Efficacy of Cognitive Behavioural Therapy for Insomnia With Adjuvant Melatonin Treatment in Older Adults With Chronic Insomnia: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Insomnia Symptoms - Insomnia Severity Index
研究概览
简要总结
This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin in older adults with insomnia. Adults aged 60 or above with chronic insomnia will be randomly assigned to one of three groups: (1) CBT-I plus nightly melatonin, (2) CBT-I plus nightly placebo tablet, or (3) sleep health psychoeducation plus nightly placebo tablet. All group sessions occur weekly for four weeks.
详细描述
This randomized, double-blind, placebo-controlled trial examines whether cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin improves sleep and circadian outcomes as well as daytime functioning in older adults with chronic insomnia.
Eligible participants (aged ≥60 years, meeting DSM-5 criteria for insomnia disorder) will be recruited and randomly assigned to one of the three parallel groups: (1) CBT-I combined with nightly melatonin, (2) CBT-I with nightly placebo, or (3) sleep-health psychoeducation with nightly placebo. All interventions involve four weekly 90-minute group sessions (6-8 participants per group) conducted in person. Melatonin (3 mg immediate-release) or a matched placebo will be taken 30 minutes before habitual bedtime for four weeks.
Assessments will be conducted at baseline, mid-treatment (week 2, for the primary outcome only), and post-treatment (week 4) for all participants, and additionally at three-month and six-month follow-ups for participants in the two CBT-I groups. Data collection includes validated questionnaires on sleep, circadian, mood, fatigue, and quality of life, as well as computerized cognitive tasks to assess domains such as attention, working memory, and executive function. Objective sleep and circadian parameters will be measured by actigraphy for seven consecutive nights, along with a daily sleep diary. Participants will also complete polysomnography (PSG) for objective sleep assessment. To index circadian timing, a subset of participants will collect saliva samples (about 1 mL each) every 30 minutes under dim-light conditions in the evening to estimate dim-light melatonin onset (DLMO).
The primary outcome is the change in self-reported insomnia severity from baseline to post-treatment. Secondary outcomes include resumption and treatment response of insomnia, clinical symptom severity, objective and subjective sleep- and circadian-related outcomes, mood, daytime functioning, quality of life, and cognitive performance.
The study is conducted across two sites - The University of Hong Kong (Department of Psychology) and The Chinese University of Hong Kong (Department of Psychiatry). Findings are expected to clarify whether melatonin can augment the efficacy and sustainability of CBT-I in older adults, providing new insights into circadian-based strategies for improving sleep health in late life.
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 (Participant, Outcomes Assessor)
盲法说明
Melatonin and placebo tablets are identical in appearance. Participants are blinded to their tablet assignment. Outcome assessors are blinded to treatment allocation throughout.
Therapists delivering CBT-I are not blinded to the therapy arm but are blinded to tablet assignment.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chinese aged ≥
- •Provision of written informed consent.
- •Having a DSM-5 diagnosis of insomnia disorder (i.e., having difficulty initiating sleep, maintaining sleep, or early morning awakening at least three times a week for at least three months, with clinically significant impairment or distress).
- •Having a score of > 14 on the ISI, indicating clinical insomnia.
排除标准
- •Having a current diagnosis or a history of manic or hypomanic episodes, schizophrenia spectrum disorders, neurodevelopmental disorders, neurocognitive disorders, organic mental disorders, intellectual disabilities, or substance abuse or dependence.
- •Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain).
- •Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy).
- •Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder.
- •Having mild to significant cognitive impairment, defined by having a score of < 22 on MOCA.
- •Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon).
- •Receiving concurrent psychological treatment for insomnia.
- •Meeting potential contraindications for melatonin (e.g., undergoing dialysis) or concurrently using medications that have a potential drug interaction with melatonin (e.g., anticoagulant and anti-platelet).
- •Being a night shift worker.
研究组 & 干预措施
CBT-I + Melatonin
Four weekly group-based CBT-I sessions (120-min, 6-8 participants) plus oral melatonin 3 mg immediate-release taken 30 min before habitual bedtime for 4 weeks.
干预措施: Cognitive behavioural therapy for insomnia (Behavioral)
CBT-I + Melatonin
Four weekly group-based CBT-I sessions (120-min, 6-8 participants) plus oral melatonin 3 mg immediate-release taken 30 min before habitual bedtime for 4 weeks.
干预措施: Melatonin 3 mg immediate-release (Dietary Supplement)
CBT-I + Placebo
Identical four weekly group-based CBT-I sessions plus placebo capsule (identical appearance) taken 30 min before habitual bedtime for 4 weeks.
干预措施: Cognitive behavioural therapy for insomnia (Behavioral)
CBT-I + Placebo
Identical four weekly group-based CBT-I sessions plus placebo capsule (identical appearance) taken 30 min before habitual bedtime for 4 weeks.
干预措施: Placebo Oral Tablet (Drug)
Psychoeducation + Placebo
Four weekly group-based sleep psychoeducation sessions (sleep hygiene, healthy diet, and exercise for older adults; no active CBT-I components) plus placebo capsule for 4 weeks.
干预措施: Psychoeducation (Behavioral)
Psychoeducation + Placebo
Four weekly group-based sleep psychoeducation sessions (sleep hygiene, healthy diet, and exercise for older adults; no active CBT-I components) plus placebo capsule for 4 weeks.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Insomnia Symptoms - Insomnia Severity Index
时间窗: Baseline, Mid-session (Week 2 of the intervention), Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.
Insomnia symptoms measured by Insomnia Severity Index (ISI). ISI is a 5-item self-rated scale. Possible scores range from 0 to 20, with higher scores indicating greater insomnia severity.
次要结局
- Treatment Response of Insomnia(Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Remission of insomnia(Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self Report Sleep Quality - The Pittsburgh Sleep Quality Index(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self-Report Chronotype Measures The Munich Chronotype Questionnaire(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self-Report Chronotype Preference: The Morningness-Eveningness Questionnaire(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self-report Mood Symptoms - Hospital Anxiety and Depression Scale(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self-report Daytime Sleepiness - Epworth Sleepiness Scale(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Cognitive Performance (working memory by N-Back)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self-report Daytime Fatigue - Multidimensional Fatigue Inventory(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Overall Severity of Clinical Symptoms(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Cognitive Performance (problem solving)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Cognitive Performance (episodic memory)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Overall Treatment Response(Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self Report Quality of Life - 36-Item Short Form Health Survey(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Cognitive Performance (attention/inhibitory ability)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Cognitive Performance (Alertness)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self-report Cognition - Multifactorial Memory Questionnaire(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self-report Depressive Symptoms - Beck Depression Inventory-II(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Clinician Rated Depressive Symptoms - The Hamilton Rating Scale for Depression(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self Report: Dysfunctional sleep beliefs(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self-report Cognitive Functioning: Cognitive Failures Questionnaire Score(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self Report: Pre-sleep somatic arousal(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self Report: Stress-related insomnia vulnerability(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Self Report: Sleep Hygiene Practices Scale (SHPS)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Sleep Diary Measure - Time in Bed (TIB)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Sleep Diary Measure - Total Sleep Time (TST)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Sleep Diary Measure - Sleep Onset Latency (SOL)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Sleep Diary Measure - Wake After Sleep Onset (WASO)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Sleep Diary Measure - Sleep Efficiency (SE)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Time in Bed (TIB)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Total Sleep Time (TST)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Sleep Onset Latency (SOL)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Wake After Sleep Onset (WASO)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Sleep Midpoint Variability(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Sleep Efficiency (SE)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Acrophase(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Amplitude(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Intradaily Variability (IV)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Interdaily Stability (IS)(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - L5(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - M10(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Actigraphy - Fluctuation of the midpoint of sleep(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Objective Circadian Measures: Dim-Light Melatonin Onset (DLMO) - Sleep Onset Phase angle(Baseline and Post-Treatment (one-week after treatment conclusion))
- Objective Circadian Measures: Dim-Light Melatonin Onset (DLMO) - DLMO Timing(Baseline and Post-Treatment (one-week after treatment conclusion))
- Polysomnography - Wake After Sleep Onset(Baseline and Post-Treatment (one-week after treatment conclusion))
- Objective Circadian Measures: Dim-Light Melatonin Onset (DLMO) - Sleep Midpoint Phase Angel(Baseline and Post-Treatment (one-week after treatment conclusion))
- Dim Light Melatonin Onset - Lights-Off Phase Angel(Baseline and Post-Treatment (one-week after treatment conclusion))
- Pupil Light Reflex - T75 Recovery Time(Baseline, Post-Treatment (one-week after treatment conclusion) for all participants, and at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.)
- Polysomnography - Time in Bed(Baseline and Post-Treatment (one-week after treatment conclusion))
- Polysomnography - Total Sleep Time(Baseline and Post-Treatment (one-week after treatment conclusion))
- Polysomnography - Sleep Efficiency(Baseline and Post-Treatment (one-week after treatment conclusion))
- Polysomnography - Sleep Latency(Baseline and Post-Treatment (one-week after treatment conclusion))
研究者
Dr. Shirley Xin Li
Associate Professor
The University of Hong Kong