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

NCT06969040 | Recruiting

• 1 other identifier: CBTI+tACS for TRI
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Keywords

Standard Cognitive Behavioural Therapy; tACS; Treatment-Resistant Insomnia

Outcome Measures

Primary Outcomes (1)

• Differences in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment in the two groups

  Baseline to week 6

Secondary Outcomes (5)

• Differences in changes in PSQI scores compared to baseline during follow-up at 3, 6, and 12 months between the two groups

  Baseline to week 6, month 3, month 6, and month 12

• Differences in the changes in Beck Depression Inventory (BDI) scores from baseline at the end of treatment and follow-up at 3, 6, and 12 months between the two groups

  Baseline to week 6, month 3, month 6, and month 12

• Differences in Beck Anxiety Inventory (BAI) scores between the two groups at the end of treatment, 3 months, 6 months, and 12 months of follow-up compared to baseline.

  Baseline to week 6, month 3, month 6, and month 12

• Differences in changes in sleep hygiene awareness and practice scale (SHAPS) between the two groups compared to baseline at the end of treatment, 3 months, 6 months, and 12 months of follow-up [2].

  Baseline to week 6, month 3, month 6, and month 12

• Differences in changes in the Insomnia Severity Index (ISI) scores between the two groups at the end of treatment, 3 months, 6 months, and 12 months of follow-up compared to baseline.

  Baseline to week 6, month 3, month 6, and month 12

Study Arms (2)

CBTI+tACS

EXPERIMENTAL

Other: CBTI + tACS

CBTI + Sham tACS

SHAM COMPARATOR

Other: CBTI + Sham tACS

Interventions

CBTI + tACS OTHER

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.

CBTI+tACS

CBTI + Sham tACS OTHER

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.

CBTI + Sham tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Hongxing Wang, MD & PhD

CONTACT

+86 13911127385; wanghongxing@xwh.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)