Investigating a Sleep Intervention for Adolescents Attending Mental Health Services

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870228
• Other study ID #: UEC2331
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Strathclyde
• Contact: Stephanie McCrory
• Phone: 0141 552 4400
• Email: stephanie.mccrory[@]strath.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Mental Health Issue
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Strathclyde Sleep Intervention
Manual-based CBT-I

Locations

Country	Name	City	State
United Kingdom	East Renfrewshire Healthier Minds Team	Glasgow	Lanarkshire

Sponsors (1)

Lead Sponsor	Collaborator
Stephanie McCrory

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited and rates of retention	How many participants have been referred, consented and recruited overall. How many participants have dropped out.	From participant referral to study completion (up to 1 year)
Primary	Number of participants who attend each session	Measured through attendance logs. How many participants attended the sessions, number of non-attendance.	From participant consent to study completion (up to 1 year)
Primary	Staff satisfaction with training	Measured through qualitative interviews	Post-intervention (up to 3 weeks)
Primary	Intervention fidelity	An intervention delivery checklist will be used by the researchers to assess the adherence to the SIESTA Delivery protocol.	Through intervention delivery, up to 6 months
Primary	Number of participant who adhere to components of intervention.	Captured through sleep diaries.	Through intervention delivery, up to 6 months
Secondary	Acceptability of intervention to participants	Measured through qualitative interviews	Post-intervention (up to 3 weeks)
Secondary	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)	Captured through consensus sleep diary	Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Secondary	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)	Measured with the Sleep Condition Indicator (SCI) which measures symptoms of insomnia. The 8-item scale includes recommended cut-off score (<16) to indicate probable insomnia.	Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Secondary	Depression and anxiety symptoms assessed by RCADS-25 (change from baseline, post-intervention and follow-up)	Measured by Revised Child Anxiety and Depression Scale - 25 (RCADS-25). The 25-item scale measures symptoms of depression and anxiety using two sub-scales. Each sub-scale is calculated and then converted into a t-score. T-scores indicate levels of symptom severity including: <65 low severity, 65-70 medium severity (borderline clinical threshold), >70 high severity (clinical threshold).	Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Secondary	Anxiety symptoms measured by GAD-7 (change from baseline, post-intervention and follow-up)	Measured by Generalised Anxiety Disorder Assessment (GAD-7). The GAD-7 will be utilised to measure symptoms of anxiety. The measure consists of 7 items assessing anxiety symptoms over the previous 2 weeks. Scores range from 0-21, higher scores indicate greater symptom severity (5- mild, 10 - moderate, 15- severe).	Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Secondary	Depression symptoms measured by PHQ-9 (change from baseline, post-intervention and follow-up)	Measured by Patient Health Questionnaire-9 (PHQ-9). Scores range from 0-27 with higher scores indicating greater symptom severity (5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe).	Baseline (2-weeks before intervention delivery), post-intervention (2-weeks following intervention delivery) and follow-up (3-months following intervention delivery))
Secondary	Circadian Phase Preference measured by MESC	Measured by Morningness/eveningness scale for children (MESC). This 10-item measure will be used to assess circadian phase preference. Items are scored on a 4 or 5 item scale and scores range from 10-42. Lower scores indicate greater eveningness and higher scores indicate greater morningness. This item will be collected in the baseline assessment.	Baseline only