Cognitive Therapy/MethodsNCT06969066
Memory Training in Insomnia With Cognitive Impairment
A study testing Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE) and Sleep Hygiene Education Only (SHE) in people with Cognitive Therapy/Methods and Insomnia Chronic, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cognitive Therapy/Methods, Insomnia Chronic, Cognitive Dysfunction
- What is being tested?
- Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE) and Sleep Hygiene Education Only (SHE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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.
- 6.Normal daily functional abilities. 7.Exclusion of dementia or any major physical or psychiatric disorders that could impair brain function.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Hongxing Wang, MD & PhD, +86 13911127385, wanghongxing@xwh.ccmu.edu.cn
About this study
Official title: Effect of Cognitive Remediation Therapy (CRT) for Chronic Insomnia (CI) With Cognitive Impairment
This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment.
Read the detailed description
Chronic insomnia (CI) is a prevalent sleep disorder that not only causes night-time sleep difficulties but also impairs daytime functioning and cognitive abilities, including deficits in attention, memory, and executive function. Persistent insomnia may diminish the brain's information processing capacity, affecting memory, attention, and decision-making. CRT, a structured cognitive training intervention, has been shown in psychiatric populations to enhance memory, attention, and executive function by promoting neuroplasticity, neurotransmitter modulation, and optimizing brain activity patterns.
Applying CRT to CI patients may similarly support cognitive recovery and indirectly improve sleep quality. However, empirical evidence remains limited.
This randomized controlled trial will enroll 70 patients with CI and cognitive decline. Participants will be randomly assigned to either a CRT plus Sleep Hygiene Education (SHE) group or an SHE-only group (n=35 each). The CRT intervention will last 6 weeks, with daily 50-minute sessions. Evaluations will occur at baseline, post-intervention, and at 3, 6, and 12 months follow-up. This study aims to provide evidence for CRT as a treatment for CI with cognitive impairment and inform future clinical practices.
- Being tested
- Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE), Sleep Hygiene Education Only (SHE)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE)Behavioural
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.
Sleep Hygiene Education Only (SHE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CRT plus Sleep Hygiene Education | Experimental | Not described Receives: Behavioral: Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE) |
| Sleep Hygiene Education Only | Active comparator | Not described Receives: Behavioral: Sleep Hygiene Education Only (SHE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks
Secondary outcomes (12)
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.
Measured: Baseline, 3 months, 6 months, 12 months
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.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
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).
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
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.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.
The SF-36 quantifying the quality of life in relation to health status consists of 36-items with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The total score ranges from 0-100 (the worst possible to the most possible).
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months.
The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The PHQ-4 comprises a 2-item depression scale and a 2-item anxiety scale. Each instrument can reach values from 0-6. Higher Scores are indicating higher distress.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The BDI assessing the existence and severity of symptoms of depression consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe depressive symptoms.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The BAI assessing the existence and severity of symptoms of anxiety consists of 21 items, and the total score ranges from 0 to 63 with higher scores indicating more severe anxiety.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The PHQ-15 measuring somatic distress consists of 15 items, and the total score ranges from 0 to 30 with higher scores indicating more severe somatic distress.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The PDQ-D-5 assessing perceived cognitive deficits from the patient's perspective consists of 5 items, and the total score ranges from 0 to 20 with higher scores indicating greater perceived deficit.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Life Events Scale (LES) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
The LES assessing the perceived stress and number of stressful life events experienced consists of 48 items which are classified into three dimensions: family life events (28 items), work and study events (13 items), and social events (7 items) with higher scores in LES perceived greater stressfulness
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Nov 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Therapy/MethodsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969066
- Sponsor's protocol ID
- CI-CRT
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitive Remediation Therapy (CRT) for Chronic Insomnia (CI) With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06969066
- Acronym / sponsor ID
- CI-CRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial investigates the effects of Cognitive Remediation Therapy (CRT) on chronic insomnia (CI) with mild cognitive impairment.
Detailed description
Chronic insomnia (CI) is a prevalent sleep disorder that not only causes night-time sleep difficulties but also impairs daytime functioning and cognitive abilities, including deficits in attention, memory, and executive function. Persistent insomnia may diminish the brain's information processing capacity, affecting memory, attention, and decision-making. CRT, a structured cognitive training intervention, has been shown in psychiatric populations to enhance memory, attention, and executive function by promoting neuroplasticity, neurotransmitter modulation, and optimizing brain activity patterns.
Applying CRT to CI patients may similarly support cognitive recovery and indirectly improve sleep quality. However, empirical evidence remains limited.
This randomized controlled trial will enroll 70 patients with CI and cognitive decline. Participants will be randomly assigned to either a CRT plus Sleep Hygiene Education (SHE) group or an SHE-only group (n=35 each). The CRT intervention will last 6 weeks, with daily 50-minute sessions. Evaluations will occur at baseline, post-intervention, and at 3, 6, and 12 months follow-up. This study aims to provide evidence for CRT as a treatment for CI with cognitive impairment and inform future clinical practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRT plus Sleep Hygiene Education | Experimental | Behavioral: Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE) |
| Sleep Hygiene Education Only | Active comparator | Behavioral: Sleep Hygiene Education Only (SHE) |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive 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. | Behavioural | CRT plus Sleep Hygiene Education |
| Sleep 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. | Behavioural | Sleep Hygiene Education Only |
Primary outcome
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks.
Time frame: Baseline, 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.
12 secondary outcomes
The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months.
Time frame: Baseline, 3 months, 6 months, 12 months
The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
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.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months.
The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
The change of Life Events Scale (LES) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months.
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
Related trials for Cognitive Therapy/Methods
Recruiting
Short Term Effects of a Multimodal Intervention With RGM on Cognition in People With Parkinson's Disease.
Parkinson Disease (PD), Cognition
Not yet recruiting
Examining a New Insomnia Treatment for People Living With Secondary Breast Cancer.
Insomnia, Breast Cancer Metastatic Breast Cancer
Recruiting
Enhancing Self-Esteem in Patients With Multiple Sclerosis: A Randomised Controlled Trial of the Lexical Association Technique
Multiple Sclerosis, Quality of Life (QOL)
Not yet recruiting
Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders
Bipolar Disorder, Bipolar and Related Disorders
Recruiting
Cognitive Load and Inhaler Technique in COPD
COPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy plus Sleep Hygiene Education (CRT+SHE) and Sleep Hygiene Education Only (SHE) in people with Cognitive Therapy/Methods and Insomnia Chronic, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongxing Wang, MD & PhD (+86 13911127385, wanghongxing@xwh.ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks. (time frame: Baseline, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.