Clinical trial · Interventional
Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial
Cancer Caregiver Burden: Targeting Emotion Regulation in a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Depression | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Emotion Regulation Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Emotion Regulation Therapy
- description
- 8 sessions of Emotion Regulation Therapy.
- interventionNames
- Behavioral: Emotion Regulation Therapy
- type
- NO_INTERVENTION
- label
- Usual Medical Care
- description
- No planned psychotherapy.
Primary outcomes (4)
- measure
- Change in The Caregiver Reaction Assessment and EORTC-QLQ-30
- timeFrame
- Between-group effect at post, based on the whole treatment duration (pre-, mid- and post-therapy).
- description
- Questionnaire measuring burden in ICs and quality of life cancer patients, respectively
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Medium levels of distress (distress thermometer \> 3) and at least moderate levels of worry or rumination * Caregiver of patient with cancer Exclusion Criteria: * an expected survival of the patient of \<6 months, * active substance abuse (alcohol or drugs), and * participation in other psychosocial trials.
References
Publications (1)
- DERIVEDMikkelsen 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