Brief Behavioural Treatment for Insomnia in Dementia Carers

NCT02983032 | Unknown

• 1 other identifier: 16/WS/0252
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Dementia

Keywords

Caregivers; Insomnia

Outcome Measures

Primary Outcomes (1)

• Sleep quality

  Change in Pittsburgh Sleep Quality Index (PSQI) score

  Baseline and four weeks post-intervention

Secondary Outcomes (6)

• Sleep condition

  Baseline and four weeks post-intervention

• Anxiety

  Baseline and four weeks post-intervention

• Burden

  Baseline and four weeks post-intervention

• Sleep efficiency

  Baseline and four weeks post-intervention

• Sleep latency

  Baseline and four weeks post-intervention

Study Arms (1)

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.

Behavioral: BBTI

Interventions

BBTI BEHAVIORAL

3 group sessions over 4 weeks

Brief behavioural treatment for insomnia (BBTI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Dementia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Maria Gardani, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosie Begbie, MA (Hons)

CONTACT

k.begbie.1@research.gla.ac.uk

Maria Gardani, PhD

CONTACT

maria.gardani@glasgow.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: January 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 12, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)