A Randomised Controlled Feasibility Study of a Digital Cognitive Behavioural Therapy for Insomnia Intervention in Mild Cognitive Impairment and Mild Dementia: The Randomised Evaluation of Sleep in Cognitive Impairment Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Participant Recruitment
研究概览
简要总结
The purpose of this study is to assess the feasibility of conducting a definitive randomised controlled trial that will determine the effectiveness of a digital cognitive behavioural therapy for insomnia intervention (Sleepio) in improving sleep, psychosocial health and cognitive performance in people with Mild Cognitive Impairment or mild dementia and co-morbid sleep disturbance.
详细描述
Sleep is essential to maintain good physical and mental health and plays a central role in many physiological functions. Nevertheless, insomnia is common with approximately one-third of all adults experiencing insomnia symptoms, increasing to 75% in those aged over 65 years. Two recent meta-analyses suggest that insomnia increases the risk of developing dementia.
Cognitive behavioural therapy for insomnia (CBT-I) is the first-line treatment recommended for insomnia and is supported by a large evidence base. Unfortunately, however, CBT-I is often difficult to access due to the shortage of trained therapists. Digital CBT-I (dCBT-I) provides a possible solution to overcome the barriers associated with accessing the traditional therapist-delivered model of CBT-I. There is good evidence regarding the effectiveness of dCBT-I, which has also recently been shown to be feasible and effective in older people. A small mixed-methods study involving 12 participants has demonstrated preliminary acceptability of dCBT-I among older people with Mild Cognitive Impairment (MCI).
Sleepio is a dCBT-I programme that is specifically recommended as first-line treatment for insomnia by the National Institute for Health and Care Excellence (NICE). Underlying algorithms organise the delivery of evidence-based cognitive and behavioural techniques in a manner tailored to each individual based on their responses to an initial sleep study questionnaire and subsequent sleep diary entries throughout the duration of the programme. The Sleepio programme consists of six sessions. The programme can be completed within a six-week period. However, the average time taken to complete the programme is 9-10 weeks.
The investigators aim to conduct a randomised controlled feasibility study of this NICE-recommended dCBT-I intervention in participants with MCI and mild dementia.
Study participants will be community-dwelling adults aged fifty years and older with insomnia and established MCI or mild dementia. All patients attending outpatient memory clinics affiliated with the Mercy University Hospital in Cork City in the south of Ireland will be screened for eligibility. Consecutive patients who meet eligibility criteria will be invited to participate in the study. Where possible, study partners, being close friends or family members of study participants, will be recruited to support participants throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years.
- •Sleep Condition Indicator Score ≤16/
- •Established Mild Cognitive Impairment (MCI) or mild dementia, diagnosed by a consultant physician specialised in cognitive disorders prior to enrolment in the study. Dementia will be defined using DSM-5 classification and staged according to the Reisberg FAST scale into early/mild stage (Stages 1-4). MCI will be defined using Petersen's criteria. To participate those with MCI/mild dementia must score:
- •≥18 on the Mini-Mental State Examination (MMSE), and
- •≥0.5-1.0 on the Clinical Dementia Rating (CDR) scale.
- •Internet access for the duration of the intervention (via computer/tablet/smartphone).
- •Sufficient physical/sensory (visual/hearing) capacity to use the intervention, as judged by the clinician/investigator.
- •English-speaker (intervention only available in English).
- •Community-dwellers (non-institutionalised).
排除标准
- •Known history of an International Classification of Diseases (ICD) defined sleep disorder other than insomnia disorder.
- •Receipt of a sleep-related cognitive behavioural therapy (CBT) intervention within the past six months.
- •MMSE score <18 at enrolment, to facilitate adherence and ensure recruitment of those with mild-stage disease.
- •Severe depression (defined as depression requiring hospitalisation in the past 12-months or visit to psychiatry outpatient clinic in the past 3 months).
- •Unstable depression/anxiety disorders or panic attacks (unstable will be defined as changes in antidepressant medications within the last 3 months, i.e. no start, stop or change in dose).
- •Other relevant major neuropsychiatric disorders, including schizophrenia, psychosis, mania, bipolar affective disorder, epilepsy or seizure disorder.
- •Ongoing substance or alcohol abuse.
- •Long-term physical or sensory impairment, pain or other medical condition which, in the opinion of the principal investigator, could impair participation for reasons other than cognitive impairment.
- •Planned surgery or hospitalisation during the study that could interfere with participation.
- •Medical conditions rendering the patient too unwell to continue to participate in the study in the opinion of the principal investigator.
- •A change in the following medication within the three months prior to enrolment:
- •Benzodiazepine and non-benzodiazepine hypnotic or anxiolytics agents
- •Cholinesterase inhibitors or Memantine
- •Antidepressants
- •Antipsychotics
- •Amphetamine derivatives
- •Decongestants (pseudoephedrine, phenylephrine, phenyl¬propanolamine)
- •Narcotic analgesics
- •Pulmonary medications (theophylline and albuterol)
研究组 & 干预措施
Intervention Group
Participants allocated to the intervention group will be provided with access to Sleepio, a fully-automated digital cognitive behavioural therapy for insomnia programme designed to treat insomnia using a combination of evidence-based cognitive and behavioural techniques. Underlying algorithms organise the delivery of information, support, and advice in a manner tailored to each individual participant based on their responses to an initial sleep study questionnaire and subsequent sleep diary entries throughout the duration of the programme.
The Sleepio programme consists of six sessions, each ranging from five-to twenty minutes in duration. After the first session, each subsequent session is 'unlocked' one week after delivery of the prior session. Accordingly, the programme can be completed within a six-week period. However, the average time taken to complete the programme is 9-10 weeks.
干预措施: Digital cognitive behavioural therapy for insomnia (Other)
Control Group
Participants allocated to the control group will continue to receive 'treatment-as-usual' throughout the duration of the study period. They will be informed that they will be provided with access to the intervention at the end of the study period.
结局指标
主要结局
Participant Recruitment
时间窗: Six Month Study Period
The aim of this study is to determine the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess recruitment of the target number of 30 eligible participants during the six-month study period.
Participant Retention
时间窗: Six Month Study Period
The purpose of this study is to determine the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess retention of the target number of 70% of enrolled participants throughout the study period.
Participant Adherence
时间窗: Six Month Study Period
The purpose of this study is to determine the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess whether participants allocated to the intervention group achieve the target of 66% adherence to the intervention, defined as completion of four out of the six sessions involved in the intervention programme.
Acceptability of the Intervention
时间窗: Six Month Study Period
The purpose of this study is to assess the feasibility of conducting a definitive randomised controlled trial. This primary outcome will assess the acceptability of the intervention among the study population using a bespoke questionnaire incorporating the System Usability Scale adapted for cognitive impairment (targeting \>70% participants allocated to the intervention group scoring \>70/100) and the Usability Metric for User Experience - Lite (UMUX -Lite). The System Usability Scale is a validated and commonly employed 10-item Likert-type scale that provides a global assessment of how user-friendly a system or product is perceived to be. The UMUX-Lite is a more condensed 2-item Likert-type scale that also measures user-satisfaction with a system or product.
次要结局
- Sleep - Insomnia Severity Index (ISI)(Baseline (enrollment) and 10 weeks post-enrollment)
- Sleep - Sleep Condition Indicator (SCI)(Baseline (enrollment) and 10 weeks post-enrollment)
- Psychosocial Health - Patient Health Questionnaire 8 (PHQ-8)(Baseline (enrollment) and 10 weeks post-enrollment)
- Psychosocial Health - Generalised Anxiety Disorder 7 (GAD-7),(Baseline (enrollment) and 10 weeks post-enrollment)
- Psychosocial Health - Euroqol EQ 5D Visual Analogue Scale(Baseline (enrollment) and 10 weeks post-enrollment)
- Psychosocial Health - Dementia Quality of Life Instrument (DEMQOL)(Baseline (enrollment) and 10 weeks post-enrollment)
- Cognition and Function - Mini-Mental State Examination (MMSE)(Baseline (enrollment) and 10 weeks post-enrollment)
- Cognition and Function - Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)(Baseline (enrollment) and 10 weeks post-enrollment)
- Cognition and Function - Clinical Dementia Rating (CDR) scale(Baseline (enrollment) and 10 weeks post-enrollment)
- Cognition and Function - Disability Assessment for Dementia (DAD)(Baseline (enrollment) and 10 weeks post-enrollment)
- Cognition and Function - British Columbia Cognitive Complaints Inventory (BC-CCI)(Baseline (enrollment) and 10 weeks post-enrollment)