Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial

NCT02322905 | Completed

• 1 other identifier: ERT15-17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

informal caregivers; caregiving; psychotherapy for caregivers; cancer; emotion regulation; distress; inflammation

Outcome Measures

Primary Outcomes (4)

• Change in The Caregiver Reaction Assessment and EORTC-QLQ-30

  Questionnaire measuring burden in ICs and quality of life cancer patients, respectively

  Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

• Change in Hospital Anxiety and Depression Scale (HADS)

  Questionnaire measuring anxiety and depression

  Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

• Change in Penn State Worry Questionnaire

  Questionnaire measuring worry

  Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

• Change in Rumination Response Scale - Brooding subscale only

  Questionnaire measuring brooding

  Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

Secondary Outcomes (9)

• Change in Difficulty in Emotion Regulation Scale

  Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

• Change in Emotion Regulation Questionnaire

  Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

• Change in Five Facet Mindfulness Questionnaire

  Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

• Change in Experiences Questionnaire

  Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

• Change in The Pittsburgh Sleep Quality Index

  Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).

Study Arms (2)

Emotion Regulation Therapy

EXPERIMENTAL

8 sessions of Emotion Regulation Therapy.

Behavioral: Emotion Regulation Therapy

Usual Medical Care

NO INTERVENTION

No planned psychotherapy.

Interventions

Emotion Regulation Therapy BEHAVIORAL

8 sessions of ERT

Emotion Regulation Therapy

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medium levels of distress (distress thermometer \> 3) and at least moderate levels of worry or rumination
• Caregiver of patient with cancer

You may not qualify if:

• an expected survival of the patient of \<6 months,
• active substance abuse (alcohol or drugs), and
• participation in other psychosocial trials.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Unit for Psychooncology and Health Psychology

Aarhus C, DK8000, Denmark

Location

Related Publications (1)

• Mikkelsen MB, Elkjaer E, Mennin DS, Fresco DM, Zachariae R, Applebaum A, O'Toole MS. The impact of emotion regulation therapy on emotion differentiation in psychologically distressed caregivers of cancer patients. Anxiety Stress Coping. 2021 Jul;34(4):479-485. doi: 10.1080/10615806.2021.1929934. Epub 2021 May 28.

  PMID: 34047220 DERIVED

MeSH Terms

Conditions

Neoplasms; Emotional Regulation; Inflammation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mia S O'Toole, MSc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 23, 2014
• Study Start: August 1, 2015
• Primary Completion: June 25, 2018
• Study Completion: December 31, 2018
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

DK (1)