InsomniaNCT05870228
Investigating a Sleep Intervention for Adolescents Attending Mental Health Services
A study testing Strathclyde Sleep Intervention in people with Insomnia and Mental Health Issue, run by Stephanie McCrory at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Insomnia, Mental Health Issue
- What is being tested?
- Strathclyde Sleep Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Renfrewshire Healthier Minds Team
Glasgow, Lanarkshire, g781sy
About this study
Official title: 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:
- 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.
- To examine participant acceptability. The researchers will conduct qualitative interviews with the participants and delivery staff to examine the acceptability of the programme.
- 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.
Read the 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
- Being tested
- Strathclyde Sleep Intervention
- Keywords
- Adolescent Sleep, Insomnia, Mental Health, CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strathclyde Sleep InterventionBehavioural
Manual-based CBT-I
| Study group | Role | What they receive |
|---|---|---|
| Single-arm intervention group | Other | Single-arm intervention Receives: Behavioral: Strathclyde Sleep Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1-4 months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start13 Oct 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: The study was 'completed' within allocated timeframe. However, we were unable to recruit the initial target number of adolescent participants, thus concluding it is not currently feasible to recruit adolescents to complete the intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie McCrory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie McCrory, University of Strathclyde
- Investigators
- Leanne Fleming, PhD, Principal investigator, University of Strathclyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870228
- Sponsor's protocol ID
- UEC2331
- Status last verified
- Sep 2025
- First submitted
- 24 Apr 2023
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility, Acceptability, and Preliminary Effectiveness of a Sleep Intervention for Adolescents With Co-morbid Insomnia and Mental Health Difficulties
- ClinicalTrials.gov ID
- NCT05870228
- Acronym / sponsor ID
- UEC2331
- Conditions
- Insomnia, Mental Health Issue
- Keywords
- Adolescent Sleep, Insomnia, Mental Health, CBT-I
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was 'completed' within allocated timeframe. However, we were unable to recruit the initial target number of adolescent participants, thus concluding it is not currently feasible to recruit adolescents to complete the intervention.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Stephanie McCroryUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Posted 26 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objectives of the study are to:
- 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.
- To examine participant acceptability. The researchers will conduct qualitative interviews with the participants and delivery staff to examine the acceptability of the programme.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm intervention group | Other | Behavioral: Strathclyde Sleep InterventionSingle-arm intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strathclyde Sleep InterventionManual-based CBT-I | Behavioural | Single-arm intervention group |
Primary outcome
Number of Adolescent Participants Recruited
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Acceptability of Intervention to Practitioners
Time frame: Up to 9 months post-training
Sleep Outcomes (Change From Baseline, Post-intervention and Follow-up)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (2-weeks before intervention delivery)
Anxiety Symptoms Measured by GAD-7 (Change From Baseline, Post-intervention and Follow-up)
Time frame: Baseline (2-weeks before intervention delivery)
Depression Symptoms Measured by PHQ-9 (Change From Baseline, Post-intervention and Follow-up)
Time frame: Baseline (2-weeks before intervention delivery)
Circadian Phase Preference Measured by Morningness/Eveningness Scale for Children
Time frame: Baseline only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne Fleming, PhD principal investigator
University of Strathclyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strathclyde Sleep Intervention in people with Insomnia and Mental Health Issue, run by Stephanie McCrory at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adolescent Participants Recruited (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.