- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05842863
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide: A Pilot RCT
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Michele Berk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia
|
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 (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.
|
Active Comparator: Dialectical Behavior Therapy Only
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Suicide Attempt Self-Injury Interview and Count
Time Frame: Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
|
Structured clinical interview that measures number, dates, method, intent and lethality of suicide attempts and non-suicidal self-injury episodes.
|
Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
|
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.
|
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.
|
Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
|
Insomnia Severity Index (ISI)
Time Frame: Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
|
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.
|
Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide and Self-harm
-
Harvard UniversityNational Institute of Mental Health (NIMH); Massachusetts General HospitalUnknownSuicide, Attempted | Suicide and Self-harmUnited States
-
Region StockholmKarolinska InstitutetRecruitingSuicide and Self-harmSweden
-
National Taiwan University HospitalAcademia Sinica, TaiwanUnknownThe Effect of a Brief Psychological Intervention on Reducing Self-harm Repetition: Feasibility StudySuicide and Self-harmTaiwan
-
VA Eastern Colorado Health Care SystemCompleted
-
University of California, Los AngelesPatient-Centered Outcomes Research Institute; Brown University; Duke University; University of Utah and other collaboratorsRecruiting
-
Butler HospitalNational Institute of Mental Health (NIMH); Brown UniversityRecruitingSuicidal Ideation | Suicide, Attempted | Suicide | Suicide and Self-harmUnited States
-
St. Luke's Health System, Boise, IdahoUniversity of Washington; American Foundation for Suicide Prevention; Idaho Crisis...RecruitingSuicide | Suicide and Self-harm | Suicide PreventionUnited States
-
Butler HospitalMichigan State UniversityActive, not recruitingSuicide and Self-harmUnited States
-
Winnipeg Regional Health AuthorityPrimary Supervisor: Dr. James Bolton MD FRCPCUnknownSuicidal Ideation | Suicide, Attempted | Suicide | Suicide and Self-harm | Suicide GestureCanada
-
National Taiwan University HospitalRecruitingSuicide and Self-harmTaiwan
Clinical Trials on Dialectical Behavior Therapy
-
University Hospital, Strasbourg, FranceRecruitingEncephalitis | Meningitis | Acquired Brain Injury | Cerebral Anoxia | Stroke/ Cerebrovascular Accident (Ischemic or Hemorrhagic) | Brain Tumor (After Recovery)France
-
Pontificia Universidad Catolica de ChileUniversity Diego PortalesNot yet recruitingBorderline Personality DisorderChile
-
University of WashingtonNational Institute of Mental Health (NIMH)CompletedSuicide | Post-traumatic Stress Disorder | Self-injurious BehaviorUnited States
-
Fordham UniversityNot yet recruitingAntisocial Personality DisorderUnited States
-
Rutgers, The State University of New JerseyActive, not recruitingBorderline Personality DisorderUnited States
-
University of ManitobaCompletedBorderline Personality DisorderCanada
-
Alexandria UniversityCompleted
-
Evangelisches Krankenhaus Bielefeld gGmbHCompletedBorderline Personality Disorder | Psychotherapy | DropoutGermany
-
Evangelisches Krankenhaus Bielefeld gGmbHCompletedBorderline Personality Disorder | PostTraumatic Stress Disorder | Psychotherapy | DropoutGermany
-
University Hospital, Strasbourg, FranceRecruitingAutism Spectrum DisordersFrance