About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Evidence of obstructive sleep apnea,

Evidence of restless legs syndrome

Evidence of psychosis

Evidence of bipolar disorder

Trial design

Design model

Parallel

Treatments tested in this trial

TranS-C
Behavioral
This intervention includes participants attending 6-8 sessions with a Sleep Therapist.
Sleep Feedback
Behavioral
Participants are provided with an actigraphy watch that is used to monitor their sleep and activity throughout the day and complete a sleep diary daily. Along with wearing the watch they also will be provided access to their actigraphy and sleep diary graphs that document their data.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Sleep FeedbackExperimental treatment 1 intervention

Group B: TranS-C + Sleep FeedbackExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Feasibility-Attendance

Feasibility of interventions as by measured by the mean of number of sessions attended. Local study documents are used to track each session that was completed.

Time frame

From enrollment to the end of the treatment (up to 4 months)

2

Feasibility-Attrition

Attrition will be assessed using a study-specific form reflecting participants who withdraw or are withdrawn from the TranS-C+ intervention. The proportion of patients who withdraw or are withdrawn will be calculated.

Time frame

From enrollment until withdrawal or completing treatment sessions.

3

Acceptability-Treatment Satisfaction

Treatment satisfaction will be measured by the patient-reported Treatment Satisfaction Questionnaire administered post-treatment. The Treatment Satisfaction Questionnaire assesses satisfaction with the treatment received and perception of progress; each item is rated on a Likert scale. Additional open-ended questions allow for participants to share feedback on strengths and weaknesses as well as any other feedback related to their satisfaction with the intervention. The Questionnaire has questions on a 1(Not at all)-7(Very Much). Questions on study clinicians are asked on a 1(Poor)-7(Superior) Likert scale. Questions on the duration of study on a 1(Much too short)-7(Much to long) Likert scale. Questions about frequency of visits on a 1(Much too infrequent)-7(Much to frequent). Questions for recommendations to other rated on a 1(Strongly recommend)-7(Strongly not recommend). Questions on future outlook rated on a 1(Very Pessimistic)-7(Very Optimistic).

Time frame

4 month

Secondary outcomes

1

Sleep Disturbance

Self-reported sleep disturbance will be assessed via the Pediatric PROMIS Sleep Disturbance and Sleep Related Impairment Measures. The Patient-Reported Outcomes Measurement Information System is an 8-item measure. The scoring ranges from Never (1) Almost Never (2) Sometimes (3) Almost Always (4) Always (5). The PROMIS scale is scored on the T-score metric scale. The higher the participant scores more of the concept being measured. With the general population getting a score of 50 with a standard deviation of 10

Time frame

Baseline

2

Depression

Depressive symptom severity will be assessed via the self-reported PHQ-9-M. The Patient Health Questionnaire is a 13-item measure. The questions are rating on a 0(Not at all)- 3(Nearly Every day) Likert scale. Additional questions rated on a scale of Not difficult at all to Extremely difficult, along with yes/no questions. The PHQ-9M is rated on a scale from 0 to 27. Higher scores are associated with higher levels of, or more severe, depression

Time frame

Baseline

3

Risk for Suicidal Thoughts and Behaviors

Suicidal thoughts and behaviors will be assessed via the C-SSRS. The Columbia-Suicide Severity Rating Scale is an 18-item measure. This measure contains yes/no questions, asking about both about suicidality over the past 3 months and lifetime. In the C-SSRS the higher the score the more risk of suicidality (0 = No risk reported (all "no" responses),1 - 2 = Low risk ,3 - 6 = Moderate to high risk)

Time frame

Baseline

4

Sleep Disturbance

Self-reported sleep disturbance will be assessed via the Pediatric PROMIS Sleep Disturbance and Sleep Related Impairment Measures. The Patient-Reported Outcomes Measurement Information System is an 8-item measure. The scoring ranges from Never (1) Almost Never (2) Sometimes (3) Almost Always (4) Always (5). The PROMIS scale is scored on the T-score metric scale. The higher the participant scores more of the concept being measured. With the general population getting a score of 50 with a standard deviation of 10

Time frame

1 month

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts