N/A
N=30
Treatments for Improving Mood in Depressed Teens-3
Depression
Bottom Line
View on ClinicalTrials.gov: NCT03831360 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Acceptability — 11; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Yoga (Behavioral); Group CBT (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability |
11; 13 | — |
| PRIMARY Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale |
0.72; 0.71 | — |
| PRIMARY Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale |
0.57; 0.55 | — |
| PRIMARY The Client Satisfaction Questionnaire (CSQ-8) |
26.8; 26.1 | — |
| PRIMARY Home Practice Questionnaire |
3; 8 | — |
| PRIMARY Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) |
0; 0 | — |
| SECONDARY Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) |
6.92; 8.23 | — |
Summary
Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.
Eligibility Criteria
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).
- 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 Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03831360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.