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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT012238 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Beth Israel Deaconess Medical Center | OTHER |
| Nationwide Children's Hospital | OTHER |
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In this study, we will conduct a pilot RCT of a yoga-based intervention (YBI) vs. group cognitive-behavioral therapy (gCBT) at two sites. We will recruit 48 adolescent participants each in Columbus, OH and Boston, MA (96 total). We have a priori targets for indices of feasibility and acceptability, including recruitment rate, retention for assessments, class attendance, interventionist fidelity to manuals, and participant satisfaction. We hypothesize that we will meet these metrics at both sites.
In this study, we will conduct a pilot RCT of a yoga-based intervention (YBI) vs. group cognitive-behavioral therapy (gCBT) at two sites. We will recruit 48 adolescent participants each in Columbus, OH and Boston, MA (96 total). We have a priori targets for indices of feasibility and acceptability, including recruitment rate, retention for assessments, class attendance, interventionist fidelity to manuals, and participant satisfaction. We hypothesize that we will meet these metrics at both sites. We will examine preliminary outcomes of depression, functional impairment, and anxiety, as well as engagement of hypothesized mechanisms of self-compassion, and metacognitive awareness. Participants will be adolescents with depression who will receive their assigned intervention for 3 months and be followed for 3 additional months. Parents will also be invited to participate in assessments regarding their child. Adolescent participants will be comprised of Set A (n=72) vs. Set B (where Set B participants do not meet Set A criteria for severity of depression symptoms or stability of other depression treatment. For both sets, in-person CBT groups and the yoga intervention will occur on the campus of the study hospital site. Randomization will be stratified by site and by set (A/B). Masked evaluators will assess depression symptom severity, which will be the primary outcome in a future fully-powered effectiveness trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga arm | Experimental | Yoga-based intervention |
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| gCBT arm | Active Comparator | group CBT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga-Based Intervention | Behavioral | This intervention consists of twice-weekly yoga classes. Classes will be led by trained yoga teachers. Each week for 12 weeks, classes will occur once in person (55 mins) and once virtually (30 mins). |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility | Assessed by Credibility scale of Credibility Expectancy Questionnaire | Start of treatment |
| Expectancy | Assessed by Expectancy scale of Credibility Expectancy Questionnaire | Start of treatment |
| Program Satisfaction | Assessed by the Client Satisfaction Questionnaire (CSQ-8) | 12 weeks |
| Class Attendance | Assessed via staff observation | Week 0-12 |
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Set A Inclusion Criteria. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Set A Exclusion criteria: Adolescents will be excluded if they:
Set B Eligibility criteria
Participants who are not eligible for Set A may be enrolled in Phase 2 Set B, such that they will be eligible to attend classes but their data will not be considered in our main analyses.
Set B Inclusion Criteria. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Set B Exclusion criteria: Adolescents will be excluded if they:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bailey O'Keeffe, MA | Contact | 401-455-6219 | bokeeffe@butler.org | |
| Julie Desaulniers | Contact | 401-455-6219 | jdesaulniers@butler.org |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Uebelacker, PhD | Butler Hospital | Principal Investigator |
| Shirley Yen, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02115 | United States |
De-identified data reflecting demographics, primary, and secondary outcomes.
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| group CBT | Behavioral | This intervention consists of twice-weekly group CBT sessions. Sessions will be led by trained behavioral health specialists. Each week for 12 weeks, sessions will occur once in person (55 mins) and once virtually (30 mins). |
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| Nationwide Children's Hospital | Recruiting | Columbus | Ohio | 43215 | United States |
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