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NCT05842863
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
NA trial testing Dialectical Behavior Therapy in Suicide and Self-harm in 44 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Stanford University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 14 August 2024 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Dialectical Behavior Therapy
- Cognitive Behavioral Therapy for Insomnia
Conditions studied
- Suicide and Self-harm — all drugs for Suicide and Self-harm →
Sponsor
Stanford University
Who can join
Adults 12 to 18, any sex, with Suicide and Self-harm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05842863
- Europe PMC full search
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Related trials
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Other recruiting trials for Suicide and Self-harm
Currently open trials in the same condition.
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- NCT05180344 — Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Open Tria · NA · recruiting
- NCT06476886 — Intensive Crisis Intervention · NA · recruiting
- NCT06273995 — Telehealth Behavioral Activation for Teens · NA · recruiting
- NCT06210100 — aiTBS for NSSI and Suicide in Adolescent Depression · NA · recruiting
Other Stanford University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05842863 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stanford University
- Last refreshed: 16 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05842863.
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