Sleep intervention for adolescents with mental health issues
Investigating the Feasibility, Acceptability, and Preliminary Effectiveness of a Sleep Intervention for Adolescents With Co-morbid Insomnia and Mental Health Difficulties
This study is testing a new sleep program that uses therapy techniques to help teenagers with mental health issues improve their sleep and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 12 Years to 15 Years |
| Sex | All |
| Sponsor | University of Strathclyde Academic / other |
| Locations | 1 site (Glasgow, Lanarkshire) |
| Trial ID | NCT05870228 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and acceptability of the Strathclyde Sleep Intervention, which incorporates cognitive behavioral therapy for insomnia (CBT-I) components, for adolescents aged 12-15 attending mental health services. The research will assess recruitment, retention, participant attendance, and staff training, while also evaluating the preliminary effectiveness of the intervention on sleep parameters and mental health symptoms. Qualitative interviews will be conducted to gather insights on participant and staff acceptability of the program. Data will be collected at baseline, post-intervention, and at a 3-month follow-up to measure outcomes.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-15 who meet the criteria for insomnia disorder and are currently receiving mental health support.
Not a fit: Patients with active suicidal ideation, certain psychiatric disorders, or those currently undergoing CBT-I elsewhere may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and mental health outcomes for adolescents facing these challenges.
How similar studies have performed: While there is limited research on CBT-I for adolescents with co-morbid mental health issues, similar interventions have shown promise in other populations, making this approach both novel and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adolescents (12-15 years) 2. Meeting thresholds for insomnia disorder (determined by cut-off scores on the 2 item Sleep Condition Indicator (score \<2 indicates probable insomnia) 3. Attending CAMHS for mental health intervention/support 4. Able to engage with intervention protocol Exclusion Criteria: 1. Active suicide ideation and/or recent suicidal attempts 2. Contraindicators for components of CBT-I (sleep restriction therapy) including seizure disorders/conditions including epilepsy, bipolar disorder, symptoms of psychosis, obstructive sleep apnea and parasomnias. 3. Diagnosis of Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Foetal Alcohol Spectrum Disorder (Neurodiversity) 4. Those who are currently completing, or have recently completed (in the past 6 months), CBT-I for insomnia elsewhere (or components of CBT-I including e.g. sleep restriction therapy, stimulus control, cognitive techniques). This will only include in-person, one-to-one methods of delivery
Where this trial is running
Glasgow, Lanarkshire
- East Renfrewshire Healthier Minds Team — Glasgow, Lanarkshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Leanne Fleming, PhD — University of Strathclyde
- Study coordinator: Stephanie McCrory
- Email: stephanie.mccrory@strath.ac.uk
- Phone: 0141 552 4400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.