Randomized Controlled Trial of Stress Management Training in HIV (SWISSIT)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Cognitive behavioral stress management training
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- Adults between 18 and 65 years of age
- Sufficient German-speaking abilities to participate in group therapy
- cARTwithin the previous three months,
- CD4 lymphocyte count above 100 cells/mL
Exclusion Criteria:
- Active opportunistic infection at baseline
- Formal psychotherapy within the previous three months
- Intravenous drug users
- Diagnosable current major psychiatric disorder (bipolar affective disorder, psychotic disorders, major depression with melancholia) and diagnosis of antisocial and borderline personality disorders at baseline
Sites / Locations
- University Hospital Zurich
Outcomes
Primary Outcome Measures
CD4 cell count
HIV viral load
Secondary Outcome Measures
Depression and Anxiety
QUality of life
Full Information
NCT ID
NCT00436085
First Posted
February 15, 2007
Last Updated
February 15, 2007
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00436085
Brief Title
Randomized Controlled Trial of Stress Management Training in HIV
Acronym
SWISSIT
Official Title
Randomized Controlled Trial of Stress Management Training in Individuals With HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
4. Oversight
5. Study Description
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 naïve 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral stress management training
Primary Outcome Measure Information:
Title
CD4 cell count
Title
HIV viral load
Secondary Outcome Measure Information:
Title
Depression and Anxiety
Title
QUality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults between 18 and 65 years of age
Sufficient German-speaking abilities to participate in group therapy
cARTwithin the previous three months,
CD4 lymphocyte count above 100 cells/mL
Exclusion Criteria:
Active opportunistic infection at baseline
Formal psychotherapy within the previous three months
Intravenous drug users
Diagnosable current major psychiatric disorder (bipolar affective disorder, psychotic disorders, major depression with melancholia) and diagnosis of antisocial and borderline personality disorders at baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Gaab, PhD
Organizational Affiliation
Clinical Psychology and PSychotherapy, Institute of Psychology, University of Zürich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rainer Weber, MD
Organizational Affiliation
University Hospital, Zürich
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrike Ehlert, PhD
Organizational Affiliation
Clinical Psychology and Psychotherapy, Institute of Psychology, University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zuerich
ZIP/Postal Code
8006
Country
Switzerland
12. IPD Sharing Statement
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Randomized Controlled Trial of Stress Management Training in HIV
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