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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT009886 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Butler Hospital | OTHER |
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Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hatha Yoga | Experimental | 12 weeks of hatha yoga |
|
| Group CBT | Experimental | 12 weeks of group CBT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Behavioral | Hatha yoga for depressed adolescents |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater. | 12 weeks |
| Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale | Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are each scored on a range of 0-1, and the mean of thise is used in analyses. Higher scores indicate greater credibility. | Week 1 |
| Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale | Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 and the mean of those scores are analyzed, with higher scores indicating greater expectations. | Week 1 |
| The Client Satisfaction Questionnaire (CSQ-8) | Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction. | Post intervention (month 3) |
| Home Practice Questionnaire | Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire. | Post intervention (month 3) |
| Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) | Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms. | Baseline to post intervention (month 3) |
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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).
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Uebelacker, PhD | Butler Hospital | Principal Investigator |
| Shirley Yen, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
IPD will be made available to other researchers upon request.
upon study completion
PIs will review requests for IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hatha Yoga | 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents |
| FG001 | Group CBT | 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hatha Yoga | 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents |
| BG001 | Group CBT | 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability | Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater. | Posted | Count of Participants | Participants | 12 weeks |
|
|
Three months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hatha Yoga | 12 weeks of hatha yoga Yoga: Hatha yoga for depressed adolescents |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| flu | Immune system disorders | Systematic Assessment | flu or mild COVID related symptoms |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Uebelacker | Butler Hospital | 401-455-6381 | LUebelacker@butler.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2020 | Oct 26, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2020 | Oct 16, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Group CBT |
| Behavioral |
Group cognitive behavioral therapy for depressed adolescents |
|
Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga.
| Post intervention (month 3) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Credibility Expectancy Questionnaire (CEQ) - Credibility Subscale | Credibility assessed with Credibility Expectancy Questionnaire (CEQ), credibility subscale. The credibility subscale of the CEQ, is a 3 item subscale of the 6 item CEQ. The 3 items are each scored on a range of 0-1, and the mean of thise is used in analyses. Higher scores indicate greater credibility. | Posted | Mean | Standard Deviation | score on a scale | Week 1 |
|
|
|
| Primary | Credibility Expectancy Questionnaire (CEQ) - Expectancy Subscale | Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. Score ranges from 0-1 and the mean of those scores are analyzed, with higher scores indicating greater expectations. | Posted | Mean | Standard Deviation | score on a scale | Week 1 |
|
|
|
| Primary | The Client Satisfaction Questionnaire (CSQ-8) | Satisfaction with treatment assessed with The Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measure with each item measured on a 1-4 scale, and total score range from 8-32. Higher scores indicate greater client satisfaction. | Posted | Mean | Standard Deviation | score on a scale | Post intervention (month 3) |
|
|
|
| Primary | Home Practice Questionnaire | Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire. | Posted | Count of Participants | Participants | Post intervention (month 3) |
|
|
|
| Primary | Systematic Assessment of Treatment-emergent Events-general Inquiry (SAFTEE) | Participant safety/adverse events will be measured using the SAFTEE. Participants will also be asked weekly if they experienced any injuries as a result of yoga. | Posted | Count of Participants | Participants | Post intervention (month 3) |
|
|
|
| Secondary | Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) | Change in depression symptom severity will be assessed via blind evaluator using the the QIDS. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms. | Posted | Mean | Standard Deviation | score on a scale | Baseline to post intervention (month 3) |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Group CBT | 12 weeks of group CBT Group CBT: Group cognitive behavioral therapy for depressed adolescents | 0 | 15 | 0 | 15 | 2 | 15 |
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| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |