An interventional study of BBTI in Dementia, sponsored by NHS Greater Glasgow and Clyde. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-12.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Supportive care
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.
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:
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).
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's planned enrollment of 15 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: BBTI
3 group sessions over 4 weeks
Sleep quality
Change in Pittsburgh Sleep Quality Index (PSQI) score
Time frame: Baseline and four weeks post-intervention
Sleep condition
Change in score from Sleep Condition Indicator (SCI)
Time frame: Baseline and four weeks post-intervention
Anxiety
Change in score from Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and four weeks post-intervention
Burden
Change in score from the Zarit Burden Interview (ZBI)
Time frame: Baseline and four weeks post-intervention
Sleep efficiency
Change in sleep efficiency (calculated by dividing time spent in bed by time actually asleep)
Time frame: Baseline and four weeks post-intervention
Sleep latency
Change in sleep latency (the time taken to fall asleep)
Time frame: 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
Time frame: Baseline and four weeks post-intervention
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NHS Greater Glasgow and Clyde