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?

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?

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Memory Impairment
• Intervention / Treatment: Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C)

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison G Harvey, PhD; Phone Number: 5106427138; Email: aharvey@berkeley.edu

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720-1650
      • Recruiting
      • University of California, Berkeley
      • Contact: Allison G. Harvery, Ph.D.; Phone Number: 510-642-7138; Email: aharvey@berkeley.edu
      • Contact: Alice Mullin; Phone Number: (510) 643-3797; Email: alicemullin@berkeley.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of items recalled on the free recall task to assess outcome for constructive memory support	Assesses patient memory for treatment	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	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	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	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	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	Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One time point: At the end of the treatment session in which constructive memory support was delivered

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-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).	At baseline
PROMIS-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).	At baseline
British Columbia Cognitive Complaints Inventory	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	At baseline
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.	At baseline
Montreal Cognitive Assessment	An assessment of cognitive functioning	At baseline
Structured Clinical Interview for Sleep Disorders - revised	An assessment of the sleep and circadian problems experienced by the participant	At baseline
Learning behavior exhibited by the patient	Coded from video tapes of the two treatment sessions in which the support was delivered	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
Signs of patient understanding the memory support items	Coded from video tapes of the two treatment sessions in which the support was delivered	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

Collaborators and Investigators

• Sponsor: University of California, Berkeley

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: mild cognitive impairment; sleep and circadian functioning; improving treatment outcome
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Cognition Disorders; Sleep Wake Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Protocol 2022-12-15881

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No