RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide: A Pilot RCT

Quick Facts

Study Start:2024-06-15

Study Completion:2026-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05842863

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

Michele Berk

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-15

Study Completion Date2026-05-31

Study Record Updates

Study Start Date2024-06-15

Study Completion Date2026-05-31

Terms related to this study

Additional Relevant MeSH Terms

Suicide and Self-harm