Improving Patient Memory for Treatment for Mild Cognitive Impairment

Not Applicable

Recruiting

• Conditions: Sleep Disorder; Memory Impairment
• Interventions: Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C)

• Registration Number: NCT05668481
• Lead Sponsor: University of California, Berkeley

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.

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-29
• Study Start: 2023-05-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Constructive memory support	Transdiagnostic sleep and circadian intervention (TranS-C)	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.
Non-constructive memory support	Transdiagnostic sleep and circadian intervention (TranS-C)	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.

Primary Outcome Measures

Name	Time	Method
Number of items recalled on the free recall task to assess outcome for non-constructive memory support	Delivered 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 thoughts about the material covered in the prior treatment session in which constructive memory supports were delivered	Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports	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 non-constructive memory supports were delivered	Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports	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 of items recalled on the free recall task to assess outcome for constructive memory support	Delivered two times: At the session in which constructive memory supports were used (baseline) and 1 week later.	Assesses patient memory for treatment
Number and accuracy of thoughts about the material covered in the prior treatment session in which non-constructive memory supports were delivered	Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports	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	Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports	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

Name	Time	Method
Acceptability of constructive memory support	One time point: At the end of the treatment session in which constructive memory support was delivered	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.

Trial Locations

Locations (1)

University of California, Berkeley; 🇺🇸 Berkeley, California, United States