Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity of Calgary
About this trial
Emerging evidence has shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for improves sleep and subthreshold depressive and anxiety symptoms in adolescents at risk (i.e., with a parental history of depressive or anxiety disorders).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between the ages of 12 and 18.
Having at least one parent with a history of depressive or anxiety disorders but having no clinically significant history (per the Diagnostic and Statistical Manual of Mental Disorders 5) of internalizing disorders themselves.
Adolescents who score 10/25 or greater on the Insomnia Severity Index, indicating subthreshold insomnia or greater.
Disqualifiers
Experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome [RLS], sleep-disordered breathing [SDB].
Having a history of untreated, serious psychiatric illness (i.e., bipolar disorder, schizophrenia).
Active suicidal ideation.
Currently taking prescribed medications for sleep problems.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy for Insomnia
BehavioralDigital CBT-I is an online, six-module, self-guided CBT-I intervention. It includes videos and read information on behavioral (e.g., stimulus control, relaxation) and cognitive (e.g., restructuring, reducing arousal, and problem-solving) techniques, as well as psychoeducation (e.g., sleep hygiene). Participants complete homework following each session and track their sleep using an online diary. Young people could choose to involve their parents, for example, through completing sessions together. However, we will add a virtual session for parents as their involvement may improve adolescent engagement with the intervention as well as outcomes for adolescent sleep problems (Gradisar et al., 2011). This module will include an overview of the program components (behavioural, cognitive, and educational), goals and homework, and addresses parents' beliefs about sleep.
Active Control
Other interventionParticipants are encouraged to continue any care they are already receiving and will be placed on a wait-list for digital CBT-I after their final assessment. All activities participants try for improving their own sleep problems between assessments will be recorded and coded for.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Cognitive-Behavioural Therapy GroupExperimental treatment 1 intervention
Group B: Treatment as Usual waitlist with Psychoeducational PamphletActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia Severity Index
The ISI is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes. The ISI assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems. It was found to be a clinically useful tool in assessing changes in insomnia symptoms and had been reliably used in treatment research with adolescents. Scores on the ISI range from 0-28 with higher scores indicating greater insomnia severity.
Time frame
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.2
Pittsburgh Sleep Quality Index
The PSQI instrument is used in assessing one's sleep quality during the previous month. It consists of 19 self-rated items. It has been reliably used in treatment research with adolescents. Scores range from 0 to 19, with higher scores indicating worse sleep quality.
Time frame
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.3
Internalizing Symptoms Subscale of the Youth Self-Report
The internalizing symptoms subscale of the Youth Self Report (YSR) questionnaire is a widely used measure of global internalizing (depression, anxiety, and somatic) symptoms. T-scores which range from 26 to 100 are generated, with higher scores indicating greater symptom severity.
Time frame
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.Secondary outcomes
1
Sleep Logs - Total sleep time
Sleep logs provide self-reported subjective sleep. Participants will be asked to report on their estimated total sleep time.
Time frame
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.2
Sleep Logs - Onset latency
Sleep logs provide self-reported subjective sleep. One of the variables participants will report is the amount of time they think it takes them to fall asleep.
Time frame
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.3
Sleep Logs - Wake after sleep onset
Sleep logs provide self-reported subjective sleep. One of the variables participants will report is the amount of time they think they spent awake at night after initially falling asleep.
Time frame
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.4
Sleep Logs - Sleep efficiency
Sleep logs provide self-reported subjective sleep. Sleep efficiency (percent of time spent asleep while in bed) will be calculated based on participants reports of total sleep time divided by time spent in bed.
Time frame
Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
Hotchkiss Brain Institute, University of Calgary
Collaborator
Source ClinicalTrials.gov