Treatments for Improving Mood in Depressed Teens-3 (TeenThrive)
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|ClinicalTrials.gov Identifier: NCT03831360|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Yoga Behavioral: Group CBT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: Hatha Yoga
12 weeks of hatha yoga
Hatha yoga for depressed adolescents
Experimental: Group CBT
12 weeks of group CBT
Behavioral: Group CBT
Group cognitive behavioral therapy for depressed adolescents
- 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: Baseline to post intervention (month 3); Baseline to 6 months; Baseline to 9 months ]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.
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): NCT03831360
|Contact: Lisa Uebelacker, PhDemail@example.com|
|Contact: Shirley Yen, PhDfirstname.lastname@example.org|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Principal Investigator:||Lisa Uebelacker, PhD||Butler Hospital|
|Principal Investigator:||Shirley Yen, PhD||Brown University|