Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436085
Status:
COMPLETED
Last Update Posted:
2007-02-16
First Post:
2007-02-15
Brief Title:
Randomized Controlled Trial of Stress Management Training in HIV
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Randomized Controlled Trial of Stress Management Training in Individuals With HIV Infection
Status:
COMPLETED
Status Verified Date:
2007-02
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:
SWISSIT
Brief Summary:
The introduction of highly active antiretroviral therapy HAART has dramatically changed the consequences of an HIV infection which is now viewed as a chronic disease As in other chronic diseases emotional distress and depressive symptoms are highly prevalent in HIV-infected patients Psychological factors such as these have been associated with lower quality of life lower adherence to therapy and also with a higher risk for mortality and disease progression Psychosocial interventions such as group-based cognitive behavioral stress management CBSM training have been shown to reduce distress and psychological symptoms in HIV-infected patients These psychosocial effects are paralleled by changes in physiological parameters such as cortisol DHEA-S testosterones catecholamines and naive T-cell counts While these results are congruent with recent evidence of the interaction between psychological neuroendocrine and immunological parameters in HIV-infected patients it needs to be shown whether the reported effects hold true in the HAART era Most importantly it also needs to be ascertained whether these interventions have an impact on immunological and virological HIV parameters as well as on mortality and morbidity in HIV patients We propose a randomized controlled one-year prospective evaluation of a group-based CBSM training in 80 HIV-infected patients Participating patients will be recruited at cooperating centers of the Swiss HIV Cohort Study and randomly assigned to CBSM training or waiting control group condition At baseline post-training and two follow-up 6 and 12 months assessments effects of the CBSM on psychological physiological and clinical out-come variables in HIV-infected patients under HAART will be evaluated Additionally the effects of CBSM on the neuroendocrine and autonomic stress reactivity in HIV-infected patients will be assessed thus evaluating a possible direct pathway between emotional distress and physiological HIV-relevant parameters In conclusion the planned research project evaluates the effectiveness of a standardized psychosocial intervention as a possible component of a comprehensive disease management in HIV-infected patients under HAART
Detailed Description:
None
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