Back to resultsCombined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
Primary Purpose
Suicide and Self-harm
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialectical Behavior Therapy
Cognitive Behavioral Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Suicide and Self-harm
Eligibility Criteria
Inclusion Criteria: 12-18 years of age and not yet graduated from high school. Insomnia symptoms, defined as a total score of ≥ 9 on the Insomnia Severity Index . 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.). If taking medication for psychiatric disorders or sleep, must be on a stable dose (>2 months). Youth and parent both speak English. At least one family member or responsible adult agrees to participate in assessments and in the DBT multi-family skills group. Youth lives at home. Exclusion Criteria: 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. A history of being diagnosed with an Autism Spectrum Disorder. 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. Insomnia symptoms are significantly impacted by substance use or withdrawal of psychoactive medications. Has conditions that require caution when implementing CBTI, such as bipolar and seizure disorders. Court-ordered to treatment.
Sites / Locations
- Michele Berk
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia
Dialectical Behavior Therapy Only
Arm Description
Outcomes
Primary Outcome Measures
Suicidal Ideation Questionnaire Junior (SIQ-JR)
The SIQ-JR (Reynolds 1987) is a 15-item self-report questionnaire that assesses suicidal thoughts on a 7-point scale (I never had this thought to almost every day). Scores range from 0 to 90, with a published clinical cut-off score of 31.
Insomnia Severity Index (ISI)
The ISI (Morin, 1993) is a 7-item self-report questionnaire that measures insomnia symptoms on a 4-point scale. Total score ranges from 0-28, with a total score of > 9 being validated as the optimal cutoff for a likely insomnia diagnosis.
Suicide Attempt Self-Injury Interview and Count
Structured clinical interview that measures number, dates, method, intent and lethality of suicide attempts and non-suicidal self-injury episodes.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05842863
Brief Title
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
Official Title
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide: A Pilot RCT
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide and Self-harm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia
Arm Type
Experimental
Arm Title
Dialectical Behavior Therapy Only
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy
Intervention Description
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
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicidal Ideation Questionnaire Junior (SIQ-JR)
Description
The SIQ-JR (Reynolds 1987) is a 15-item self-report questionnaire that assesses suicidal thoughts on a 7-point scale (I never had this thought to almost every day). Scores range from 0 to 90, with a published clinical cut-off score of 31.
Time Frame
Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
Title
Insomnia Severity Index (ISI)
Description
The ISI (Morin, 1993) is a 7-item self-report questionnaire that measures insomnia symptoms on a 4-point scale. Total score ranges from 0-28, with a total score of > 9 being validated as the optimal cutoff for a likely insomnia diagnosis.
Time Frame
Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
Title
Suicide Attempt Self-Injury Interview and Count
Description
Structured clinical interview that measures number, dates, method, intent and lethality of suicide attempts and non-suicidal self-injury episodes.
Time Frame
Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
12-18 years of age and not yet graduated from high school.
Insomnia symptoms, defined as a total score of ≥ 9 on the Insomnia Severity Index .
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.).
If taking medication for psychiatric disorders or sleep, must be on a stable dose (>2 months).
Youth and parent both speak English.
At least one family member or responsible adult agrees to participate in assessments and in the DBT multi-family skills group.
Youth lives at home.
Exclusion Criteria:
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.
A history of being diagnosed with an Autism Spectrum Disorder.
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.
Insomnia symptoms are significantly impacted by substance use or withdrawal of psychoactive medications.
Has conditions that require caution when implementing CBTI, such as bipolar and seizure disorders.
Court-ordered to treatment.
Facility Information:
Facility Name
Michele Berk
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
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