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

Suicide and Self-harm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842863
• Other study ID #: 69003
• Secondary ID: 1R34MH130634-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: June 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicide
• Suicide and Self-harm

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Michele Berk	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
Primary	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.	Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.
Primary	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.	Baseline and change from baseline at 4, 8, 12, 16, 20, 24 and 36 weeks after the start of the DBT program.