DBT + CBT for Insomnia for Adolescents at High Risk of Suicide

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Psychoactive medications

Disqualifiers: Mania, Psychosis, Autism, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 24 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding sleep-focused therapy (Cognitive Behavioral Therapy for Insomnia, or CBT-I) to suicide-focused therapy (Dialectical Behavior Therapy, or DBT) can more effectively reduce suicidal thoughts and self-harm in teens. The study compares two groups: one receiving both therapies and another receiving only DBT. Teens aged 12-18 who have trouble sleeping and are at high risk for suicide may be suitable candidates, particularly if they have experienced multiple suicide attempts or episodes of self-harm. Participants will wear a wrist device to track sleep and complete assessments about their mental health and sleep every four weeks.

As an unphased trial, this study offers teens a unique opportunity to potentially benefit from innovative therapy combinations while contributing to important mental health research.

Do I have to stop taking my current medications for the trial?

The trial requires that if you are taking medication for psychiatric disorders or sleep, you must be on a stable dose for more than 2 months. This means you can continue your current medications as long as they have been stable for that period.

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

Research has shown that Dialectical Behavior Therapy (DBT) and Cognitive Behavioral Therapy for Insomnia (CBT-I) are generally safe and well-tolerated. DBT has long helped individuals manage strong emotions and reduce self-harm, proving effective and safe for various groups, including teenagers.

CBT-I, an online therapy, aims to improve sleep habits by altering thoughts and behaviors related to sleep. Insomnia can increase suicide risk, particularly in teens. Studies have demonstrated that CBT-I can reduce insomnia symptoms without major side effects. Combining DBT with CBT-I is a new approach, but both treatments have strong safety records when used independently. This combination seeks to address both emotional and sleep issues to support teens at high risk of suicide. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for adolescent insomnia, which often involve medication or basic cognitive-behavioral therapy, this trial combines Dialectical Behavior Therapy (DBT) with Cognitive Behavioral Therapy specifically for insomnia. Researchers are excited about this approach because DBT, typically used for managing emotions and behaviors, is being tailored to address sleep issues, potentially offering a dual benefit for adolescents at high risk of suicide. This method not only aims to improve sleep but also provides tools to handle emotional distress, setting it apart from more traditional insomnia treatments.

What evidence suggests that this trial's treatments could be effective for reducing suicidality and self-harm in adolescents with insomnia?

Research has shown that Dialectical Behavior Therapy (DBT), which participants in this trial may receive, can reduce suicidal thoughts and self-harm in teenagers. Studies also indicate that Cognitive Behavioral Therapy for Insomnia (CBT-I), another treatment option in this trial, improves sleep by changing sleep habits and thoughts about sleep. This trial will compare the combination of DBT with CBT-I against DBT alone. Although CBT-I alone has successfully treated insomnia, which often links to mood problems, this combination aims to enhance the benefits of DBT and may further lower the risk of suicide. Early findings suggest that better sleep can improve mental health and reduce harmful behaviors. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for English-speaking teens aged 12-18 who are at high risk for suicide, have had a suicide attempt or multiple self-harm episodes, and suffer from insomnia. They must be on stable medication if they're taking any for psychiatric disorders or sleep issues, and live at home with a family member willing to participate.

Inclusion Criteria

High suicide risk, defined as: >1 lifetime suicide attempt, > 3 lifetime SH episodes (with at least 1 in the 12 weeks before baseline screening) and elevated SI (≥31 on the SIQ-Jr.)

My psychiatric or sleep medication dose has been stable for over 2 months.

At least one family member or responsible adult agrees to participate in assessments and in the DBT multi-family skills group

Exclusion Criteria

Court-ordered to treatment

Significant current mania or psychosis; life-threatening anorexia, or other diagnosis of a severe mental or physical condition requiring treatment specific to that disorder and/or that interferes with participation in assessments or treatment

A history of being diagnosed with an Autism Spectrum Disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of Dialectical Behavior Therapy (DBT) with or without Cognitive Behavioral Therapy for Insomnia (CBT-I)

24 weeks

Research assessments every 4 weeks

Follow-up

Participants complete a post-treatment follow-up assessment and wear a device to collect sleep data

4 weeks

1 post-treatment follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Insomnia
• Dialectical Behavior Therapy

Trial Overview The study tests whether adding digital Cognitive Behavioral Therapy for Insomnia (CBT-I) to Dialectical Behavior Therapy (DBT) helps reduce suicidal thoughts and behaviors more effectively than DBT alone in adolescents. Participants will also wear a sleep-tracking device.

How Is the Trial Designed?

Group I: Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia Experimental Treatment 2 Interventions

Group II: Dialectical Behavior Therapy Only Active Control 1 Intervention

Dialectical Behavior Therapy is already approved in United States, European Union for the following indications:

Approved in United States as DBT for:

• Borderline Personality Disorder
• Suicidal Behavior
• Emotional Dysregulation

Approved in European Union as DBT for:

• Borderline Personality Disorder
• Suicidal Behavior
• Emotional Dysregulation

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A study involving 24 high-risk adolescents showed that 6 months of Dialectical Behavior Therapy (DBT) in a community clinic significantly reduced suicide attempts, self-harming behaviors, and suicidal thoughts.

DBT also led to improvements in various suicide risk factors, such as emotion regulation, depression, and impulsivity, while maintaining high treatment retention and satisfaction rates, highlighting its effectiveness in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Dialectical Behavior Therapy with Suicidal and Self-Harming Adolescents in a Community Clinic. Berk, MS., Starace, NK., Black, VP., et al.[2022]

Dialectical Behavior Therapy for adolescents (DBT-A) showed significant effectiveness in reducing self-injurious behavior and preventing suicide attempts in a pilot study of 12 adolescents, with effect sizes ranging from 1.1 to 2.9.

None of the participants who had previously attempted suicide made any attempts during the treatment, highlighting the potential safety and efficacy of DBT-A in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dialectical Behaviour Therapy for adolescents (DBT-A)--a pilot study on the therapy of suicidal, parasuicidal, and self-injurious behaviour in female patients with a borderline disorder]. Fleischhaker, C., Munz, M., Böhme, R., et al.[2022]

Dialectical behavior therapy for adolescents (DBT-A) is effective in reducing suicidal behaviors and can also be adapted for young adults aged 18-26, although the observed effect size in this study was smaller than in previous efficacy trials.

Young adults in the study had different service utilization patterns compared to adolescents, participating in fewer family sessions and graduating from the program more quickly, indicating potential differences in treatment needs and outcomes between these age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of the family-based model of dialectical behavior therapy for both suicidal adolescents and young adults in an academic medical center. Darrow, SM., Maliken, AC., Piatigorsky, A., et al.[2022]

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]

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]

A study involving 405 Veterans showed that cognitive behavioral therapy for insomnia (CBT-I) significantly reduced suicidal ideation, with rates dropping from 32% at baseline to 21% after treatment.

Each 7-point decrease in insomnia severity was linked to a 65% reduction in the odds of suicidal thoughts, highlighting the potential of CBT-I as an effective intervention for improving mental health and reducing suicide risk among Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cognitive behavioral therapy for insomnia on suicidal ideation in veterans. Trockel, M., Karlin, BE., Taylor, CB., 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]

Dialectical behavior therapy (DBT) shows promise as an effective treatment for adolescents dealing with various problematic behaviors, including suicidal thoughts and self-injury.

The article discusses the theoretical foundations of DBT and its specific adaptations for suicidal adolescents, highlighting the growing body of evidence supporting its use despite some research limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dialectical behavior therapy for suicidal adolescents with borderline personality disorder. Klein, DA., Miller, AL.[2022]

The article proposes a new model for integrating family therapy with dialectical behavior therapy (DBT) specifically tailored for multiproblem suicidal adolescents, addressing the unique treatment needs of this age group.

It emphasizes the importance of balancing acceptance and change in therapy, suggesting specific strategies that can enhance the effectiveness of DBT when working with adolescents and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family therapy and dialectical behavior therapy with adolescents: Part I: Proposing a clinical synthesis. Miller, AL., Glinski, J., Woodberry, KA., 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]

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved suicidal ideation in a sample of 522 patients seeking treatment for insomnia, despite their low levels of suicidal thoughts before treatment.

The study found that improvements in depressive symptoms were the strongest predictor of reduced suicidal ideation, suggesting that addressing depression may be crucial in preventing suicidal thoughts in patients with insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Low Levels of Suicidal Ideation Still Improve After Cognitive Behavioral Therapy for Insomnia in Regular Psychiatric Care. Jernelöv, S., Forsell, E., Kaldo, V., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05842863

Combined Dialectical Behavior Therapy and Digital ... Cognitive Behavioral Therapy for Insomnia (CBTI) is a type of counseling that helps people improve sleep by changing their sleep behaviors and thinking about ...

2. reporter.nih.gov reporter.nih.gov/project-details/11105906

Project Details - NIH RePORTER This will be the first study that we know of to examine the feasibility and preliminary effectiveness of augmenting a suicide-focused treatment (Dialectical ...

3. med.stanford.edu med.stanford.edu/psychiatry/news/new-funding-announcement/sleepandsuicidality.html

Stanford Psychiatry team awarded grant to examine the ... Stanford Psychiatry team awarded grant to examine the impact of improving sleep on reducing adolescent suicidality and self-harm.

4. kleimanlab.org kleimanlab.org/research/current-projects/

Current Projects This study will examine the feasibility and acceptability of delivering dCBT-I to suicidal adolescents with co-occurring insomnia during the post- ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10002474/

Cognitive Behavioral Therapy for Insomnia (CBT-I): A Primer CBT-I is a multi-component treatment for insomnia that targets difficulties with initiating and/or maintaining sleep and is delivered over the course of six to ...

6. stanfordhealthcare.org stanfordhealthcare.org/trials/c/NCT05842863.html

Combined Dialectical Behavior Therapy and Digital ... Participants will be randomly assigned to receive 6 months of DBT plus CBT-I or to DBT alone and will complete research assessments measuring suicidal ideation, ...