Treatments for Improving Mood in Depressed Teens-2 (TeenThrive)
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|ClinicalTrials.gov Identifier: NCT03831347|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Hatha Yoga||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: Hatha Yoga
12 weeks of modified Hatha Yoga specifically designed to be administered to teens with depression.
Behavioral: Hatha Yoga
12 weeks of Hatha Yoga
- Qualitative interview [ Time Frame: Post intervention (month 3) ]Acceptability assessed with Qualitative interview
- Credibility Expectancy Questionnaire (CEQ) - Credibility subscale [ Time Frame: Week 1 ]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 measured on a 1-9 scale (not at all - very), Higher scores indicate greater credibility.
- Credibility Expectancy Questionnaire (CEQ) - Expectancy subscale [ Time Frame: Week 1 ]Patient expectations assessed with the Credibility Expectancy Questionnaire (CEQ), expectancy subscale. The expectancy subscale is a 3 item subscale of the 6 item CEQ. One of the 3 items are measured on a 1-9 scale (not at all - very), 2 are on a 0-10 scale (0-100%). Higher scores indicate greater expectations.
- The Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post intervention (month 3) ]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. Higher scores indicate greater client satisfaction.
- Home practice questionnaire [ Time Frame: Post intervention (month 3) ]Yoga home practice assessed with a Home practice questionnaire. Duration, frequency, and type of formal and informal home yoga practice between class sessions.
- Systematic assessment of treatment-emergent events-general inquiry (SAFTEE) [ Time Frame: Post intervention (month 3) ]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.
- Quick Inventory of Depression - Adolescent Version - Clinician Rating (QIDS-A-CR) [ Time Frame: From baseline to post intervention (month 3) ]Change in depression symptom severity will be assessed using the QIDS. The QIDS is a 17 item measure with scores ranging from 0-30. Higher scores indicate greater depressive symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831347
|Contact: Lisa Uebelacker, PhDemail@example.com|
|Contact: Shirley Yen, PhDfirstname.lastname@example.org|
|United States, Rhode Island|
|Butler Hospital||Not yet recruiting|
|Providence, Rhode Island, United States, 02906|
|Contact: Shirley Yen 401-444-1915 Shirley_Yen_PhD@Brown.edu|
|Principal Investigator:||Lisa Uebelacker, PhD||Butler Hospital|
|Principal Investigator:||Shirley Yen, PhD||Brown University|