Sleep Intervention for Suicidal Behavior

(TAILOR Trial)

Overseen By Elizabeth Cannon, MA, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Jeff Bridge

Must not be taking: Antipsychotics, Mood stabilizers, Anticonvulsants

Disqualifiers: Bipolar, Psychosis, Obstructive Sleep Apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called TAILOR, designed to assist adolescents with sleep issues who have recently experienced suicidal thoughts. The program focuses on improving sleep through behavioral strategies like Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI). Participants will be divided into two groups: one receiving the TAILOR intervention and the other receiving Enhanced Usual Care (EUC), which includes regular check-ins and support. This study suits adolescents who have faced sleep problems and thoughts of suicide in the past few months. As an unphased trial, it offers participants the chance to contribute to important research that could lead to new solutions for sleep and mental health challenges.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that sleep problems can increase the risk of suicidal thoughts and behaviors. The TAILOR program aims to address this by using methods like Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) to improve sleep. CBT helps change negative thoughts and actions, while MI encourages positive changes.

Studies have found that CBT for sleep issues is generally easy for people to handle, with few reports of problems or side effects. No reports of harmful effects from using MI in these situations exist. Although specific safety data for the TAILOR program is not yet available, these methods are known to be safe based on their use in other treatments.

In summary, the TAILOR program is expected to be safe for participants. The techniques it uses have been shown to be well-tolerated in other studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TAILOR intervention for suicidal behavior because it combines cutting-edge Cognitive Behavioral Therapy (CBT) strategies for insomnia with Motivational Interviewing (MI), a unique communication style that engages participants in meaningful change. Unlike standard treatments that may focus solely on mental health or sleep separately, TAILOR tackles both by assessing and improving existing sleep problems while simultaneously addressing suicidal risk through personalized safety plans. This dual approach not only aims to improve sleep but also potentially reduces suicide risk, offering a comprehensive treatment that stands apart from the typical care options available today.

What evidence suggests that the TAILOR intervention could be effective for preventing suicidal behavior in adolescents?

Research has shown that sleep problems, such as insomnia and insufficient sleep, are linked to a higher risk of suicidal behavior in teenagers. Studies have found that teens with sleep issues are 3.5 times more likely to attempt suicide. Early results suggest that treating sleep problems can help reduce suicidal thoughts, although the effects might be small. This trial tests the TAILOR program, which uses Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) to improve sleep, as a potential way to lower the risk of suicide. Addressing sleep issues might be a promising way to help at-risk teens. Participants in this trial may receive either the TAILOR intervention or Enhanced Usual Care (EUC), which includes suicide risk screening and safety planning. ^{3 6 7 8 9}

Who Is on the Research Team?

Jeff Bridge

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

No access to a telephone or internet-connecting device

Body Mass Index > 40

I am currently getting help for a sleep disorder from a clinic.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• TAILOR

Trial Overview 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.

How Is the Trial Designed?

Group I: TAILOR Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

Jeff Bridge

Lead Sponsor

Trials

2

Recruited

270+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Published Research Related to This Trial

In a study of 1700 college students, 82.7% of those at risk for suicide also reported sleep problems, highlighting a strong overlap between poor sleep and suicide risk.

Poor sleep was found to be significantly associated with suicidal behaviors independently of depression, with specific sleep issues like shorter sleep duration and bad dreams being particularly linked to increased suicide risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep problems and suicidal behaviors in college students. Becker, SP., Dvorsky, MR., Holdaway, AS., et al.[2019]

In a study of 746 fifth and seventh graders, suspected sleep apnea was found to be independently associated with suicidal ideation, with an odds ratio of 2.25, indicating a significant risk factor beyond depression and perceived stress.

Overall, 8.8% of students reported recent suicidal thoughts, and 33% showed signs of suspected sleep apnea, highlighting the importance of screening for sleep disorders in adolescents to help prevent suicidal behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep apnea may be associated with suicidal ideation in adolescents. Tseng, WC., Liang, YC., Su, MH., et al.[2020]

In a study of 691 adolescents in an intensive outpatient program, sleep disturbance was consistently linked to suicidal ideation (SI), with higher sleep issues at admission predicting greater SI at discharge.

The results indicated that addressing sleep disturbances during treatment could potentially reduce the risk of suicidal thoughts and behaviors, as those with severe SI showed increased sleep problems, while those without SI reported significant improvement in sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent suicidal ideation in a large intensive outpatient adolescent population sample: A preliminary report on the role of sleep disturbance. Gazor, A., Brown, WD., Naqvi, SK., et al.[2022]

Adolescent suicide completers exhibited significantly higher rates of sleep disturbances, including insomnia and hypersomnia, compared to a matched control group, indicating a strong link between sleep issues and suicide risk.

The study suggests that sleep difficulties are prevalent in the week leading up to suicide and should be a focus in prevention and intervention strategies for at-risk adolescents, as they may serve as important warning signs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disturbance preceding completed suicide in adolescents. Goldstein, TR., Bridge, JA., Brent, DA.[2022]

In a study of 223 adolescents with mood disorders, two-thirds reported severe sleep complaints, which were linked to higher rates of nonsuicidal self-injury.

Specific sleep disturbances, such as middle insomnia and circadian reversal, were significant predictors of suicide attempts, while terminal insomnia was associated with suicidal thoughts, highlighting the need to assess sleep issues in at-risk youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Sleep Disturbance in Suicidal and Nonsuicidal Self-Injurious Behavior among Adolescents. McGlinchey, EL., Courtney-Seidler, EA., German, M., et al.[2022]

A study of 8,530 adolescents in South Korea found that those with behaviorally induced insufficient sleep syndrome (BISS) had significantly higher scores for suicidal ideation compared to those who slept 7 hours or more on weekdays.

The research indicated that both longer weekend oversleep and shorter weekday sleep duration were linked to increased suicidality, suggesting that chronic sleep restriction may elevate the risk of suicidal thoughts among teenagers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insufficient sleep and suicidality in adolescents. Lee, YJ., Cho, SJ., Cho, IH., et al.[2022]

Insomnia and nightmares in adolescents are strongly linked to current suicide risk and can predict future suicidal thoughts, highlighting the importance of addressing sleep disturbances in mental health assessments.

Therapeutic interventions like cognitive behavior therapy for insomnia and imagery rehearsal treatment, along with pharmacological options, show promise in effectively treating both sleep disorders and associated suicidal behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When Night Falls Fast: Sleep and Suicidal Behavior Among Adolescents and Young Adults. Fernandes, SN., Zuckerman, E., Miranda, R., et al.[2022]

In a study of 206 adolescents aged 12-17 in a suicide prevention program, initial insomnia symptoms were linked to a higher risk of suicide attempts within six months after discharge, highlighting the importance of addressing sleep issues in at-risk youth.

While insomnia symptoms at discharge did not directly predict attempts, persistent suicidal thoughts at discharge were strongly associated with future attempts, suggesting that treating both insomnia and suicidal ideation could be crucial in reducing suicide risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between baseline insomnia symptoms and future suicide attempts within an intensive outpatient treatment program for suicide. Lau, JW., Stewart, SM., King, JD., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7685287/

Sleep and Suicidal Behavior Among Adolescents ... Insomnia, short sleep duration, and nightmares have been repeatedly found to be associated with increased suicide risk.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15586788/

Sleep and adolescent suicidal behavior Results: Overall, 19.3% of the sample reported having suicidal ideation, 10.5% having suicide attempts in the past 6 months, 16.9% having insomnia symptoms ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000084

The effect and safety of sleep interventions on suicidal ... A meta-analysis of cohort studies found that sleep disturbances are predictive of suicidality, demonstrating a 3.5-fold higher risk for suicide attempt and a ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.14133

A systematic review and meta‐analysis on the efficacy of ... This meta-analysis revealed that initial studies exploring the efficacy of sleep interventions on suicidal ideation demonstrate small effect ...

5. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.ajp.2019.19030267

Reducing Suicidal Ideation Through Insomnia Treatment ... At baseline, only 18% of participants described “a lot” of difficulty or an inability to control their suicidal thoughts, and 76% described ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05390918?intr=tailor&aggFilters=studyType:int&viewType=Table&rank=3&checkSpell=

Targeting Adolescent Insomnia to Lessen Overall Risk of ... A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A group or subgroup ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12378765/

Suicide Prevention in Youth - PMC This review presents new research pertinent to youth suicide prevention with a focus on suicide risk screening; therapeutic interventions, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6982579/

Adolescent Suicide Attempt Prevention: Predictors of ... This study examines predictors of response to a DBT-informed cognitive-behavioral family treatment (SAFETY), among 50 youth with recent suicide attempts/self- ...

9. jahonline.org jahonline.org/article/S1054-139X(24)00066-1/fulltext

Insufficient Sleep is Associated With Increasing Trends in ... Insufficient sleep was disproportionately associated with increasing trends in suicidal behaviors among female, younger, and non-White adolescent students.