A Comparison of Cognitive Behaviour Therapy for Insomnia (CBTi) and Usual Audiological Rehabilitation in the Management of Tinnitus Related Insomnia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity Index (ISI) score
研究概览
简要总结
There is evidence that CBT for insomnia (CBTi) is an effective treatment for sleep disturbance both as a primary problem and when co-morbid with other health problems, such as chronic pain.
This study will investigate the effectiveness of CBTi as a treatment for tinnitus related insomnia. Tinnitus patients reporting clinically significant insomnia will be offered sleep-specific treatment. Six sessions of CBTi will be offered to one group of patients and 2 sessions standard audiological care (psycho-education and sleep hygiene) will be offered to another group. Both groups will be offered sound enrichment at night. In order to take account of the possible effects of clinical contact a third group will be offered 6 sessions of support without a focused tinnitus or sleep intervention. Accepted measures of sleep disturbance will be used as well as measures of tinnitus complaint.
All treatment/contact will be provided at the Royal National Throat Nose & Ear Hospital. Participants will be involved in the study (inc. baseline period {2 weeks}, intervention {8 weeks} and follow-ups {4 and 20 weeks}) for 34 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least moderately distressing tinnitus (above a set minimum score on the Mini TQ) for at least six months and problematic insomnia (above a set minimum score on the Insomnia Severity Index (ISI) and for tinnitus related insomnia to be identified in clinical interview) as result of tinnitus, for at least three months.
- •Patient wishes to work on improving sleep.
- •Sufficient understanding of English and sufficient hearing ability to take part in for group discussions and to complete questionnaires.
- •Patient has had tinnitus assessed by a doctor and an audiological specialist.
- •Willing and able to provide written consent. Able to regularly attend clinic in London, United Kingdom.
排除标准
- •• Organic sleep disorders present (e.g. Obstructive Sleep Apnoea, delayed phase sleep, etc.) assessed with a subscale of the hospital sleep unit's sleep disorder and snoring proforma.
- •Currently pregnant, planning pregnancy or breastfeeding.
- •Alcohol or drug dependent.
- •Currently suffering with severe mental illness (psychosis, severe anxiety or mood disorder).
- •Reports active risk to themselves or others. Still undergoing medical investigations into sleep and / or tinnitus.
研究组 & 干预措施
Cognitive Behaviour Therapy for Insomnia (CBTi)
A standard CBTi programme for the treatment of primary insomnia, with six, 2 hour, group sessions over eight weeks. There will be minor adaptations for tinnitus, including making specific reference to tinnitus and psycho-education about tinnitus. Every session concludes with provision of a homework task and a sleep diary to complete over the next week. The CBTi course will be supported by providing participants with a CD with some relaxation exercises and a booklet that covers the information given in the session.
CBTi includes: Sleep restriction, stimulus control, Sleep hygiene, Relaxation training, Paradoxical intention, Cognitive therapy: Targeting unhelpful beliefs about sleep and worry, Behavioural experiments: Testing unhelpful beliefs and adjusting sleep related behaviour.
干预措施: Cognitive Behaviour Therapy for Insomnia (Behavioral)
Standard Audiological Care (SAC)
A group intervention that fits with reported audiological treatment of people with tinnitus and significant sleep impairment. This involves psycho-education about tinnitus, habituation, sleep and sleep hygiene. Relaxation will be advised and information provided. A bedside sound generator, as used in routine clinical practice will be provided. Information will be based on standard advice given by hearing therapists/audiologists and will not include specific psychological techniques which are not part of SAC. The group will be generally supportive.
SAC tends not to involve repeated meetings; after the initial session, there will be one follow up session 8 weeks later. Follow up will allow for question and answer, and reports on what has been useful. Both sessions will last for 2 hours
干预措施: Standard Audiological Care (Behavioral)
Sleep Support Group (SSG)
Participants will meet in a group, which will offer equivalent contact with therapists and a supportive group milieu as CBTi. It will focus on the potential benefits of a supportive group and will not include specific advice.
Participants will complete 2-week sleep diaries as baseline and outcome measures at the four time-points, which will be checked within the session to ensure that participants know how to complete them correctly. The SSG will meet in a group for six sessions, over eight weeks, each of 2 two hours duration.
干预措施: Sleep Support Group (Behavioral)
结局指标
主要结局
Change in Insomnia Severity Index (ISI) score
时间窗: At first and last treatment sessions and at 1 and 6 month follow-ups
7-item questionnaire, each item rates 0 - 4. Total scores range from 0-28 with higher scores indicating more severity.
Change in the amount of sleep obtained
时间窗: A 2-week sleep diary will be kept 2 weeks prior to the first and last treatment sessions and to the 1 and 6 month follow-ups.
Average of all of the following metrics obtained from 2 weeks of sleep diary measure: Sleep Onset Latency - lower score indicates better sleep; Wake Time After Sleep Onset - lower score indicate better sleep; Number of night time awakenings - lower scores indicate better sleep; Total Sleep Time - higher scores indicate better sleep; Time in Bed - included only so that Sleep Efficiency can be calculated: Sleep Efficiency (Total Sleep Time / Time in Bed x 100) - higher scores indicate better sleep. Diary measures for sleep quality (0= worst possible to 10=best possible), tinnitus annoyance (0= not at all to 10= extremely), refreshed at waking (0= not at all to 10= very refreshed) and quality of day time functioning (0= very poor to 10= very good).
次要结局
- Change in Patient Health Questionnaire-9 score(At first and last treatment sessions and at 1 and 6 month follow-ups)
- Change in Generalized Anxiety Disorder Assessment-7 score(At first and last treatment sessions and at 1 and 6 month follow-ups)
- Change in Pittsburgh Sleep Quality Index score(At first and last treatment sessions and at 1 and 6 month follow-ups)
- Change in Dysfunctional Beliefs and Attitudes About Sleep Questionnaire - abbreviated version (DBAS-16) score(At first and last treatment sessions and at 1 and 6 month follow-ups)
- Change in Tinnitus Catastrophizing Scale score(At first and last treatment sessions and at 1 and 6 month follow-ups)
- Mini Tinnitus Questionnaire score(Screening)
- Change in the Tinnitus Questionnaire score(At first and last treatment sessions and at 1 and 6 month follow-ups)
- Change in subjective measure of tinnitus loudness(At first and last treatment sessions and at 1 and 6 month follow-ups)
- Change in Clinical Outcome in Routine Evaluation - Outcome Measure score(At first and last treatment sessions and at 1 and 6 month follow-ups)
- Change in EuroQOL score(At first and last treatment sessions and at 1 and 6 month follow-ups)
- Satisfaction and feedback(At the end of treatment and at six month follow-up point)
- Change in Work and Social Adjustment Scale score(At first and last treatment sessions and at 1 and 6 month follow-ups)
研究者
Dr Laurence McKenna
Consultant Clinical Psychologist
University College London Hospitals