Treatments for Improving Mood in Depressed Teens-3 (TeenThrive)

Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents

Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Yoga; Behavioral: Group CBT

Detailed Description

In Phase 3, Study A, the investigators will conduct a pilot Randomized Control Trial (RCT) of 12 weeks of hatha yoga vs. 12 weeks of group CBT.

Participants will be adolescents with depression. Parents will also be invited to participate in assessments regarding their child.

Study B, which will run concurrent to Phase 3, will be for participants who did not meet the depression inclusion criteria or had recent changes in therapy or medications that make them ineligible for Phase 3. Their data will not be analyzed. They are recruited only for group participation.

Participants will be randomized to Phase 3 groups of 12 weeks of hatha yoga or group CBT. Parents will also be invited to participate in assessments regarding their child.

* Due to social distancing requirements related to COVID-19, all interventions have been delivered remotely via video-based platforms as of late March 2020.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Please note, inclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical, with the exception that, for Phase 3/ Study B, we will not require elevated depressive symptoms (a) or stable treatment (b).

1. Adolescents must have elevated depressive symptoms, defined by a score of 10 or higher on the Quick Inventory of Depression -Adolescent Version-- Clinician Rating (QIDS-A-CR), including endorsement of either sad mood or anhedonia on the QIDS.
2. Other treatment for depression must be stable at baseline. Adolescents do not have to be in other treatment for depression, but, if they are, it must be stable for the past 8 weeks.
3. Adolescents must be aged 13-18.
4. Adolescents must be medically cleared for moderate physical activity by their primary care physician. This criterion may be met by a current (dated in the past year) statement from their pediatrician that the adolescent may participate in school or camp programs including physical education.
5. Adolescents must be able to read and write English sufficient to complete informed consent and engage in interventions.
6. Adolescents aged 13-17 must assent to be in the study, and their parent or legal guardian must consent to their participation. Adolescents aged 18 must consent to be in the study.
7. Able to attend one of the class times.

Exclusion Criteria:

Exclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical.

1. QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.

2. Adolescents may not meet criteria for the following:

   • Autism spectrum disorder "cannot be ruled out", and symptoms are of sufficient severity to interfere with study treatment per clinician judgement
   • Current psychotic disorder
   • Lifetime history of a manic episode
   • Anorexia or Bulimia in past 3 months
   • Substance use disorders in past 12 months, and symptoms are of sufficient severity to interfere with study treatment per clinician judgment These will be assessed with the Mini-International Neuropsychiatric Interview (MINI).
3. Adolescents may not have suicide ideation so severe it will interfere with study participation.
4. Adolescents cannot currently be engaged in yoga classes, as this is the study intervention.
5. Adolescents cannot be pregnant as yoga should be modified for pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Hatha Yoga; 12 weeks of hatha yoga	Behavioral: Yoga; Hatha yoga for depressed adolescents
EXPERIMENTAL: Group CBT; 12 weeks of group CBT	Behavioral: Group CBT; Group cognitive behavioral therapy for depressed adolescents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.	12 weeks
Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale	Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are each scored on a range of 0-1, and the mean of thise is used in analyses. Higher scores indicate greater credibility.	Week 1
Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale	Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 and the mean of those scores are analyzed, with higher scores indicating greater expectations.	Week 1
The Client Satisfaction Questionnaire (CSQ-8)	Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction.	Post intervention (month 3)
Home Practice Questionnaire	Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.	Post intervention (month 3)
Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)	Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.	Post intervention (month 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)	Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.	Baseline to post intervention (month 3)

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH); Butler Hospital
• Investigators: Principal Investigator: Shirley Yen, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 21, 2019
• Primary Completion (ACTUAL): September 29, 2021
• Study Completion (ACTUAL): September 29, 2021

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (ACTUAL): February 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 1801001977; R34AT009886 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be made available to other researchers upon request.
• IPD Sharing Time Frame: upon study completion
• IPD Sharing Access Criteria: PIs will review requests for IPD.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No