Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT05842863
Status
Recruiting
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Conditions

  • Suicide and Self-harm

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Dialectical Behavior Therapy — BEHAVIORAL
    Dialectical Behavior Therapy (DBT) is a treatment program that helps teens reduce suicidal and self-harm behaviors by teaching them coping skills for managing negative emotions. DBT includes weekly individual therapy, weekly multifamily skills group, and 24/7 telephone-based skills coaching from the therapist.
  • Cognitive Behavioral Therapy for Insomnia — BEHAVIORAL
    Cognitive Behavioral Therapy for Insomnia (CBTI) is a type of counseling that helps people improve sleep by changing their sleep behaviors and thinking about sleep. In CBTI, people learn about sleep regulation, factors that influence quantity and quality of sleep, and specific techniques to optimize sleep. In this study, CBTI will be delivered using a self-guided online program called Firefly.

Study Details

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.

Key Dates

Start date
Aug 14, 2024
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia
  • Active Comparator: Dialectical Behavior Therapy Only

Primary Outcome Measure

Suicidal Ideation Questionnaire Junior (SIQ-JR) [ Time Frame: Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Michele BerkStanfordCalifornia94305
Michele Berk
[email protected]
6507360077

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Michele Berk· Stanford, CA

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