Trial Outcomes & Findings for Investigating a Sleep Intervention for Adolescents Attending Mental Health Services (NCT NCT05870228)

NCT ID: NCT05870228

Last Updated: 2025-09-26

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 16 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2025-09-26

Participant Flow

Participants recruited from 2 mental health services in Scotland

Participant milestones

Measure	Adolescent Participants Single-arm intervention comprised of adolescent participants Strathclyde Sleep Intervention: Manual-based CBT-I	Practitioner Participants Practitioner participants recruited to complete training, deliver the intervention and/or participate in interview.
Overall Study STARTED	3	13
Overall Study COMPLETED	0	13
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Adolescent Participants Single-arm intervention comprised of adolescent participants Strathclyde Sleep Intervention: Manual-based CBT-I	Practitioner Participants Practitioner participants recruited to complete training, deliver the intervention and/or participate in interview.
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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.

Baseline characteristics by cohort

Measure	Adolescent Participants n=3 Participants Single-arm intervention comprised of adolescent participants (n=3)	Practitioner Participants n=13 Participants Practitioner participants recruited to complete training, deliver the intervention and/or participate in interview (n=13)	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=3 Participants	0 Participants n=13 Participants	3 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=3 Participants	13 Participants n=13 Participants	13 Participants n=16 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants	0 Participants n=13 Participants	0 Participants n=16 Participants
Age, Continuous	15.33 years STANDARD_DEVIATION 1.24 • n=3 Participants • 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.	38 years STANDARD_DEVIATION 10 • n=13 Participants • 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.	33.69 years STANDARD_DEVIATION 12.77 • n=16 Participants • 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.
Sex: Female, Male Female	2 Participants n=3 Participants • 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.	12 Participants n=13 Participants • 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.	14 Participants n=16 Participants • 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.
Sex: Female, Male Male	1 Participants n=3 Participants • 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.	1 Participants n=13 Participants • 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.	2 Participants n=16 Participants • 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.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	3 Participants n=3 Participants	13 Participants n=13 Participants	16 Participants n=16 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Adolescents referred to the study (N = 7 eligible participants)

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.

Outcome measures

Measure	Adolescent Participants n=7 Participants Adolescent participants who consented to participate in the intervention feasibility study.
Number of Adolescent Participants Recruited	3 Participants

PRIMARY outcome

Timeframe: Over 4 session intervention period (1 - 4 months) 1-4 months 1-4 months

Population: Adolescents

Measured through attendance logs. This outcome reports the number of adolescent participants who completed each session of the 4-session intervention.

Outcome measures

Measure	Adolescent Participants n=3 Participants Adolescent participants who consented to participate in the intervention feasibility study.
Number of Adolescent Participants Who Attend Each Session Completed all sessions	1 Participants
Number of Adolescent Participants Who Attend Each Session Completed 3 sessions	1 Participants
Number of Adolescent Participants Who Attend Each Session Completed 1 session	1 Participants

PRIMARY outcome

Timeframe: 1-4 months

Population: Practitioners who delivered the intervention and submitted recordings for fidelity assessment.

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.

Outcome measures

Measure	Adolescent Participants n=2 Participants Adolescent participants who consented to participate in the intervention feasibility study.
Intervention Fidelity Delivered intervention as intended	2 participants
Intervention Fidelity Deviated from intended delivery	0 participants

SECONDARY outcome

Timeframe: Up to 9 months post-training

Population: Mental health practitioners who received training and service managers who overseen the implementation of the intervention.

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.

Outcome measures

Measure	Adolescent Participants n=13 Participants Adolescent participants who consented to participate in the intervention feasibility study.
Acceptability of Intervention to Practitioners The training and CBTi intervention was acceptable for practitioners in mental health services	13 Participants
Acceptability of Intervention to Practitioners The CBTi intervention may not be suitable for most adolescents attending mental health services	12 Participants
Acceptability of Intervention to Practitioners CBTi must be delivered flexibly, balancing patient need and available resource	13 Participants
Acceptability of Intervention to Practitioners Sleep problems are common, but they are poorly assessed and treated	13 Participants
Acceptability of Intervention to Practitioners 'Red tape' restrictions make conducting research in mental health services challenging	12 Participants

SECONDARY outcome

Timeframe: Baseline (2 weeks before intervention delivery)

Population: All 3 adolescent participants completed baseline sleep assessments. No participants completed post-intervention or follow-up assessments.

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.

Outcome measures

Measure	Adolescent Participants n=3 Participants Adolescent participants who consented to participate in the intervention feasibility study.
Sleep Outcomes (Change From Baseline, Post-intervention and Follow-up)	84.71 units on a scale Standard Deviation 11.64

SECONDARY outcome

Timeframe: Baseline (2 weeks before intervention) Baseline (2 weeks before intervention) Baseline (2 weeks before intervention)

Population: Adolescents - Baseline only as none completed post-intervention or follow-up outcome measures.

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.

Outcome measures

Measure	Adolescent Participants n=3 Participants Adolescent participants who consented to participate in the intervention feasibility study.
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)	7 score on a scale Standard Deviation 1

SECONDARY outcome

Timeframe: Baseline (2-weeks before intervention delivery)

Population: Baseline RCADS-25 scores were submitted by 3 adolescent participants. No post-intervention or follow-up data were collected.

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

Outcome measures

Measure	Adolescent Participants n=3 Participants Adolescent participants who consented to participate in the intervention feasibility study.
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) Depression sub-scale	14 score on a scale Standard Deviation 7.94
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) Anxiety subscale	17.67 score on a scale Standard Deviation 5.69
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) Total score	31.67 score on a scale Standard Deviation 13.65

SECONDARY outcome

Timeframe: Baseline (2-weeks before intervention delivery)

Population: Baseline GAD-7 scores were submitted by 3 adolescent participants. No post-intervention or follow-up data were collected.

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.

Outcome measures

Measure	Adolescent Participants n=1 Participants Adolescent participants who consented to participate in the intervention feasibility study.
Anxiety Symptoms Measured by GAD-7 (Change From Baseline, Post-intervention and Follow-up)	11 score on a scale

SECONDARY outcome

Timeframe: Baseline (2-weeks before intervention delivery)

Population: Adolescents - Baseline only. None completed post-intervention or follow-up assesments.

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.

Outcome measures

Measure	Adolescent Participants n=3 Participants Adolescent participants who consented to participate in the intervention feasibility study.
Depression Symptoms Measured by PHQ-9 (Change From Baseline, Post-intervention and Follow-up)	15.33 score on a scale Standard Deviation 7.51

SECONDARY outcome

Timeframe: Baseline only

Population: Adolescents

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.

Outcome measures

Measure	Adolescent Participants n=3 Participants Adolescent participants who consented to participate in the intervention feasibility study.
Circadian Phase Preference Measured by Morningness/Eveningness Scale for Children	21.33 score on a scale Standard Deviation 2.89

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 9 months post-training

Population: All practitioners who completed training (n=10)

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).

Outcome measures

Measure	Adolescent Participants n=10 Participants Adolescent participants who consented to participate in the intervention feasibility study.
Staff Satisfaction With Training Staff were satisfied with training	10 Participants
Staff Satisfaction With Training Staff not satisfied with training	0 Participants

Adverse Events

Adolescent Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

Adolescent Participants n=3 participants at risk Single arm - Adolescent participants only.

Social circumstances Social circumstance, unexpected & possibly related

33.3% 1/3 • Number of events 1 • 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.

Other adverse events

Adverse event data not reported

Additional Information

Stephanie McCrory

University of Strathclyde

Phone: 07538376660

Email: stephanie.mccrory@strath.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place