A Comparison of the Benefits of Mindfulness Based Cognitive Therapy, Relaxation Therapy and a Waiting List Control in the Management of Distress in Chronic Tinnitus Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in Tinnitus Questionnaire score over time
研究概览
简要总结
The principal hypotheses to be tested is that Mindfulness Based Cognitive Therapy (MBCT) reduces the distressing impact of tinnitus to a significantly greater extent than a waiting list control or relaxation therapy.
This study is a mixed design, with two groups assessed at a number of time points. The primary outcome measure will be that of tinnitus distress, and secondary outcomes will be taken of psychological distress and tinnitus loudness.
The outcome measures will be measured first at 8 weeks pre-treatment. All subjects then wait for 8 weeks before being randomly allocated to either an 8 week course of Mindfulness-Based Cognitive Therapy (MBCT) (Group 1) or an 8 week course of Relaxation Therapy (RT) (Group 2). All participants will be assessed at two main time-points (pre and post-treatment). The outcome measures will be repeated at 1 and 6 month follow-up points.
详细描述
Experimental design and methods (including statistical analysis)
Participant recruitment:
Potential participants who meet the eligibility criteria will be identified from among patients referred to the adult clinical psychology service within the department of Adult Audiology at the Royal National Throat Nose & Ear Hospital. These patients will be approached and invited to discuss participation in the project. The potential participants will be given full information about the study and invited to consider whether they wish to participate.
Design
This study an independent groups, repeated measures design. Two groups will be assessed at different time points. Group 1 will receive 8 weeks of Mindfulness-Based Cognitive Therapy (MBCT) and Group 2 will receive 8 weeks of Relaxation Training (RT; an active control). All participants will be assessed at five main time-points:
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
- •Only patients with chronic tinnitus (i.e. have had tinnitus for six months or more) will be included
- •Only patients who show at least a minimum level of distress (defined by a cut off score on the CORE measure of psychological well-being).
- •Only patients whose hearing permits them to take part in group discussions in a quiet room will be included.
- •Only patients with sufficient understanding of English to take part in group discussions and complete questionnaires will be included.
排除标准
- •Patients who are subject to ongoing medical investigations will be excluded. Patients who are alcohol or drug dependent will be excluded Patients who are suffering with psychosis or who are actively suicidal will be excluded.
结局指标
主要结局
Change in Tinnitus Questionnaire score over time
时间窗: 8 weeks pre treatment; start of treatment; end of treatment; 1 month post treatment; 6 months post treatment
次要结局
- Change in Clinical Outcomes in Routine Evaluation (Outcome measure) score over time(8 weeks pre treatment; start of treatment; end of treatment; 1 month post treatment; 6 months post treatment)
研究者
Dr Laurence McKenna
Clinical psychologist
University College London Hospitals