Improving Patient Memory for Treatment for Mild Cognitive Impairment

Sleep Disorder Clinical Trial

Official title:

Improving Memory for Treatment for Patients Experiencing Mild Cognitive Impairment: Are Constructive or Non-constructive Memory Supports More Helpful?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05668481
• Other study ID #: Protocol 2022-12-15881
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: University of California, Berkeley
• Contact: Allison G Harvey, PhD
• Phone: 5106427138
• Email: aharvey[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Memory Impairment
• Sleep Disorder
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Montreal Cognitive Assessment	An assessment of cognitive functioning	At baseline
Other	Structured Clinical Interview for Sleep Disorders - revised	An assessment of the sleep and circadian problems experienced by the participant	At baseline
Other	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
Other	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
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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	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