Clinical trial NCT03386123: A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia
Official title: A Comparison of Cognitive Behaviour Therapy for Insomnia (CBTi) and Usual Audiological Rehabilitation in the Management of Tinnitus Related Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Insomnia
Keywords: Tinnitus
Insomnia
Cognitive Behaviour Therapy
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: British Tinnitus Association
name: University College, London
First posted: 2017-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI) score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Change in the amount of sleep obtained
timeFrame: 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.
Secondary outcomes:
measure: Change in Pittsburgh Sleep Quality Index score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Change in Dysfunctional Beliefs and Attitudes About Sleep Questionnaire - abbreviated version (DBAS-16) score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Change in Tinnitus Catastrophizing Scale score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Mini Tinnitus Questionnaire score
timeFrame: Screening
measure: Change in the Tinnitus Questionnaire score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Change in subjective measure of tinnitus loudness
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Change in Clinical Outcome in Routine Evaluation - Outcome Measure score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Change in Patient Health Questionnaire-9 score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Change in Generalized Anxiety Disorder Assessment-7 score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Change in EuroQOL score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Change in Work and Social Adjustment Scale score
timeFrame: At first and last treatment sessions and at 1 and 6 month follow-ups
measure: Satisfaction and feedback
timeFrame: At the end of treatment and at six month follow-up point
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Uclh (Rntneh)
Study officials:
affiliation: UCLH
name: Laurence Laurence, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marks E, Hallsworth C, McKenna L. Cognitive behavioural therapy for insomnia (CBTi) as a treatment for tinnitus-related insomnia: protocol for a randomised controlled trial. Trials. 2019 Dec 2;20(1):667. doi: 10.1186/s13063-019-3778-5.