Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorChristin Lang

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • SLEEPAC

    Behavioral

    6x 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

140 Participants
are divided into 2 treatment groups
Group A: SLEEPACExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
10 minutes

Secondary outcomes

1

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.

Time frame
10-20 min (questionnaire), 7 days (sleep tracker Oura Gen3)
2

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.

Time frame
7 days
3

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.

Time frame
10 min
4

Self-esteem

Self-esteem will be assessed with the Rosenberg Self-Esteem Scale

Time frame
5 min

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: