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

NARecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

October 1, 2025

Study Completion Date

November 1, 2025

Conditions
Insomnia
Interventions
OTHER

CBTI + 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.

OTHER

CBTI + 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.

Trial Locations (1)

100053

RECRUITING

Xuanwu Hospital, Capital Medical University, Beijing

All Listed Sponsors
lead

Xuanwu Hospital, Beijing

OTHER