Mental Disorder in AdolescenceSLEEPACNCT06407258
Promoting Sleep and Physical Activity Among Adolescent Psychiatric Patients
A study testing SLEEPAC in people with Mental Disorder in Adolescence and Insomnia, run by Christin Lang at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Mental Disorder in Adolescence, Insomnia, Delayed Sleep-Wake Phase Disorder
- What is being tested?
- SLEEPAC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of Sport, Exercise, and Health, University of Basel
Basel, Canton of Basel-City, 4052
Christin Lang, PhD, 0041 61 207 61 45, christin.lang@unibas.ch
Markus Gerber, Prof, markus.gerber@unibas.ch
University Hospital of Child and Adolescent Psychiatry and Psychotherapy
Bern, Canton of Bern, 3000
Christin Lang, PhD, 0041 79 109 22 74, christin.lang@unibas.ch
Leila Tarokh, Prof, leila.tarokh2@unibe.ch
About this study
Official title: Transdiagnostic Sleep Intervention Combined With Physical Activity Counseling (SLEEPAC) in Adolescent Psychiatric Patients: A Blended Care Approach
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.
Read the detailed description
Background and rationale. Mental health disorders are the leading cause of disability in adolescents worldwide. 70 to 80% of individuals with mental disorders experience sleep disturbances. Preliminary evidence from adult studies suggest that treating sleep disturbances in these patients can improve mental health outcomes. Moreover, regular physical activity (PA) is increasingly promoted as a remedy for sleep and other mental health problems. Thus, combining sleep therapy and PA counseling may synergistically improve mental health outcomes in adolescent psychiatric patients. Guidance on how to address sleep disturbances and PA counselling among this population in routine clinical care has the potential to improve clinical and psychosocial outcomes.
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.
- Being tested
- SLEEPAC
- Keywords
- adolescents, CBT-I, light therapy, circadian adaptation, physical activity counseling, transdiagnostic
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLEEPACBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: SLEEPAC |
| Control | No intervention | Participants of the control group continue with their treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (4)
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.
Measured: 10-20 min (questionnaire), 7 days (sleep tracker Oura Gen3)
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.
Measured: 7 days
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.
Measured: 10 min
Self-esteem
Self-esteem will be assessed with the Rosenberg Self-Esteem Scale
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorder in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christin Lang
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Sport, Exercise, and Health, University of Basel, University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University Children's Hospital Basel, Psychiatry Baselland
- Responsible party
- Sponsor-investigator, Christin Lang, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407258
- Sponsor's protocol ID
- SLEEPAC
- Acronym
- SLEEPAC
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdiagnostic Sleep Intervention Combined With Physical Activity Counseling (SLEEPAC) in Adolescent Psychiatric Patients: A Blended Care Approach
- ClinicalTrials.gov ID
- NCT06407258
- Acronym / sponsor ID
- SLEEPAC / SLEEPAC
- Keywords
- adolescents, CBT-I, light therapy, circadian adaptation, physical activity counseling, transdiagnostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Christin LangUniversity, hospital or other
- Collaborators
- Department of Sport, Exercise, and Health, University of Basel, University Hospital of Child and Adolescent Psychiatry and Psychotherapy, University Children's Hospital Basel, Psychiatry Baselland
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and rationale. Mental health disorders are the leading cause of disability in adolescents worldwide. 70 to 80% of individuals with mental disorders experience sleep disturbances. Preliminary evidence from adult studies suggest that treating sleep disturbances in these patients can improve mental health outcomes. Moreover, regular physical activity (PA) is increasingly promoted as a remedy for sleep and other mental health problems. Thus, combining sleep therapy and PA counseling may synergistically improve mental health outcomes in adolescent psychiatric patients. Guidance on how to address sleep disturbances and PA counselling among this population in routine clinical care has the potential to improve clinical and psychosocial outcomes.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLEEPAC | Experimental | Behavioral: SLEEPACIn 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. |
| Control | No intervention | –Participants of the control group continue with their treatment as usual |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLEEPAC6x 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. | Behavioural | SLEEPAC |
Primary outcome
Psychopathology
Time frame: 10 minutes
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.
4 secondary outcomes
Composite Sleep Health
Time frame: 10-20 min (questionnaire), 7 days (sleep tracker Oura Gen3)
Physical Activity
Time frame: 7 days
Cognitive performance
Time frame: 10 min
Self-esteem
Time frame: 5 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLEEPAC in people with Mental Disorder in Adolescence and Insomnia, run by Christin Lang at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christin Lang, PhD (+41 61 207 61 45, christin.lang@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychopathology (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.