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Improving Patient Memory for Treatment for Mild Cognitive Impairment

Improving Memory for Treatment for Patients Experiencing Mild Cognitive Impairment: Are Constructive or Non-constructive Memory Supports More Helpful?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05668481
Enrollment
119
Registered
2022-12-29
Start date
2023-05-19
Completion date
2025-06-26
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Memory Impairment, Sleep Disorder

Keywords

mild cognitive impairment, sleep and circadian functioning, improving treatment outcome

Brief 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?

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: 1. Recall of the content of treatment will be lower in the MCI group relative to the non-MCI group. 2. Constructive memory support will be more effective for the non-MCI group relative to the MCI group. 3. 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.

Interventions

BEHAVIORALTransdiagnostic 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.

Sponsors

University of California, Berkeley
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants will not be aware that they are receiving constructive memory support in one session and non-constructive memory support in the next session

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Participants 60 years and older will be recruited. 2. Fluent in English. 3. 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.

Exclusion criteria

1. Presence of an active and progressive mental or physical illness or neurological degenerative disease; 2. Night shift work \>2 nights per week in the past 3 months; 3. Not able and willing to participate in and/or complete the assessments and participate in the treatment.

Design outcomes

Primary

MeasureTime frameDescription
Number and accuracy of thoughts about the material covered in the prior treatment session in which constructive memory supports were deliveredDelivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supportsTo assess if the participant thought about the therapy session and if the thoughts accurately reflected the prior treatment session
Number of items recalled on the free recall task to assess outcome for constructive memory supportDelivered 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 supportDelivered 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 applications of the material covered in the prior treatment session in which non-constructive memory supports were deliveredDelivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supportsTo 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 thoughts about the material covered in the prior treatment session in which non-constructive memory supports were deliveredDelivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supportsTo 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 deliveredDelivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supportsTo assess if the participant applied the material covered in the therapy session and if the participant accurately applied the material prior treatment session

Secondary

MeasureTime frameDescription
Acceptability of constructive memory supportOne time point: At the end of the treatment session in which constructive memory support was deliveredParticipants 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.

Other

MeasureTime frameDescription
PROMIS-Sleep DisturbanceAt baselineAssesses 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).
Signs of patient understanding the memory support itemsTwo time points: During the treatment session that constructive memory support was delivered and during the treatment session that non-constructive memory support was deliveredCoded from video tapes of the two treatment sessions in which the support was delivered
PROMIS-Sleep-related impairmentAt baselineAssesses 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).
British Columbia Cognitive Complaints InventoryAt baselineAssessed perceived cognitive difficulties, scale consists of 6 items. Scores can range from 0-18 with higher scores indicating higher levels of perceived cognitive difficulties
Cognitive Failures QuestionnaireAt baselineUsed to assess the frequency with which people experienced cognitive failures. Scores range from 0-100, with higher scores indicating higher levels of cognitive failures.
Montreal Cognitive AssessmentAt baselineAn assessment of cognitive functioning
Structured Clinical Interview for Sleep Disorders - revisedAt baselineAn assessment of the sleep and circadian problems experienced by the participant
Learning behavior exhibited by the patientTwo time points: During the treatment session that constructive memory support was delivered and during the treatment session that non-constructive memory support was deliveredCoded from video tapes of the two treatment sessions in which the support was delivered

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026