Memory Training in Insomnia With Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorXuanwu Hospital, Beijing
About this trial
This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE)
BehavioralParticipants 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.
Sleep Hygiene Education Only (SHE)
BehavioralParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: CRT plus Sleep Hygiene EducationExperimental treatment 1 intervention
Group B: Sleep Hygiene Education OnlyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
Time frame
Baseline, 6 weeksSecondary outcomes
1
The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months.
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
Time frame
Baseline, 3 months, 6 months, 12 months2
The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia.
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months3
The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency).
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 months4
The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The DBAS assessing sleep related cognitions in 16 items rated on a 10-point Likert scale, and the total score ranges from 0 to 160 with higher scores indicating more intensive dysfunctional beliefs.
Time frame
Baseline, 6 weeks, 3 months, 6 months, and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov