Investigating a Sleep Intervention for Adolescents Attending Mental Health Services

NCT ID: NCT05870228

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-13
• Study Completion Date: 2024-12-31

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.

Conditions

Insomnia; Mental Health Issue

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-arm intervention group

Single-arm intervention

Group Type: OTHER

Strathclyde Sleep Intervention

Intervention Type: BEHAVIORAL

Manual-based CBT-I

Interventions

Strathclyde Sleep Intervention

Manual-based CBT-I

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stephanie McCrory

OTHER

Sponsor Role: lead

Responsible Party

Stephanie McCrory

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Leanne Fleming, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Strathclyde

Locations

East Renfrewshire Healthier Minds Team

Glasgow, Lanarkshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UEC2331

Identifier Type: -

Identifier Source: org_study_id