CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 126 enrolled
Drug / intervention
Cognitive Behavioral Stress Management (CBSM) group interventionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00121160
NCT00121160Phase 1Completed

Can Stress Management Improve Vaccine Immune Response

Fred Hutchinson Cancer Center·interventional·Posted Jul 21, 2005·Updated Mar 27, 2012

In Brief

A Phase 1 clinical trial evaluating Cognitive Behavioral Stress Management (CBSM) group intervention for Psychological Stress. Completed, enrolled 126 participants across 1 site.

Detailed Summary

The proposed investigation will conduct a randomized, clinical trial to test the efficacy of a cognitive behavioral stress management (CBSM) group intervention on immune response to vaccine and distress among women at elevated risk for breast cancer. Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to vaccines compared to women in the comparison group. Hypothesis 2: Women who participate in a 10-week CBSM group intervention will report lower levels of distress immediately after and 6 months after the intervention compared to women in the comparison group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2005
Enrollment StartSep 1, 2005
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.9 years ago

Interventions

Cognitive Behavioral Stress Management (CBSM) group interventionbehavioral

Participants will meet in closed, structured groups of 4 to 6 women for ten weekly, 2-hour group sessions. The intervention employs CBSM techniques interwoven with information in a supportive group format. The information portion of the intervention focuses on learning to cope with daily stressors, and learning about optimal use of social support. Group members and group leaders are used as role models for effective coping and the use of social support. The groups also encourage emotional expression and provide an opportunity to practice techniques learned in the group and experience social support. Avoidance coping is discouraged, and acceptance and reframing are instead encouraged as coping responses. Health behavior change, framed as a coping technique, will also be discussed using motivational interviewing techniques. Each week participants also experience a different relaxation technique. The goal of the CBSM intervention is thus to reduce distress through a variety of techniques.