Improving Patient Memory for Treatment for Mild Cognitive Impairment

NCT ID: NCT05668481

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-19

Study Completion Date

2025-06-26

Brief Summary

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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

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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.

Conditions

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Memory Impairment Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Constructive memory support

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.

Group Type ACTIVE_COMPARATOR

Transdiagnostic sleep and circadian intervention (TranS-C)

Intervention Type BEHAVIORAL

TranS-C is a psychosocial treatment that helps people who have sleep and circadian problems to improve their sleep health.

Non-constructive memory support

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.

Group Type ACTIVE_COMPARATOR

Transdiagnostic sleep and circadian intervention (TranS-C)

Intervention Type BEHAVIORAL

TranS-C is a psychosocial treatment that helps people who have sleep and circadian problems to improve their sleep health.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, Berkeley

Berkeley, California, United States

Site Status

Countries

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United States

Other Identifiers

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Protocol 2022-12-15881

Identifier Type: -

Identifier Source: org_study_id

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