Clinical trial NCT05668481: 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
Overall status: RECRUITING
Phase: NA
Conditions: Memory Impairment
Sleep Disorder
Keywords: mild cognitive impairment
sleep and circadian functioning
improving treatment outcome
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of items recalled on the free recall task to assess outcome for constructive memory support
timeFrame: Delivered two times: At the session in which constructive memory supports were used (baseline) and 1 week later.
measure: Number of items recalled on the free recall task to assess outcome for non-constructive memory support
timeFrame: Delivered two times: At the end of the session in which non-constructive memory supports were used (baseline) and 1 week later.
measure: Number and accuracy of thoughts about the material covered in the prior treatment session in which constructive memory supports were delivered
timeFrame: Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports
measure: Number and accuracy of thoughts about the material covered in the prior treatment session in which non-constructive memory supports were delivered
timeFrame: Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports
measure: Number and accuracy of applications of the material covered in the prior treatment session in which constructive memory supports were delivered
timeFrame: Delivered once: At the beginning of the session held 1 week after the delivery of the constructive memory supports
measure: Number and accuracy of applications of the material covered in the prior treatment session in which non-constructive memory supports were delivered
timeFrame: Delivered once: At the beginning of the session held 1 week after the delivery of the non-constructive memory supports
Secondary outcomes:
measure: Acceptability of constructive memory support
timeFrame: One time point: At the end of the treatment session in which constructive memory support was delivered
Other outcomes:
measure: PROMIS-Sleep Disturbance
timeFrame: At baseline
measure: PROMIS-Sleep-related impairment
timeFrame: At baseline
measure: British Columbia Cognitive Complaints Inventory
timeFrame: At baseline
measure: Cognitive Failures Questionnaire
timeFrame: At baseline
measure: Montreal Cognitive Assessment
timeFrame: At baseline
measure: Structured Clinical Interview for Sleep Disorders - revised
timeFrame: At baseline
measure: Learning behavior exhibited by the patient
timeFrame: 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
measure: Signs of patient understanding the memory support items
timeFrame: 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
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
References: