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A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

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ClinicalTrials.gov Identifier: NCT03386123
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Collaborators:
British Tinnitus Association
University College, London
Information provided by (Responsible Party):
Dr Laurence McKenna, University College London Hospitals

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.


Condition or disease Intervention/treatment Phase
Tinnitus Insomnia Behavioral: Cognitive Behaviour Therapy for Insomnia Behavioral: Standard Audiological Care Behavioral: Sleep Support Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Cognitive Behaviour Therapy for Insomnia (CBTi) and Usual Audiological Rehabilitation in the Management of Tinnitus Related Insomnia
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: 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.

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.

Active Comparator: 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

Behavioral: Standard Audiological Care
Maintenance of sleep diary at key times. Psycho-education, provision of bedside sound generator.

Placebo Comparator: 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.

Behavioral: Sleep Support Group
Maintenance of sleep diary at key times. Social support focused on tinnitus and sleep problems.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Change in Pittsburgh Sleep Quality Index score [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    10-item questionnaire. Sum of 7 components; global score range 0 - 21; higher scores indicate worse sleep quality.

  2. Change in Dysfunctional Beliefs and Attitudes About Sleep Questionnaire - abbreviated version (DBAS-16) score [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    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.

  3. Change in Tinnitus Catastrophizing Scale score [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    13-item questionnaire scored on a 0-4 scale. Total sum of scores range from 0 - 52. Higher scores indicate higher levels of catastrophizing.

  4. Mini Tinnitus Questionnaire score [ Time Frame: Screening ]
    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.

  5. Change in the Tinnitus Questionnaire score [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    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.

  6. Change in subjective measure of tinnitus loudness [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    Visual Analogue Scale from 0mm to 100mm; higher scores indicate greater loudness of tinnitus.

  7. Change in Clinical Outcome in Routine Evaluation - Outcome Measure score [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    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.

  8. Change in Patient Health Questionnaire-9 score [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    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.

  9. Change in Generalized Anxiety Disorder Assessment-7 score [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    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.

  10. Change in EuroQOL score [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    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).

  11. Change in Work and Social Adjustment Scale score [ Time Frame: At first and last treatment sessions and at 1 and 6 month follow-ups ]
    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.

  12. Satisfaction and feedback [ Time Frame: At the end of treatment and at six month follow-up point ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386123


Contacts
Contact: Laurence McKenna, PhD 020 3456 5345 laurence.mckenna@nhs.net
Contact: Elizabeth Marks, D.Clin.Psych 020 3456 5345 e.marks@nhs.net

Locations
United Kingdom
Uclh (Rntneh) Recruiting
London, United Kingdom, WC!X 8DA
Contact: Laurence McKenna, PhD    020 3456 5345    laurence.mckenna@nhs.net   
Contact: Elizabeth Marks, D.Clin.Psych    020 3456 5345    e.marks@nhs.net   
Sponsors and Collaborators
University College London Hospitals
British Tinnitus Association
University College, London
Investigators
Principal Investigator: Laurence Laurence, PhD UCLH

Responsible Party: Dr Laurence McKenna, Consultant Clinical Psychologist, University College London Hospitals
ClinicalTrials.gov Identifier: NCT03386123     History of Changes
Other Study ID Numbers: UCLondonH
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Laurence McKenna, University College London Hospitals:
Tinnitus
Insomnia
Cognitive Behaviour Therapy

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Tinnitus
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms