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
| Condition | Suicide and Self-harm |
| Intervention | Dialectical Behavior Therapy; Cognitive Behavioral Therapy for Insomnia |
| Phase | NA |
| Status | Recruiting |
| Participants | 44 |
| Est. Completion | 30 June 2026 |
| Last Updated | 29 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
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