CBT vs ERT for Cancer Caregivers

Not currently recruiting at 4 trial locations

Overseen By Allison Applebaum, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Dementia, Severe psychopathology, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8-16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two therapies for caregivers of cancer patients: Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C) and Emotion Regulation Therapy for Cancer Caregivers (ERT-C). The goal is to determine if ERT-C reduces caregiver stress, anxiety, and depression more effectively than CBT-C. Researchers will also examine how these therapies affect caregivers' hormone and stress levels and the quality of life for the cancer patients they support. Caregivers experiencing significant stress related to assisting someone with cancer and residing in New York, New Jersey, or Massachusetts may be interested in participating. As an unphased trial, this study offers caregivers the opportunity to explore new therapeutic options that could enhance their well-being and the quality of life for those they support.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have a medical condition or take medications that affect inflammation, you may not be eligible to participate.

What prior data suggests that these therapies are safe for caregivers?

Research has shown that both Emotion Regulation Therapy for Cancer Caregivers (ERT-C) and Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C) are safe for participants.

Studies have found that individuals who try ERT-C generally tolerate it well. Participants who completed ERT-C reported reduced depression and anxiety, experienced fewer negative thoughts, and gained better control over their emotions. This indicates that ERT-C is not only safe but also effective for managing stress.

CBT-C is also safe and has proven effective in reducing anxiety and depression in caregivers. It enhances resilience, enabling caregivers to better cope with stress and challenges. Research has also shown that CBT-C reduces fatigue in cancer patients, highlighting its broad benefits.

Overall, both therapies have been tested in various settings with positive results. As non-drug treatments, they avoid the side effects associated with medications, making them well-tolerated options for caregivers seeking to manage stress and improve their quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these therapies because they offer innovative approaches to supporting cancer caregivers. Unlike standard treatments that typically focus on managing stress and providing general support, Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C) specifically aims to transform negative thought patterns and behaviors. Emotion Regulation Therapy for Cancer Caregivers (ERT-C) takes it further by enhancing emotional processing and regulation, addressing both early and late stages of emotional distress. These therapies are promising because they not only target the caregivers' immediate stress but also equip them with long-term coping strategies, potentially leading to more sustainable well-being improvements.

What evidence suggests that this trial's therapies could be effective for cancer caregivers?

Research has shown that Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C), one of the therapies studied in this trial, can reduce depression and anxiety in those caring for cancer patients. Although it may not significantly enhance overall quality of life, it provides emotional benefits. Emotion Regulation Therapy for Cancer Caregivers (ERT-C), another therapy under study, also appears promising. It reduces depression, anxiety, and negative thoughts. ERT-C improves caregivers' emotional management, offering valuable support. Both therapies could effectively reduce caregiver stress. ^{2 6 7 8 9}

Who Is on the Research Team?

Christian Nelson, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adult caregivers in New York, New Jersey, or Massachusetts who speak English very well and are caring for a cancer patient treated within the last year. Caregivers must be experiencing distress related to their role. Patients also participate if they're adults, fluent in English, and cared for by an eligible caregiver.

Inclusion Criteria

Caregivers:

I am a close contact of a cancer patient who has been treated in the last year.

Patient of an eligible IC per self-report or the EMR.

Exclusion Criteria

As per self-report, currently enrolled in another study focused on supportive care for caregivers (MGH participants only).

As per self-report, presence of disorder that compromises comprehension of assessments or informed consent information (e.g., dementia).

Presence of disorder that compromises comprehension of assessments or informed consent information (e.g., dementia) as per EMR or clinician judgment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Emotion Regulation Therapy for Cancer Caregivers (ERT-C) or Cognitive Behavioral Therapy (CBT-C) over 8 sessions

8-16 weeks

8 sessions (telepsychiatry)

Follow-up

Participants are monitored for changes in anxiety and depressive symptoms

up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C)
• Emotion Regulation Therapy for Cancer Caregivers (ERT-C)

Trial Overview

The study compares Emotion Regulation Therapy (ERT-C) with Cognitive Behavioral Therapy (CBT-C) to see which better reduces caregiver distress. It measures anxiety, depression, quality of life of caregivers and patients' stress levels through saliva samples.

How Is the Trial Designed?

Group I: Training case group Experimental Treatment 1 Intervention

Will be assigned to receive ERT-C only and will not complete questionnaires.

Group II: ERT-C: Emotion Regulation Therapy for Cancer Caregivers Experimental Treatment 1 Intervention

Emotion Regulation Therapy for Cancer Caregivers (ERT-C) is an 8-session intervention that builds upon the foundations of CBT-C and addresses earlier motivational processing components of the caregivers context while targeting earlier and later components of internal distress and resultant maladaptive behavioral coping.

Group III: CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers Experimental Treatment 1 Intervention

Cognitive Behavioral Therapy (CBT-C) is an evidence-based psychotherapeutic approach that is grounded in the cognitive model that purports that a person's emotional, behavioral, and physiological reactions to a situation is based on their appraisal of that situation. The focus of therapy is on changing cognitions and beliefs about a situation and altering automatic behavioral responses evoked by that perception. CBT-C aims to improve emotion regulation by challenging and changing unhelpful cognitions and behaviors and improving personal coping strategies.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

University of Aarhus

Collaborator

Trials

1,441

Recruited

14,600,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

University of California

Collaborator

Trials

46

Recruited

208,000+

Published Research Related to This Trial

Emotion Regulation Therapy adapted for cancer informal caregivers (ERT-C) was well tolerated and showed promising initial efficacy, with 31 participants completing eight weekly sessions and reporting significant reductions in depression, anxiety, and perseverative negative thinking (PNT).

Despite the reduction in emotional distress, caregiver burden remained unchanged; however, participants felt more capable of facing caregiving challenges, indicating that ERT-C may help improve coping strategies for informal caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotion regulation therapy for cancer caregivers-an open trial of a mechanism-targeted approach to addressing caregiver distress. Applebaum, AJ., Panjwani, AA., Buda, K., et al.[2021]

A multi-site randomized trial is being conducted with 200 family caregivers of cancer patients to compare the effectiveness of two adapted therapies, Emotion Regulation Therapy for Caregivers (ERT-C) and Cognitive Behavioral Therapy for Caregivers (CBT-C), in reducing caregiver distress.

The study aims to assess not only the psychological outcomes like anxiety and depression but also the impact of these interventions on the caregivers' quality of life and potential biological markers of stress, providing a comprehensive understanding of caregiver support needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of emotion regulation therapy for cancer caregivers: A mechanism-targeted approach to addressing caregiver distress. Applebaum, AJ., Loschiavo, M., Morgan, K., et al.[2023]

In a randomized controlled trial involving 81 informal caregivers, Emotion Regulation Therapy adapted for caregivers (ERT-C) significantly reduced psychological distress, worry, and caregiver burden, with medium to large effect sizes, particularly post-treatment.

Caregivers who participated in ERT-C also reported a large increase in quality of life for themselves and the cancer patients they cared for, highlighting the therapy's potential benefits in comprehensive cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Emotion Regulation Therapy for Psychologically Distressed Caregivers of Cancer Patients. O'Toole, MS., Mennin, DS., Applebaum, A., et al.[2022]

Citations

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However, as a non-pharmaceutical treatment, it remains unclear whether CBT improves chemotherapy-induced side effects and immune function in CRC patients.

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The current systematic review and meta-analysis encompasses 10 RCTs. CBT demonstrated a significant reduction in fatigue scores among cancer patients.

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sciencedirect.com

sciencedirect.com/science/article/pii/S0923753419354031

Original Article Cognitive behavioral therapy or graded ...

Cognitive behavioral therapy (CBT) reduced fatigue in severely fatigued patients receiving cancer treatment with palliative intent.