16 Participants Needed

Cognitive Behavioral Stress Management for HIV/AIDS and Cancer

(C-SmartManage Trial)

SS
Overseen BySara St. George, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a one year study to develop and test a culturally-tailored, web-based cognitive behavioral stress management (CBSM) intervention for Latino sexual minority men living with both HIV and cancer. Sexual minority Latino men living with HIV and cancer experience a variety of health disparities related to their diagnoses, including higher distress. The project will use a single-group pre-post design. The project will use a community-based participatory research approach, and the investigators have included (and will continue to include) LGBT-serving community partners in all phases of the research from study design to implementation and dissemination of findings. The proposed study will aid in attenuating health disparities among Latino sexual minority men living with HIV and cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is Cognitive Behavioral Stress Management (CBSM) safe for humans?

Research on Cognitive Behavioral Stress Management (CBSM) for conditions like breast cancer and HIV/AIDS shows it is generally safe and can help reduce stress and improve quality of life. Studies have not reported significant safety concerns, indicating it is a safe option for managing stress in these populations.12345

What makes Cognitive Behavioral Stress Management (CBSM) unique for HIV/AIDS and cancer treatment?

Cognitive Behavioral Stress Management (CBSM) is unique because it combines stress management, cognitive-behavioral skills, relaxation techniques, and expressive-supportive therapy to help patients manage stress and improve mental health, which can lead to decreased depression and improved coping skills, as shown in studies with breast cancer and AIDS patients.23567

What data supports the effectiveness of the treatment Cognitive Behavioral Stress Management for HIV/AIDS and Cancer?

Research shows that Cognitive Behavioral Stress Management (CBSM) can help reduce depression in women with AIDS and improve coping skills and mood regulation in breast cancer patients. It has also been effective in reducing anxiety and depression in lung cancer patients, suggesting it may be beneficial for managing stress and improving mental health in people with HIV/AIDS and cancer.23568

Who Is on the Research Team?

SS

Sara M St. George, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for Latino sexual minority men over the age of 18, living with HIV and non-metastatic solid tumor cancer, who are past their primary cancer treatment. Participants must have internet access and be fluent in English. Those with a life expectancy under 12 months, active severe mental illness or substance dependence, or certain types of cancers (like leukemia or brain cancer) cannot join.

Inclusion Criteria

I have been diagnosed with HIV.
It's been over 30 days since my last main cancer treatment.
I identify as a sexual minority man.
See 3 more

Exclusion Criteria

I have had leukemia, non-melanoma skin cancer, brain cancer, eye cancer, or a pediatric cancer as my only cancer diagnosis.
I have or am being treated for advanced cancer.
My doctor expects I have less than 12 months to live due to my health conditions.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a culturally-tailored, web-based cognitive behavioral stress management (CBSM) intervention

4 weeks
Web-based sessions

Follow-up

Participants are monitored for stress, distress, and quality of life after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Behavioral Stress Management
  • Culturally-tailored Cognitive Behavioral Stress Management
Trial Overview The study tests a web-based cognitive behavioral stress management program tailored for Latino sexual minority men with HIV and cancer. It compares this specialized version to a standard one over one year to see if it better reduces health disparities related to distress from their diagnoses.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Culturally-tailored CBSMExperimental Treatment1 Intervention
Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+

Published Research Related to This Trial

An online cognitive behavioral stress management intervention for early-stage breast cancer survivors significantly improved self-efficacy in coping with cancer and regulating negative mood after 10 weeks compared to a waitlist control group.
Participants in the intervention group also reported lower levels of cancer-related post-traumatic symptoms, indicating that this online approach can effectively support psychological well-being in breast cancer patients.
An online stress management workbook for breast cancer.Carpenter, KM., Stoner, SA., Schmitz, K., et al.[2022]
Cognitive-behavioral stress management (CBSM) has been shown to significantly improve relaxation, positive affect, and benefit finding in breast cancer patients, based on a meta-analysis of 18 randomized controlled trials involving 2564 participants.
CBSM effectively reduces anxiety, depression, and negative mood, while also lowering serum cortisol levels, indicating its potential to help patients cope with the stress of cancer treatment.
The Effects of Cognitive-Behavioral Stress Management for Breast Cancer Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials.Tang, M., Liu, X., Wu, Q., et al.[2021]
Cognitive-behavioral stress management (CBSM) significantly reduced anxiety and depression levels in 172 non-small cell lung cancer patients over a 10-week intervention, with improvements observed at both 3 and 6 months post-treatment.
Patients receiving CBSM reported enhanced quality of life, with increased global health status and function scores, particularly benefiting those with baseline depression or undergoing additional therapy.
Anxiety, depression, and quality of life in postoperative non-small cell lung cancer patients under the intervention of cognitive-behavioral stress management.Wang, F., Zhang, S., Song, B., et al.[2023]

Citations

An online stress management workbook for breast cancer. [2022]
The Effects of Cognitive-Behavioral Stress Management for Breast Cancer Patients: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2021]
Anxiety, depression, and quality of life in postoperative non-small cell lung cancer patients under the intervention of cognitive-behavioral stress management. [2023]
Decreased depression up to one year following CBSM+ intervention in depressed women with AIDS: the smart/EST women's project. [2018]
Differential psychological effects of cognitive-behavioral stress management among breast cancer patients with high and low initial cancer-specific distress. [2023]
[Interest of computer-based cognitive behavioral stress management. Feasability of the Seren@ctif program]. [2018]
Context and common ground: cultural adaptation of an intervention for minority HIV infected individuals. [2018]
Effects of cognitive behavioral stress management on HIV-1 RNA, CD4 cell counts and psychosocial parameters of HIV-infected persons. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security