Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598579
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-15
Brief Title:
Evaluation of MBCT Implemented in Vietnamese Buddhist Pagoda
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effectiveness of Mindfulness-Based Cognitive Therapy for Depression Implemented in Vietnamese Buddhist Pagoda
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MBCT-VN
Brief Summary:
Background
Depression presents a substantial public health burden around the world Evidence-based psychotherapy treatments psychotherapy EBT for depression exist but access is often limited particularly in low- and middle-income countries LMIC by mental health stigma and scarcity of professional mental health providers One approach to address these issues is mental health task-shifting transferring mental health services from highly trained mental health professionals operating in formal mental health settings to non-mental health professionals or lay people receiving focused training in a particular mental health program operating in non-mental health settings eg schools religious settings Purposes of the present study are to a adapt Mindfulness-Based Cognitive Therapy MBCT for depression - a psychotherapy depression EBT - for implementation in Vietnamese Buddhist pagoda in VN MBCT-VN and b conduct a cluster-randomized clinical trial of MBCT-VN implemented in Vietnamese Buddhist pagoda Vietnamese Buddhist pagoda are selected as the task-shifting site because they represent a potentially low stigma culturally-congruent site for task-shifting implementation of mindfulness-based mental health treatments
Methods
MBCT was adapted for the present project through a collaborative team process producing the MBCT-VN program The clinical trial evaluation will involve a cluster-randomized comparison between a the treatment condition MBCT-VN and b a treatment-as-usual control condition Buddhist meditation as implemented in pagoda To reduce cross-group contamination pagoda will be the unit of assignment Outcome assessments will include four timepoints across four months One hundred and sixty adult participants will be recruited from eight four treatment four control Buddhist pagoda in the Hanoi Vietnam area The primary outcome will be level of depression PHQ-9 the secondary outcome will be quality of life Q-LES-Q The study will assess and evaluate several Implementation Science factors eg Treatment Acceptability as well as other potential moderators of treatment effects and potential mediators such as increase in depression mental health literacy and decrease in depression stigma Inferential analyses will use a general linear mixed model framework as well as a latent growth curve framework with propensity covariates
Depression presents a substantial public health burden around the world Evidence-based psychotherapy treatments psychotherapy EBT for depression exist but access is often limited particularly in low- and middle-income countries LMIC by mental health stigma and scarcity of professional mental health providers One approach to address these issues is mental health task-shifting transferring mental health services from highly trained mental health professionals operating in formal mental health settings to non-mental health professionals or lay people receiving focused training in a particular mental health program operating in non-mental health settings eg schools religious settings Purposes of the present study are to a adapt Mindfulness-Based Cognitive Therapy MBCT for depression - a psychotherapy depression EBT - for implementation in Vietnamese Buddhist pagoda in VN MBCT-VN and b conduct a cluster-randomized clinical trial of MBCT-VN implemented in Vietnamese Buddhist pagoda Vietnamese Buddhist pagoda are selected as the task-shifting site because they represent a potentially low stigma culturally-congruent site for task-shifting implementation of mindfulness-based mental health treatments
Methods
MBCT was adapted for the present project through a collaborative team process producing the MBCT-VN program The clinical trial evaluation will involve a cluster-randomized comparison between a the treatment condition MBCT-VN and b a treatment-as-usual control condition Buddhist meditation as implemented in pagoda To reduce cross-group contamination pagoda will be the unit of assignment Outcome assessments will include four timepoints across four months One hundred and sixty adult participants will be recruited from eight four treatment four control Buddhist pagoda in the Hanoi Vietnam area The primary outcome will be level of depression PHQ-9 the secondary outcome will be quality of life Q-LES-Q The study will assess and evaluate several Implementation Science factors eg Treatment Acceptability as well as other potential moderators of treatment effects and potential mediators such as increase in depression mental health literacy and decrease in depression stigma Inferential analyses will use a general linear mixed model framework as well as a latent growth curve framework with propensity covariates
Detailed Description:
Detailed Description
The study has three research aims and hypotheses
1 To investigate the effects of MBCT-VN on the primary outcome level of depression symptoms It is hypothesized that the Treatment Group MBCT-VN will show significantly more reduction than the Control Group in PHQ-9 depression scores
2 To investigate the effects of MBCT-VN on the secondary outcome level of quality of life It is hypothesized that the Treatment Group MBCT-VN will show significantly more increase than the Control Group in Q-LES-Q quality of life scores
3 To investigate change from pre-treatment to post-treatment depression symptoms It is hypothesized that the Treatment Group MBCT-VN will show pre-treatment to post-treatment change on the PHQ-9 that does not differ significantly from other within-group change in MBCT depression treatment evaluations using statistical benchmarking methodology
The study has three research aims and hypotheses
1 To investigate the effects of MBCT-VN on the primary outcome level of depression symptoms It is hypothesized that the Treatment Group MBCT-VN will show significantly more reduction than the Control Group in PHQ-9 depression scores
2 To investigate the effects of MBCT-VN on the secondary outcome level of quality of life It is hypothesized that the Treatment Group MBCT-VN will show significantly more increase than the Control Group in Q-LES-Q quality of life scores
3 To investigate change from pre-treatment to post-treatment depression symptoms It is hypothesized that the Treatment Group MBCT-VN will show pre-treatment to post-treatment change on the PHQ-9 that does not differ significantly from other within-group change in MBCT depression treatment evaluations using statistical benchmarking methodology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None