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临床试验/NCT06407258
NCT06407258尚未招募不适用

Transdiagnostic Sleep Intervention Combined With Physical Activity Counseling (SLEEPAC) in Adolescent Psychiatric Patients: A Blended Care Approach

Christin Lang4 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
4
主要终点
Psychopathology

研究概览

简要总结

Mental health disorders pose a significant burden on adolescent populations globally, often accompanied by sleep disturbances. Emerging evidence suggests that addressing sleep issues can improve mental health outcomes, while physical activity is increasingly recognized as beneficial for both sleep and mental well-being. This study aims to assess the effectiveness of a novel intervention (SLEEPAC), combining cognitive-behavioral therapy for insomnia (CBT-I), circadian treatment, and PA counseling, compared to treatment as usual (TAU), in improving psychopathology among adolescent psychiatric outpatients with sleep disturbances. Secondary outcomes include improvements in sleep health, physical activity levels, cognitive performance and self-esteem. Additionally, the study seeks to explore the predictive value of sleep neurophysiological biomarkers using high-density sleep electroencephalography (EEG), contributing to advancements in precision psychiatry for this population.

详细描述

Background and rationale. Mental health disorders are the leading cause of disability in adolescents worldwide. 70 to 80% of individuals with mental disorders experience sleep disturbances. Preliminary evidence from adult studies suggest that treating sleep disturbances in these patients can improve mental health outcomes. Moreover, regular physical activity (PA) is increasingly promoted as a remedy for sleep and other mental health problems. Thus, combining sleep therapy and PA counseling may synergistically improve mental health outcomes in adolescent psychiatric patients. Guidance on how to address sleep disturbances and PA counselling among this population in routine clinical care has the potential to improve clinical and psychosocial outcomes.

Overall objectives. To improve psychopathology in adolescent psychiatric outpatients with comorbid sleep disturbances by testing a novel behavioral intervention (TRANSPAC) that improves both sleep and PA levels. This multi-component intervention combines CBT-I, circadian treatment, and PA counseling and will be compared against treatment as usual (TAU).

Specific aims. With the prospect of further developing and fine-tuning transdiagnostic treatment protocols for young psychiatric patients with comorbid sleep disturbances, the objectives of the proposed study are twofold: (1) To test the efficacy of a novel transdiagnostic blended care e-health sleep (CBT-I + circadian treatment) and PA therapy and to test its efficacy against TAU. The primary endpoint is severity reduction of psychopathology. Improvements of sleep health and regular PA levels will be investigated as secondary outcomes. (2) To evaluate the prognostic value of sleep neurophysiological biomarkers (high-density sleep-EEG) on intervention efficiency, thereby advancing current approaches in precision psychiatry.

Methods. The proposed study will recruit 140 psychiatric outpatients with comorbid sleep problems from our partner clinics in Basel and Bern (KJP-UPD Bern, UKBB Basel). Inclusion criteria: aged 13-18 years, presence of sleep problems in addition to a psychiatric diagnosis. Adolescents will be serially randomized over 1,5 years into one of 2 intervention arms: (a) TRANSPAC; or (b) TAU. The intervention will be delivered in 6 sessions over 12 weeks. Data will be collected at 3 time points: Baseline, post-intervention, and 6-months follow-up. Psychopathological load will be assessed via Symptom Checklist-90-Revised. The composite sleep health score is based on self-reported sleep quality, -quantity, and timing, complemented by 7-day sleep tracker (Oura Ring Gen3). PA will be assessed objectively via the same device (Oura Ring was selected due to prior compliance issues among this population with Actigraph). Primary biomarkers are the micro-architectural features of sleep assessed by a high-density sleep-EEG, such as sleep spindles, slow wave activity, and REM-latency. Secondary biomarkers include heart rate variability, and fitness.

Expected results. The proposed study aims to further develop and fine-tune transdiagnostic treatment protocols (i.e. for multiple psychiatric disorders) in adolescent psychiatric outpatients with sleep disturbances. Testing the potential of sleep treatments for improving psychopathology in young psychiatric patients is a promising and highly novel approach. Thus, it is expected that both TRANSPAC and TAU will improve psychopathology in youth, with TRANSPAC resulting in superior effects than TAU alone.

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)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 13 to 18 years
  • Presence of insomnia and/or delayed sleep-wake phase disorder
  • At least one further diagnosis of DSM-5
  • Written informed consent of parents / primary caregiver

排除标准

  • Organic sleep- and brain disorders (i.e., obstructive sleep apnea, narcolepsy, epilepsy)
  • Suffering from medical conditions, which prevent participation in physical activity
  • Changes to medication regime during the study protocol
  • Color-blindness (due to stroop test)

结局指标

主要结局

Psychopathology

时间窗: 10 minutes

Symptom Checklist-90-Revised (SCL-90-R) is one of the most comprehensive and widely used questionnaires to assess psychopathology. It is validated for youth psychiatric inpatients from age 13 onwards. The Symptom Checklist contains a list of problems and complaints that people sometimes have. Participants are asked how much they were bothered by that problem during the past week. Answers range from 0=not at all to 4=extremely. Thus, a higher factor score indicated more serious psychiatric symptoms problems.

次要结局

  • Physical Activity(7 days)
  • Cognitive performance(10 min)
  • Self-esteem(5 min)
  • Composite Sleep Health(10-20 min (questionnaire), 7 days (sleep tracker Oura Gen3))

研究者

发起方
Christin Lang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christin Lang

PhD

University of Basel

研究点 (4)

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