Ignite Creation Date:
2024-05-06 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03412227
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2017-10-15
Brief Title:
Transdiagnostic Individual Behavioral Activation and Exposure Therapy
Sponsor:
Rutgers University
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Randomized Clinical Trial of Transdiagnostic Behavioral Activation and Exposure Therapy for Youth A Comparison of Effects and Mediators
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Overall Aim of the this project is to compare treatment outcomes and change in putative treatment mediators in Individual Behavioral Activation Therapy IBAT against two active psychological interventions Coping Cat PASCET and a wait-list control Participants will be 200 youth ages 9-17 diagnosed with a principal anxiety or depression disorder and their caregivers
Detailed Description:
Anxiety and unipolar depression are highly debilitating and commonly co-occurring in young adolescents with lifetime prevalence rates estimated at 84 for major depression or dysthymia and at 314 for any anxiety disorder in youth ages 13-14 Merikangas et al 2010 Cognitive and behavioral therapies CBT have received strong support for reducing distress in youth Silverman Pina Viswesvaran 2008 David-Ferdon Kaslow 2008 but efficacy rates peak around 50-70 for anxiety and less for depression Evidence is accumulating that transdiagnostic behavioral therapies that address multiple problems at the same time can enhance treatment outcomes by targeting the mechanisms that underlie commonly co-occurring problems like anxiety and depression Chu Temkin Toffey 2016 Temkin Yadegar Laurine Chu in press Furthermore consolidated transdiagnostic treatment protocols can provide the same level of clinical benefit while delivering active components in a more efficient package which can increase treatment efficiency and potentially make it easier to train novice clinicians in the future Chu 2012 Ehrenreich Chu 2013 While the evidence-base is growing for adult conditions transdiagnostic interventions have been examined less in child and adolescent populations Our team has demonstrated the efficacy of a school-based group transdiagnostic intervention that made use of behavioral activation BA and exposure therapy to address anxiety and depression for middle-school youth Chu Crocco Esseling Areizaga Lindner Skriner 2016 BA refers to a set of interventions that teach youth how to assess which stressors trigger avoidant coping responses in their lives ie functional assessment and learn how to address problems with pro-active problem solving strategies Exposure therapy refers to a set of behavioral interventions that foster new learning tendencies by encouraging and reinforcing contact with the situations that scare individuals Both sets of strategies have received substantial support in treating youth anxiety and depression The Chu et al 2016 trial demonstrated that these two treatment components could be combined and effectively treat a sample of youth reporting either anxiety or depression
The Chu et al 2016 study was novel because most forms of evidence-based treatment have been designed as single disorder protocols such that the interventions were designed to target one clinical problem at a time The current trial takes the following innovative steps The study will a adapt the Chu et al group-based protocol to an individual format b deliver the program in a clinical outpatient setting and c utilize three comparison conditions including a wait-list control and two active psychological interventions The two active interventions will be single disorder cognitive behavioral therapies CBT that were designed to specifically address either youth depression Primary and Secondary Control Enhancement Therapy PASCET Weisz Thurber Sweeney Proffitt LeGagnoux 1997 or youth anxiety Coping Cat Kendall 1994 Kendall et al 1997 Both have received substantial support in the literature for supporting clinical improvements in brief individual formats 12 - 16 weeks By comparing Individual Behavioral Activation Therapy IBAT to each of these active interventions the study aims to demonstrate a superior treatment outcomes to wait-list control b comparable treatment outcomes to PASCET and Coping Cat and c differential mediator effects across the four conditions Findings will provide support for the feasibility acceptability and efficacy of IBAT and provide conceptual support for its purported mediators of change
The current study is a Randomized Controlled Trial RCT comparing a novel behavioral intervention Individual Behavioral Activation Therapy IBAT against two established cognitive-behavioral interventions Coping Cat PASCET and a 14-week waitlist WL control Participants will be 160 youth ages 9-16 years old who receive a diagnosis of a Diagnostic and Statistical Manual - 5th edition DSM-5 APA 2013 anxiety or depression disorder and their caregivers Participants will be randomly assigned evenly to each of four conditions The study intends to recruit participants within a 25-year period and complete all active participant participation within 3 years
Specific aims include the following
Aim 1 - Treatment Efficacy To evaluate differences in treatment outcomes across IBAT PASCET CC and WL conditions across pre- mid- and post-treatment in treatment efficacy focusing on key diagnostic and symptom outcomes ie CGI principal diagnosis presence to absence and clinical severity RCADS anxiety and depression scores MASC CESD
Hypothesis 1 IBAT will produce superior outcomes to 14-week WL control
Hypothesis 2 The three active treatment conditions IBAT PASCET CC will demonstrate superior treatment outcomes to 14-week WL control but will not be different from each other
Aim 2 - Mediator Analysis To examine the strength of putative mediators in explaining the effects of active treatments IBAT CC PASCET in comparison to the 14-week WL and in comparison to each other Putative mediators will include multiple domains a youth socio-emotional functioning cognitive behavioral and affective responses b distress tolerance as assessed by computer tasks c family environment and interactions d caregiver distress and functioning e client and therapist perception of psychotherapy process f ecological momentary assessment and passive sensor data
Hypothesis 3 Each domain will prove to provide significant mediators for each treatment in comparison to the WL control
Hypothesis 4 Cognitive mediators will prove to provide significant mediation of CC and PASCET treatment effects but not necessarily for IBAT
Hypothesis 5 Distress tolerance will prove to provide significant mediator for IBAT treatment effects but not necessarily for CC or PASCET
Aim 3 Note patterns of additional youth mental health services and auxiliary services that families seek beyond treatment received at the Youth Anxiety and Depression Clinic
The Chu et al 2016 study was novel because most forms of evidence-based treatment have been designed as single disorder protocols such that the interventions were designed to target one clinical problem at a time The current trial takes the following innovative steps The study will a adapt the Chu et al group-based protocol to an individual format b deliver the program in a clinical outpatient setting and c utilize three comparison conditions including a wait-list control and two active psychological interventions The two active interventions will be single disorder cognitive behavioral therapies CBT that were designed to specifically address either youth depression Primary and Secondary Control Enhancement Therapy PASCET Weisz Thurber Sweeney Proffitt LeGagnoux 1997 or youth anxiety Coping Cat Kendall 1994 Kendall et al 1997 Both have received substantial support in the literature for supporting clinical improvements in brief individual formats 12 - 16 weeks By comparing Individual Behavioral Activation Therapy IBAT to each of these active interventions the study aims to demonstrate a superior treatment outcomes to wait-list control b comparable treatment outcomes to PASCET and Coping Cat and c differential mediator effects across the four conditions Findings will provide support for the feasibility acceptability and efficacy of IBAT and provide conceptual support for its purported mediators of change
The current study is a Randomized Controlled Trial RCT comparing a novel behavioral intervention Individual Behavioral Activation Therapy IBAT against two established cognitive-behavioral interventions Coping Cat PASCET and a 14-week waitlist WL control Participants will be 160 youth ages 9-16 years old who receive a diagnosis of a Diagnostic and Statistical Manual - 5th edition DSM-5 APA 2013 anxiety or depression disorder and their caregivers Participants will be randomly assigned evenly to each of four conditions The study intends to recruit participants within a 25-year period and complete all active participant participation within 3 years
Specific aims include the following
Aim 1 - Treatment Efficacy To evaluate differences in treatment outcomes across IBAT PASCET CC and WL conditions across pre- mid- and post-treatment in treatment efficacy focusing on key diagnostic and symptom outcomes ie CGI principal diagnosis presence to absence and clinical severity RCADS anxiety and depression scores MASC CESD
Hypothesis 1 IBAT will produce superior outcomes to 14-week WL control
Hypothesis 2 The three active treatment conditions IBAT PASCET CC will demonstrate superior treatment outcomes to 14-week WL control but will not be different from each other
Aim 2 - Mediator Analysis To examine the strength of putative mediators in explaining the effects of active treatments IBAT CC PASCET in comparison to the 14-week WL and in comparison to each other Putative mediators will include multiple domains a youth socio-emotional functioning cognitive behavioral and affective responses b distress tolerance as assessed by computer tasks c family environment and interactions d caregiver distress and functioning e client and therapist perception of psychotherapy process f ecological momentary assessment and passive sensor data
Hypothesis 3 Each domain will prove to provide significant mediators for each treatment in comparison to the WL control
Hypothesis 4 Cognitive mediators will prove to provide significant mediation of CC and PASCET treatment effects but not necessarily for IBAT
Hypothesis 5 Distress tolerance will prove to provide significant mediator for IBAT treatment effects but not necessarily for CC or PASCET
Aim 3 Note patterns of additional youth mental health services and auxiliary services that families seek beyond treatment received at the Youth Anxiety and Depression Clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None