Insomnia Clinical Trial
Official title:
Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
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).
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | July 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Moderate to severe head injury. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Hotchkiss Brain Institute, University of Calgary |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. | |
Primary | 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. | Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. | |
Primary | 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. | Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. | |
Secondary | Sleep Logs - Total sleep time | Sleep logs provide self-reported subjective sleep. Participants will be asked to report on their estimated total sleep time. | Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. | |
Secondary | 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. | Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. | |
Secondary | 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. | Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. | |
Secondary | 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. | Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. |
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