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Emotion Regulation Therapy to Address Distress Among Caregivers

Emotion Regulation Therapy to Address Distress Among Caregivers

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02697357
Enrollment
32
Registered
2016-03-03
Start date
2015-10-31
Completion date
2020-07-09
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Care Givers

Keywords

Emotion Regulation Therapy, Distress Among Caregivers, 15-219

Brief summary

The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation Therapy (ERT-C) for informal caregivers of patients with cancer. Informal caregivers include partners, family members, children, parents, and friends providing informal care to a patient. Providing care to someone with cancer can be difficult. The purpose of this intervention is to improve coping and physical well-being among caregivers, which in turn will allow them to provide better care for their loved ones. Investigators would also like to learn about biological factors like stress that may affect one's emotional and physical well-being. This study will allow to better understand caregivers needs, and further develop a program to provide services to caregivers within MSKCC community and nationwide.

Interventions

BEHAVIORALPsychosocial Instruments

Sponsors

Hunter College of City University of New York
CollaboratorOTHER
Weill Medical College of Cornell University
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
number of patients completing at least 6 out of the 8-sessions1 yearfeedback from participants by qualitative research methods

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026