Evaluation of the Efficacy of Standard Cognitive Behavioural Therapy + Transcranial Alternating Current in the Treatment of Refractory Insomnia Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Differences in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment in the two groups
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CBTI+tACS
干预措施: CBTI + tACS (Other)
CBTI + Sham tACS
干预措施: CBTI + Sham tACS (Other)
结局指标
主要结局
Differences in change from baseline in Pittsburgh sleep quality index (PSQI) scores at the end of treatment in the two groups
时间窗: Baseline to week 6
次要结局
- 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)