Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients

NCT06407258 | Not Yet Recruiting DMC

• 1 other identifier: SLEEPAC
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

adolescents; CBT-I; light therapy; circadian adaptation; physical activity counseling; transdiagnostic

Outcome Measures

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.

  10 minutes

Secondary Outcomes (4)

• Composite Sleep Health

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

• Physical Activity

  7 days

• Cognitive performance

  10 min

• Self-esteem

  5 min

Study Arms (2)

SLEEPAC

EXPERIMENTAL

In addition to treatment-as-usual (TAU), participants of the SLEEPAC arm will receive a multi-component sleep intervention combining elements of CBT-i, circadian adaptation, and physical activity counselling.

Behavioral: SLEEPAC

Control

NO INTERVENTION

Participants of the control group continue with their treatment as usual

Interventions

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.

SLEEPAC

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Christin Lang: lead
• Department of Sport, Exercise, and Health, University of Basel: collaborator
• University Hospital of Child and Adolescent Psychiatry and Psychotherapy: collaborator
• University Children's Hospital of Basel: collaborator
• Psychiatry Baselland: collaborator

Study Sites (2)

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

Basel, Canton of Basel-City, 4052, Switzerland

Location

University Hospital of Child and Adolescent Psychiatry and Psychotherapy

Bern, Canton of Bern, 3000, Switzerland

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Chronobiology Disorders; Occupational Diseases

Central Study Contacts

Christin Lang, PhD

CONTACT

+41 61 207 61 45; christin.lang@unibas.ch

Leila Tarokh, Prof

CONTACT

+41 31 932 86 19; leila.tarokh2@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 9, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)