A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

NCT ID: NCT03386123

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-28
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Behaviour Therapy for Insomnia

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

Standard Audiological Care

Intervention Type: BEHAVIORAL

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

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.

Group Type: PLACEBO_COMPARATOR

Sleep Support Group

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Standard Audiological Care

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

Intervention Type: BEHAVIORAL

Sleep Support Group

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

British Tinnitus Association

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: collaborator

University College London Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Dr Laurence McKenna

Consultant Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laurence Laurence, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLH

Locations

Uclh (Rntneh)

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31791396 (View on PubMed)

Other Identifiers

UCLondonH

Identifier Type: -

Identifier Source: org_study_id