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Improving Patient Memory for Treatment for Mild Cognitive Impairment

Primary Purpose

Memory Impairment, Sleep Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transdiagnostic sleep and circadian intervention (TranS-C)
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Impairment focused on measuring mild cognitive impairment, sleep and circadian functioning, improving treatment outcome

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion criteria: 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.

Sites / Locations

  • University of California, BerkeleyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Constructive memory support

Non-constructive memory support

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of items recalled on the free recall task to assess outcome for constructive memory support
Assesses patient memory for treatment
Number of items recalled on the free recall task to assess outcome for non-constructive memory support
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
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
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
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
To assess if the participant applied the material covered in the therapy session and if the participant accurately applied the material prior treatment session

Secondary Outcome Measures

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.

Full Information

First Posted
December 12, 2022
Last Updated
August 2, 2023
Sponsor
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT05668481
Brief Title
Improving Patient Memory for Treatment for Mild Cognitive Impairment
Official Title
Improving Memory for Treatment for Patients Experiencing Mild Cognitive Impairment: Are Constructive or Non-constructive Memory Supports More Helpful?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Berkeley

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Impairment, Sleep Disorder
Keywords
mild cognitive impairment, sleep and circadian functioning, improving treatment outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
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
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Constructive memory support
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-constructive memory support
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Transdiagnostic sleep and circadian intervention (TranS-C)
Intervention Description
TranS-C is a psychosocial treatment that helps people who have sleep and circadian problems to improve their sleep health.
Primary Outcome Measure Information:
Title
Number of items recalled on the free recall task to assess outcome for constructive memory support
Description
Assesses patient memory for treatment
Time Frame
Delivered two times: At the session in which constructive memory supports were used (baseline) and 1 week later.
Title
Number of items recalled on the free recall task to assess outcome for non-constructive memory support
Description
Assesses patient memory for treatment
Time Frame
Delivered two times: At the end of the session in which non-constructive memory supports were used (baseline) and 1 week later.
Title
Number and accuracy of thoughts about the material covered in the prior treatment session in which constructive memory supports were delivered
Description
To assess if the participant thought about the therapy session and if the thoughts accurately reflected the prior treatment session
Time Frame
Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports
Title
Number and accuracy of thoughts about the material covered in the prior treatment session in which non-constructive memory supports were delivered
Description
To assess if the participant thought about the therapy session and if the thoughts accurately reflected the prior treatment session
Time Frame
Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports
Title
Number and accuracy of applications of the material covered in the prior treatment session in which constructive memory supports were delivered
Description
To assess if the participant applied the material covered in the therapy session and if the participant accurately applied the material prior treatment session
Time Frame
Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports
Title
Number and accuracy of applications of the material covered in the prior treatment session in which non-constructive memory supports were delivered
Description
To assess if the participant applied the material covered in the therapy session and if the participant accurately applied the material prior treatment session
Time Frame
Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports
Secondary Outcome Measure Information:
Title
Acceptability of constructive memory support
Description
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.
Time Frame
One time point: At the end of the treatment session in which constructive memory support was delivered
Other Pre-specified Outcome Measures:
Title
PROMIS-Sleep Disturbance
Description
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
At baseline
Title
PROMIS-Sleep-related impairment
Description
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
At baseline
Title
British Columbia Cognitive Complaints Inventory
Description
Assessed perceived cognitive difficulties, scale consists of 6 items. Scores can range from 0-18 with higher scores indicating higher levels of perceived cognitive difficulties
Time Frame
At baseline
Title
Cognitive Failures Questionnaire
Description
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
At baseline
Title
Montreal Cognitive Assessment
Description
An assessment of cognitive functioning
Time Frame
At baseline
Title
Structured Clinical Interview for Sleep Disorders - revised
Description
An assessment of the sleep and circadian problems experienced by the participant
Time Frame
At baseline
Title
Learning behavior exhibited by the patient
Description
Coded from video tapes of the two treatment sessions in which the support was delivered
Time Frame
Two time points: During the treatment session that constructive memory support was delivered and during the treatment session that non-constructive memory support was delivered
Title
Signs of patient understanding the memory support items
Description
Coded from video tapes of the two treatment sessions in which the support was delivered
Time Frame
Two time points: During the treatment session that constructive memory support was delivered and during the treatment session that non-constructive memory support was delivered

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison G Harvey, PhD
Phone
5106427138
Email
aharvey@berkeley.edu
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-1650
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison G. Harvery, Ph.D.
Phone
510-642-7138
Email
aharvey@berkeley.edu
First Name & Middle Initial & Last Name & Degree
Alice Mullin
Phone
(510) 643-3797
Email
alicemullin@berkeley.edu

12. IPD Sharing Statement

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Improving Patient Memory for Treatment for Mild Cognitive Impairment

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