This cross-over design was adopted to increase the number of observations of the constructive and non-constructive memory support.
| Arm | Type | Receives |
|---|---|---|
| Constructive memory support | Active comparator | Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C)Participants will watch videos of a sleep expert delivering treatment components from the Transdiagnostic Sleep and Circadian Intervention (TranS-C). After each video, a team member will deliver constructive memory supports. |
| Non-constructive memory support | Active comparator | Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C)Participants will watch videos of a sleep expert delivering treatment components from the Transdiagnostic Sleep and Circadian Intervention (TranS-C). After each video, a team member will deliver non-constructive memory supports. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants 60 years and older will be recruited.
- Fluent in English.
- Experiencing some difficulties relating to sleep and circadian functioning and (d) a score of 19-25 on the Montreal Cognitive Assessment (for the MCI group) and score 26-30 on the Montreal Cognitive Assessment (for the non-MCI group) (e) Have a computer to use and an internet connection and (f) be able to attend sessions weekly and on the same day each week.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Transdiagnostic sleep and circadian intervention (TranS-C)TranS-C is a psychosocial treatment that helps people who have sleep and circadian problems to improve their sleep health. | Behavioural | Constructive memory support, Non-constructive memory support |
Primary outcome
Number of items recalled on the free recall task to assess outcome for constructive memory support
Time frame: Delivered two times: At the session in which constructive memory supports were used (baseline) and 1 week later.
Assesses patient memory for treatment
Number of items recalled on the free recall task to assess outcome for non-constructive memory support
Time frame: Delivered two times: At the end of the session in which non-constructive memory supports were used (baseline) and 1 week later.
Assesses patient memory for treatment
Number and accuracy of thoughts about the material covered in the prior treatment session in which constructive memory supports were delivered
Time frame: Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports
To assess if the participant thought about the therapy session and if the thoughts accurately reflected the prior treatment session
Number and accuracy of thoughts about the material covered in the prior treatment session in which non-constructive memory supports were delivered
Time frame: Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports
To assess if the participant thought about the therapy session and if the thoughts accurately reflected the prior treatment session
Number and accuracy of applications of the material covered in the prior treatment session in which constructive memory supports were delivered
Time frame: Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports
To assess if the participant applied the material covered in the therapy session and if the participant accurately applied the material prior treatment session
Number and accuracy of applications of the material covered in the prior treatment session in which non-constructive memory supports were delivered
Time frame: Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports
To assess if the participant applied the material covered in the therapy session and if the participant accurately applied the material prior treatment session
1 secondary outcome
Acceptability of constructive memory support
Time frame: One time point: At the end of the treatment session in which constructive memory support was delivered
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic sleep and circadian intervention (TranS-C) in people with Memory Impairment and Sleep Disorder, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of items recalled on the free recall task to assess outcome for constructive memory support (time frame: Delivered two times: At the session in which constructive memory supports were used (baseline) and 1 week later.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2025.