Butler Hospital
Providence, Rhode Island, 02906, United States
NCT Number: NCT03831360
Phase 3 is a randomized clinical trial of yoga vs group Cognitive Behavioral Therapy (CBT) for adolescents with depression.
Looking for future studies?
Notify Me13 year–18 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Hatha yoga for depressed adolescents
Group cognitive behavioral therapy for depressed adolescents
Time frame: 12 weeks
Acceptability is operationalized by the number of participants who attended 8 or more classes out of possible 12. Target was 70% or greater.
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 each scored on a range of 0-1, and the mean of thise is used in analyses. Higher scores indicate greater credibility.
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. Score ranges from 0-1 and the mean of those scores are analyzed, with higher scores indicating greater expectations.
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, and total score range from 8-32. Higher scores indicate greater client satisfaction.
Time frame: Post intervention (month 3)
Number of participants who met criteria for home practice (target of two practices per week) as assessed with a home practice questionnaire.
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.
Time frame: Baseline to post intervention (month 3)
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.
Brown University
Other
Adaptation and Pilot Study of Yoga to Reduce Depression in Adolescents
Acronym: TeenThrive
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06139016
Behavior, Behavioral Symptoms
New Haven, Connecticut, United States
View Trial DetailsNCT06942637
Adolescents, Anxiety
Bandung, West Java, Indonesia
View Trial DetailsNCT04276259
Behavior, Behavioral Symptoms
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT07737652
Anxiety, Anxiety Disorders
Tuscaloosa, Alabama, United States
View Trial Details