Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients
NCT ID: NCT06407258
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
140 participants
INTERVENTIONAL
2024-06-01
2026-06-30
Brief Summary
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Detailed Description
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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.
Impact. The onset of mental health disorders is often during adolescence, requiring countermeasures at an early developmental stage. Since sleep disturbances are a diagnostic feature for many psychiatric disorders, treating sleep problems transdiagnostically may positively impact other health outcomes. PA counseling may complement the benefits of the sleep intervention, working in concert to improve mental health outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SLEEPAC
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.
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.
Control
Participants of the control group continue with their treatment as usual
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Suffering from medical conditions, which prevent participation in physical activity
* Changes to medication regime during the study protocol
* Color-blindness (due to stroop test)
13 Years
18 Years
ALL
No
Sponsors
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Department of Sport, Exercise, and Health, University of Basel
UNKNOWN
University Hospital of Child and Adolescent Psychiatry and Psychotherapy
UNKNOWN
University Children's Hospital of Basel
UNKNOWN
Psychiatry Baselland
UNKNOWN
Christin Lang
OTHER
Responsible Party
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Christin Lang
PhD
Locations
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Department of Sport, Exercise, and Health, University of Basel
Basel, Canton of Basel-City, Switzerland
University Hospital of Child and Adolescent Psychiatry and Psychotherapy
Bern, Canton of Bern, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SLEEPAC
Identifier Type: -
Identifier Source: org_study_id
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