Sleep Intervention for Suicidal Behavior
(TAILOR Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jeff Bridge
Must not be taking: Antipsychotics, Mood stabilizers, Anticonvulsants
Disqualifiers: Bipolar, Psychosis, Obstructive Sleep Apnea, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study will test the effectiveness of a sleep-related primary suicide prevention program entitled TAILOR (Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior), which includes specific behavior-change strategies for adolescents at risk of suicidal behavior who suffer from difficulties falling asleep, staying asleep, and/or insufficient sleep.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have had a change in antipsychotic or mood stabilizer medications in the last 2 months, you may not be eligible to participate.
What data supports the effectiveness of the treatment Enhanced Usual Care, Duphalac, Kristalose, TAILOR, Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior?
Research shows that sleep disturbances are linked to suicidal thoughts and behaviors in adolescents. Addressing sleep issues, such as insomnia, during treatment may help reduce the risk of suicidal behavior.
12345Is the sleep intervention for suicidal behavior safe for humans?
The research suggests that managing sleep disturbances, such as insomnia and nightmares, is important for reducing suicide risk, but it does not provide specific safety data for the sleep intervention itself. However, therapeutic approaches like cognitive behavior therapy for insomnia and imagery rehearsal treatment are generally considered safe and show promise in treating sleep disorders and suicidal behavior.
15678What makes the TAILOR treatment unique for addressing suicidal behavior in adolescents?
The TAILOR treatment is unique because it specifically targets sleep disturbances, such as insomnia, which are linked to suicidal thoughts and behaviors in adolescents. By focusing on improving sleep, this treatment aims to reduce the risk of suicide, which is a novel approach compared to traditional methods that may not address sleep issues directly.
12457Eligibility Criteria
This trial is for adolescents aged 11-18 who are patients at Nationwide Children's Hospital, have had suicidal thoughts and sleep problems recently, and live with a caregiver who can consent to research. It excludes those with certain sleep disorders, recent substance use, inadequate English skills, no phone or internet access, recent suicide attempt or medication changes.Inclusion Criteria
Resides with primary caregiver who has legal authority to consent to research participation
I have had thoughts about suicide and problems sleeping in the last 3 months.
I am between 11 and 18 years old and a patient at Nationwide Children's Hospital.
Exclusion Criteria
No access to a telephone or internet-connecting device
Body Mass Index > 40
I have been diagnosed with narcolepsy.
+11 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive the TAILOR intervention, which includes Cognitive Behavioral Therapy, Motivational Interviewing, and voice- or video call-based assistance over 2 months
8 weeks
4 calls (virtual)
Follow-up
Participants are monitored for changes in sleep problems and suicidal ideation at 2 and 4 months post-randomization
16 weeks
2 assessments (in-person or virtual)
Participant Groups
TAILOR (Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior) is being tested against Enhanced Usual Care. TAILOR includes behavior strategies for teens at risk of suicide with insomnia issues. The study aims to see if improving sleep reduces suicidal behaviors.
2Treatment groups
Experimental Treatment
Group I: TAILORExperimental Treatment1 Intervention
Half of the participants will be randomized into the experimental arm of this study. A study clinician will call each family approximately 4 times over 2 months. The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary. The TAILOR intervention will then be administered. TAILOR includes the assessment of existing sleep problems and sleep practices and education on Cognitive Behavioral Therapy (CBT) strategies for insomnia, with Motivational Interviewing (MI) as the communication style.
Group II: Enhanced Usual Care (EUC)Experimental Treatment1 Intervention
Half of the participants will be randomized into Enhanced Usual Care (EUC). A study clinician will call each family approximately 4 times over 2 months. The study clinician will conduct suicide risk screening and further assessment and safety planning where deemed necessary.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nationwide Children's HospitalColumbus, OH
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Who Is Running the Clinical Trial?
Jeff BridgeLead Sponsor
Centers for Disease Control and PreventionCollaborator
References
Persistent suicidal ideation in a large intensive outpatient adolescent population sample: A preliminary report on the role of sleep disturbance. [2022]Sleep disturbance is a unique, yet understudied, risk factor for suicidal thoughts and behaviors (STBs). The present study sought to explore the relationship between suicidal ideation (SI) and self-reported sleep disturbance in a sample of adolescents in an intensive outpatient program targeting suicidality (N = 691). Analyses conducted include paired samples t tests, multiple linear regression, and analysis of variance to examine group differences in sleep disturbance over time. Sleep disturbance and SI were associated at each timepoint, and sleep disturbance at admission predicted SI at discharge. Those with the most severe SI at discharge indicated increased sleep disturbance relative to admission, whereas those reporting no SI at discharge nearly resolved all sleep difficulties. Future studies should utilize objective sleep measures, longitudinal assessments, and include a more diverse sample to better inform the relationship of sleep and SI. These findings suggest that directly managing sleep disturbance during treatment could decrease the risk of STBs.
Insufficient sleep and suicidality in adolescents. [2022]To investigate the association between the behaviorally induced insufficient sleep and suicidality among adolescents.
Sleep apnea may be associated with suicidal ideation in adolescents. [2020]Suicide is a major threat to adolescent health. Sleep problems increase the risk of adolescent suicidal behavior, but the role of sleep-disordered breathing (e.g., sleep apnea) is unclear. We investigated whether sleep apnea had an effect on suicidal ideation that was independent of depression and perceived stress. We examined a series of sleep variables with suicidal ideation in 746 fifth and seventh graders using self-reported questionnaires to assess time in bed, sleep quality, insomnia, and sleep apnea while controlling depression and perceived stress. Overall, 8.8% of students aged 10-14 years reported having recent suicidal ideation, and 33% or 3.8%, depending on the screening criteria, reported having suspected sleep apnea. The sleep variables were all associated with an increased risk of suicidal ideation, but the magnitude of effects was largely attenuated when depression and perceived stress were included in the models. Suspected sleep apnea using daytime sleepiness as a screening criterion was independently associated with suicidal ideation (odds ratio = 2.25, p
The Role of Sleep Disturbance in Suicidal and Nonsuicidal Self-Injurious Behavior among Adolescents. [2022]The relationship between different sleep disturbances and self-harm thoughts and behaviors was examined among 223 adolescents presenting to a community clinic for mood disorders and suicidal and nonsuicidal self-injurious behaviors. Two-thirds of the adolescents reported nightly, severe sleep complaints. Relative to adolescents without significant sleep complaints, patients with severe sleep complaints at the time of clinic entry endorsed significantly more engagement in nonsuicidal self-injury. Middle insomnia and circadian reversal were both significant predictors of suicide attempts. Terminal insomnia was significantly associated with suicidal ideation. Results support the importance of assessing sleep difficulties among adolescents at risk for suicide.
The association between baseline insomnia symptoms and future suicide attempts within an intensive outpatient treatment program for suicide. [2022]This study examines the prospective relationship between insomnia symptoms and suicide attempts in high-risk youth. We obtained depressive symptoms, insomnia symptoms, and suicide ideation measures from clinical records of 206 adolescents ages 12-17 at entry and discharge from a suicide prevention intensive outpatient program. Information about whether the participant made a suicide attempt was available through six months after discharge. Patients were mainly girls (79.1%; n = 163) with depression (89.8%; n = 185). Associations between insomnia symptoms, attempts within 6 months of discharge, persistent insomnia symptoms, and suicide ideation at discharge were tested with multiple regression analyses. Entry insomnia symptoms were prospectively associated with attempts when controlling for age, sex, and previous attempts, but insomnia symptoms at discharge were not. Suicide ideation at discharge was associated both with entry insomnia symptoms and attempts within 6 months of discharge. When entry and discharge suicide ideation were controlled, the association between entry insomnia symptoms and attempts lost significance. However, the association between discharge ideation and attempts remained significant. Insomnia symptoms contribute indirectly to suicide attempt risk after discharge. Intensive treatment for ideation and reducing insomnia symptoms could reduce discharge suicide risk and subsequent suicide attempts.
Sleep problems and suicidal behaviors in college students. [2019]Using a large sample of college students, objectives were to examine (1) the overlap between poor sleep and suicide risk status, (2) whether poor sleep was associated with suicide behaviors above and beyond depression, (3) whether sleep problems and depression interacted to predict increased suicidal behaviors or risk, and (4) which specific components of sleep were uniquely associated with suicidal behaviors. Participants were 1700 college students (ages 18-29 years; 65% female) from two universities who completed measures assessing sleep, depressive symptoms, and suicidal behaviors (Suicidal Behaviors Questionnaire-Revised [SBQ-R], a composite measure including ideation, past attempt, disclosure to others, and future likelihood of suicide that includes a cutoff for determining participants with suicide risk). Approximately one-quarter (24%) of participants were classified with suicide risk. Four-fifths (82.7%) of participants classified with suicide risk also met cutoff criteria for sleep problems; conversely, almost one-third (31.3%) of the participants classified with sleep problems were also classified with suicide risk. Total sleep problems remained significantly associated with suicidal behaviors above and beyond depressive symptoms, though sleep and depression did not interact to predict suicidal behaviors or risk. When considered together and controlling for sex, the odds of being classified with suicide risk were 6.54 times greater for participants with elevated depressive symptoms and 2.70 times greater for participants with sleep problems. Analyses examining specific sleep domains found shorter sleep duration, having bad dreams, feeling too cold while sleeping, and sleep medication use to each be independently associated with suicidal behaviors. Findings add to a growing body of literature linking sleep and suicide in college students.
Sleep disturbance preceding completed suicide in adolescents. [2022]We examined sleep difficulties preceding death in a sample of adolescent suicide completers as compared with a matched sample of community control adolescents. Sleep disturbances were assessed in 140 adolescent suicide victims with a psychological autopsy protocol and in 131 controls with a similar semistructured psychiatric interview. Rates of sleep disturbances were compared between groups. Findings indicate suicide completers had higher rates of overall sleep disturbance, insomnia, and hypersomnia as compared with controls within both the last week and the current affective episode. Group differences in overall sleep disturbance (both within the last week and present episode), insomnia (last week), and hypersomnia (last week) remained significant after controlling for the differential rate of affective disorder between groups. Similarly, overall sleep disturbance (last week and present episode) and insomnia (last week) distinguished completers in analyses accounting for severity of depressive symptoms. Only a small percentage of the sample exhibited changes in sleep symptom severity in the week preceding completed suicide, but of these, a higher proportion were completers. These findings support a significant and temporal relationship between sleep problems and completed suicide in adolescents. Sleep difficulties should therefore be carefully considered in prevention and intervention efforts for adolescents at risk for suicide.
When Night Falls Fast: Sleep and Suicidal Behavior Among Adolescents and Young Adults. [2022]Sleep disturbances have been linked to suicidal ideation and behaviors in adolescents. Specifically, insomnia and nightmares are associated with current suicide risk and predict future ideation. Associations between hypersomnia, sleep apnea, and suicide remain inconclusive. Potential biological mechanisms underlying these relationships include executive functioning deficits and hyperarousal. Related psychological factors may include thwarted belongingness, perceived burdensomeness, and negative appraisals. Assessing suicide risk in patients with sleep disturbances, and vice versa, is needed. Therapeutic interventions such as cognitive behavior therapy for insomnia and imagery rehearsal treatment, as well as pharmacologic treatments, show promise in treating sleep disorders and suicidal behavior.