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Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
Not Recruiting
Trial ID: NCT05842863
Purpose
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.
Official Title
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide: A Pilot RCT
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
1. 12-18 years of age and not yet graduated from high school.
2. Insomnia symptoms, defined as a total score of ≥ 9 on the Insomnia Severity Index .
3. High suicide risk, defined as: >1 lifetime suicide attempt, b) > 3 lifetime SH
episodes (with at least 1 in the 12 weeks before baseline screening) and c) elevated
SI (≥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.
Intervention(s):
behavioral: Dialectical Behavior Therapy
behavioral: Cognitive Behavioral Therapy for Insomnia
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305