Combining therapies to help teens with insomnia and suicidal thoughts

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

This study is testing whether a combination of two therapies can help teens with insomnia and suicidal thoughts feel better compared to just one therapy alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Stanford University (Academic / other)
• Locations: 1 site (Stanford, California)
• Trial ID: NCT05842863 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining Dialectical Behavior Therapy (DBT) with a digital version of Cognitive Behavioral Therapy for Insomnia (CBT-I) in adolescents at high risk for suicide. Participants aged 12-18 will be randomly assigned to receive either the combined treatment or DBT alone for six months. The study aims to assess changes in suicidal ideation, self-harm behaviors, and insomnia symptoms through regular assessments. Additionally, participants will wear a wrist device to monitor their sleep patterns throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-18 who experience insomnia and are at high risk for suicide.

Not a fit: Patients with severe mental health conditions requiring specific treatments or those diagnosed with Autism Spectrum Disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce suicidality and self-harm in adolescents struggling with insomnia.

How similar studies have performed: While this specific combination of therapies is novel, previous studies have shown that both DBT and CBT-I are effective in their respective domains.

Eligibility criteria

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: \> 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.).
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.

Where this trial is running

Stanford, California

• Michele Berk — Stanford, California, United States (Recruiting)

Conditions Suicide and Self-harm