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NCT Number: NCT06969040

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location status: Recruiting

Location contact

Hongxing Wang, MD & PhD

CONTACT

[email protected]

+86 13911127385

About this study

Difficult to treat insomnia is a sleep disorder that significantly reduces the quality of sleep for patients, seriously affecting their daily work and study. At present, the main treatment method for refractory insomnia in clinical practice is drug therapy. The problems with drug therapy mainly include easy recurrence after discontinuation and the need for long-term or even lifelong medication. However, tolerance or other adverse reactions limit its long-term use. In recent years, studies have shown that cognitive-behavioral therapy and transcranial alternating current stimulation are effective in treating chronic insomnia, prolonging sleep time and improving sleep quality. However, there have been no reports on the efficacy and safety of CBTI combined with tACS in the treatment of refractory insomnia. Based on the important role of tACS in regulating cortical excitability and spontaneous EEG activity, as well as the precise efficacy of CBTI in improving insomnia, we plan to use CBTI combined with tACS to treat refractory insomnia disorders, in order to improve the effectiveness of treatment. This study adopts a randomized double-blind controlled trial to investigate the efficacy and safety of CBT+tACS in the treatment of refractory insomnia, aiming to provide a basis for clinical data of CBT+tACS in the treatment of refractory insomnia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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 + 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.

Primary outcomes

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

    Time frame: Baseline to week 6

Secondary outcomes

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

    Time frame: Baseline to week 6, month 3, month 6, and month 12

  2. 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

    Time frame: Baseline to week 6, month 3, month 6, and month 12

  3. 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.

    Time frame: Baseline to week 6, month 3, month 6, and month 12

  4. 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].

    Time frame: Baseline to week 6, month 3, month 6, and month 12

  5. 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.

    Time frame: Baseline to week 6, month 3, month 6, and month 12

Study contacts

Contact information is provided by the study sponsor or research team.

Hongxing Wang, MD & PhD

CONTACT

[email protected]

+86 13911127385

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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