DBT + CBT for Insomnia for Adolescents at High Risk of Suicide
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Must not be taking: Psychoactive medications
Disqualifiers: Mania, Psychosis, Autism, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The proposed research addresses the urgent need to reduce suicide rates among teens. This will be the first study that the investigators know of that will examine the feasibility and preliminary effectiveness of augmenting a suicide-focused treatment (Dialectical Behavior Therapy, \[DBT\]) with an evidence-based treatment protocol for insomnia (a digital version of Cognitive Behavioral Therapy for Insomnia \[CBT-I\]). The goal of this clinical trial is to learn providing insomnia treatment in conjunction with suicide-focused treatment leads to greater reductions in suicidality and self-harm than suicide-focused treatment alone. 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, self-harm behavior and insomnia symptoms every four weeks over the course of the study, as well as one post-treatment follow-up assessment. Participants will also wear a device on their wrist (like a Fitbit or wristwatch) for 10 days following each assessment to collect data about their sleep.
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.
What data supports the effectiveness of the treatment DBT + CBT for Insomnia for Adolescents at High Risk of Suicide?
Research shows that addressing sleep disturbances, like insomnia, can reduce suicidal thoughts and behaviors in adolescents. Dialectical Behavior Therapy (DBT) has been effective in decreasing suicide attempts and related risk factors in high-risk adolescents, while Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to reduce suicidal ideation in other populations, such as veterans.12345
Is DBT + CBT for Insomnia safe for adolescents at high risk of suicide?
Cognitive Behavioral Therapy for Insomnia (CBT-I) has been shown to be safe and can reduce suicidal thoughts in people with insomnia, including those with depression. Dialectical Behavior Therapy (DBT) is also generally considered safe and is used to help manage emotions and reduce self-harm behaviors.13567
How is Dialectical Behavior Therapy (DBT) unique for treating insomnia in adolescents at high risk of suicide?
Dialectical Behavior Therapy (DBT) is unique because it combines strategies for acceptance and change, helping adolescents manage emotions and reduce suicidal behaviors, which is particularly beneficial for those with high suicide risk. Unlike other treatments, DBT also involves family therapy components, addressing both individual and family dynamics to support the adolescent's overall well-being.4891011
Eligibility Criteria
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.
Youth and parent both speak English
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Exclusion Criteria
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
My insomnia is significantly affected by substance use or stopping certain medications.
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Trial Timeline
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
Treatment Details
Interventions
- Cognitive Behavioral Therapy for Insomnia (Behavioral Intervention)
- Dialectical Behavior Therapy (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Dialectical Behavior Therapy + Cognitive Behavioral Therapy for InsomniaExperimental Treatment2 Interventions
Group II: Dialectical Behavior Therapy OnlyActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Michele BerkStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
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 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.
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.
Implementation of Dialectical Behavior Therapy with Suicidal and Self-Harming Adolescents in a Community Clinic. [2022]The object of this research was to examine the feasibility and effectiveness of Dialectical Behavior Therapy (DBT) with suicidal and self-harming adolescents treated in a community clinic. A group of 24 adolescents at high risk for suicide were enrolled in 6 months of comprehensive DBT, provided by therapists and trainees at a county-run outpatient mental health clinic serving disadvantaged, ethnic minority clients. Results showed significant pre/post-treatment decreases in suicide attempts, non-suicidal self-injury behaviors (NSSI), and suicidal ideation. Results also showed significant decreases in other suicide risk factors, including emotion dysregulation, depression, impulsivity, BPD symptoms, psychopathology, PTSD symptoms, and substance use, as well as increases in family expressiveness and reasons for living. Treatment retention and satisfaction rates were high. As many youth at risk for suicide will be treated in community settings, findings showing that receiving DBT in a community clinic resulted in significant improvements across a range of suicide risk factors are an important contribution to the adolescent suicide prevention literature.
Effects of cognitive behavioral therapy for insomnia on suicidal ideation in veterans. [2022]To examine the effects of cognitive behavioral therapy for insomnia (CBT-I) on suicidal ideation among Veterans with insomnia.
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.
Initial Low Levels of Suicidal Ideation Still Improve After Cognitive Behavioral Therapy for Insomnia in Regular Psychiatric Care. [2021]Insomnia disorder is highly prevalent, and has been identified as a risk factor for many psychiatric problems, including depression, suicide ideation and suicide death. Previous studies have found that cognitive behavioral therapy for insomnia (CBT-I) reduce depression and suicidal ideation in samples with high levels of suicidal ideation. This study aims to investigate associations of CBT-I with suicidal ideation in a sample of 522 patients primarily seeking internet-delivered treatment for insomnia in regular psychiatric care. The sample had high pretreatment insomnia severity levels and a relatively high level of comorbid depression symptoms. Suicidal ideation levels were relatively low pretreatment but still improved significantly after CBT-I. Contrary to previous findings, the strongest predictor of changes in suicidal ideation were improvements in depressive symptoms, rather than improvements in insomnia. We conclude that suicidal ideation may not be a major problem in these patients primarily seeking treatment for insomnia, despite comorbid depressive symptoms, but that suicidal ideation still improves following CBT-i. Considering the increased risk for patients with untreated insomnia to develop depression, this finding is of interest for prevention of suicidal ideation.
[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]. [2022]In Germany suicide ranks as the second leading cause of death in adolescents. Risk factors for suicide are impulsive and self-injurious behaviour, depression, and conduct disorder. The main hypothesis of our study is that Dialectical Behavior Therapy (DBT) for adolescents is an effective method of treatment for these patients.
Family therapy and dialectical behavior therapy with adolescents: Part I: Proposing a clinical synthesis. [2022]Although the practice of family therapy in dialectical behavior therapy (DBT) with multiproblem suicidal adolescents is common and generally indicated, a particular model has yet to be delineated with this age group. The purpose of this article is to propose a coherent clinical synthesis of the more individually oriented DBT strategies with a broader family-systems orientation that maintains the integrity of both theoretical approaches while addressing the treatment needs of adolescents and their families. First, the authors briefly review the literature. Second, they describe the core dialectic of DBT, balancing acceptance and change, and its relevance to family therapy. Finally, the authors propose several specific acceptance and change strategies useful when implementing DBT family therapy with multi-problem adolescents.
Dialectical behavior therapy for suicidal adolescents with borderline personality disorder. [2022]Although research to date on dialectical behavior therapy (DBT) for adolescents has its limitations, growing evidence suggests that DBT is a promising treatment for adolescents with a range of problematic behaviors, including but not limited to suicidal and nonsuicidal self-injury. This article introduces dialectical behavior therapy's theoretical underpinnings, describes its adaptation for suicidal adolescents, and provides a brief review of the empirical literature evaluating DBT with adolescents.
Effectiveness of the family-based model of dialectical behavior therapy for both suicidal adolescents and young adults in an academic medical center. [2022]Dialectical behavior therapy (DBT) is an effective approach to decreasing suicidal behaviors; the adapted, family-based model for adolescents (through 18 years old; DBT-A) also demonstrates efficacy. Data on higher dropout rates based on age, initial research on DBT with young adults in the community, and the theory that underlies DBT suggest that adaptations may also be appropriate for young adults. This study examines the effectiveness of DBT-A, presents preliminary data on delivering DBT-A to young adults (ages 18-26), and compares clinical characteristics, service utilization, and outcomes to adolescent clients (ages 13-17) to guide clinical considerations and future research on implementing DBT-A.