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Completed

NCT Number: NCT05668481

Improving Patient Memory for Treatment for Mild Cognitive Impairment

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?

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Key information

Conditions

Memory Impairment Cognition Disorders Cognitive Dysfunction Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Berkeley

Berkeley, California, 94720-1650, United States

About this study

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:

  • Recall of the content of treatment will be lower in the MCI group relative to the non-MCI group.
  • Constructive memory support will be more effective for the non-MCI group relative to the MCI group.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Number of items recalled on the free recall task to assess outcome for constructive memory support

    Time frame: Delivered two times: At the session in which constructive memory supports were used (baseline) and 1 week later.

    Assesses patient memory for treatment

  2. Number of items recalled on the free recall task to assess outcome for non-constructive memory support

    Time frame: 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

  3. Number and accuracy of thoughts about the material covered in the prior treatment session in which constructive memory supports were delivered

    Time frame: 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

  4. Number and accuracy of thoughts about the material covered in the prior treatment session in which non-constructive memory supports were delivered

    Time frame: 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

  5. Number and accuracy of applications of the material covered in the prior treatment session in which constructive memory supports were delivered

    Time frame: 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

  6. Number and accuracy of applications of the material covered in the prior treatment session in which non-constructive memory supports were delivered

    Time frame: 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

Secondary outcomes

  1. Acceptability of constructive memory support

    Time frame: 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.

Other outcomes

  1. PROMIS-Sleep Disturbance

    Time frame: At baseline

    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).

  2. PROMIS-Sleep-related impairment

    Time frame: At baseline

    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).

  3. British Columbia Cognitive Complaints Inventory

    Time frame: At baseline

    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

  4. Cognitive Failures Questionnaire

    Time frame: At baseline

    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.

  5. Montreal Cognitive Assessment

    Time frame: At baseline

    An assessment of cognitive functioning

  6. Structured Clinical Interview for Sleep Disorders - revised

    Time frame: At baseline

    An assessment of the sleep and circadian problems experienced by the participant

  7. Learning behavior exhibited by the patient

    Time frame: 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

    Coded from video tapes of the two treatment sessions in which the support was delivered

  8. Signs of patient understanding the memory support items

    Time frame: 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

    Coded from video tapes of the two treatment sessions in which the support was delivered

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2022
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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