Status:
COMPLETED
Treatments for Improving Mood in Depressed Teens-3
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Butler Hospital
Conditions:
Depression
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief Summary
Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.
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. Paren...
Eligibility Criteria
Inclusion
- 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).
- 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.
- 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.
- Adolescents must be aged 13-18.
- 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.
- Adolescents must be able to read and write English sufficient to complete informed consent and engage in interventions.
- 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.
- Able to attend one of the class times.
Exclusion
- Exclusion criteria for Phase 3 Study A, and Phase 3 Study B are identical.
- QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
- 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).
- Adolescents may not have suicide ideation so severe it will interfere with study participation.
- Adolescents cannot currently be engaged in yoga classes, as this is the study intervention.
- Adolescents cannot be pregnant as yoga should be modified for pregnancy.
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03831360
Start Date
October 21 2019
End Date
September 29 2021
Last Update
June 2 2022
Active Locations (1)
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1
Butler Hospital
Providence, Rhode Island, United States, 02906