grant

Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide: A Pilot RCT

Organization STANFORD UNIVERSITYLocation STANFORD, UNITED STATESPosted 15 Jul 2023Deadline 31 Dec 2026
NIHUS FederalResearch GrantFY202514 year old14 years of age21+ years oldAddressAdolescentAdolescent YouthAdultAdult HumanAgeBehaviorBehavior Conditioning TherapyBehavior ModificationBehavior TherapyBehavior TreatmentBehavioral Conditioning TherapyBehavioral ModificationBehavioral TherapyBehavioral TreatmentCause of DeathCell Communication and SignalingCell SignalingCognition TherapyCognitive PsychotherapyCognitive TherapyCognitive treatmentComorbid InsomniaConditioning TherapyDeliberate Self-HarmDetectionDiagnosticDialectical behavior therapyDisease remissionDropoutEffectivenessEmotional DepressionEvidence based treatmentExperimental TherapiesFeeling suicidalGoalsInsomniaInsomnia DisorderInternationalInterventionInterviewIntracellular Communication and SignalingInvestigational TherapiesInvestigational TreatmentsLinkMeasuresMediatingMediatorNIMHNational Institute of Mental HealthOutcomePrevention ResearchProtocolProtocols documentationPublic HealthRandomizedRemissionReportingResearchRisk FactorsSafetySamplingSelf-Injurious BehaviorSeveritiesSignal TransductionSignal Transduction SystemsSignalingSleepSleeplessnessSpeedStrategic PlanningSuicidal thoughtsSuicideSuicide precautionSuicide preventionSymptomsTeenTeenagersTimeTreatment PeriodTreatment ProtocolsTreatment RegimenTreatment ScheduleUnited StatesWorkYouthYouth 10-21adulthoodage 14 yearsagesbehavior interventionbehavioral interventionbiological signal transductionco-morbid insomniacognitive behavior interventioncognitive behavior modificationcognitive behavior therapycognitive behavioral interventioncognitive behavioral modificationcognitive behavioral therapycognitive behavioral treatmentdeliberate self harmdepression symptomdepressivedepressive symptomsdevelop therapydigitaldigital therapeuticsdigital therapydigital treatmenteffectiveness researcheffectiveness trialefficacious therapyefficacious treatmentefficacy trialevidence baseexperimental therapeutic agentsexperimental therapeuticsfatal attemptfatal suicidefeasibility trialfourteen year oldfourteen years of agehigh riskimprovedinclusion criteriainnovateinnovationinnovativeintent to dieintentional self harmintentional self injuryinternet based deliveryinternet deliveredinternet deliveryintervention developmentjuvenilejuvenile humanneglectnew approachesnovelnovel approachesnovel strategiesnovel strategypilot trialprevent suicidalityprevent suiciderandomisationrandomizationrandomly assignedreduce suicidalityreduce suicidereducing suicidalityreducing suicidesatisfactionself harmself injurysleep-focused interventionsstandard carestandard treatmentsuccesssuicidalsuicidal adolescentsuicidal adolescentssuicidal ideationsuicidal morbiditysuicidal risksuicidal thinkingsuicidal youthsuicidal youthssuicidalitysuicidality preventionsuicide deathsuicide ideationsuicide interventionsuicide morbiditysuicide ratesuicide risksuicidesteen yearsteenagetherapeutic outcometherapy developmenttherapy outcomethoughts about suicidetimelinetreatment daystreatment developmenttreatment durationtreatment trialuptakeyouth age
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Full Description

PROJECT SUMMARY/ABSTRACT
Suicide is the 2nd leading cause of death among 10-14-year-olds and the 3rd leading cause of death among

15-24 year-olds in the United States. Reducing adolescent suicide rates is an urgent public health objective.

Insomnia is a robust yet neglected transdiagnostic risk factor for suicidality and suicide deaths in adolescents

that is modifiable using brief, evidence-based behavioral treatments. Despite this, to the best of our knowledge,

insomnia treatments have never been studied in combination with suicide-focused treatments in youths. The

purpose of the proposed research is to conduct an initial feasibility and preliminary effectiveness trial of

combining evidence-based behavioral treatments for insomnia and suicidality/self-harm as a novel approach to

adolescent suicide prevention. We anticipate that augmenting a suicide-focused treatment with an insomnia

treatment will have a synergistic effect and lead to greater reductions in self-harm (SH) behaviors and suicidal

ideation (SI) than suicide-focused treatment alone. We will use dialectical behavior therapy (DBT) as the

suicide-focused treatment for the present study and internet-delivered, digital cognitive-behavioral therapy

(dCBTI) for insomnia as the sleep-focused intervention. We will begin with a small open trial to obtain input

from five youth and their DBT therapists to inform the proposed feasibility trial, adjusting the protocol as

needed to enhance youth engagement in dCBTI. We will then use the modified protocol to conduct a pilot RCT

with 40 youth, ages 12-18, with insomnia and high suicide risk to 6 months dCBTI plus DBT or to DBT alone.

We will assess feasibility, acceptability, and safety of dCBTI + DBT, as well as reductions in insomnia symptom

severity, SH, and SI. Following a baseline assessment, insomnia, SI and SH outcomes will be measured every

4 weeks over the 24-week treatment period to allow us to examine time to remission as well as to increase

statistical power and mitigate impact of attrition. Exploratory analyses will examine if reduction in insomnia

symptom severity mediates any observed between-condition differences in SH and SI. To the best of our

knowledge, this will be the first study to explore the effectiveness of combining both an evidence-based

insomnia treatment and a suicide-focused treatment for adolescents. We believe the approach of combining

two existing evidence-based treatments that target risk factors for suicide is innovative and novel, as well as

practical. This approach is consistent with the 2022 NIMH Strategic Plan for Research, Objective 3.2: Develop

strategies for tailoring existing interventions to optimize outcomes. By leveraging existing treatments that we

already know work and have robust uptake in the real world, we reduce time spent on treatment development

and can move faster to dissemination, should the approach prove effective. If dCBTI + DBT is effective, our

goal will be to disseminate dCBTI broadly as an adjunct to any suicide-focused treatment.

Grant Number: 5R34MH130634-03
NIH Institute/Center: NIH

Principal Investigator: Michele Berk

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