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CompletedNCT00436085SWISSITUpdated Feb 16, 2007

Randomized Controlled Trial of Stress Management Training in HIV

A Phase 3 interventional study of Cognitive behavioral stress management training in HIV Infections, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-02-16.

Sponsored by University of Zurich · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,342 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 100 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.

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Lead sponsor

University of Zurich is the lead sponsor of 1,048 studies on the registry; 132 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants

Interventions

  • BehavioralCognitive behavioral stress management training
06

What researchers measure

Primary outcomes

  1. CD4 cell count

  2. HIV viral load

Secondary outcomes

  1. Depression and Anxiety

  2. QUality of life

07

Study locations

1 site
  • University Hospital Zurich
    Zurich, 8006, Switzerland
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2003 and a completion of Dec 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 15, 2007
First posted
Feb 16, 2007
Start
Dec 2003
Completion
Dec 2005
Last update
Feb 16, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Feb 16, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00436085
Collaborators
Swiss National Science Foundation
First posted
Feb 16, 2007
Start date
Dec 2003
Completion
Dec 2005
Last update
Feb 16, 2007

Study contacts

Jens Gaab, PhD
principal investigator · Clinical Psychology and PSychotherapy, Institute of Psychology, University of Zürich
Rainer Weber, MD
principal investigator · University Hospital, Zürich
Ulrike Ehlert, PhD
principal investigator · Clinical Psychology and Psychotherapy, Institute of Psychology, University of Zurich
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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