Treatments for Improving Mood in Depressed Teens-2 (TeenThrive)

Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents

Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test the adapted hatha yoga intervention

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Hatha Yoga

Detailed Description

In Phase 2, the investigators will conduct an open single-arm pilot trial of our 12 week adapted hatha yoga intervention.

the investigators will enroll 12 adolescents in the open pilot trial.

• Study Type: Interventional
• Enrollment (Actual): 11
• 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:

1. Adolescents must have elevated depressive symptoms, defined by a score of 11 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 12 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:

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

2. Adolescents who meet criteria for:

   • Current (past year) autism spectrum disorder (AS), if of sufficient severity to interfere with study treatment per clinician judgment;
   • Schizophrenia;
   • Bipolar disorder;
   • Clinically significant psychotic symptoms in the past month;
   • Anorexia or Bulimia in past 3 months
   • Substance use disorders in the 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 current suicide ideation or behavior that warrants immediate treatment. They may have passive ideation (i.e., thoughts that life is not worth living), but may not have active suicide ideation, intent, plan, or an attempt within the previous 6 months.
4. Adolescents cannot currently be engaged in or 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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hatha Yoga; 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.	Behavioral: Hatha Yoga; 12 weeks of Hatha Yoga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Acceptability	Acceptability assessed based on number of participants who remained in the intervention (retention).	Post intervention (month 3)
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 scored on a range of 0-1. 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 with higher scores indicating greater expectations.	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)	Depression symptom severity at Month 3. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.	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): March 1, 2019
• Primary Completion (Actual): August 14, 2019
• Study Completion (Actual): August 29, 2019

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): March 23, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD underlying publication if required by journal.
• IPD Sharing Time Frame: One year after study collection.
• IPD Sharing Access Criteria: Information available upon request, please send to PIs Lisa Uebelacker or Shirley Yen.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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