Status:
COMPLETED
Treatments for Improving Mood in Depressed Teens-2
Lead Sponsor:
Brown University
Collaborating Sponsors:
Butler Hospital
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Depression
Eligibility:
All Genders
13-18 years
Phase:
NA
Brief Summary
Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test the adapted hatha yoga intervention
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.
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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
- QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
- 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).
- 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.
- Adolescents cannot currently be engaged in or yoga classes, as this is the study intervention.
- Adolescents cannot be pregnant as yoga should be modified for pregnancy
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03831347
Start Date
March 1 2019
End Date
August 29 2019
Last Update
March 23 2022
Active Locations (1)
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1
Butler Hospital
Providence, Rhode Island, United States, 02906