Treatments for Improving Mood in Depressed Teens-3



Status:Not yet recruiting
Conditions:Depression, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:13 - 18
Updated:2/7/2019
Start Date:October 2019
End Date:May 31, 2021
Contact:Lisa Uebelacker, PhD
Email:luebelacker@butler.org
Phone:401-455-6381

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Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents

Phase 3 is a randomized clinical trial of yoga vs group CBT for adolescents with depression.

In Phase 3, Study A, the investigators will conduct a pilot 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.

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.

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 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:

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 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 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.
We found this trial at
1
site
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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mi
from
Providence, RI
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