Clinical trial NCT06358495: Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
Official title: Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Sleep Disturbance
Depressive Symptoms
Anxiety Symptoms
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Hotchkiss Brain Institute, University of Calgary
First posted: 2024-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either CBT for insomnia or TAU waitlist with a psychoeducational pamphlet about sleep hygiene.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
measure: Pittsburgh Sleep Quality Index
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
measure: Internalizing Symptoms Subscale of the Youth Self-Report
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Secondary outcomes:
measure: Sleep Logs - Total sleep time
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
measure: Sleep Logs - Onset latency
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
measure: Sleep Logs - Wake after sleep onset
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
measure: Sleep Logs - Sleep efficiency
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 19-week follow-up.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Daniel Kopala-Sibley, PhD
role: PRINCIPAL_INVESTIGATOR
References: