Clinical trial · Interventional
Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
Can Stress Management Improve Vaccine Immune Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psychological Stress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavioral Stress Management (CBSM) group intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Independent sample t-test will be used to compare 1) antibody change scores from before to after the first and second dose of vaccine, and 2) distress change scores from before to after the intervention
- timeFrame
- length of protocol
Secondary outcomes (1)
- measure
- Multiple regression analyzes will be used to test changes in cortisol and changes in perceived risk of breast cancer; coping or social support mediate the effects of the intervention on antibody response to vaccine and distress
- timeFrame
- length of protocol
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Female, age 18-60 years * Family history of breast cancer * Fluent in English * Working phone * Working address * Plan to live in the area for one year Exclusion Criteria: * Prior cancer diagnosis (except non-melanoma skin cancer) * Current major depressive episode * History of Bipolar Disorder or Schizophrenia * History of autoimmune disease * History of Hepatitis A or HA vaccination * Current infectious disease * Use of immune modulating drugs
References
Publications (12)
- BACKGROUNDMcEwen BS. Protective and damaging effects of stress mediators. N Engl J Med. 1998 Jan 15;338(3):171-9. doi: 10.1056/NEJM199801153380307. No abstract available. PMID 9428819
- BACKGROUNDReichlin S. Alternative pathways of neural control of the immune process. Ann N Y Acad Sci. 1998 May 1;840:301-16. doi: 10.1111/j.1749-6632.1998.tb09570.x. PMID 9629258
- BACKGROUNDCohen S, Miller GE, Rabin BS. Psychological stress and antibody response to immunization: a critical review of the human literature. Psychosom Med. 2001 Jan-Feb;63(1):7-18. doi: 10.1097/00006842-200101000-00002. PMID 11211068
- BACKGROUNDMiller GE, Cohen S. Psychological interventions and the immune system: a meta-analytic review and critique. Health Psychol. 2001 Jan;20(1):47-63. doi: 10.1037//0278-6133.20.1.47. PMID 11199066
- BACKGROUNDCohen M, Klein E, Kuten A, Fried G, Zinder O, Pollack S. Increased emotional distress in daughters of breast cancer patients is associated with decreased natural cytotoxic activity, elevated levels of stress hormones and decreased secretion of Th1 cytokines. Int J Cancer. 2002 Jul 20;100(3):347-54. doi: 10.1002/ijc.10488. PMID 12115552
- BACKGROUNDLerman C, Kash K, Stefanek M. Younger women at increased risk for breast cancer: perceived risk, psychological well-being, and surveillance behavior. J Natl Cancer Inst Monogr. 1994;(16):171-6. PMID 7999461
- BACKGROUNDKash KM, Holland JC, Halper MS, Miller DG. Psychological distress and surveillance behaviors of women with a family history of breast cancer. J Natl Cancer Inst. 1992 Jan 1;84(1):24-30. doi: 10.1093/jnci/84.1.24. PMID 1738170
- BACKGROUNDLloyd S, Watson M, Waites B, Meyer L, Eeles R, Ebbs S, Tylee A. Familial breast cancer: a controlled study of risk perception, psychological morbidity and health beliefs in women attending for genetic counselling. Br J Cancer. 1996 Aug;74(3):482-7. doi: 10.1038/bjc.1996.387.