Clinical trial NCT05870228: Investigating a Sleep Intervention for Adolescents Attending Mental Health Services
Official title: Investigating the Feasibility, Acceptability, and Preliminary Effectiveness of a Sleep Intervention for Adolescents With Co-morbid Insomnia and Mental Health Difficulties
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Mental Health Issue
Keywords: Adolescent Sleep
Insomnia
Mental Health
CBT-I
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 46
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objectives of the study are to:

1. To assess the feasibility of delivering the Strathclyde Sleep Intervention to adolescents with co-morbid insomnia and mental health attending a mental health services The following feasibility benchmarks will be assessed: recruitment and retention, participant attendance, staff training, intervention fidelity and participant adherence.
2. To examine participant acceptability. The researchers will conduct qualitative interviews with the participants and delivery staff to examine the acceptability of the programme.
3. To investigate the preliminary effectiveness by assessing the following: sleep parameters, insomnia symptoms, Circadian phase preference (baseline only) and mental health symptoms. Data will be collected at baseline, post-intervention and 3 month follow-up.

Detailed description: Sleep problems have a significant detrimental impact on physical health, development, and functioning and are commonly experienced co-morbidly with other mental health problems. Therefore, many adolescents who are attending mental health services, also experience significant sleep disturbances. However, sleep problems are rarely addressed within mental health services due to lack of awareness of the importance of sleep and/or training in effective treatments. Cognitive behavioural therapy for insomnia (CBT-I) is the recommended approach for treating insomnia in both adult and adolescent populations. Despite this, there has been limited research investigating the delivery of CBT-I interventions to adolescents with co-morbid mental health problems, and to our knowledge, no such studies exist within the Scottish context. The Strathclyde Sleep Intervention incorporates CBT-I components to improve adolescent sleep. This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of the intervention for adolescents attending mental health services. Staff within the service will receive training to deliver the Strathclyde Sleep Intervention to adolescents with co-morbid mental health and sleep problems. The following feasibility benchmarks will be assessed: recruitment and retention, participant attendance, facilitator training, intervention fidelity and participant adherence. Acceptability will be measured via qualitative interviews with participants and staff. Baseline, post-intervention, and follow-up assessments will be conducted to assess preliminary effectiveness of the intervention for improving sleep and mental health. This research is necessary to inform future trials of the Strathclyde Sleep Intervention and to support its wider implementation within services.

Eligibility 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

Primary outcomes:
measure: Number of participants recruited and rates of retention
timeFrame: From participant referral to study completion (up to 1 year)
measure: Number of participants who attend each session
timeFrame: From participant consent to study completion (up to 1 year)
measure: Staff satisfaction with training
timeFrame: Post-intervention (up to 3 weeks)
measure: Intervention fidelity
timeFrame: Through intervention delivery, up to 6 months
measure: Number of participant who adhere to components of intervention.
timeFrame: Through intervention delivery, up to 6 months
Secondary outcomes:
measure: Acceptability of intervention to participants
timeFrame: Post-intervention (up to 3 weeks)
measure: Sleep outcomes including sleep onset, total sleep time, total time in bed, wake after sleep onset, sleep efficiency (change from baseline, post-intervention and follow-up)
timeFrame: Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
measure: Insomnia symptoms assessed using SCI (<16 indicates probable insomnia, higher scores indicate better sleep, scores range 0-32) (change from baseline, post-intervention and follow-up)
timeFrame: Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
measure: Depression and anxiety symptoms assessed by RCADS-25 (change from baseline, post-intervention and follow-up)
timeFrame: Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
measure: Anxiety symptoms measured by GAD-7 (change from baseline, post-intervention and follow-up)
timeFrame: Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
measure: Depression symptoms measured by PHQ-9 (change from baseline, post-intervention and follow-up)
timeFrame: Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
measure: Circadian Phase Preference measured by MESC
timeFrame: Baseline only
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: East Renfrewshire Healthier Minds Team
state: Lanarkshire
Study officials:
affiliation: University of Strathclyde
name: Leanne Fleming, PhD
role: PRINCIPAL_INVESTIGATOR
References: