RecruitingNot ApplicableNCT06969066

Memory Training in Insomnia With Cognitive Impairment

Effect of Cognitive Remediation Therapy (CRT) for Chronic Insomnia (CI) With Cognitive Impairment


Sponsor

Xuanwu Hospital, Beijing

Enrollment

70 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment.


Eligibility

Min Age: 8 Years

Inclusion Criteria7

  • Meets the diagnostic criteria for Insomnia Disorder according to DSM-5.
  • Pittsburgh Sleep Quality Index (PSQI) total score > 5.
  • Age ≥ 8 years.
  • Voluntary participation with signed informed consent.
  • Meets the cognitive impairment criteria associated with CI:
  • (1) Right-handedness. (2) Age between 55 and 75 years. (3) Education duration ≥ 12 years. (4) At least junior high school education level; fulfills Petersen's diagnostic criteria for mild cognitive impairment: 1.Subjective complaints of memory decline. 2.Duration of cognitive complaints ≥ 3 months. 3.Assessment scores: Global Deterioration Scale (GDS) rating of stage 1-2; Clinical Dementia Rating (CDR) score of 0-0.5. 4.Memory test scores falling ≥ 1.5 standard deviations below the age- and education-matched norms: MMSE ≥ 24, MoCA < 26, Activities of Daily Living (ADL) score > 26. 5.Memory impairment as the primary deficit, with relatively preserved functioning in other cognitive domains.
  • Normal daily functional abilities. 7.Exclusion of dementia or any major physical or psychiatric disorders that could impair brain function.

Exclusion Criteria5

  • Presence of severe physical illnesses or major psychiatric disorders, or assessed risk of suicide.
  • Diagnosed or suspected sleep breathing disorders, restless legs syndrome, circadian rhythm sleep disorders, or currently engaged in shift work.
  • Pregnancy or breastfeeding.
  • Currently undergoing any form of psychological therapy.
  • History of infectious diseases such as syphilis or HIV.

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Interventions

BEHAVIORALCognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE)

Participants will receive Cognitive Remediation Therapy (CRT) combined with Sleep Hygiene Education (SHE). CRT includes structured training sessions targeting attention, memory, visuospatial skills, calculation ability, logical reasoning, and language abilities. Sessions will be conducted daily for 50 minutes over 6 weeks. Sleep Hygiene Education will cover standard recommendations to improve sleep behaviors.

BEHAVIORALSleep Hygiene Education Only (SHE)

Participants will receive Sleep Hygiene Education (SHE) only, including guidance on adjusting sleep schedules, maintaining healthy sleep environments, minimizing stimulant intake, and managing sleep-related behaviors, without any CRT intervention.


Locations(1)

Xuanwu Hospital, Capital Medical University

Beijing, China

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NCT06969066


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