Translation and Validation of internet based Cognitive Behavioural Therapy (iCBT) for Tinnitus in Tamil, Kannada and Hindi
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- three scales are being used to measure the outcome along with a semi-structured interview on the participants experience of treatment
研究概览
简要总结
Brief introduction:
Individuals with continuous tinnitus often experience distress, anxiety, depression, irritability, poor concentration, and lifestyle changes due to the lack of silence in their life. Cognitive Behavioral Therapy (CBT) is proven to be effective in reducing tinnitus and it’s related distress. In order to increase the accessibility and reach, CBT was provided via the internet guided either by a psychologist or an audiologist. This internet-based treatment delivery of CBT is referred to as iCBT. Research in European countries like Sweden, the United Kingdom, and Germany have indicated its potential effectiveness. There is a dearth of such tinnitus treatment programme in India, where non-standardized and non-evidence based treatment maneuver is in practice. Adaptation of such protocols in India seems to be a virtuous start towards standard and evidence-based treatment for individuals with tinnitus. The current version of iCBT running consist of an 8-week treatment that is hosted online with interactions to an audiologist. The current study enfolds three phases, aiming to translate the Indian English version of CBT into three Indian Languages (Tamil, Kannada and Hindi) followed by, converting this material into an electronic module with the usage of videos and web-based platform to deliver this treatment. Subsequently the developed iCBT module will undergo a field test to check its feasibility and the satisfaction of the participants with tinnitus who underwent the treatment. The proposed project systematically assesses the acceptability, feasibility and efficacy of iCBT in Indian population.
Study Objectives
1. To translate and adapt CBT for tinnitus into Tamil, Kannada and Hindi Language to be suitable for Indian population and validate the CBT targeting tinnitus treatment.
2. To develop an internet module for the delivery of CBT (iCBT)
3. To assess the acceptability of the intervention amongst service users and professionals and determine the feasibility of iCBT in Indian Scenario.
The study includes 3 phases.
Phase 1 mainly involves in the translation of treatment material (22 modules) in three Indian Languages with the help of professional translators and then checking the familiarity of words used along with the comprehensibility of the modules by both individuals with tinnitus and non-medical professionals. Finally content validation of the material with the help of subject experts.
Phase 2 involves development of videos that aid in understanding of the modules better and create an internet based platform to host the treatment with the help of our technical team
Phase 3 involves checking the feasibility of the treatment with the help of individuals with tinnitus. Participants can log in through their phone or laptop and undergo the 8 week treatment for tinnitus. A pre and post evaluation will be carried out to check for any improvement and a semi-structured interview will be conducted to obtain the participants opinion on the treatment and further modification.
The current study is to translate and validate an internet based treatment for tinnitus and check its feasibility in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Individuals who are above 18 years of age and living in India Individuals with bothersome and continuous tinnitus for about 3 months and at least mild degree of handicap (as indexed using Tinnitus Handicap Inventory, THI) Access to a computer and the Internet and the ability to browse the Internet and send e-mail Ability to read and comprehend English/ Tamil/ Kannada or Hindi.
- •Motivated and interested to participate in the treatment programme.
排除标准
- •Individuals with any major medical, psychological, or neurological conditions which will hamper their ability to undertake the intervention will be excluded When the cause of tinnitus is still under medical investigation, individuals may be excluded if further medical treatment is indicated (such as surgical procedures) Individuals who are currently undergoing treatment for tinnitus.
结局指标
主要结局
three scales are being used to measure the outcome along with a semi-structured interview on the participants experience of treatment
时间窗: 0 weeks and 8 weeks and 1 month follow up
Tinnitus Handicap Index (THI) Scores
时间窗: 0 weeks and 8 weeks and 1 month follow up
Participant Health Questionnaire (PHQ-9)
时间窗: 0 weeks and 8 weeks and 1 month follow up
Subjective rating of tinnitus (VAS)
时间窗: 0 weeks and 8 weeks and 1 month follow up
次要结局
- distress and annoyance caused by tinnitus using a Visual Analogue Scale (VAS)(three time points)
