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NCT05870228 | Recruiting | Insomnia


Investigating a Sleep Intervention for Adolescents Attending Mental Health Services
Sponsor:

Stephanie McCrory

Information provided by (Responsible Party):

Stephanie McCrory

Brief Summary:

The overall objectives of the study are to: 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. To examine participant acceptability. The researchers will conduct qualitative interviews with the participants and delivery staff to examine the acceptability of the programme. 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.

Condition or disease

Insomnia

Mental Health Issue

Intervention/treatment

Strathclyde Sleep Intervention

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 46 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Investigating the Feasibility, Acceptability, and Preliminary Effectiveness of a Sleep Intervention for Adolescents With Co-morbid Insomnia and Mental Health Difficulties
Actual Study Start Date : October 13, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024
Arm Intervention/treatment

Other: Single-arm intervention group

Single-arm intervention

Behavioral: Strathclyde Sleep Intervention

Ages Eligible for Study: 12 Years to 15 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Adolescents (12-15 years)
  • Meeting thresholds for insomnia disorder (determined by cut-off scores on the 2 item Sleep Condition Indicator (score <2 indicates probable insomnia)
  • Attending CAMHS for mental health intervention/support
  • Able to engage with intervention protocol
Exclusion Criteria
  • Active suicide ideation and/or recent suicidal attempts
  • 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.
  • Diagnosis of Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Foetal Alcohol Spectrum Disorder (Neurodiversity)
  • 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

Investigating a Sleep Intervention for Adolescents Attending Mental Health Services

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Investigating a Sleep Intervention for Adolescents Attending Mental Health Services

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Locations


Recruiting

United Kingdom, Lanarkshire

East Renfrewshire Healthier Minds Team

Glasgow, Lanarkshire, United Kingdom, g781sy

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