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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.
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The overall objectives of the study are to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm intervention group | Other | Single-arm intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strathclyde Sleep Intervention | Behavioral | Manual-based CBT-I |
|
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leanne Fleming, PhD | University of Strathclyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Renfrewshire Healthier Minds Team | Glasgow | Lanarkshire | g781sy | United Kingdom |
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Participants recruited from 2 mental health services in Scotland
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| ID | Title | Description |
|---|---|---|
| FG000 | Adolescent Participants | Single-arm intervention comprised of adolescent participants Strathclyde Sleep Intervention: Manual-based CBT-I |
| FG001 | Practitioner Participants | Practitioner participants recruited to complete training, deliver the intervention and/or participate in interview. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
3 adolescent participants
13 practitioner participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Adolescent Participants | Single-arm intervention comprised of adolescent participants (n=3) |
| BG001 | Practitioner Participants | Practitioner participants recruited to complete training, deliver the intervention and/or participate in interview (n=13) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Adolescents referred to the study (N = 7 eligible participants) | Posted | Count of Participants | Participants | 1 year |
|
|
up to 6 months
Adverse events will be monitored throughout the intervention and will be defined as either unrelated, possibly unrelated, probably, or definitely related to the intervention. Serious adverse events will be defined as reactions that threaten life or functioning. In line with the CONSORT guidelines, adverse events will be defined as anticipated or unexpected. Deaths and Adverse Events not assessed for practitioners.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adolescent Participants | Single arm - Adolescent participants only. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Social circumstance, unexpected & possibly related | Social circumstances | Systematic Assessment | Participant experienced a deterioration in mental health while participating. The event was deemed as unexpected, possibly related. The participant decided to withdraw and appropriate support was in place via mental health practitioner. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie McCrory | University of Strathclyde | 07538376660 | stephanie.mccrory@strath.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2025 | Apr 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | There was low numbers of adolescents recruited (n = 3), poor retention rates (2 lost to follow-up, & 1 withdrew) and lack of post-intervention or follow-up data. No adolescents participated in the qualitative interviews. Therefore, there was 13 practitioner participants who completed the qualitative interviews. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | There was low numbers of adolescents recruited (n = 3), poor retention rates (2 lost to follow-up, & 1 withdrew) and lack of post-intervention or follow-up data. No adolescents participated in the qualitative interviews. Therefore, there was 13 practitioner participants who completed the qualitative interviews. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | 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. | Adolescents | Posted | Count of Participants | Participants | Over 4 session intervention period (1 - 4 months) 1-4 months 1-4 months |
|
|
|
| Primary | 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. | Practitioners who delivered the intervention and submitted recordings for fidelity assessment. | Posted | Number | participants | 1-4 months |
|
|
|
| Secondary | 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. | Mental health practitioners who received training and service managers who overseen the implementation of the intervention. | Posted | Count of Participants | Participants | Up to 9 months post-training |
|
|
|
| Secondary | 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. | All 3 adolescent participants completed baseline sleep assessments. No participants completed post-intervention or follow-up assessments. | Posted | Mean | Standard Deviation | units on a scale | Baseline (2 weeks before intervention delivery) |
|
|
|
| Secondary | 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. | Adolescents - Baseline only as none completed post-intervention or follow-up outcome measures. | Posted | Mean | Standard Deviation | score on a scale | Baseline (2 weeks before intervention) Baseline (2 weeks before intervention) Baseline (2 weeks before intervention) |
|
|
|
| Secondary | 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 RCADS-25 scores were submitted by 3 adolescent participants. No post-intervention or follow-up data were collected. | Posted | Mean | Standard Deviation | score on a scale | Baseline (2-weeks before intervention delivery) |
|
|
|
| Secondary | 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 GAD-7 scores were submitted by 3 adolescent participants. No post-intervention or follow-up data were collected. | Posted | Number | score on a scale | Baseline (2-weeks before intervention delivery) |
|
|
|
| Secondary | 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. | Adolescents - Baseline only. None completed post-intervention or follow-up assesments. | Posted | Mean | Standard Deviation | score on a scale | Baseline (2-weeks before intervention delivery) |
|
|
|
| Secondary | 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. | Adolescents | Posted | Mean | Standard Deviation | score on a scale | Baseline only |
|
|
|
| Other Pre-specified | 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). | All practitioners who completed training (n=10) | Posted | Count of Participants | Participants | Up to 9 months post-training |
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| 3 |
| 1 |
| 3 |
| 0 |
| 3 |
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| D001523 |
| Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
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| CBTi must be delivered flexibly, balancing patient need and available resource |
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| 'Red tape' restrictions make conducting research in mental health services challenging |
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| Title | Measurements |
|---|---|
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