Suicide and Self-harmNCT05842863
Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide
A study testing Dialectical Behavior Therapy and Cognitive Behavioral Therapy for Insomnia in people with Suicide and Self-harm, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide and Self-harm
- What is being tested?
- Dialectical Behavior Therapy and Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 12-18 years of age and not yet graduated from high school.
- Insomnia symptoms, defined as a total score of ≥ 8 on the Insomnia Severity Index .
- High suicide risk, defined as: > 3 lifetime self-harm episodes (with at least 1 in the 12 weeks before baseline screening) and elevated suicidal ideation (≥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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Suicide and Self-harm
- Being tested
- Dialectical Behavior Therapy, Cognitive Behavioral Therapy for Insomnia
- Medical subject headings
- Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavior TherapyBehavioural
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 InsomniaBehavioural
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 group | Role | What they receive |
|---|---|---|
| Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia | Experimental | Not described Receives: Behavioral: Dialectical Behavior Therapy; Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Dialectical Behavior Therapy Only | Active comparator | Not described Receives: Behavioral: Dialectical Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
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.
Measured: Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start14 Aug 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide and Self-harmStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michele Berk, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842863
- Sponsor's protocol ID
- 69003
- Other IDs
- 1R34MH130634-01A1
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Dialectical Behavior Therapy and Digital Cognitive Behavioral Therapy for Insomnia for Adolescents at High Risk for Suicide: A Pilot RCT
- ClinicalTrials.gov ID
- NCT05842863
- Acronym / sponsor ID
- 69003
- Conditions
- Suicide and Self-harm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia | Experimental | Behavioral: Dialectical Behavior Therapy, Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Dialectical Behavior Therapy Only | Active comparator | Behavioral: Dialectical Behavior Therapy |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 12-18 years of age and not yet graduated from high school.
- Insomnia symptoms, defined as a total score of ≥ 8 on the Insomnia Severity Index .
- High suicide risk, defined as: > 3 lifetime self-harm episodes (with at least 1 in the 12 weeks before baseline screening) and elevated suicidal ideation (≥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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectical Behavior TherapyDialectical 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. | Behavioural | Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia, Dialectical Behavior Therapy Only |
| Cognitive Behavioral Therapy for InsomniaCognitive 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. | Behavioural | Dialectical Behavior Therapy + Cognitive Behavioral Therapy for Insomnia |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behavior Therapy and Cognitive Behavioral Therapy for Insomnia in people with Suicide and Self-harm, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.