A Randomized Controlled Trial of Internet-based Cognitive Behavioral Therapy for Insomnia Versus Patient Education in Patients With Tinnitus and Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory (THI)
研究概览
简要总结
This single-center, single-blind, randomized controlled trial is designed to evaluate the efficacy of therapist-guided, internet-based cognitive behavioral therapy for insomnia (CBT-I) compared with patient education in patients with chronic subjective tinnitus and clinically significant insomnia. A total of 168 participants will be randomized in a 1:1 ratio to receive either an 8-week internet-based CBT-I intervention or an online patient education intervention. The primary outcome is the between-group mean difference in Tinnitus Handicap Inventory (THI) score at 2 months after randomization. Secondary outcomes include insomnia severity, subjective sleep parameters, tinnitus loudness, anxiety and depression symptoms, and dysfunctional beliefs and attitudes about sleep. Participants will be assessed at baseline, 1 month, 2 months, 3 months, and 5 months.
详细描述
Insomnia is one of the most common comorbidities in patients with chronic tinnitus and is closely associated with tinnitus-related distress and impaired quality of life. Although CBT-I is an established treatment for insomnia, access to conventional face-to-face CBT-I may be limited by the availability of trained therapists, geographic barriers, and time constraints.
This study is designed to evaluate whether therapist-guided, internet-based CBT-I can improve tinnitus-related distress and sleep-related outcomes in patients with chronic subjective tinnitus and clinically significant insomnia.
Eligible participants will be recruited at the Eye & ENT Hospital of Fudan University and randomly assigned in a 1:1 ratio to either the internet-based CBT-I group or the patient education group. Both interventions will be delivered through smartphone-based platforms over an 8-week period.
The CBT-I intervention consists of eight weekly modules incorporating stimulus control, sleep restriction therapy, cognitive restructuring, relaxation and mindfulness practices, and sleep hygiene education. Participants will complete daily relaxation exercises and weekly homework assignments, with treatment progress monitored by trained therapists through the online platform.
The patient education group will receive a non-individualized online education package covering general information about tinnitus and insomnia, their potential interaction, and general recommendations for sleep and lifestyle management. The educational materials will remain accessible throughout the intervention period without therapist involvement.
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)
盲法说明
Statistical analysts will be masked to participants' treatment allocation during outcome analysis.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 65 years;
- •Diagnosis of chronic subjective tinnitus persisting for at least 6 months;
- •A score of 38 or higher on the Tinnitus Handicap Inventory (THI);
- •An Insomnia Severity Index (ISI) score of 8 or higher;
- •Ability to understand the study procedures and provide informed consent;
- •Proficiency in reading and writing Chinese;
- •Access to a smartphone for participation in the digital intervention.
排除标准
- •Objective or pulsatile tinnitus;
- •Specific otologic conditions requiring immediate medical treatment, such as sudden sensorineural hearing loss;
- •Diagnosed organic sleep disorders, such as obstructive sleep apnea;
- •Serious psychiatric disorders, including schizophrenia;
- •Concurrent enrollment in another clinical trial targeting tinnitus or insomnia.
结局指标
主要结局
Tinnitus Handicap Inventory (THI)
时间窗: 1 month, 2 months, 3 months, and 5 month from baseline
The Tinnitus Handicap Inventory (THI) is a 25-item self-report questionnaire assessing the functional, emotional, and catastrophic impact of tinnitus. Each item is scored as "yes" (4 points), "sometimes" (2 points), or "no" (0 points), with higher total scores indicating greater tinnitus-related impairment.
次要结局
- Insomnia Severity Index (ISI)(1 month, 2 months, 3 months, and 5 month from baseline)
- Sleep Onset Latency (SOL)(Baseline and during the 8-week intervention period)
- Wake Time After Sleep Onset (WASO)(Baseline and during the 8-week intervention period)
- Total Sleep Time (TST)(Baseline and during the 8-week intervention period)
- Sleep Efficiency (SE%)(Baseline and during the 8-week intervention period)
- Visual Analogue Scale (VAS) for Tinnitus Loudness(1 month, 2 months, 3 months, and 5 month from baseline)
- Hospital Anxiety and Depression Scale (HADS)(1 month, 2 months, 3 months, and 5 month from baseline)
- Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS)(1 month, 2 months, 3 months, and 5 month from baseline)