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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT009886 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Butler Hospital | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test the adapted hatha yoga intervention
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hatha Yoga | Experimental | 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hatha Yoga | Behavioral | 12 weeks of Hatha Yoga |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Acceptability assessed based on number of participants who remained in the intervention (retention). | Post intervention (month 3) |
| 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 scored on a range of 0-1. 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 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) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) | Depression symptom severity at Month 3. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms. | post intervention (month 3) |
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Inclusion Criteria:
Exclusion Criteria:
QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
Adolescents who meet criteria for:
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.
Adolescents cannot currently be engaged in or 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 |
All IPD underlying publication if required by journal.
One year after study collection.
Information available upon request, please send to PIs Lisa Uebelacker or Shirley Yen.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hatha Yoga | 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hatha Yoga | 12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga |
| 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 assessed based on number of participants who remained in the intervention (retention). | Entire sample | Posted | Count of Participants | Participants | Post intervention (month 3) |
|
|
3 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 modified Hatha Yoga specifically designed to be administered to teens with depression. Hatha Yoga: 12 weeks of Hatha Yoga |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Uebelacker | Butler Hospital | 401-455-6200 | 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 | Feb 17, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2019 | Oct 19, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Post intervention (month 3) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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 scored on a range of 0-1. 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 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 | Number | adverse events | Post intervention (month 3) |
|
|
|
| Secondary | Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) | Depression symptom severity at Month 3. 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 | post intervention (month 3) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 2 |
| 11 |
| Celiac | Gastrointestinal disorders | Systematic Assessment |
|
| GI distress | Gastrointestinal disorders | Systematic Assessment |
|
| Gynecological issue | General disorders | Systematic Assessment |
|
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