Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02697357
Eligibility Criteria:
Inclusion Criteria:
* As per self-report, age 18 or over
* As per self-report, a current caregiver to a patient with any site or stage of cancer
* score of ≥ 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role. Potential participants will be asked whether or not their distress is in any way related to their caregiving experience. Individuals who answer "no" will be asked whether or not their distress started or has gotten worse since the patient began treatment or was diagnosed.
* Either a score of ≥ 15 on the Brief Penn State Worry Questionnaire OR a score \> 12 on the Brooding Subscale of the Rumination Response Scale
* In the judgment of the investigators and/or consenting professional, able to read and comprehend English
* In the judgment of the consenting professional cognitively able to provide informed consent
Exclusion Criteria:
* As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder
* In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
* If participating in optional biospecimen collection;as per self-report, has medical conditions that affect the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; Type I diabetes; acute hepatitis; recent vaccination for viral disease)
* As per self-report, is a regular smoker (daily use)
* As per self-report, is a heavy drinker (regularly having more than 14 alcoholic beverages per week for men, 7 for women)
* As per self- report, engaging in night shift work
* As per self- report, currently engaged in ongoing psychotherapy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02697357
Study Brief:
Protocol Section:
NCT02697357