Triple Chronotherapy in Adolescents

Summary

Study Purpose This study is a randomized controlled trial examining the effectiveness of TCT in the acute treatment of depression and suicidality in adolescents compared to usual treatment care, which includes individual and group therapy, and medication adjustments. All potential participants will be identified at admission to the Psychiatric Youth Inpatient Unit of Billings Clinic and invited to participate. The length of participation is 2 months.

Study Design The primary research question of this RCT is whether adjunctive TCT in depressed adolescents is more effective in the management of depression symptoms and in reducing suicidal ideation at two months follow-up, than those adolescents who are receiving usual care. A total of three aims are proposed.

Hypothesis: Adjunctive TCT is more effective in the management of depression symptoms and in reducing suicidal ideation at two month follow-up than those adolescents who are receiving usual care.

The first aim is to track the trajectories of depression symptoms, suicidal ideation, and insomnia severity in participants receiving TCT and in those receiving treatment as usual over 4 days of initial treatment, thereby answering the question of whether adjunctive TCT can effectively reduce the severity of depression, insomnia and suicidal ideation.

The second aim is to examine whether TCT is more effective than usual care in sustaining treatment effects to the end of study period (2 months follow-up), therefore answering the question whether the effectiveness of the 4-day intervention of adjunctive TCT arm is sustainable up to the end of a two-month follow-up.

Hypothesis: TCT is more effective than usual care in sustaining treatment effects to the end of the study period than usual care.

The third aim is to assess the link to the clinical outcomes (change in depression symptoms, suicidal ideation, insomnia severity, and disease-associated quality of life) and patient satisfaction with the treatment.

Hypothesis: Clinical outcomes (depression symptoms, suicidal ideation, insomnia, and disease-related quality of life) and patient satisfaction are more effective than usual care alone.

Conditions

• Depressive Disorder, Major
• Bipolar Depression
• Suicidal Ideation

Interventions

BEHAVIORAL

Triple Chronotherapy

Day 0: One night of total sleep deprivation. The first 24 hours are spent with 1:1 nursing care for provision of comfort measures to stimulate wakefulness and to encourage completion of the intervention. Day 1-4: Sleep phase advancement Day 1: Sleep from 6 PM to 1 AM Day 2: Sleep from 8 PM to 3 AM Day 3: Sleep from 10 PM and 5 AM Day 4: Awaken at 5 AM; discharge following light therapy On days 1-4 patients will receive bright light therapy at 7am to 7:30am using a 10,000 Verilux light box. At discharge patients will be given a light box, strongly advised to continue the maintenance sleep schedule and bright light therapy at 7am daily for 30 minutes. Patients will be scheduled for follow-up appointments at 1-week, 1-month and 2-month following discharge.

BEHAVIORAL

Treatment as Usual

Normal inpatient care, including pharmacotherapy, psychotherapy, milieu therapy and social work interventions

Sponsors & Collaborators

• Billings Clinic

  lead OTHER

Principal Investigators

• Mariela Herrera, MD · Billings Clinic

• Laurie Riemann, BSN · Billings Clinic

• Jamie Besel, MSN · Billings Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-25

Primary Completion

2023-03-13

Completion

2023-03-14

Countries

• United States

Study Locations