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

NCT ID: NCT05842863

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-14
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Suicide and Self-harm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia

Group Type: EXPERIMENTAL

Dialectical Behavior Therapy

Intervention Type: 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

Intervention Type: 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.

Dialectical Behavior Therapy Only

Group Type: ACTIVE_COMPARATOR

Dialectical Behavior Therapy

Intervention Type: 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.

Interventions

Dialectical Behavior Therapy

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.

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia

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.

Intervention Type: BEHAVIORAL

Eligibility 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: >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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Michele Berk

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Michele Berk

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Michele Berk

Role: primary

mberk2@stanford.edu

6507360077

Other Identifiers

1R34MH130634-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

69003

Identifier Type: -

Identifier Source: org_study_id