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New treatment option for Depression in Adolescence
Official title Teenthrive 2: Treatments for Improving Mood in Teens
ClinicalTrials.gov ID: NCT07475845
What this study is testing
- What it's testing
- In this study, we will conduct a pilot RCT of a yoga-based intervention (YBI) vs. group cognitive-behavioral therapy (gCBT) at two sites.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- Set A . In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Have elevated depressive symptoms, defined by: a) a score of 1 or greater on the PHQ-2 and 5 or greater on the PHQ-8 at screening; and b) a score of...
- Be aged 12-18;
- Be allowed to participate in gym class or sports at school (or, if not, medically cleared by their primary care provider or other relevant healthcare...
- Be able to read and write in English;
You likely can't join if
- Adolescents will be excluded if they:
- Meet criteria for lifetime bipolar I disorder, a current psychotic disorder, or current anorexia or bulimia; or currently be in treatment for...
- Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study...
- Have severe depression (QIDS-A-CR score \> = 16);
- Have moderate or high risk for suicide (Response of "yes" on CSSRS-Screener item 3,4,5,6 with regard to the past 3 months).
- Have suicide ideation (Response of "yes" on CSSRS- Screener item 2) and do not currently have other mental health treatment (pharmacotherapy or...
See the full eligibility criteria
Who can join
- Set A . In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Have elevated depressive symptoms, defined by: a) a score of 1 or greater on the PHQ-2 and 5 or greater on the PHQ-8 at screening; and b) a score of 10 or higher on the Quick Inventory of Depression-Adolescent...
- Be aged 12-18;
- Be allowed to participate in gym class or sports at school (or, if not, medically cleared by their primary care provider or other relevant healthcare provider);
- Be able to read and write in English;
- Provide consent/assent appropriate to age;
- Be able to attend group session times:
- Have access to a private space once per week that is suitable for synchronous intervention sessions. Set A
What rules you out
- Adolescents will be excluded if they:
- Meet criteria for lifetime bipolar I disorder, a current psychotic disorder, or current anorexia or bulimia; or currently be in treatment for anorexia or bulimia;
- Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study participation;
- Have severe depression (QIDS-A-CR score \> = 16);
- Have moderate or high risk for suicide (Response of "yes" on CSSRS-Screener item 3,4,5,6 with regard to the past 3 months).
- Have suicide ideation (Response of "yes" on CSSRS- Screener item 2) and do not currently have other mental health treatment (pharmacotherapy or psychotherapy)
- Are pregnant;
- Are currently (past 4 weeks) engaged in yoga classes or in gCBT;
- Have had substantive changes in other psychiatric treatment in the previous 4 weeks (e.g., started a new depression medication; stopped or started attending psychotherapy).
- Have a sibling or other household member active in a study intervention (for this study) at the same time. Set B Eligibility criteria Participants who are not eligible for Set A may be enrolled in Phase 2 Set B, such...
- Have elevated depressive symptoms, defined by: a) a score of 1 or greater on the PHQ-2 and 5 or greater on the PHQ-8 at screening; and b) a score of 6 or higher on the Quick Inventory of Depression-Adolescent...
- Be aged 12-18;
- Be allowed to participate in gym class or sports at school (or, if not, medically cleared by their primary care provider or other relevant healthcare provider);
- Be able to read and write in English;
- Provide consent/assent appropriate to age;
- Be able to attend group session times:
- Have access to a private space once per week that is suitable for synchronous intervention sessions. Set B Exclusion criteria: Adolescents will be excluded if they:
- Meet criteria for lifetime bipolar I disorder, a current psychotic disorder, or current anorexia or bulimia; or currently be in treatment for anorexia or bulimia;
- Meet criteria for substance use disorder (SUD) in the previous 12 months, with current symptoms of sufficient severity to interfere with study participation;
- Have severe depression (QIDS-A-CR score \> = 16);
- Have moderate or high risk for suicide (Response of "yes" on CSSRS-Screener item 3,4,5,6 with regard to the past 3 months).
- Have suicide ideation (Response of "yes" on CSSRS- Screener item 2) and do not currently have other mental health treatment (pharmacotherapy or psychotherapy)
- Are pregnant;
- Are currently (past 4 weeks) engaged in yoga classes or in gCBT;
- Have a sibling or other household member active in a study intervention (for this study) at the same time.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.