SoundMind Trial: a Randomized Controlled Trial of Online Acceptance and Commitment Therapy and Sound Therapy for Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Tinnitus Handicap Inventory (THI)
研究概览
简要总结
Considering the lack of evidence on the effects of combining acceptance and commitment therapy (ACT) with customized sound therapy for tinnitus-related insomnia patients, investigators designed this single-blind, 5-months randomized, controlled trial with two parallel groups. One is the ACT + sound therapy group, and the other is the sound therapy group.
详细描述
Insomnia is one of the most frequent and severe comorbidities in patients with tinnitus and is highly relevant for the perceived tinnitus severity. Both tinnitus and insomnia significantly affect the quality of life of patients and represent a huge burden to society. While interventions exist to alleviate tinnitus distress, they often do not address sleep disturbances in tinnitus patients. Patients affected by tinnitus and insomnia suffer from long-term functional and psychological problems. Sound therapy is widely used to treat tinnitus, often combined with education and counseling, and can effectively improve the quality of life. In addition, acceptance and commitment therapy (ACT) for tinnitus improves both tinnitus and sleep. However, there is a lack of evidence on the effects of combining ACT with sound therapy for tinnitus-related insomnia patients.
To fully characterize tinnitus patients, standardized measures of tinnitus and insomnia are essential. These measures include pure tone audiometry (PTA), acoustic immittance (AI), tinnitus pitch matching (PM) and loudness matching (LM), minimum masking level (MML), tinnitus handicap inventory (THI), insomnia severity index (ISI), and hospital anxiety and depression scale (HADS).
Investigators hypothesize that the combination of ACT and sound therapy will be superiority to sound therapy alone in reducing tinnitus distress.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 80 years old.
- •Experiencing subjective tinnitus for at least 3 months.
- •A score of 38 or more on THI.
- •A score of 8 or more on ISI.
- •55 dB HL or less on the average pure tone threshold (0.5, 1, 2kHz) of the worse ear.
- •Ability to read and write in Chinese and use a smartphone with an internet connection to work with text material.
排除标准
- •Pulsatile tinnitus and objective tinnitus.
- •Organic sleep disorders.
- •Other diseases that need to be treated first (e.g., infections, tumors, otosclerosis, Meniere's disease, the acute stage of sudden sensorineural hearing loss).
- •Severe mental illness.
- •Undergoing other research that may affect tinnitus and sleep.
研究组 & 干预措施
ACT + sound therapy group
The combined treatment group will receive Internet-delivered guided self-help tinnitus treatment based on ACT combined with customized sound therapy.
The online ACT program includes 8 modules of structured self-help material over 8 weeks. Each module includes information, exercises, and homework. The self-help material covers the six core processes of ACT: acceptance, cognitive defusion, being present, self-as-context, values, and committed action, emphasizing psychological flexibility.
Customized sound therapy will be provided by the Fudan Tinnitus Relieving System (FTRS) app. Participants will listen to tailor-made music through the app for more than two hours per day.
干预措施: ACT for tinnitus (Behavioral)
ACT + sound therapy group
The combined treatment group will receive Internet-delivered guided self-help tinnitus treatment based on ACT combined with customized sound therapy.
The online ACT program includes 8 modules of structured self-help material over 8 weeks. Each module includes information, exercises, and homework. The self-help material covers the six core processes of ACT: acceptance, cognitive defusion, being present, self-as-context, values, and committed action, emphasizing psychological flexibility.
Customized sound therapy will be provided by the Fudan Tinnitus Relieving System (FTRS) app. Participants will listen to tailor-made music through the app for more than two hours per day.
干预措施: Customized sound therapy (Other)
sound therapy group
The single treatment group will receive customized sound therapy provided by the FTRS app for more than two hours per day.
干预措施: Customized sound therapy (Other)
结局指标
主要结局
Tinnitus Handicap Inventory (THI)
时间窗: 2 months from baseline
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
Tinnitus Handicap Inventory (THI)
时间窗: 3 months from baseline
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
Tinnitus Handicap Inventory (THI)
时间窗: 5 months from baseline
The THI questionnaire, widely used in research, including functional, emotional, and catastrophic subscales. It consists of 25 questions, and answers are rated on a "yes" (4 points), "sometimes" (2 points), and "no" (0 points) scale. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).
次要结局
- Insomnia Severity Index (ISI)(2 months from baseline)
- Insomnia Severity Index (ISI)(3 months from baseline)
- Visual Analogue Scale (VAS)(2 months from baseline)
- Visual Analogue Scale (VAS)(3 months from baseline)
- Hospital Anxiety and Distress Scale (HADS)(2 months from baseline)
- Hospital Anxiety and Distress Scale (HADS)(3 months from baseline)
- Tinnitus Acceptance Questionnaire (TAQ)(2 months from baseline)
- Tinnitus Acceptance Questionnaire (TAQ)(3 months from baseline)
- Insomnia Severity Index (ISI)(5 months from baseline)
- Visual Analogue Scale (VAS)(5 months from baseline)
- Hospital Anxiety and Distress Scale (HADS)(5 months from baseline)
- Tinnitus Acceptance Questionnaire (TAQ)(5 months from baseline)