Investigating a Sleep Intervention for Adolescents Attending Mental Health Services

NCT05870228 | Terminated Results

• 1 other identifier: UEC2331
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objectives of the study are to:

1. 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. 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. 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.

Conditions

Insomnia; Mental Health Issue

Keywords

Adolescent Sleep; Insomnia; Mental Health; CBT-I

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Acceptability of Intervention to Practitioners

  Up to 9 months post-training

• Sleep Outcomes (Change From Baseline, Post-intervention and Follow-up)

  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)

  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)

  Baseline (2-weeks before intervention delivery)

• Anxiety Symptoms Measured by GAD-7 (Change From Baseline, Post-intervention and Follow-up)

  Baseline (2-weeks before intervention delivery)

Other Outcomes (1)

• Staff Satisfaction With Training

  Up to 9 months post-training

Study Arms (1)

Single-arm intervention group

OTHER

Single-arm intervention

Behavioral: Strathclyde Sleep Intervention

Interventions

Strathclyde Sleep Intervention BEHAVIORAL

Manual-based CBT-I

Single-arm intervention group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stephanie McCrory: lead

Study Sites (1)

East Renfrewshire Healthier Minds Team

Glasgow, Lanarkshire, g781sy, United Kingdom

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Personal Satisfaction; Behavior

Limitations and Caveats

Recruitment and retention of adolescents was challenging. Key barriers included: most adolescents had diagnosis of NDD (exclusion criteria), time pressure and demands on the services made it difficult to implement. Qualitative feedback only obtained from practitioners, therefore, not able to examine acceptability from adolescents' perspective.

Results Point of Contact

• Title: Stephanie McCrory
• Organization: University of Strathclyde

stephanie.mccrory@strath.ac.uk

07538376660

Study Officials

• Leanne Fleming, PhD

  University of Strathclyde

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 23, 2023
• Study Start: October 13, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)