Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Sleep diary - Total Wake Time (TWT)
研究概览
简要总结
The goal of this clinical trialis to compare a digital Cognitive-behavioral intervention for insomnia to digital administered applied relaxation in participants with Multiple Sclerosis.
The treatments will be compared in following outcomes:
- Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and early morning awakening (EMA).
- Insomnia symptoms
- Depressive symptoms
- Client satisfaction
- Negative effects
- Worry
- Fatigue
- Quality of life
- MS symptoms/function
详细描述
In order to start evaluate the digital treatment format, this study will use a Randomized Controlled Trial design (RCT). Participants with MS and insomnia from a Neurology clinic in Sweden will be randomized to either Cognitive-behavioral intervention for insomnia (iCBT) or Applied relaxation (AR). The treatments will consits of six sessions and will be administered digitally. Psychologists will have contact with the participants via a secure video call platform.Follow-up data will be gathered at six and 12 months after the treatments.
The treatments will be compared in following outcomes:
- Sleep diary: total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and early morning awakening (EMA).
- Insomnia symptoms
- Depressive symptoms
- Worry
- Fatigue
- Quality of life
- MS symptoms/function
- Client satisfaction
- Negative effects
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 (Outcomes Assessor)
盲法说明
Outcomes will be adiministered via a digital platform.
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
- •be medically assessed
- •meet criteria for MS and insomnia disorder
- •have access to the internet and a smart phone with internet access
- •have good reading ability, and
- •be over 18 years of age
排除标准
- •have a planned treatment that may prevent participation
- •were involved in ongoing medical research that may prevent participation,
- •do not have a command of the Swedish language
- •have a more serious acute psychiatric and/or somatic condition which prevented participation; or benefit from the treatment
- •have an increased risk of suicide to the extent that participation in study was considered inappropriate,
- •suffers from other primary sleep disorders such as sleep apnea, restless legs syndrome, periodic limb movement disorder, circadian rhythm disorder, or parasomnia
- •have insomnia due to environmental factors such as shift work.
结局指标
主要结局
Sleep diary - Total Wake Time (TWT)
时间窗: Baseline, daily through study completion, up to 8 weeks
Total wake time (TWT) is calculated by summing the variables Sleep onset latensy, Wake after slepp onset and Early morning awakening in minutes from the sleep diary. This measure has been used as an outcome measure in clinical studies of CBT-I because it may have better explanatory power than other variables in the sleep diary. .
次要结局
- Patient Health Questionnaire (PHQ-9)(Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.s.)
- Insomnia Severity Index (ISI)(Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment, and 6 and 12 months after the treatment.)
- The Brunnsviken Brief Quality of Life Scale (BBQ)(Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment, and 6 and 12 months after the treatment.)
- Negative effects(After the intervention.)
- Multiple Sclerosis Impact Scale (MSIS-29)(Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.)
- Sleep diary. early morning awakening (EMA)(Baseline, daily through study completion, up to 8 weeks)
- Fatigue Severity Scale (FSS)(Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.)
- Sleep diary- wake after sleep onset (WASO)(Baseline, daily through study completion, up to 8 weeks)
- Client Satisfaction Questionnaire-8 (CSQ-8)(After the treatment that is 6 to 8 weeks after entering the treatment)
- The Generalized Anxiety Disorder (GAD-7)(Baseline (before the treatment) after the treatment that is 6 to 8 weeks after entering the treatment and 6 and 12 months after the treatment.)
- Sleep diary- Sleep onset latensy (SOL)(Baseline, daily through study completion, up to 8 weeks)
研究者
Monica Buhrman
Associate professor
Uppsala University