Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057538
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2003-04-04
Brief Title:
Curb Alter Lower or Manage Stress in HIV CALMS-HIV
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Curb Alter Lower or Manage Stress in HIV CALMS-HIV
Status:
COMPLETED
Status Verified Date:
2006-08
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 purpose of this study is to determine the effectiveness of a stress management group intervention for people with HIV The study will evaluate several outcomes including perceived stress quality of life psychosocial factors and physiological measures of stress
Detailed Description:
It is well documented that living with HIVAIDS can cause a great amount of stress and evidence suggests that stress may hasten HIV disease progression by increasing viral replication and suppressing the immune response Stress management intervention studies using more complex combinations of cognitive and relaxation therapies have shown improvements in both psychological and physiological measures in HIV infected persons However no studies have focused on only one intervention or have addressed the spiritual component using a comparable control group to determine which of these interventions is most effective
Participants will be randomly assigned to receive either a spiritually-based cognitive intervention to an educational control group The intervention will be given over a 10-week period with 5 weekly classes 4 weekly automated phone calls and one final class meeting Assessments will be conducted at pre-intervention fifth class midpoint tenth week post-intervention and 3-month follow-up Time commitment can vary from 6 months to 9 months depending on when participants are screened
Participants will be randomly assigned to receive either a spiritually-based cognitive intervention to an educational control group The intervention will be given over a 10-week period with 5 weekly classes 4 weekly automated phone calls and one final class meeting Assessments will be conducted at pre-intervention fifth class midpoint tenth week post-intervention and 3-month follow-up Time commitment can vary from 6 months to 9 months depending on when participants are screened
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