Ignite Creation Date:
2024-05-05 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00722644
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2008-07-23
Brief Title:
Cognitive Behavioral Stress Management for HIV Drug Abusers
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Cognitive Behavioral Treatment of HIV Drug Abusers
Status:
COMPLETED
Status Verified Date:
2008-07
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 primary purpose of this 5-year study is to determine whether a Cognitive Behavioral Stress Management CBSM intervention demonstrated to be effective in reducing distress enhancing coping and maintaining health among HIV non-drug abusers see Schneiderman and Antoni 2000 can be effectively adapted for our target population of culturally diverse HIV low-income Recovering Drug Abusers RDAs Since the late 1980s members of our research team ie Schneiderman Antoni Klimas Fletcher have been developing refining and evaluating the effects of CBSM among HIV Men who have Sex with Men MSM In the earlymid 90s we began to adapt and evaluate the effects of CBSM in other non-drug abusing subgroups that were emerging with increasing levels of HIV seroprevalence eg pregnant women African American and Hispanic men and women After accumulating considerable support for the effectiveness of CBSM in these subgroups in the late 90s our research team ie Malow Schneiderman Antoni Klimas Page turned its attention to developing the CBSM for one of the most neglected and understudied populations affected by the HIVAIDS epidemic in this country inner city minority drug abusers With supplemental funding on two NIH grants to conduct formative stage1 pilot research our project team has been able to develop and document the feasibility and potential promise of the CBSM approach adaptedtranslated for RDAs CBSM-RDA This application proposes to take the next logical step in continuing this work conducting a 3 6 8 10 and 12 month follow-up outcome study comparing CBSM-RDA with a matched attention time and interest value Health Promotion Comparison HPC condition in 225 male and 225 female HIV RDAs with respect to key biopsychosocial health endpoints distress ie depressive symptoms and mood state quality of life drug abuse relapse unsafe sex Combination Antiretroviral Therapy CART medication adherence and health status indicators eg Viral Load CD4 count physical symptoms
Detailed Description:
The primary purpose of this proposed 5-year study is to determine whether a Cognitive Behavioral Stress Management CBSM intervention demonstrated to be effective in reducing distress enhancing coping and maintaining health among HIV non-drug abusers see Schneiderman and Antoni 2000 can be effectively adapted for our target population of culturally diverse HIV low-income Recovering Drug Abusers RDAs Since the late 1980s members of our research team ie Schneiderman Antoni Klimas Fletcher have been developing refining and evaluating the effects of CBSM among HIV Men who have Sex with Men MSM In the earlymid 90s we began to adapt and evaluate the effects of CBSM in other non-drug abusing subgroups that were emerging with increasing levels of HIV seroprevalence eg pregnant women African American and Hispanic men and women After accumulating considerable support for the effectiveness of CBSM in these subgroups in the late 90s our research team ie Malow Schneiderman Antoni Klimas Page turned its attention to developing the CBSM for one of the most neglected and understudied populations affected by the HIVAIDS epidemic in this country inner city minority drug abusers With supplemental funding on two NIH grants to conduct formative stage1 pilot research our project team has been able to develop and document the feasibility and potential promise of the CBSM approach adaptedtranslated for RDAs CBSM-RDA This application proposes to take the next logical step in continuing this work conducting a 3 6 8 10 and 12 month follow-up outcome study comparing CBSM-RDA with a matched attention time and interest value Health Promotion Comparison HPC condition in 225 male and 225 female HIV RDAs with respect to key biopsychosocial health endpoints distress ie depressive symptoms and mood state quality of life drug abuse relapse unsafe sex Combination Antiretroviral Therapy CART medication adherence and health status indicators eg Viral Load CD4 count physical symptoms
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