Insomnia Clinical Trial
Official title:
Investigating the Feasibility, Acceptability, and Preliminary Effectiveness of a Sleep Intervention for Adolescents With Co-morbid Insomnia and Mental Health Difficulties
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
| Recruiting |
NCT05963542 -
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
|
N/A | |
| Completed |
NCT06339853 -
Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
|
N/A | |
| Recruiting |
NCT04069247 -
Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia
|
N/A | |
| Completed |
NCT04493593 -
Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility
|
N/A | |
| Recruiting |
NCT06278077 -
Neurexan - a Clinical Trial in Short-Term Insomnia Patients
|
Phase 2 | |
| Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
| Completed |
NCT04661306 -
The Better Sleep for Supporters With Insomnia Study
|
N/A | |
| Recruiting |
NCT06207279 -
Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
|
||
| Recruiting |
NCT06006299 -
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
|
N/A | |
| Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
| Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
| Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
| Completed |
NCT04035200 -
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
|
Phase 2 | |
| Active, not recruiting |
NCT05027438 -
Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention
|
N/A | |
| Recruiting |
NCT06053840 -
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia
|
Phase 4 | |
| Not yet recruiting |
NCT06348082 -
Project Women's Insomnia Sleep Health Equity Study (WISHES)
|
N/A | |
| Not yet recruiting |
NCT06363799 -
Osteopathic Protocol for Insomnia in College Students
|
N/A | |
| Not yet recruiting |
NCT05991492 -
Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
|
N/A | |
| Not yet recruiting |
NCT06025968 -
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
|
N/A |