Internet-delivered Cognitive Behavioral Therapy for Tinnitus Compared to an Internet-delivered Mindfulness Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Change in score on Tinnitus Handicap Inventory (THI)
研究概览
简要总结
Tinnitus can be very distressing for some individuals who experience it. The most studied intervention that works well for tinnitus distress is cognitive behavioral therapy (CBT). There is enough evidence to claim that internet-delivered guided CBT for tinnitus is as effective as CBT delivered face-to-face. The goal of this randomized controlled trial is to test the effectiveness of an internet-delivered cognitive behavioral therapy (CBT) for tinnitus and an internet-delivered mindfulness-based tinnitus stress reduction intervention by comparing them one against each other and a waiting list control group in the adult population experiencing tinnitus.
The main questions this study aims to answer are:
- Feasibility of delivering interventions for tinnitus distress over the internet.
- Is any of the two interventions more effective in reducing tinnitus-related stress than the waiting list control?
- Is the effectiveness of mindfulness intervention non-inferior to CBT intervention for tinnitus?
- Is participant engagement and dropout different in mindfulness and CBT interventions?
Participants will be randomly assigned to a CBT, Mindfulness, or control group and will be asked to engage with the materials prescribed to that group for eight weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Experience tinnitus for at least three months;
- •Scores 28 or more on THI;
- •Has the ability to use a computer (or smartphone or tablet) with a connection to the internet for the duration of the study;
- •Comprehension and ability to write and speak in the Lithuanian language.
排除标准
- •Inability to allocate sufficient time for participation in an 8-week intervention;
- •Significant medical or psychiatric conditions which would prevent participation;
- •Participation in other tinnitus interventions during the study.
结局指标
主要结局
Change in score on Tinnitus Handicap Inventory (THI)
时间窗: Pre-treatment, week 8, 3 and 12 months post-treatment
The Tinnitus Handicap Inventory is designed to measure the subject's sensations caused by tinnitus and to assess the impact of tinnitus on daily life. It is also suitable for measuring the change in the severity of a murmur before and after an intervention. The THI questionnaire consists of 25 questions. The subject completes the questionnaire by ticking the most appropriate answer. The researcher scores the questionnaire as follows: 'Yes' is scored with 4 points, 'No' is scored with 0 points and 'Sometimes' is scored with 2 points. The total score is obtained by summing the number of responses to all 25 questions, multiplied by the coefficients given in the table. The higher the scale estimates, the higher the score, the more significant the disability caused by the murmur and the more significantly it affects the life of the subject. The severity scale is as follows: 0-16 mild; 18-36 moderate; 38-56 moderate; 58-76 severe; 78-100 catastrophic.
次要结局
- Change in score on Patient Health Questionnaire (PHQ-9)(Pre-treatment, week 8, 3 and 12 months post-treatment)
- Change in score on Tinnitus and Hearing Survey (THS)(Pre-treatment and week 8.)
- Change in score on Tinnitus Cognitions Questionnaire (TCQ)(Pre-treatment, week 8, 3 and 12 months post-treatment)
- Change in score on Generalized Anxiety Disorder-7 (GAD-7)(Pre-treatment, week 8, 3 and 12 months post-treatment)
- Change in score on Insomnia Severity Index (ISI)(Pre-treatment, week 8, 3 and 12 months post-treatment)
- Change in score on The Mindful Attention Awareness Scale (MAAS])(Pre-treatment, week 8, 3 and 12 months post-treatment)
研究者
Jonas Eimontas
Principal investigator
Vilnius University