Improving Patient Memory for Treatment for Mild Cognitive Impairment

NCT05668481 | Completed

• 1 other identifier: Protocol 2022-12-15881
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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?

Conditions

Memory Impairment; Sleep Disorder

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Acceptability of constructive memory support

  One time point: At the end of the treatment session in which constructive memory support was delivered

Other Outcomes (8)

• PROMIS-Sleep Disturbance

  At baseline

• PROMIS-Sleep-related impairment

  At baseline

• British Columbia Cognitive Complaints Inventory

  At baseline

Study Arms (2)

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.

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.

Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C)

Interventions

Transdiagnostic sleep and circadian intervention (TranS-C) BEHAVIORAL

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

Constructive memory support; Non-constructive memory support

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720-1650, United States

Location

MeSH Terms

Conditions

Memory Disorders; Sleep Wake Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be aware that they are receiving constructive memory support in one session and non-constructive memory support in the next session
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 29, 2022
• Study Start: May 19, 2023
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)