RecruitingNot ApplicableNCT06969040

The Effect of Standard Cognitive-behavioral Therapy+Transcranial Alternating Current on Refractory Insomnia Disorder

Evaluation of the Efficacy of Standard Cognitive Behavioural Therapy + Transcranial Alternating Current in the Treatment of Refractory Insomnia Disorder

Sponsor

Xuanwu Hospital, Beijing

Enrollment

70 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Insomnia

Summary

The main purpose of this study is to investigate the efficacy of CBTI + transcranial alternating current (TAC) technology in the treatment of refractory insomnia and the mechanism of 'cognitive-behavioural-brain network' interactions.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Meets the diagnostic criteria for insomnia in DSM-5;
Pittsburgh Sleep Quality Index (PSQI) total score>5 points;
Age ≥ 18 years old, with a junior high school education or above;
Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria4

Individuals with severe physical or mental illnesses are at risk of suicide;
Clinically diagnosed or suspected sleep breathing disorders, restless leg syndrome, and sleep wake rhythm disorders, as well as workers on rotating shifts;
Pregnant and lactating women;
Currently undergoing any psychological therapy.

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Interventions

OTHERCBTI + tACS

CBTI + tACS group method: CBTI for about 50 minutes each time, for a total of 6 weeks: ① first interview: enrolment assessment; ② second interview: treatment initiation; ③ third interview: sleep titration and sleep hygiene; ④ fourth interview: sleep titration; ⑤ fifth-seventh interview: sleep titration; ⑥ eighth interview: sleep titration (end of standardised CBTI treatment. tACS true stimulation) : Transcranial alternating current therapy (tACS) was operated during the same period of CBTI, with 3 electrodes, placed in the prefrontal lobe and bilateral mastoid; the stimulation intensity was 77.5 Hz, 15 mA, 40 min each time, once a day, 5 days a week, for 6 weeks.

OTHERCBTI + Sham tACS

CBTI+sham tACS group method: CBTI treatment method was the same as before. tACS pseudo-stimulation: the electrode placement position, stimulation frequency, and time settings were the same as the real stimulation, and the stimulation process only had the output of gradual rising and falling current at the beginning and the last 10s, respectively, so as to make the subjects produce the same subjective feelings as the real stimulation.