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

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. ^{1 2 3 4 5}

Is 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. ^{1 5 6 7 8}

What 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. ^{1 2 4 5 7}

Research Team

Jeff Bridge

Principal Investigator

Nationwide Children's Hospital

Eligibility 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.

Exclusion Criteria

No access to a telephone or internet-connecting device

Body Mass Index > 40

I have been diagnosed with narcolepsy.

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Insufficient sleep and suicidality in adolescents. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Sleep apnea may be associated with suicidal ideation in adolescents. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The Role of Sleep Disturbance in Suicidal and Nonsuicidal Self-Injurious Behavior among Adolescents. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

The association between baseline insomnia symptoms and future suicide attempts within an intensive outpatient treatment program for suicide. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Sleep problems and suicidal behaviors in college students. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Sleep disturbance preceding completed suicide in adolescents. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

When Night Falls Fast: Sleep and Suicidal Behavior Among Adolescents and Young Adults. [2022]