Teenthrive 2: Treatments for Improving Mood in Teens

ConditionDepression in Adolescence

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-18

SponsorButler Hospital

About this trial

In this study, we will conduct a pilot RCT of a yoga-based intervention (YBI) vs. group cognitive-behavioral therapy (gCBT) at two sites. We will recruit 48 adolescent participants each in Columbus, OH and Boston, MA (96 total). We have a priori targets for indices of feasibility and acceptability, including recruitment rate, retention for assessments, class attendance, interventionist fidelity to manuals, and participant satisfaction. We hypothesize that we will meet these metrics at both sites.

Eligibility criteria

Qualifiers

Have elevated depressive symptoms, defined by: a) a score of 1 or greater on the PHQ-2 and 5 or greater on the PHQ-8 at screening; and b) a score of 10 or higher on the Quick Inventory of Depression-Adolescent Version-Clinician Rating (QIDS-A-CR), including either sad mood or anhedonia;

Be aged 12-18;

Be allowed to participate in gym class or sports at school (or, if not, medically cleared by their primary care provider or other relevant healthcare provider);

Be able to read and write in English;

Disqualifiers

Meet criteria for lifetime bipolar I disorder, a current psychotic disorder, or current anorexia or bulimia; or currently be in treatment for anorexia or bulimia;

Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study participation;

Have severe depression (QIDS-A-CR score > = 16);

Have moderate or high risk for suicide (Response of "yes" on CSSRS-Screener item 3,4,5,6 with regard to the past 3 months).

Trial design

Treatments tested in this trial

Yoga-Based Intervention
group CBT

Treatment groups

96 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Butler Hospital

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Beth Israel Deaconess Medical Center

Collaborator

Nationwide Children's Hospital

Collaborator

Source ClinicalTrials.gov