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Effects of Cognitive Behavioral Therapy System for Insomnia (CBT-I) on sleep quality, cognitive function, and brain functional connectivity in patients with chronic insomnia disorder

Effects of Cognitive Behavioral Therapy System for Insomnia (CBT-I) on sleep quality, cognitive function, and brain functional connectivity in patients with chronic insomnia disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076090
Enrollment
Unknown
Registered
2023-09-25
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disorder

Interventions

Drug treatment group:Medication for insomnia was given
Medication and cognitive behavioral therapy group:Insomnia medication was given along with six weeks of cognitive behavioral therapy
Healthy control group:NA

Sponsors

The Second Affiliated Hospital of Xinxiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Criteria for inclusion of patients with CID: (1) CID diagnostic criteria of the International Classification of Sleep Disorders, 3rd edition (ICSD-3); (2) Age 18-60 years old, right-handed; (3) Junior high school education or above; (4) Pittsburgh Sleep Quality Index score of more than 7 (PSQI score > 7). Healthy control group: (1) matched with patients with chronic insomnia disorder in terms of age, gender, and years of education; (2) Good sleep quality and PSQI score = 7;

Exclusion criteria

Exclusion criteria: Exclusion criteria for patients with CID: (1) sleep disorders other than CID (based on ICSD-3 criteria); (2) Hamilton Depression Scale score =18 and Hamilton Anxiety Scale =14; (3) heart, cerebrovascular, liver, kidney, hematopoietic system has serious diseases; (4) any contraindications to MRI scans with pacemakers, neurostimulators, artificial metal heart valves, etc., and claustrophobia, etc.; (5) a history of mental or neurological disorders or head trauma and loss of consciousness; (6) Pregnant, pregnant or nursing.

Design outcomes

Primary

MeasureTime frame
fMRI data;PSG data;Sleep diary;

Secondary

MeasureTime frame
PSQI;ISI;DBAS;HAMA;HAMD;

Countries

China

Contacts

Public ContactXu Yahui

The Second Affiliated Hospital of Xinxiang Medical University

18737354427@163.com+86 185 6738 9001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026