A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

NCT03386123 | Unknown

• 1 other identifier: UCLondonH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus; Insomnia

Keywords

Tinnitus; Insomnia; Cognitive Behaviour Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• 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

Study Arms (3)

Cognitive Behaviour Therapy for Insomnia (CBTi)

EXPERIMENTAL

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

Standard Audiological Care (SAC)

ACTIVE COMPARATOR

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

Sleep Support Group (SSG)

PLACEBO COMPARATOR

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

Interventions

Cognitive Behaviour Therapy for Insomnia BEHAVIORAL

Continuous maintenance of sleep diary, cognitive behaviour therapy, including cognitive restructuring, and behavioural change focusing on sleep restriction and safety behaviours.

Cognitive Behaviour Therapy for Insomnia (CBTi)

Standard Audiological Care BEHAVIORAL

Maintenance of sleep diary at key times. Psycho-education, provision of bedside sound generator.

Standard Audiological Care (SAC)

Sleep Support Group BEHAVIORAL

Maintenance of sleep diary at key times. Social support focused on tinnitus and sleep problems.

Sleep Support Group (SSG)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College London Hospitals: lead
• British Tinnitus Association: collaborator
• University College, London: collaborator

Study Sites (1)

Uclh (Rntneh)

London, WC!X 8DA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31791396 DERIVED

MeSH Terms

Conditions

Tinnitus; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Laurence Laurence, PhD

  UCLH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Clinical Psychologist

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 29, 2017
• Study Start: June 28, 2017
• Primary Completion: December 10, 2019
• Study Completion: December 31, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)