Internet-based Self-help for Tinnitus: The Role of Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in tinnitus distress
研究概览
简要总结
Internet-based cognitive behavioural self-help (iCBT) has become increasingly popular to provide psychotherapy. For several psychological and psychosomatic disorders, treatment efficacy was shown. Previously, iCBT has also been applied to patients suffering from tinnitus and results show significant and long-term stable improvements in tinnitus distress. However, the role of therapeutic support in iCBT has not been thoroughly investigated. Previous results suggest that iCBT without therapeutic support is less effective and leads to higher dropout rates than therapist-guided iCBT. The aim of the randomized controlled trial is thus to investigate the role of therapeutic support in an iCBT for tinnitus sufferers.
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
- 否
入选标准
- •tinnitus duration of more than 6 months
- •severe or most severe tinnitus distress
- •age of at least 18 years
- •fluent in German
排除标准
- •psychosis, severe psychological disorder, risk for suicide
- •prior participation in associated study
- •medical disorder as reason for tinnitus, i.e. morbus ménière
研究组 & 干预措施
iCBT with therapeutic support
Participants work with the online self-help and receive additional therapeutic support on demand
干预措施: iCBT (internet-based, cognitive-behavioural therapy) (Behavioral)
iCBT without therapeutic support
Participants work with the online self-help on their own and do not receive additional therapeutic support
干预措施: iCBT (internet-based, cognitive-behavioural therapy) (Behavioral)
结局指标
主要结局
Change in tinnitus distress
时间窗: 1 year; pre, post, 6-mo-follow-up
Assessment of tinnitus distress with the Tinnitus Handicap Inventory (THI) and the Mini-Tinnitus Questionnaire (Mini-TQ) Newman, C. W., Jacobson, G. P., \& Spitzer, J. B. (1996). Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg, 122(2), 143-148. Hiller, W., \& Goebel, G. (2004). Rapid assessment of tinnitus-related psychological distress using the Mini-TQ. Int J Audiol, 43(10), 600-604.
次要结局
- Change in depressive Symptoms(1 year; pre, post, 6mo-follow-up)
- Change in tinnitus-related thoughts(1 year; pre, post, 6mo-follow-up)
- Change of tinnitus acceptance(1 year; pre, post, 6mo-follow-up)
研究者
Cornelia Weise
Dr. rer. nat.
Philipps University Marburg Medical Center