About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
SLEEPAC
Behavioral6x individual blended-care counselling sessions: * 1 x face-to-face kick-off sessions at study site (45 min) * 1 x try-out exercise sessions at study site (45 min) * 4 x online face-to-face sessions via zoom (30 min) * Both the intervention and the waitlist control condition will continue with TAU. Component 1: CBT-I: Sleep restriction, and cognitive therapy strategies with education about sleep-wake regulation, sleep hygiene, and pre-bedtime counter arousal methods. Component 2: Circadian treatment: Morning bright light therapy with a gradual advanced sleep schedule and timed morning exercise. Component 3: Physical activity counselling involves providing personalized guidance and support to individuals to help them adopt and maintain a physically active lifestyle tailored to their preferences and needs.
Treatment groups
Trial outcomes
Primary outcomes
Psychopathology
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.
Secondary outcomes
Composite Sleep Health
The use of a single disorder-focused sleep measure might be problematic to capture intervention effects among a transdiagnostic sample. A composite sleep health score comprising 6 dimensions of sleep and circadian functioning (daytime alertness, sleep satisfaction, -timing, -efficiency, -duration, and -regularity) was found to predicted mental health in adolescents. Using these components, a weighted summary sleep health score will be calculated, based on results from exploratory factor analyses. The following questionnaires will be used: The Pittsburgh Sleep Quality Index (PSQI) The Pediatric Daytime Sleepiness Scale (PDSS) The Sleep condition indicator (SCI) 7-day Habitual sleep-wake pattern (Oura Ring Gen3) Children's Morningness-Eveningness Preference Scale (CMEP) Munich Chronotype Questionnaire (MCTQ) According to LuDong et al. 2019, each dimension will be dichotomized as "good" (=1) or "poor" (=0). Thus a higher score indicates better sleep health.
Physical Activity
Habitual physical activity patterns will be captured with the Oura Ring Gen3. For 7 consecutive days and nights, participants will wear the small finger ring on their non-dominant hand over 7 days and nights to collect objective physical activity patterns. Additionally, a 7-day physical activity recall will be conducted at the end of the week with a trained staff member.
Cognitive performance
Cognitive Performance will be assessed with a modified version of the Stroop task, which includes trials demanding inhibitory control and emotion recognition. The computer-based task is administered with E-Prime 3.0 (PST, USA). Participants complete testing in a seated position, with a viewing distance of approximately 80 cm. Assessments are performed in a dimly lit room at an environmental temperature of 21-22 °C. The surrounding noise is reduced to a minimum and participants are instructed to avoid movements and noise during cognitive testing. The testing sequence is identical for all participants and lasts 10 to 15 min.
Self-esteem
Self-esteem will be assessed with the Rosenberg Self-Esteem Scale
Sponsors and contacts
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Christin Lang
Lead sponsor
University of Basel
Sponsor institution
Department of Sport, Exercise, and Health, University of Basel
Collaborator
University Hospital of Child and Adolescent Psychiatry and Psychotherapy
Collaborator
University Children's Hospital Basel
Collaborator
Psychiatry Baselland
Collaborator
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