Internet-Based Cognitive Behavioral Therapy and Physical Activity for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Feasibility: Pilot RCT recruitment rate
研究概览
简要总结
Internet-based cognitive behavioural therapy for insomnia (iCBT-I) has shown promise for reducing insomnia symptoms. Additionally, physical activity has long been known to contribute to better sleep. The current protocol describes a planned a two-phased project aiming to examine the effect of a randomised controlled trial, including iCBT-I (standard care) alone or with additional physical activity components (iCBT-I-PA). Adults with sleep problems and insufficient physical activity levels will be included in the 6-8-week intervention. Outcomes measured will include insomnia severity (primary outcome), physical activity, sedentary behaviour, psychological distress, cognitive function and quality of life. Measures will be taken at baseline, immediately post-intervention, and at 6- and 12-month follow-ups. We hypothesise that the iCBT-I-PA group will show greater reductions in insomnia severity and increase physical activity compared to the iCBT-I group.
详细描述
Design and aims:
Internet-based cognitive behavioural therapy for insomnia (iCBT-I) has shown promise for treating insomnia. Physical activity has been proposed as a potential adjuvant to insomnia treatments as it has positive benefits for optimal sleep. An intervention has been developed that incorporates physical activity components into the standard iCBT-I (iCBT-I-PA). The current protocol describes the planned project which consists of two phases: Phase 1 will evaluate the feasibility and acceptability of iCBT-I-PA. The results of the feasibility and acceptability outcomes will inform adjustments to the study procedures ahead of the full-scale trial. Phase 2 will be a full-scale randomised controlled trial (RCT) with the aim to examine the effectiveness of iCBT-I-PA compared to iCBT-I as standard care (control).
Phase 1: A pilot RCT with the aims to:
- study the feasibility regarding recruitment, randomization and adherence of study protocol.
- analyse the within-group changes of sleep, physical activity, sedentary time, cognitive impairment, depression and anxiety, from baseline and directly after the intervention.
- explore participants' experiences of the new treatment and of participating in the study including acceptance of study protocol.
Phase 2: An RCT with the aims to:
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
Participants will be aware of the treatment but will not be aware of the different conditions included in the RCT.
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
- •18 years or older
- •Experiencing clinically relevant insomnia (Insomnia Severity Index score >10)
- •Do not meet the recommended levels of physical activity (weekly 150-300 minutes of moderate intensity physical activity or 75-150 minutes of vigorous physical activity)
排除标准
- •Have any ongoing diagnosed medical conditions known to affect PA participation as assessed by intervention clinician.
- •Increased risk for suicide as assessed by intervention clinician.
研究组 & 干预措施
iCBT-I
Standard care (control): Internet-based cognitive behavioural therapy targeting insomnia
干预措施: Behavioral: Internet-based cognitive behavioral therapy & physical ACtivity for INSOMNIa (iCBT-I) (Behavioral)
iCBT-I-PA
Experimental condition: Internet-based cognitive behavioural therapy targeting insomnia combined with physical activity
干预措施: Internet-based cognitive behavioral therapy & physical ACtivity for INSOMNIa (iCBT-I-PA) (Behavioral)
结局指标
主要结局
Feasibility: Pilot RCT recruitment rate
时间窗: Following recruitment to randomisation of the final pilot participant (up to 52 weeks).
For Phase 1 pilot RCT only: Recruitment rate will be assessed as the average rate of participant recruitment as participants per week throughout the pilot RCT. Measurement tool: Study screening and enrolment log.
Feasibility: Pilot RCT consent rate
时间窗: Following recruitment to randomisation of the final pilot participant (up to 52 weeks).
For Phase 1 pilot RCT only: Consent rate will be assessed as the proportion of eligible/recruited participants who consent to participate. Measurement tool: Study screening and consent log.
Feasibility: Pilot RCT adherence rate
时间窗: Baseline and post-intervention measure (6-8 weeks)
For Phase 1 pilot RCT only: Intervention adherence will be assessed as the proportion of participants completing ≥3 modules (50% of intervention), the minimum number required for an expected change in insomnia outcomes. Measurement tool: The number of completed modules indicated by study clinician.
Feasibility: Pilot RCT data collection completion rate
时间窗: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
For Phase 1 pilot RCT only: Data collection completion will be assessed as the proportion of randomised participants who provide complete outcome data at baseline, post-intervention, 6 months, and 12 months. Measurement tool: the outcome assessment database.
Feasibility: Pilot RCT retention rate
时间窗: 6 and 12 months follow-up after intervention
For Phase 1 pilot RCT only: Retention will be assessed as the proportion of randomised participants who have not withdrawn and who complete the follow-up assessments at 6 and 12 months. Measurement tool: The participant tracking and follow-up log.
Feasibility: Pilot RCT intervention fidelity rate
时间窗: Post-intervention (6-8 weeks)
For Phase 1 pilot RCT only: Intervention fidelity will be assessed as the percentage of planned intervention components delivered as intended. Measurement tool: Study-specific intervention fidelity checklist completed by study clinicians and platform delivery records.
Acceptability: Pilot RCT acceptability of the iCBT-I-PA intervention assessed by semi-structured interview
时间窗: Post-intervention (6-8 weeks)
For Phase 1 pilot RCT only: Acceptability will be assessed using semi-structured interviews with participants randomised to the iCBT-I-PA condition who completed at least the baseline measures. Interviews will explore participants' experiences of the intervention and pilot RCT procedures, including acceptability of the intervention, randomisation, outcome assessments, follow-up schedule, and barriers and facilitators to engagement. Measurement tool: Semi-structured interview topic. Themes identified using thematic analysis.
Insomnia severity
时间窗: Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up
For Phase 1 pilot RCT and Phase 2 full-scale RCT: Insomnia severity will be the primary outcome that the intervention will aim to change. Insomnia severity will be measured using the Insomnia Severity Index (ISI). The ISI comprises seven items, measuring the severity and impact of insomnia and the extent to which it interferes with the individual's daily life. The ISI is scored on a 5-point Likert scale (0="Not at all", 4="Very much"). A sum score represents overall insomnia severity, ranging from 0 to 28. Measurement tool: The Insomnia Severity Index (ISI)
次要结局
- Sleep: Diary(Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up)
- Sleep: Device-measured(Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up)
- Physical activity: Diary(Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up)
- Physical activity: Self-report(Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up)
- Physical activity: Device-measured(Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up)
- Sedentary behaviour: Diary(Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up)
- Sedentary behaviour: Self-report(Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up)
- Sedentary behaviour: Device-measured(Baseline, post-intervention (6-8 weeks), 6- and 12-month follow-up)
研究者
Sören Spörndly-Nees
Research supervisor
Uppsala County Council, Sweden