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A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

Primary Purpose

Tinnitus, Insomnia

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Cognitive Behaviour Therapy for Insomnia

Standard Audiological Care

Sleep Support Group

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Insomnia, Cognitive Behaviour Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Uclh (Rntneh)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Cognitive Behaviour Therapy for Insomnia (CBTi)

Standard Audiological Care (SAC)

Sleep Support Group (SSG)

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

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.

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.

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.

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.

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.

Change in subjective measure of tinnitus loudness

Visual Analogue Scale from 0mm to 100mm; higher scores indicate greater loudness of tinnitus.

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.

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.

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.

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).

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.

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.

Full Information

NCT ID

NCT03386123

First Posted

December 8, 2017

Last Updated

June 7, 2019

Sponsor

University College London Hospitals

Collaborators

British Tinnitus Association, University College, London

1. Study Identification

Unique Protocol Identification Number

NCT03386123

Brief Title

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

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 28, 2017 (Actual)

Primary Completion Date

December 10, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University College London Hospitals

Collaborators

British Tinnitus Association, University College, London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus, Insomnia

Keywords

Tinnitus, Insomnia, Cognitive Behaviour Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behaviour Therapy for Insomnia (CBTi)

Arm Type

Experimental

Arm Description

Arm Title

Standard Audiological Care (SAC)

Arm Type

Active Comparator

Arm Description

Arm Title

Sleep Support Group (SSG)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behaviour Therapy for Insomnia

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Standard Audiological Care

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Sleep Support Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Insomnia Severity Index (ISI) score

Description

7-item questionnaire, each item rates 0 - 4. Total scores range from 0-28 with higher scores indicating more severity.

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Change in the amount of sleep obtained

Description

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.

Secondary Outcome Measure Information:

Title

Change in Pittsburgh Sleep Quality Index score

Description

10-item questionnaire. Sum of 7 components; global score range 0 - 21; higher scores indicate worse sleep quality.

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Change in Dysfunctional Beliefs and Attitudes About Sleep Questionnaire - abbreviated version (DBAS-16) score

Description

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Change in Tinnitus Catastrophizing Scale score

Description

13-item questionnaire scored on a 0-4 scale. Total sum of scores range from 0 - 52. Higher scores indicate higher levels of catastrophizing.

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Mini Tinnitus Questionnaire score

Description

Time Frame

Screening

Title

Change in the Tinnitus Questionnaire score

Description

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.

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Change in subjective measure of tinnitus loudness

Description

Visual Analogue Scale from 0mm to 100mm; higher scores indicate greater loudness of tinnitus.

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Change in Clinical Outcome in Routine Evaluation - Outcome Measure score

Description

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Change in Patient Health Questionnaire-9 score

Description

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.

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Change in Generalized Anxiety Disorder Assessment-7 score

Description

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.

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Change in EuroQOL score

Description

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Change in Work and Social Adjustment Scale score

Description

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.

Time Frame

At first and last treatment sessions and at 1 and 6 month follow-ups

Title

Satisfaction and feedback

Description

Time Frame

At the end of treatment and at six month follow-up point

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurence Laurence, PhD

Organizational Affiliation

UCLH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uclh (Rntneh)

City

London

ZIP/Postal Code

WC!X 8DA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31791396

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.

Results Reference

derived

Learn more about this trial

A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia

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