DementiaNCT02983032
Brief Behavioural Treatment for Insomnia in Dementia Carers
A study testing BBTI in people with Dementia, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Background: between 50-74% of dementia carers report some sleep disturbance. However, relatively few studies have looked at psychological treatment for insomnia in this group. Dementia carers may be particularly at risk for suffering negative consequences from the impact of sleep loss on top of the stress of their… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- BBTI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Carer of person with dementia
- Live with person being cared for
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for insomnia disorder with the exception that carers not meeting the frequency criterion of 3 times per week or duration criterion of 3 months will still be included if frequency is at least twice per week and duration 2 months.
- competent in English language and have good basic literacy skills.
Who cannot join
- unstable, moderate to severe mental health issues (particularly Major Depressive Disorder and Bipolar Disorder)
- already receiving a psychological intervention
- untreated sleep disorders eg obstructive sleep apnoea, restless legs syndrome and periodic limb movement disorders.
- current serious medical condition, such as cancer or recent remission from cancer
- learning disability or a neurological condition (e.g. Multiple Sclerosis, Parkinson's disease, epilepsy)
- being investigated for or existing diagnosis of degenerative condition
- sleep problem primarily due to having to be awake during the night/early morning to respond to the needs of the person they care for
Trial locations and contacts
1 site in 1 country.
Rosie Begbie, MA (Hons) contact
Maria Gardani, PhD contact
About this study
Official title: Brief Behavioural Treatment for Insomnia (BBTI) in Family Carers of People With Dementia: a Feasibility Study
Background: between 50-74% of dementia carers report some sleep disturbance. However, relatively few studies have looked at psychological treatment for insomnia in this group. Dementia carers may be particularly at risk for suffering negative consequences from the impact of sleep loss on top of the stress of their carer role. Researchers have found that Brief Behavioural Treatment for Insomnia (BBTI) can be effective for improving symptoms of insomnia in older adults. BBTI focusses on sleep-related behaviour such as napping and when a person gets up and goes to bed.
Aims: this study aims to explore whether delivering group-based, Brief Behavioural Treatment for Insomnia (BBTI) to family carers of people with dementia is feasible, given that, to date, this has not yet been explored.
Read more
Who is eligible?: carers with insomnia who care for a family member with dementia and live with them at home are eligible for inclusion in this study.
What is involved for participants?: taking part will involve an initial telephone discussion with a researcher to check suitability. Participants will then meet the researcher for assessment. Assessment includes a sleep interview and completing some questionnaires. Participants will then be required to attend 3 group sessions of BBTI across the space of 4 weeks. After attending the BBTI group, participants will be asked to fill in some of the same questionnaires that they filled in during assessment and again 4 weeks later. Participants will also be invited to take part in a focus group to give feedback about the treatment and their overall experience of being in the study.
Read the detailed description
This study will explore the feasibility of delivering adapted BBTI in a group setting to family carers of people with dementia. The study will be a feasibility study given that delivering BBTI to groups of dementia carers hasn't been done before. It is therefore necessary to explore, in essence, whether it is 'do-able'. In-line with this, the current study will be considering the following:
- How many eligible participants consent to participate in the study?
- How many carers stay in the study until the end?
- Do carers find BBTI an acceptable treatment, are they able to comply with treatment instructions, and what modifications might be required?
- Are any improvements in sleep observed?
- Are any improvements in anxiety, depression and carer burden observed? It is hypothesised that carers' sleep will improve over the course of the study. Specifically, it is hypothesised that there will be a reduction in scores on the Pittsburgh Sleep Quality Index (PSQI), an increase in scores on the Sleep Condition Indicator (SCI), and an improvement in sleep diary parameters (increased sleep efficiency, a reduction in sleep latency and a reduction in wake time after sleep onset) following participation in BBTI. Sleep efficiency is calculated by dividing time spent in bed divided by time actually asleep; sleep latency is the time it takes you to fall asleep and reduction in wake time after sleep onset is the total time you are awake during the night after you first fall asleep. Based on a calculation, the sample size required is estimated to be 11. Given that some participants may withdraw from the study the study will aim to recruit 15 participants.
Procedure Individuals who are caring for a family member with dementia will be given a Participant Invitation Letter by healthcare workers and advertisements will be place in relevant clinics. Those interested in finding out more will make contact with the research team, who will screen potential participants. Those meeting the criteria will be sent a Participant Information Sheet and invited to attend a baseline assessment appointment. At the initial assessment appointment, the researcher will answer any questions the person has about the study, the Participant Information Sheet, or the Consent Form. They will then be asked to fill in the Consent Form before starting the assessment. If they do not consent the assessment will not be initiated. If they do consent, then the researcher will proceed to completing the baseline assessment. This will include the semi-structured sleep interview and questions regarding physical and mental health. The following measures will also be administered: Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), Pittsburgh Sleep Quality Index (PSQI), Sleep Condition Indicator (SCI), Hospital Anxiety and Depression Scale (HADS) and the Zarit Burden Interview (ZBI).
Participants will also be shown how to complete a sleep diary at this appointment and will be asked to complete this for the two weeks prior to the first session of BBTI. The baseline assessment appointment is expected to last between 45-60 minutes.
The intervention will be delivered across 3 group sessions and 1 telephone consultation over a period of 4 weeks, as follows:
Week 1 - 90 minute group session (allowing time to cover all the educational material and to give individual sleep instructions as well as a break and initial group introductions) Week 2 - Group session (max 45 mins) Week 3 - Phone call (approx. 15 minutes) Week 4 - Final group session (max 45 mins) Week 5 - Appointments for post-treatment assessment
There will be two group facilitators and groups will have a maximum of 5 participants. Participants will be asked to keep sleep diaries throughout the intervention period. At the beginning of each session, participants will also be asked to complete the Stanford Sleepiness Scale in order to monitor daytime sleepiness.
The following measures will be administered post-treatment and at 4 week follow-up: Pittsburgh Sleep Quality Index (PSQI), Sleep Condition Indicator (SCI), Hospital Anxiety and Depression Scale (HADS) and the Zarit Burden Interview (ZBI).
- Conditions
- Dementia
- Being tested
- BBTI
- Keywords
- Caregivers, Insomnia
- Medical subject headings
- Dementia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBTIBehavioural
3 group sessions over 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Brief behavioural treatment for insomnia (BBTI) | Experimental | A behavioural therapy for improving symptoms of insomnia in older adults focussing on sleep-related behaviour such as napping and when a person gets up and goes to bed. Receives: Behavioral: BBTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Change in Pittsburgh Sleep Quality Index (PSQI) score
Measured: Baseline and four weeks post-intervention
Secondary outcomes (6)
Sleep condition
Change in score from Sleep Condition Indicator (SCI)
Measured: Baseline and four weeks post-intervention
Anxiety
Change in score from Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline and four weeks post-intervention
Burden
Change in score from the Zarit Burden Interview (ZBI)
Measured: Baseline and four weeks post-intervention
Sleep efficiency
Change in sleep efficiency (calculated by dividing time spent in bed by time actually asleep)
Measured: Baseline and four weeks post-intervention
Sleep latency
Change in sleep latency (the time taken to fall asleep)
Measured: Baseline and four weeks post-intervention
Wake time after sleep onset
Change in total time you are awake during the night after you first fall asleep
Measured: Baseline and four weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Maria Gardani, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983032
- Sponsor's protocol ID
- 16/WS/0252
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Behavioural Treatment for Insomnia (BBTI) in Family Carers of People With Dementia: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02983032
- Acronym / sponsor ID
- 16/WS/0252
- Conditions
- Dementia
- Keywords
- Caregivers, Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Jan 2017
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: between 50-74% of dementia carers report some sleep disturbance. However, relatively few studies have looked at psychological treatment for insomnia in this group. Dementia carers may be particularly at risk for suffering negative consequences from the impact of sleep loss on top of the stress of their carer role. Researchers have found that Brief Behavioural Treatment for Insomnia (BBTI) can be effective for improving symptoms of insomnia in older adults. BBTI focusses on sleep-related behaviour such as napping and when a person gets up and goes to bed.
Aims: this study aims to explore whether delivering group-based, Brief Behavioural Treatment for Insomnia (BBTI) to family carers of people with dementia is feasible, given that, to date, this has not yet been explored.
Who is eligible?: carers with insomnia who care for a family member with dementia and live with them at home are eligible for inclusion in this study.
What is involved for participants?: taking part will involve an initial telephone discussion with a researcher to check suitability. Participants will then meet the researcher for assessment. Assessment includes a sleep interview and completing some questionnaires. Participants will then be required to attend 3 group sessions of BBTI across the space of 4 weeks. After attending the BBTI group, participants will be asked to fill in some of the same questionnaires that they filled in during assessment and again 4 weeks later. Participants will also be invited to take part in a focus group to give feedback about the treatment and their overall experience of being in the study.
Detailed description
This study will explore the feasibility of delivering adapted BBTI in a group setting to family carers of people with dementia. The study will be a feasibility study given that delivering BBTI to groups of dementia carers hasn't been done before. It is therefore necessary to explore, in essence, whether it is 'do-able'. In-line with this, the current study will be considering the following:
- How many eligible participants consent to participate in the study?
- How many carers stay in the study until the end?
- Do carers find BBTI an acceptable treatment, are they able to comply with treatment instructions, and what modifications might be required?
- Are any improvements in sleep observed?
- Are any improvements in anxiety, depression and carer burden observed? It is hypothesised that carers' sleep will improve over the course of the study. Specifically, it is hypothesised that there will be a reduction in scores on the Pittsburgh Sleep Quality Index (PSQI), an increase in scores on the Sleep Condition Indicator (SCI), and an improvement in sleep diary parameters (increased sleep efficiency, a reduction in sleep latency and a reduction in wake time after sleep onset) following participation in BBTI. Sleep efficiency is calculated by dividing time spent in bed divided by time actually asleep; sleep latency is the time it takes you to fall asleep and reduction in wake time after sleep onset is the total time you are awake during the night after you first fall asleep. Based on a calculation, the sample size required is estimated to be 11. Given that some participants may withdraw from the study the study will aim to recruit 15 participants.
Procedure Individuals who are caring for a family member with dementia will be given a Participant Invitation Letter by healthcare workers and advertisements will be place in relevant clinics. Those interested in finding out more will make contact with the research team, who will screen potential participants. Those meeting the criteria will be sent a Participant Information Sheet and invited to attend a baseline assessment appointment. At the initial assessment appointment, the researcher will answer any questions the person has about the study, the Participant Information Sheet, or the Consent Form. They will then be asked to fill in the Consent Form before starting the assessment. If they do not consent the assessment will not be initiated. If they do consent, then the researcher will proceed to completing the baseline assessment. This will include the semi-structured sleep interview and questions regarding physical and mental health. The following measures will also be administered: Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), Pittsburgh Sleep Quality Index (PSQI), Sleep Condition Indicator (SCI), Hospital Anxiety and Depression Scale (HADS) and the Zarit Burden Interview (ZBI).
Participants will also be shown how to complete a sleep diary at this appointment and will be asked to complete this for the two weeks prior to the first session of BBTI. The baseline assessment appointment is expected to last between 45-60 minutes.
The intervention will be delivered across 3 group sessions and 1 telephone consultation over a period of 4 weeks, as follows:
Week 1 - 90 minute group session (allowing time to cover all the educational material and to give individual sleep instructions as well as a break and initial group introductions) Week 2 - Group session (max 45 mins) Week 3 - Phone call (approx. 15 minutes) Week 4 - Final group session (max 45 mins) Week 5 - Appointments for post-treatment assessment
There will be two group facilitators and groups will have a maximum of 5 participants. Participants will be asked to keep sleep diaries throughout the intervention period. At the beginning of each session, participants will also be asked to complete the Stanford Sleepiness Scale in order to monitor daytime sleepiness.
The following measures will be administered post-treatment and at 4 week follow-up: Pittsburgh Sleep Quality Index (PSQI), Sleep Condition Indicator (SCI), Hospital Anxiety and Depression Scale (HADS) and the Zarit Burden Interview (ZBI).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief behavioural treatment for insomnia (BBTI) | Experimental | Behavioral: BBTIA behavioural therapy for improving symptoms of insomnia in older adults focussing on sleep-related behaviour such as napping and when a person gets up and goes to bed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Carer of person with dementia
- Live with person being cared for
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for insomnia disorder with the exception that carers not meeting the frequency criterion of 3 times per week or duration criterion of 3 months will still be included if frequency is at least twice per week and duration 2 months.
- competent in English language and have good basic literacy skills.
Key exclusion criteria (7 listed)
- unstable, moderate to severe mental health issues (particularly Major Depressive Disorder and Bipolar Disorder)
- already receiving a psychological intervention
- untreated sleep disorders eg obstructive sleep apnoea, restless legs syndrome and periodic limb movement disorders.
- current serious medical condition, such as cancer or recent remission from cancer
- learning disability or a neurological condition (e.g. Multiple Sclerosis, Parkinson's disease, epilepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBTI3 group sessions over 4 weeks | Behavioural | Brief behavioural treatment for insomnia (BBTI) |
Primary outcome
Sleep quality
Time frame: Baseline and four weeks post-intervention
Change in Pittsburgh Sleep Quality Index (PSQI) score
6 secondary outcomes
Sleep condition
Time frame: Baseline and four weeks post-intervention
Anxiety
Time frame: Baseline and four weeks post-intervention
Burden
Time frame: Baseline and four weeks post-intervention
Sleep efficiency
Time frame: Baseline and four weeks post-intervention
Sleep latency
Time frame: Baseline and four weeks post-intervention
Wake time after sleep onset
Time frame: Baseline and four weeks post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosie Begbie, MA (Hons) contact
Maria Gardani, PhD contact
Maria Gardani, PhD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BBTI in people with Dementia, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosie Begbie, MA (Hons) (k.begbie.1@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: Baseline and four weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.