Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Yoga-Based Intervention

    Behavioral

    This intervention consists of twice-weekly yoga classes. Classes will be led by trained yoga teachers. Each week for 12 weeks, classes will occur once in person (55 mins) and once virtually (30 mins).

  • group CBT

    Behavioral

    This intervention consists of twice-weekly group CBT sessions. Sessions will be led by trained behavioral health specialists. Each week for 12 weeks, sessions will occur once in person (55 mins) and once virtually (30 mins).

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Yoga armExperimental treatment 1 intervention
Group B: gCBT armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Credibility

Assessed by Credibility scale of Credibility Expectancy Questionnaire

Time frame
Start of treatment
2

Expectancy

Assessed by Expectancy scale of Credibility Expectancy Questionnaire

Time frame
Start of treatment
3

Program Satisfaction

Assessed by the Client Satisfaction Questionnaire (CSQ-8)

Time frame
12 weeks
4

Class Attendance

Assessed via staff observation

Time frame
Week 0-12

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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