Not listed
PILOT MULTISITE RANDOMIZED CONTROLLED TRIAL OF YOGA TO REDUCE DEPRESSION INADOLESCENTS - PROJECT SUMMARY EVEN BEFORE THE ONSET OF THE COVID PANDEMIC, ADOLESCENT DEPRESSION HAS BEEN INCREASING, AND HEALTH DISPAR- ITIES AND DISPARITIES IN ACCESS TO TREATMENT HAVE CONTINUED TO WIDEN. THUS, THERE IS A CLEAR NEED FOR INNOVATIVE, ACCESSIBLE TREATMENTS FOR DEPRESSED ADOLESCENTS, INCLUDING TREATMENTS THAT DO NOT RELY ON A LIMITED POOL OF CHILD AND ADOLESCENT HEALTH PROVIDERS. YOGA-BASED INTERVENTIONS (YBIS) HAVE SHOWN PROMISE FOR ADULT DEPRESSION. SEVERAL ATTRACTIVE ASPECTS OF YOGA INCLUDE ITS: 1) AVAILABILITY THROUGHOUT THE U.S.; 2) ACCESSIBILITY VIA ONLINE CLAS- SES; 3) INDEPENDENCE FROM AN OVERBURDENED MENTAL HEALTH CARE SYSTEM; AND 4) GENERALIZABILITY--YOGA STUDENTS STATE THAT THEY USE MINDFULNESS AND BREATHING PRACTICES TO COPE WITH STRESS IN EVERYDAY LIFE. FUNDED BY A NCCIH R34, WE DEVELOPED A YBI FOR DEPRESSED ADOLESCENTS, AND DEMONSTRATED THAT THIS IN-PERSON PROGRAM WAS ACCEPTABLE AND FEASIBLE IN A SMALL SAMPLE (N=11) OF DEPRESSED ADOLESCENTS AS WELL AS IN A PILOT RCT (N=42) OF YBI VS. AN EXISTING EVIDENCE-BASED TREATMENT, GROUP COGNITIVE-BEHAVIORAL THERAPY (GCBT). THE RCT CLASSES WERE INITIALLY IN-PERSON, BUT WE MIGRATED TO SYNCHRONOUS ONLINE CLASSES DUE TO COVID-19. IN THE RCT, PARTICIPANTS WITHIN EACH STUDY ARM SHOWED DECREASED DEPRESSION SYMPTOMS AND INCREASED SELF-COMPASSION OVER TIME. MOST A PRIORI FEASIBILITY AND ACCEPTABILITY TARGETS WERE MET (E.G., RECRUITMENT, RETENTION, EXPECTANCY, SATISFACTION, CREDIBILITY, ATTENDANCE, AND ADHERENCE). HOWEVER, PARTICIPANTS DID NOT ENGAGE IN HOME (OUTSIDE-OF- CLASS) PRACTICE AT THE TARGETED RATE. THUS, IN THE PRESENT PROPOSAL WE HAVE MODIFIED OUR PROTOCOL TO PROVIDE AN OPPORTUNITY FOR TWICE-WEEKLY SUPERVISED YOGA PRACTICE (ONE IN-PERSON CLASS ON THE WEEKEND, AND ONE VIRTUAL CLASS MIDWEEK). OUR PRIOR PILOT TRIAL WAS BASED AT ONLY ONE SITE (PROVIDENCE RI) WITH ONE PRIMARY YBI INSTRUCTOR AND TWO GCBT LEADERS. MULTIPLE SITES AND INSTRUCTORS/LEADERS, AND RECRUITMENT OF A MORE RACIALLY AND ETHNICALLY DIVERSE SAMPLE, WILL BE IMPORTANT TO DEMONSTRATE GENERALIZABILITY AND TO ENHANCE EFFECTIVENESS. WE NOW PRO- POSE TO CONDUCT A TWO-PHASE MULTI-SITE FEASIBILITY TRIAL. PHASE 1 (N=20) WILL FOCUS ON INCREASING ACCESSIBILITY AND FEASIBILITY OF YBI FOR PARTICULAR GROUPS OF ADOLESCENTS. WE WILL CONDUCT INDIVIDUAL INTERVIEWS WITH TEENS WHO WERE LESS REPRESENTED IN OUR PILOT TRIAL (AFRICAN-AMERICAN/BLACK, ASIAN AMERICAN, AND MALE ADOLESCENTS) TO GAIN THEIR FEEDBACK ON YOGA BASED INTERVENTIONS, WITH A FOCUS ON INCREASING ACCESSIBILITY AND FEASIBILITY FOR ADOLESCENTS WITH THESE IDENTITIES. PHASE 2 (N=128) WILL BE A PILOT RCT OF YBI VS. GCBT AT TWO GEOGRAPHICALLY DISTINCT SITES: BOSTON, MA AND COLUMBUS, OH. GIVEN THE RISING PREVALENCE OF ADOLESCENT DEPRESSION AND THE EXISTENCE OF ESTABLISHED, EFFICACIOUS GROUP TREATMENT FOR DEPRESSION (I.E., GROUP CBT), WE DETERMINED THAT A NON-INFERIORITY TRIAL REPRESENTED THE MOST ETHICAL WAY TO PROCEED. WE WILL INCORPORATE LESSONS LEARNED FROM THIS STUDY TO FURTHER REFINE STUDY MATERIALS AND CREATE A TEMPLATE FOR ONBOARDING MULTIPLE FUTURE SITES. THIS PROJECT WILL PREPARE US TO CONDUCT A MULTISITE, ADEQUATELY POWERED, NON-INFERIORITY RCT OF YBI VS. GCBT IN DEPRESSED ADOLESCENTS.
$0 1/9/25 Not listed
PILOT MULTISITE RANDOMIZED CONTROLLED TRIAL OF YOGA TO REDUCE DEPRESSION INADOLESCENTS - PROJECT SUMMARY EVEN BEFORE THE ONSET OF THE COVID PANDEMIC, ADOLESCENT DEPRESSION HAS BEEN INCREASING, AND HEALTH DISPAR- ITIES AND DISPARITIES IN ACCESS TO TREATMENT HAVE CONTINUED TO WIDEN. THUS, THERE IS A CLEAR NEED FOR INNOVATIVE, ACCESSIBLE TREATMENTS FOR DEPRESSED ADOLESCENTS, INCLUDING TREATMENTS THAT DO NOT RELY ON A LIMITED POOL OF CHILD AND ADOLESCENT HEALTH PROVIDERS. YOGA-BASED INTERVENTIONS (YBIS) HAVE SHOWN PROMISE FOR ADULT DEPRESSION. SEVERAL ATTRACTIVE ASPECTS OF YOGA INCLUDE ITS: 1) AVAILABILITY THROUGHOUT THE U.S.; 2) ACCESSIBILITY VIA ONLINE CLAS- SES; 3) INDEPENDENCE FROM AN OVERBURDENED MENTAL HEALTH CARE SYSTEM; AND 4) GENERALIZABILITY--YOGA STUDENTS STATE THAT THEY USE MINDFULNESS AND BREATHING PRACTICES TO COPE WITH STRESS IN EVERYDAY LIFE. FUNDED BY A NCCIH R34, WE DEVELOPED A YBI FOR DEPRESSED ADOLESCENTS, AND DEMONSTRATED THAT THIS IN-PERSON PROGRAM WAS ACCEPTABLE AND FEASIBLE IN A SMALL SAMPLE (N=11) OF DEPRESSED ADOLESCENTS AS WELL AS IN A PILOT RCT (N=42) OF YBI VS. AN EXISTING EVIDENCE-BASED TREATMENT, GROUP COGNITIVE-BEHAVIORAL THERAPY (GCBT). THE RCT CLASSES WERE INITIALLY IN-PERSON, BUT WE MIGRATED TO SYNCHRONOUS ONLINE CLASSES DUE TO COVID-19. IN THE RCT, PARTICIPANTS WITHIN EACH STUDY ARM SHOWED DECREASED DEPRESSION SYMPTOMS AND INCREASED SELF-COMPASSION OVER TIME. MOST A PRIORI FEASIBILITY AND ACCEPTABILITY TARGETS WERE MET (E.G., RECRUITMENT, RETENTION, EXPECTANCY, SATISFACTION, CREDIBILITY, ATTENDANCE, AND ADHERENCE). HOWEVER, PARTICIPANTS DID NOT ENGAGE IN HOME (OUTSIDE-OF- CLASS) PRACTICE AT THE TARGETED RATE. THUS, IN THE PRESENT PROPOSAL WE HAVE MODIFIED OUR PROTOCOL TO PROVIDE AN OPPORTUNITY FOR TWICE-WEEKLY SUPERVISED YOGA PRACTICE (ONE IN-PERSON CLASS ON THE WEEKEND, AND ONE VIRTUAL CLASS MIDWEEK). OUR PRIOR PILOT TRIAL WAS BASED AT ONLY ONE SITE (PROVIDENCE RI) WITH ONE PRIMARY YBI INSTRUCTOR AND TWO GCBT LEADERS. MULTIPLE SITES AND INSTRUCTORS/LEADERS, AND RECRUITMENT OF A MORE RACIALLY AND ETHNICALLY DIVERSE SAMPLE, WILL BE IMPORTANT TO DEMONSTRATE GENERALIZABILITY AND TO ENHANCE EFFECTIVENESS. WE NOW PRO- POSE TO CONDUCT A TWO-PHASE MULTI-SITE FEASIBILITY TRIAL. PHASE 1 (N=20) WILL FOCUS ON INCREASING ACCESSIBILITY AND FEASIBILITY OF YBI FOR PARTICULAR GROUPS OF ADOLESCENTS. WE WILL CONDUCT INDIVIDUAL INTERVIEWS WITH TEENS WHO WERE LESS REPRESENTED IN OUR PILOT TRIAL (AFRICAN-AMERICAN/BLACK, ASIAN AMERICAN, AND MALE ADOLESCENTS) TO GAIN THEIR FEEDBACK ON YOGA BASED INTERVENTIONS, WITH A FOCUS ON INCREASING ACCESSIBILITY AND FEASIBILITY FOR ADOLESCENTS WITH THESE IDENTITIES. PHASE 2 (N=128) WILL BE A PILOT RCT OF YBI VS. GCBT AT TWO GEOGRAPHICALLY DISTINCT SITES: BOSTON, MA AND COLUMBUS, OH. GIVEN THE RISING PREVALENCE OF ADOLESCENT DEPRESSION AND THE EXISTENCE OF ESTABLISHED, EFFICACIOUS GROUP TREATMENT FOR DEPRESSION (I.E., GROUP CBT), WE DETERMINED THAT A NON-INFERIORITY TRIAL REPRESENTED THE MOST ETHICAL WAY TO PROCEED. WE WILL INCORPORATE LESSONS LEARNED FROM THIS STUDY TO FURTHER REFINE STUDY MATERIALS AND CREATE A TEMPLATE FOR ONBOARDING MULTIPLE FUTURE SITES. THIS PROJECT WILL PREPARE US TO CONDUCT A MULTISITE, ADEQUATELY POWERED, NON-INFERIORITY RCT OF YBI VS. GCBT IN DEPRESSED ADOLESCENTS.
$707.8k 9/23/24 Not listed
PILOT MULTISITE RANDOMIZED CONTROLLED TRIAL OF YOGA TO REDUCE DEPRESSION INADOLESCENTS - PROJECT SUMMARY EVEN BEFORE THE ONSET OF THE COVID PANDEMIC, ADOLESCENT DEPRESSION HAS BEEN INCREASING, AND HEALTH DISPAR- ITIES AND DISPARITIES IN ACCESS TO TREATMENT HAVE CONTINUED TO WIDEN. THUS, THERE IS A CLEAR NEED FOR INNOVATIVE, ACCESSIBLE TREATMENTS FOR DEPRESSED ADOLESCENTS, INCLUDING TREATMENTS THAT DO NOT RELY ON A LIMITED POOL OF CHILD AND ADOLESCENT HEALTH PROVIDERS. YOGA-BASED INTERVENTIONS (YBIS) HAVE SHOWN PROMISE FOR ADULT DEPRESSION. SEVERAL ATTRACTIVE ASPECTS OF YOGA INCLUDE ITS: 1) AVAILABILITY THROUGHOUT THE U.S.; 2) ACCESSIBILITY VIA ONLINE CLAS- SES; 3) INDEPENDENCE FROM AN OVERBURDENED MENTAL HEALTH CARE SYSTEM; AND 4) GENERALIZABILITY--YOGA STUDENTS STATE THAT THEY USE MINDFULNESS AND BREATHING PRACTICES TO COPE WITH STRESS IN EVERYDAY LIFE. FUNDED BY A NCCIH R34, WE DEVELOPED A YBI FOR DEPRESSED ADOLESCENTS, AND DEMONSTRATED THAT THIS IN-PERSON PROGRAM WAS ACCEPTABLE AND FEASIBLE IN A SMALL SAMPLE (N=11) OF DEPRESSED ADOLESCENTS AS WELL AS IN A PILOT RCT (N=42) OF YBI VS. AN EXISTING EVIDENCE-BASED TREATMENT, GROUP COGNITIVE-BEHAVIORAL THERAPY (GCBT). THE RCT CLASSES WERE INITIALLY IN-PERSON, BUT WE MIGRATED TO SYNCHRONOUS ONLINE CLASSES DUE TO COVID-19. IN THE RCT, PARTICIPANTS WITHIN EACH STUDY ARM SHOWED DECREASED DEPRESSION SYMPTOMS AND INCREASED SELF-COMPASSION OVER TIME. MOST A PRIORI FEASIBILITY AND ACCEPTABILITY TARGETS WERE MET (E.G., RECRUITMENT, RETENTION, EXPECTANCY, SATISFACTION, CREDIBILITY, ATTENDANCE, AND ADHERENCE). HOWEVER, PARTICIPANTS DID NOT ENGAGE IN HOME (OUTSIDE-OF- CLASS) PRACTICE AT THE TARGETED RATE. THUS, IN THE PRESENT PROPOSAL WE HAVE MODIFIED OUR PROTOCOL TO PROVIDE AN OPPORTUNITY FOR TWICE-WEEKLY SUPERVISED YOGA PRACTICE (ONE IN-PERSON CLASS ON THE WEEKEND, AND ONE VIRTUAL CLASS MIDWEEK). OUR PRIOR PILOT TRIAL WAS BASED AT ONLY ONE SITE (PROVIDENCE RI) WITH ONE PRIMARY YBI INSTRUCTOR AND TWO GCBT LEADERS. MULTIPLE SITES AND INSTRUCTORS/LEADERS, AND RECRUITMENT OF A MORE RACIALLY AND ETHNICALLY DIVERSE SAMPLE, WILL BE IMPORTANT TO DEMONSTRATE GENERALIZABILITY AND TO ENHANCE EFFECTIVENESS. WE NOW PRO- POSE TO CONDUCT A TWO-PHASE MULTI-SITE FEASIBILITY TRIAL. PHASE 1 (N=20) WILL FOCUS ON INCREASING ACCESSIBILITY AND FEASIBILITY OF YBI FOR PARTICULAR GROUPS OF ADOLESCENTS. WE WILL CONDUCT INDIVIDUAL INTERVIEWS WITH TEENS WHO WERE LESS REPRESENTED IN OUR PILOT TRIAL (AFRICAN-AMERICAN/BLACK, ASIAN AMERICAN, AND MALE ADOLESCENTS) TO GAIN THEIR FEEDBACK ON YOGA BASED INTERVENTIONS, WITH A FOCUS ON INCREASING ACCESSIBILITY AND FEASIBILITY FOR ADOLESCENTS WITH THESE IDENTITIES. PHASE 2 (N=128) WILL BE A PILOT RCT OF YBI VS. GCBT AT TWO GEOGRAPHICALLY DISTINCT SITES: BOSTON, MA AND COLUMBUS, OH. GIVEN THE RISING PREVALENCE OF ADOLESCENT DEPRESSION AND THE EXISTENCE OF ESTABLISHED, EFFICACIOUS GROUP TREATMENT FOR DEPRESSION (I.E., GROUP CBT), WE DETERMINED THAT A NON-INFERIORITY TRIAL REPRESENTED THE MOST ETHICAL WAY TO PROCEED. WE WILL INCORPORATE LESSONS LEARNED FROM THIS STUDY TO FURTHER REFINE STUDY MATERIALS AND CREATE A TEMPLATE FOR ONBOARDING MULTIPLE FUTURE SITES. THIS PROJECT WILL PREPARE US TO CONDUCT A MULTISITE, ADEQUATELY POWERED, NON-INFERIORITY RCT OF YBI VS. GCBT IN DEPRESSED ADOLESCENTS.
$707.8k 9/23/24