Clinical trial NCT06969040: The Effect of Standard Cognitive-behavioral Therapy+Transcranial Alternating Current on Refractory Insomnia Disorder
Official title: Evaluation of the Efficacy of Standard Cognitive Behavioural Therapy + Transcranial Alternating Current in the Treatment of Refractory Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Standard Cognitive Behavioural Therapy
tACS
Treatment-Resistant Insomnia
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Differences in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment in the two groups
timeFrame: Baseline to week 6
Secondary outcomes:
measure: Differences in changes in PSQI scores compared to baseline during follow-up at 3, 6, and 12 months between the two groups
timeFrame: Baseline to week 6, month 3, month 6, and month 12
measure: 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
timeFrame: Baseline to week 6, month 3, month 6, and month 12
measure: 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.
timeFrame: Baseline to week 6, month 3, month 6, and month 12
measure: 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].
timeFrame: Baseline to week 6, month 3, month 6, and month 12
measure: 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.
timeFrame: Baseline to week 6, month 3, month 6, and month 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: