A Comparison of Cognitive Behaviour Therapy for Insomnia (CBTi) and Usual Audiological Rehabilitation in the Management of Tinnitus Related Insomnia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tinnitus
- Sponsor
- University College London Hospitals
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Insomnia Severity Index (ISI) score
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Dr Laurence McKenna
Consultant Clinical Psychologist
University College London Hospitals
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •• 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.
Outcomes
Primary Outcomes
Change in Insomnia Severity Index (ISI) score
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- 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)