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A study on the effectiveness of core mindfulness skills combined with insomnia cognitive behavioral therapy for patients with depression and insomnia, as well as the role of the gut microbiota

A study on the effectiveness of core mindfulness skills combined with insomnia cognitive behavioral therapy for patients with depression and insomnia, as well as the role of the gut microbiota

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124336
Enrollment
Unknown
Registered
2026-05-11
Start date
2024-03-08
Completion date
Unknown
Last updated
2026-05-18

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

Conditions

Depression with Insomnia

Interventions

Intervention group:Core mindfulness skills in conjunction with the CBTI treatment program
Control group:Standard CBTI treatment plan

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged >= 18 years; (2) Meeting the criteria for insomnia disorder :1) difficulty initiating and/or maintaining sleep, with a sleep latency greater than or equal to 30 minutes and a sleep duration less than or equal to 6.5 hours; 2) insomnia at least 3 times per week for more than 3 months; 3) Accompanied by daytime functional impairment as follows: Fatigue or general discomfort, difficulty concentrating, impaired ability to maintain attention or memory, decreased learning efficiency, work ability and/or social function, decreased emotional stability or irritability, daytime sleepiness, decreased interest or lack of energy, increased tendency to make errors in work or driving and easy to be nervous. Somatic symptoms such as headache, dizziness or other physical discomfort related to lack of sleep, and excessive concern about their own sleep status; (3) Meeting the criteria for depressive disorder: 1) At least one core symptom (significant low mood, loss of interest or pleasure), accompanied by decreased energy, sleep disturbance (difficulty falling sleep/early waking or drowsiness), abnormal appetite and weight (> 5% change in 2 weeks), decreased attention and memory, feelings of meaninglessness/guilt, suicidal thoughts, psychomotor retardation, or agitation. 2) symptoms lasting for at least 2 weeks, present almost every day for most of the day, without significant periods of remission. 3) Concomitant functional impairment: decreased work and learning efficiency, social avoidance, poor self-care ability, and loss of past interests. Some patients had physical symptoms (such as fatigue and unknown pain) that affected daily activities and could not be explained by physical diseases. (4) Having the ability to read and write in Chinese; (5) Score >= 8 on the Insomnia Severity Index (ISI); (6) Score >= 5 on the Patient Health Questionnaire-9 (PHQ-9).ores

Exclusion criteria

Exclusion criteria: (1) Insomnia secondary to severe physical illness, acute phase of a disease, or prominent symptoms such as pain; (2) Inability to complete the questionnaires due to conditions such as hearing impairment or communication disorders; (3) Having received psychological therapy within 3 months. Patients receiving sedative-hypnotic or antidepressant medication treatment are not excluded

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index scale;Patient health questionnaire;

Secondary

MeasureTime frame
Perceived Stressscale-10;Mindful Attention Awareness Scale;

Countries

China

Contacts

Public ContactZhang Qingling

The Second Affiliated Hospital of the Army Medical University

413822199@qq.com+86 185 0237 1927

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026