Investigating a Sleep Intervention for Adolescents Attending Mental Health Services

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.

Study Overview

• Status: Terminated
• Conditions: Insomnia; Mental Health Issue
• Intervention / Treatment: Behavioral: Strathclyde Sleep Intervention

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
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lanarkshire
    • Glasgow, Lanarkshire, United Kingdom, g781sy
      • East Renfrewshire Healthier Minds Team

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single-arm intervention group; Single-arm intervention	Behavioral: Strathclyde Sleep Intervention; Manual-based CBT-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adolescent Participants Recruited	A total of 8 adolescents were referred between October 2023 and October 2024. Of these, 1 was ineligible, 4 declined participation / did not respond, and 3 provided consent and were enrolled.	1 year
Number of Adolescent Participants Who Attend Each Session	Measured through attendance logs. This outcome reports the number of adolescent participants who completed each session of the 4-session intervention.	Over 4 session intervention period (1 - 4 months) 1-4 months 1-4 months
Intervention Fidelity	Fidelity was assessed using an intervention delivery checklist. Practitioners were categorised based on whether they delivered the intervention as intended or deviated. Of the 10 practitioners who completed training, only 3 practitioners delivered the intervention, but only 2 submitted fidelity data for this outcome.	1-4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Intervention to Practitioners	Measured through qualitative interviews conducted with mental health practitioners and service managers (N = 13) to explore their experiences of the intervention and feasibility of delivery in practice.	Up to 9 months post-training
Sleep Outcomes (Change From Baseline, Post-intervention and Follow-up)	Sleep outcomes were intended to be assessed using a consensus sleep diary completed by adolescent participants at three time points: baseline (2 weeks prior to intervention), post-intervention (2 weeks after intervention), and follow-up (3 months after intervention). However, only baseline data were completed by 3 participants. No post-intervention or follow-up sleep diary data were collected. This table summarizes baseline sleep outcomes only, based on the sleep efficiency score - a key sleep parameter calculated as: Sleep Efficiency (%) = (Total Sleep Time / Time in Bed) × 100 Higher scores indicate better sleep efficiency, with scores above 90% typically considered good.	Baseline (2 weeks before intervention delivery)
Insomnia Symptoms Assessed Using Sleep Condition Indicator (Score of <16 Indicates Probable Insomnia, Higher Scores Indicate Better Sleep, Scores Range 0-32) (Change From Baseline, Post-intervention and Follow-up)	Insomnia symptoms were intended to be measured using the Sleep Condition Indicator (SCI), completed by adolescent participants at three time points: Baseline (2 weeks prior to intervention), Post-intervention (2 weeks following intervention), Follow-up (3 months post-intervention) Sleep Condition Indicator scores range from 0-32, with higher scores indicating better sleep. A score <16 suggests probable insomnia. However, only baseline SCI scores were collected from participants. No post-intervention or follow-up data were submitted.	Baseline (2 weeks before intervention) Baseline (2 weeks before intervention) Baseline (2 weeks before intervention)
Depression and Anxiety Symptoms Assessed by Revised Child Anxiety and Depression Scale - 25 Item Version (RCADS-25) (Change From Baseline, Post-intervention and Follow-up)	Symptoms of depression and anxiety were intended to be assessed using the Revised Child Anxiety and Depression Scale - 25 item version (RCADS-25), completed by adolescent participants at three time points: Baseline (2 weeks prior to intervention), Post-intervention (2 weeks after intervention), Follow-up (3 months after intervention) RCADS-25 provides total scores and subscale scores for anxiety and depression. The anxiety subscale includes 15 items and scores range from 0-45. The depression subscale comprises 10 items and scores range from 0-30. A total score can be calculated by summing the depression and anxiety subscales and the total scores range from 0-75. Higher scores on any subscale or the total score represent greater symptom severity. However, only baseline data were collected. No post-intervention or follow-up RCADS-25 data were submitted by any of the 3 adolescent participants	Baseline (2-weeks before intervention delivery)
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). We intended to collect data at three time points: Baseline (2 weeks prior to intervention), Post-intervention (2 weeks after intervention), Follow-up (3 months after intervention) However, only 1 participant completed this measure at baseline. No post-intervention or follow-up GAD-7 data were submitted by participants.	Baseline (2-weeks before intervention delivery)
Depression Symptoms Measured by PHQ-9 (Change From Baseline, Post-intervention and Follow-up)	Depression symptoms were intended to be measured using the Patient Health Questionnaire-9 (PHQ-9) at three time points: Baseline (2 weeks prior to intervention), Post-intervention (2 weeks after intervention), Follow-up (3 months after intervention) The PHQ-9 consists of 9 items, each scored 0-3, with total scores ranging from 0-27. Higher scores indicate more severe depressive symptoms. However, only baseline PHQ-9 data were submitted by participants. No post-intervention or follow-up data were collected.	Baseline (2-weeks before intervention delivery)
Circadian Phase Preference Measured by Morningness/Eveningness Scale for Children	Measured by Morningness/eveningness scale for children (MESC). This 10-item measure will be used to assess circadian phase preference. Items are scored on from 1- 5 item scale and scores range from 10-42. Lower scores indicate greater eveningness (<20) and higher scores indicate greater morningness (>28). This item will be collected in the baseline assessment.	Baseline only

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Staff Satisfaction With Training	Satisfaction with the training was assessed through qualitative interviews with practitioner participants. This outcome includes only those who completed the training (10 out of 13 participants).	Up to 9 months post-training

Collaborators and Investigators

• Sponsor: Stephanie McCrory
• Collaborators: NHS Ayrshire and Arran
• Investigators: Principal Investigator: Leanne Fleming, PhD, University of Strathclyde

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Mental Health; Insomnia; CBT-I; Adolescent Sleep
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Personal Satisfaction; Sleep Initiation and Maintenance Disorders; Psychological Well-Being
• Other Study ID Numbers: UEC2331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No