Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients

NCT06407258 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-05-09

No results posted yet for this study

Summary

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.

Conditions

  • Mental Disorder in Adolescence
  • Insomnia
  • Delayed Sleep-Wake Phase Disorder

Interventions

BEHAVIORAL

SLEEPAC

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.

Sponsors & Collaborators

  • Department of Sport, Exercise, and Health, University of Basel

    collaborator UNKNOWN
  • University Hospital of Child and Adolescent Psychiatry and Psychotherapy

    collaborator UNKNOWN
  • University Children's Hospital of Basel

    collaborator UNKNOWN
  • Psychiatry Baselland

    collaborator UNKNOWN
  • Christin Lang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-05-31
Completion
2026-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06407258 on ClinicalTrials.gov