RecruitingNANCT05842863

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

Sponsor: Stanford University

Trial Details

ConditionSuicide and Self-harm
InterventionDialectical Behavior Therapy; Cognitive Behavioral Therapy for Insomnia
PhaseNA
StatusRecruiting
Participants44
Est. Completion30 June 2026
Last Updated29 Apr 2026

Primary Outcome

Suicidal Ideation Questionnaire Junior (SIQ-JR); Insomnia Severity Index (ISI); Suicide Attempt Self-Injury Interview and Count

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: 1. 12-18 years of age and not yet graduated from high school. 2. Insomnia symptoms, defined as a total score of ≥ 8 on the Insomnia Severity Index . 3. High suicide risk, defined as: \> 3 lifetime self-harm episodes (with at least 1 in the 12 weeks before baseline screening) and elevated suicidal ideation (≥31 on the SIQ-Jr.). 4. If taking medication for psychiatric disorders or sleep, must be on a stable dose (\>2 months). 5. Youth and parent both speak English. 6. At least one family member or responsible adult agrees to participate in assessments and in the DBT multi-family skills group. 7. Youth lives at home. Exclusion Criteria: 1. 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. 2. A history of being diagnosed with an Autism Spectrum Disorder. 3. Has a comorbid untreated sleep apnea or a severe circadian sleep-wake disorder with a habitual bedtime after 3 AM or habitual rise time after 11 AM. 4. Insomnia symptoms are significantly impacted by substance use or withdrawal of psychoactive medications. 5. Has conditions that require caution when implementing CBTI, such as bipolar and seizure disorders. 6. Court-ordered to treatment.

Trial Sites

Countries

United States
View Registry Entry

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