Sleep Difficulties After Loss (SLEEPLOSS): Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The goal of the study is to investigate whether a brief behavioral therapy for insomnia (BBTI) improves sleep in bereaved patients screened for insomnia compared to an active control group (sleep hygiene education). The study will also explore if BBTI improves symptoms of complicated grief. The investigators will recruit approximately 58 bereaved participants with insomnia.
详细描述
The study is a randomized controlled trial comparing the effect of a brief behavioral therapy for insomnia (BBTI) on insomnia with an active control group (sleep hygiene). Participants will be 58 bereaved individuals who experience insomnia. After baseline assessment, participants will be randomized to either BBTI or sleep hygiene (active control). Both groups will undergo post-treatment assessments as well as 3- and 6-months follow-up assessments. The primary outcomes will be insomnia assessed with the Insomnia Severity Index (ISI) and improvements in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and sleep parameters using the consensus sleep diary. The secondary outcome will be complicated grief reactions (CGR) using the Aarhus Prolonged Grief Disorder scale (A-PGDs, prolonged grief). the Center of Epidemiological Studies Depression Scale (CESD-10, depression), the General Anxiety Disorder-7 questionnaire (GAD-7; anxiety), and the short-form PTSD Checklist for DSM-5 (PCL-5; PTSD).
The study has the following aims and hypotheses:
PRIMARY AIM: To investigate whether BBTI improves sleep in bereaved patients screened for insomnia when compared to an active control group.
PRIMARY HYPOTHESIS: Compared with the active control group, participants receiving BBTI will show statistically significant reductions in insomnia using the ISI, as well as improvements in sleep quality using the PSQI and sleep parameters using the consensus sleep diary.
SECONDARY AIM: To explore whether BBTI improves CGR in bereaved patients screened for insomnia when compared to an active control group.
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
- Single (Participant)
盲法说明
We aim to mask the participants as much as possible. The study uses a single-blind randomized controlled design, in which participants will know what treatment they will receive and that there are two groups. However, they will not know what treatment the other group will receive or that one group is the intervention group and the other an active control group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Bereaved (experienced the death of a perceived loved one) ≥6 months ago
- •Insomnia: a score of >10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder
排除标准
- •Other sleep disor-ders (sleep apnea, parasomnia, narcolepsy)
- •Use of drugs impacting sleep
- •Severe psychological or physical disorders that may confound sleep (symptoms of CGR allowed)
- •Neurodegenerative disorders
- •Shift work
- •Insufficient Danish proficiency
- •Previous experience with BBTI or cognitive behavioral therapy for insomnia (CBT-I)
研究组 & 干预措施
Intervention group (group 1)
Participants will retrieve individually administered BBTI by therapists through face-to-face meetings and phone-calls. Treatment will take 4 weeks.
干预措施: Brief Behavioral Therapy for Insomnia (Behavioral)
Active control group (group 2)
Participants will receive access to sleep hygiene education (SHE) through written educational material. Treatment will take 4 weeks.
干预措施: Sleep Hygiene Therapy (Behavioral)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
The ISI measures the severity of insomnia symptoms and the associated impact on daytime functioning and distress. The questionnaire consists of 7 questions the sum of which makes up a total score. The ISI has a range of 0-28, with higher scores indicate worse insomnia severity.
次要结局
- Morningness-Eveningness Questionnaire - Revised (MEQr)(Time Frame: Time Frame: Baseline (week 0))
- Aarhus Prolonged Grief Disorder Scale (A-PGDs)(Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).)
- Center for Epidemiological Studies Depression Scale - 10 Item Version (CESD-10)(Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).)
- Pittsburgh Sleep Quality Index (PSQI)(Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).)
- Consensus Sleep Diary(Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).)
- Generalized Anxiety Disorder - 7 Item Scale (GAD-7)(Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).)
- Expectancy/Credibility Questionnaire (CEQ)(Baseline (week 0))
- PTSD Checklist for DSM-5 - Short Form (PCL-5 - Short Form)(Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).)
- My Grief(Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).)
- The perceived stress scale (PSS)(Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).)
- The Short-Form (12) Health Survey (SF-12)(Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).)
- World Health Organization-Five Well-Being Index (WHO-5)(Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).)
- NEO Personality Inventory - Revised (NEO-PI-R), Neuroticism Only(Baseline (week 0))
- Experiences in Close Relationships Scale - Short Form (ECR-S)(Baseline (week 0))