Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
- Conditions
- InsomniaAnxiety SymptomsSleep DisturbanceDepressive Symptoms
- Interventions
- Other: Active ControlBehavioral: Cognitive Behavioral Therapy for Insomnia
- Registration Number
- NCT06358495
- Lead Sponsor
- University of Calgary
- Brief Summary
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).
- Detailed Description
A substantial body of literature has linked poor sleep or insomnia to the development of internalizing (i.e., depression and anxiety) disorders in adolescents. Emerging evidence has also shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) substantially improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. However, no research has examined whether sleep interventions may be effective in preventing first lifetime onsets of internalizing disorders in adolescents at high risk of internalizing disorders, but who have yet to develop them. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for adolescents improves sleep and subthreshold internalizing symptoms in high-risk adolescents. Results of this project would provide crucial preliminary evidence that a non-invasive, economical, and easily administered sleep-based intervention may prevent first onsets of the most common and debilitating illnesses in teens.
Among adolescents, internalizing disorders are a leading cause of global burden of disability, and unfortunately one of the leading causes of death due to suicide. Children with a parental history of internalizing disorders are 3-7 times more likely to develop internalizing disorders relative to children with no such family history. Approximately 75% of internalizing disorder onsets occur in adolescence. Affected youth are at risk for several sequelae including substance dependence, educational underachievement, and unemployment. For the majority of those who have had one episode, the disorder will become chronic. With each recurrence, treatment prognosis worsens. There is thus a critical need to prevent first lifetime onsets of internalizing disorders, among high-risk adolescents in particular, through interventions targeting modifiable risk factors. Improving sleep may be a feasible, economic, and effective method for prevention of internalizing disorders in high-risk teens.
Research Aims:
1. To examine if brief web-based CBT-I reduces insomnia symptoms and improves sleep quality in teens at risk for internalizing disorders, compared to a treatment as usual (TAU) waitlist group who receive a psychoeducational pamphlet about sleep hygiene.
2. To examine if CBT-I improves subthreshold internalizing symptoms in teens who have a family history of depressive or anxiety disorders but no clinically significant history themselves.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment as Usual waitlist with Psychoeducational Pamphlet Active Control Control group participants will receive a pamphlet providing information on sleep hygiene that matches the information in CBT-I arm (e.g., having a bedtime routine, maintaining a sleep schedule, avoiding exercise within several hours of bed, avoiding bright screens before bed). Otherwise, they will be encouraged to continue with treatment they are receiving, if any. After the 19 week follow-up assessment, participants have the option of receiving the digitized CBT-I intervention. Cognitive-Behavioural Therapy Group Cognitive Behavioral Therapy for Insomnia Participants will receive a 6 week online Cognitive behavioural therapy for insomnia (CBT-I) evidence-based psychotherapeutic intervention that combines cognitive and behavioural principles. Their parents will also be invited to participant in 1 virtual psychoeducation session.
- Primary Outcome Measures
Name Time Method Insomnia Severity Index Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. 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.
Internalizing Symptoms Subscale of the Youth Self-Report Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. 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.
Pittsburgh Sleep Quality Index Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. 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.
- Secondary Outcome Measures
Name Time Method Sleep Logs - Sleep efficiency Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. 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.
Sleep Logs - Total sleep time Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. Sleep logs provide self-reported subjective sleep. Participants will be asked to report on their estimated total sleep time.
Sleep Logs - Onset latency Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. 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.
Sleep Logs - Wake after sleep onset Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up. 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.
Trial Locations
- Locations (1)
University of Calgary
🇨🇦Calgary, Alberta, Canada