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Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial

NCT02322905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-03-24

No results posted yet for this study

Summary

Informal caregivers of cancer patients report high levels of psychological distress as evidenced in markedly increased levels of anxiety and depression. High levels of psychological distress in caregivers have also been found to be associated with poorer health and increased levels of pro-inflammatory cytokines that are well-established risk factors for physical illness and stress-related mortality. Previous psychological interventions using cognitive methods have only produced small effect sizes and more research on how to effectively alleviate caregiver burden is needed. The proposed project will investigate the effect of Emotion Regulation Therapy (ERT) for caregivers of cancer patients. ERT is a novel approach specifically targeting emotion regulation with the aim of improving mental and physical health. The effect of ERT will be examined in a randomized controlled trial comparing ERT to usual medical care (UMC).

Conditions

  • Anxiety Depression

Interventions

BEHAVIORAL

Emotion Regulation Therapy

8 sessions of ERT

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Mia S O'Toole, MSc · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-06-25
Completion
2018-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02322905 on ClinicalTrials.gov