Clinical trial NCT03831347: Treatments for Improving Mood in Depressed Teens-2
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: Butler Hospital
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-02-05
Enrollment: 11
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Acceptability
timeFrame: Post intervention (month 3)
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: 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: