Clinical trial NCT03831360: Treatments for Improving Mood in Depressed Teens-3
Official title: Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Butler Hospital
First posted: 2019-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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).

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.

Primary outcomes:
measure: Acceptability
timeFrame: 12 weeks
measure: Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale
timeFrame: Week 1
measure: Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale
timeFrame: Week 1
measure: The Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post intervention (month 3)
measure: Home Practice Questionnaire
timeFrame: Post intervention (month 3)
measure: Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE)
timeFrame: Post intervention (month 3)
Secondary outcomes:
measure: Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR)
timeFrame: Baseline to post intervention (month 3)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Lisa Uebelacker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Shirley Yen, PhD
role: PRINCIPAL_INVESTIGATOR
References: