Randomized Controlled Trial of Stress Management Training in HIV (SWISSIT)

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00436085
First received: February 15, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: Cognitive behavioral stress management training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Stress Management Training in Individuals With HIV Infection

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • CD4 cell count
  • HIV viral load

Secondary Outcome Measures:
  • Depression and Anxiety
  • QUality of life

Estimated Enrollment: 100
Study Start Date: December 2003
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00436085

Locations
Switzerland
University Hospital Zurich
Zuerich, Switzerland, 8006
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Investigators
Principal Investigator: Jens Gaab, PhD Clinical Psychology and PSychotherapy, Institute of Psychology, University of Zürich
Principal Investigator: Rainer Weber, MD University Hospital, Zürich
Principal Investigator: Ulrike Ehlert, PhD Clinical Psychology and Psychotherapy, Institute of Psychology, University of Zurich
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00436085     History of Changes
Other Study ID Numbers: 3346C0-100907
Study First Received: February 15, 2007
Last Updated: February 15, 2007
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014