Triple Chronotherapy in Adolescents

Study 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:

Primary Outcome

Measuring the change score of pre-post PHQ-A; a score of 5-9 indicates mild depression with watchful waiting and repeat test, 10-14 indicates moderate depression that should be followed up with due consideration as to counseling and/or pharmacotherapy, 15-19 signifies moderately severe depression what requires initiation of pharmacotherapy and/or psychotherapy, and a score of 20-27 is interpreted as severe depression with immediate initiation of pharmacotherapy and referral to a mental health sp

Interventions

• BEHAVIORAL Treatment as Usual
• BEHAVIORAL Triple Chronotherapy