Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04408469
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2020-05-26
Brief Title:
A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Randomized Controlled Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults
Status:
COMPLETED
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:
This study is to test the efficacy of an online CBT intervention EQuIP that addresses the pathways through which minority stress compromises LGBTQ young adults co-occurring mental eg depression and behavioral eg substance use condomless anal sex health problems This purpose of this study is to determine if the treatment is efficacious when delivered online and if its efficacy exceeds that of the self-monitoring control
Detailed Description:
To evaluate the preliminary efficacy of an LGBTQ-affirmative online CBT treatment and whether such an LGBTQ-affirmative focus adds benefit a 2-arm RCT that would examine 1 whether online EQuIP demonstrates significant mental health improvements compared to self-monitoring of stress and mood and 2 whether participant baseline LGBTQ-specific stress exposure moderates treatment efficacy such that participants with the most LGBTQ-specific stress exposure benefit more from online EQuIP than self-monitoring of stress and mood
The primary outcomes are depressive symptoms anxiety symptoms substance abuse sexual risk behavior and suicidality all of which disproportionally affect LGBTQ young adults Secondary outcomes include hypothesized cognitive affective and behavioral minority stress mechanisms such as internalized homophobia rejection sensitivity concealment social isolation and emotional dysregulation
Participants will be randomized to either self-monitoring control or Online EQuIP group
Self-monitoring control In this control condition participants will be asked to indicate their past 7-day mood stress experiences and mental and behavioral health on an online survey This type of self-monitoring has been shown to yield improvement in behavioral health outcomes Self-reporting LGBTQ stress experiences has also been shown to produce reductions in depression symptoms over time Participants will record these experiences once per week for 10 weeks
Online EQuIP This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks Modules contain weekly psychoeducational text and vignettes about minority stress and mental health brief videos illustrating the CBT skills and homework exercises that therapists review and provide feedback on Homework exercises include weekly tracking of stressful situations and mood practicing new skills eg mindfulness cognitive restructuring and exercises related to considering the origins of stress and negative emotions that participants may be experiencing Therapists provide feedback after each homework assignment including reviewing each participants treatment goals as part of the first sessions homework Therapists who support this condition will be instructed to incorporate LGBTQ-specific content and feedback into homework reviews Therapists will either be postdoctoral fellows in the Pachankis lab or clinicalcounseling psychology internsexterns in the Pachankis lab who possess an advanced degree in a mental health field with significant prior experience treating LGBTQ young adults with mental health concerns Modules were adapted directly from the in-person materials eg therapist manual participant handouts used in our previously successful trials of this treatment A team of six therapists and supervisors of the original in-person treatment adapted the text for the online modules including realistic vignettes and easy-to-follow skills training A video production company created accompanying videos with our clinical teams close input
In preparation for this RCT the online EQuIP treatment was delivered to 14 LGBTQ young adults who meet all eligibility criteria for the full trial The purpose of this initial test was to ensure acceptability of the treatment content and usability of the technical platform
The primary outcomes are depressive symptoms anxiety symptoms substance abuse sexual risk behavior and suicidality all of which disproportionally affect LGBTQ young adults Secondary outcomes include hypothesized cognitive affective and behavioral minority stress mechanisms such as internalized homophobia rejection sensitivity concealment social isolation and emotional dysregulation
Participants will be randomized to either self-monitoring control or Online EQuIP group
Self-monitoring control In this control condition participants will be asked to indicate their past 7-day mood stress experiences and mental and behavioral health on an online survey This type of self-monitoring has been shown to yield improvement in behavioral health outcomes Self-reporting LGBTQ stress experiences has also been shown to produce reductions in depression symptoms over time Participants will record these experiences once per week for 10 weeks
Online EQuIP This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks Modules contain weekly psychoeducational text and vignettes about minority stress and mental health brief videos illustrating the CBT skills and homework exercises that therapists review and provide feedback on Homework exercises include weekly tracking of stressful situations and mood practicing new skills eg mindfulness cognitive restructuring and exercises related to considering the origins of stress and negative emotions that participants may be experiencing Therapists provide feedback after each homework assignment including reviewing each participants treatment goals as part of the first sessions homework Therapists who support this condition will be instructed to incorporate LGBTQ-specific content and feedback into homework reviews Therapists will either be postdoctoral fellows in the Pachankis lab or clinicalcounseling psychology internsexterns in the Pachankis lab who possess an advanced degree in a mental health field with significant prior experience treating LGBTQ young adults with mental health concerns Modules were adapted directly from the in-person materials eg therapist manual participant handouts used in our previously successful trials of this treatment A team of six therapists and supervisors of the original in-person treatment adapted the text for the online modules including realistic vignettes and easy-to-follow skills training A video production company created accompanying videos with our clinical teams close input
In preparation for this RCT the online EQuIP treatment was delivered to 14 LGBTQ young adults who meet all eligibility criteria for the full trial The purpose of this initial test was to ensure acceptability of the treatment content and usability of the technical platform
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