Investigating a Sleep Intervention for Adolescents Attending Mental Health Services

Not Applicable

Terminated

Conditions: Mental Health Issue
Insomnia

Registration Number: NCT05870228

Lead Sponsor: Stephanie McCrory

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Adolescent Participants Recruited	1 year	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.
Number of Adolescent Participants Who Attend Each Session	Over 4 session intervention period (1 - 4 months) 1-4 months 1-4 months	Measured through attendance logs. This outcome reports the number of adolescent participants who completed each session of the 4-session intervention.
Intervention Fidelity	1-4 months	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability of Intervention to Practitioners	Up to 9 months post-training	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.
Sleep Outcomes (Change From Baseline, Post-intervention and Follow-up)	Baseline (2 weeks before intervention delivery)	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.
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)	Baseline (2 weeks before intervention) Baseline (2 weeks before intervention) Baseline (2 weeks before intervention)	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.
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)	Baseline (2-weeks before intervention delivery)	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
Anxiety Symptoms Measured by GAD-7 (Change From Baseline, Post-intervention and Follow-up)	Baseline (2-weeks before intervention delivery)	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.
Depression Symptoms Measured by PHQ-9 (Change From Baseline, Post-intervention and Follow-up)	Baseline (2-weeks before intervention delivery)	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.
Circadian Phase Preference Measured by Morningness/Eveningness Scale for Children	Baseline only	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.

Trial Locations

Locations (1): East Renfrewshire Healthier Minds Team
🇬🇧
Glasgow, Lanarkshire, United Kingdom
East Renfrewshire Healthier Minds Team
🇬🇧Glasgow, Lanarkshire, United Kingdom
Francis Robertson
Contact