Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)

University of Pittsburgh

Status: Enrolling

Conditions: Depression; Sleep Disturbance; Suicide; Sleep

Treatments: Behavioral: Sleep Feedback; Behavioral: TranS-C

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06963463

STUDY22040040

P50MH115838 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this clinical trial is to adapt a sleep intervention for individuals representative of all demographic groups, including those who are at the highest risk for suicidal behavior. Sleep difficulties are a promising target for youth with suicidal thoughts and behavior to focus on as a prevention measure. We aim to increase intervention acceptability and impact by adapting it for the adolescent populations at highest risk for suicidal thoughts and behavior. The research project will compare Transdiagnostic Sleep and Circadian Intervention (TranS-C), an evidence based, modularized intervention that targets a range of sleep difficulties to a treatment as usual or control condition including providing weekly sleep feedback reports from data entered into a daily sleep diary and from wearing a sleep sensing, actigraphy watch. Participants in both conditions (TranS-C vs. Sleep Feedback) will wear an actigraphy sleep watch that monitors sleep, and complete daily sleep diaries via smartphone or email. Participants in the TranS-C condition will also wear bright light (BL) and blue blocking glasses each day as well as attend weekly or biweekly sessions with a Sleep Therapist. The sleep therapist will review sleep feedback during sessions.

Full description

This study will adapt TranS-C+BL for at-risk adolescents using health equity-informed implementation science methods.

This randomized trial will enroll 75 youth aged 12-18 at risk for STB and clinically significant sleep difficulties identified in primary care. The randomization that this study uses is a 2:1 allocation to compare TranS-C+BL Sleep Feedback vs. Sleep Feedback Alone.

Enrollment: 90 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adolescents (12-18)
• Current moderate to severe depression as measured by the PHQ-9M with a total score of greater than or equal to 11
• Current clinically significant sleep disturbance measured by the PHQ-9-M sleep item greater than or equal to 2.
• English language fluency and literacy sufficient to engage in study protocol.

Exclusion criteria

• Evidence of obstructive sleep apnea,
• Evidence of restless legs syndrome
• Evidence of psychosis
• Evidence of bipolar disorder
• Evidence of a developmental disability precluding comprehension of study procedures per electronic health record and eligibility screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Sleep Feedback

Experimental group

Description:

Participants receive an actigraphy watch to track their sleep and activity levels and complete a daily sleep diary; sleep feedback graphs show participants their actigraphy watch and sleep diary data on demand.

Treatment:

Behavioral: Sleep Feedback

TranS-C + Sleep Feedback

Experimental group

Description:

Participants will attend 6-8 TranS-C sessions with a Sleep therapist. Participants will also wear bright light glasses in the morning and blue light blocking glasses in the evening throughout the intervention.

Treatment:

Behavioral: TranS-C

Behavioral: Sleep Feedback