A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

Insomnia Clinical Trial

Official title:

A Comparison of Cognitive Behaviour Therapy for Insomnia (CBTi) and Usual Audiological Rehabilitation in the Management of Tinnitus Related Insomnia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03386123
• Other study ID #: UCLondonH
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders
• Tinnitus

Intervention

Behavioral:
• Cognitive Behaviour Therapy for Insomnia
Continuous maintenance of sleep diary, cognitive behaviour therapy, including cognitive restructuring, and behavioural change focusing on sleep restriction and safety behaviours.
• Standard Audiological Care
Maintenance of sleep diary at key times. Psycho-education, provision of bedside sound generator.
• Sleep Support Group
Maintenance of sleep diary at key times. Social support focused on tinnitus and sleep problems.

Locations

Country	Name	City	State
United Kingdom	Uclh (Rntneh)	London

Sponsors (3)

Lead Sponsor	Collaborator
University College London Hospitals	British Tinnitus Association, University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index (ISI) score	7-item questionnaire, each item rates 0 - 4. Total scores range from 0-28 with higher scores indicating more severity.	At first and last treatment sessions and at 1 and 6 month follow-ups
Primary	Change in the amount of sleep obtained	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).	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	Change in Pittsburgh Sleep Quality Index score	10-item questionnaire. Sum of 7 components; global score range 0 - 21; higher scores indicate worse sleep quality.	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Change in Dysfunctional Beliefs and Attitudes About Sleep Questionnaire - abbreviated version (DBAS-16) score	16-item questionnaire scored on a 0-10 scale. The average score is calculated from all individual scores and ranges from 0-10; higher scores indicate more dysfunctional / unrealistic beliefs about / sleep.	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Change in Tinnitus Catastrophizing Scale score	13-item questionnaire scored on a 0-4 scale. Total sum of scores range from 0 - 52. Higher scores indicate higher levels of catastrophizing.	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Mini Tinnitus Questionnaire score	Construct: Tinnitus complaint 12-item questionnaire scored on a 0 - 2 scale. Total sum of scores range 0-24. Higher scores indicate presence of tinnitus. A score of 8 or more indicates the presence of a clinical level of tinnitus-related distress.	Screening
Secondary	Change in the Tinnitus Questionnaire score	Construct: Tinnitus complaint 41-item questionnaire scored on a 0 - 2 scale. Total sum of scores ranges from 0-82; higher scores indicate presence of tinnitus. The reliable change criterion is 11.08.	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Change in subjective measure of tinnitus loudness	Visual Analogue Scale from 0mm to 100mm; higher scores indicate greater loudness of tinnitus.	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Change in Clinical Outcome in Routine Evaluation - Outcome Measure score	Construct: general psychological distress 34-item questionnaire scored on a 0-4 scale. The average of all the scores is calculated and then multiplied by 10, so the scores can range from 0 to 40; a clinical cut-off score is 10 and clinically significant change is 5.	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Change in Patient Health Questionnaire-9 score	Construct: Depression 9-item questionnaire scored on a 0-3 scale; total sum of scores ranges from 0-27 with higher scores indicate greater depression severity.	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Change in Generalized Anxiety Disorder Assessment-7 score	7-items questionnaire scored on a 0-3 scale; total sum of scores ranges from total score range: 0-21 with higher score indicating more severe anxiety.	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Change in EuroQOL score	Construct: health status (dimensions: mobility, self-care, performing usual activities, pain or discomfort; anxiety or depression); each state is referred to in terms of a 5 digit code; The answers given to EQ-5D allow 243 unique health states to be identified and can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analogue Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Change in Work and Social Adjustment Scale score	Construct: impaired functioning 5-item questionnaire scored on a 0-8 scale; total sums of scores range from 0-40 with higher scores indicating greater functional impairment.	At first and last treatment sessions and at 1 and 6 month follow-ups
Secondary	Satisfaction and feedback	Questionnaire asking individuals to rate the following on a 0 - 10 scale (from not at all to extremely) How useful was treatment? How relevant was treatment? How acceptable was treatment? They are also asked to provide qualitative feedback in the form of comments in response to questions about what changes they have noticed, what aspects of treatment were most and least useful, what they would have liked to be different and any other comments.	At the end of treatment and at six month follow-up point