CBT vs ERT for Cancer Caregivers

Recruiting at 3 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

348 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare two types of therapy for caregivers of cancer patients: Emotion Regulation Therapy for Cancer Caregivers (ERT-C) and Cognitive Behavioral Therapy (CBT-C). The researchers want to see if ERT-C is better than, the same as, or worse than traditional CBT-C at improving caregiver distress. The researchers will look at how the two types of therapy affect caregivers' anxiety, depression, and quality of life. The researchers will also see how ERT-C and CBT-C affect hormone and stress levels in caregivers' saliva samples. In addition, this trial will enroll cancer patients in this study to see how their caregivers' participation in ERT-C or CBT may affect the patients' quality of life, stress, and use of healthcare services. Participants who become bereaved while on study will be given the option to withdraw or remain on study. Assessments for bereaved caregivers will not include the Caregiver Quality of Life Index-Cancer (CQOLC) or the Caregiver Reaction Assessment (CRA).

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 data supports the effectiveness of this treatment for cancer caregivers?

Emotion Regulation Therapy adapted for cancer caregivers (ERT-C) has shown promising results in reducing symptoms of depression and anxiety, as well as improving emotion regulation in caregivers, according to a study where participants reported moderate to large improvements after treatment. ^{1 2 3 4 5}

Is CBT-C or ERT-C safe for cancer caregivers?

ERT-C was well tolerated by participants, with most completing the treatment and reporting reduced symptoms of depression and anxiety, suggesting it is generally safe for cancer caregivers. ^{1 3 4 5 6}

How does the treatment CBT-C and ERT-C differ from other treatments for cancer caregivers?

CBT-C and ERT-C are unique because they are specifically adapted to address the emotional distress of cancer caregivers, with ERT-C focusing on managing negative thinking patterns and emotional responses to stress, which are often not targeted by traditional therapies. ^{1 3 4 5 6}

Research Team

Christian Nelson, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Emotion regulation therapy for cancer caregivers-an open trial of a mechanism-targeted approach to addressing caregiver distress. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of Group Intervention on Enhancing Cognitive Emotion Regulation Strategies in Breast Cancer Patients: A 2-Year Follow-up. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of emotion regulation therapy for cancer caregivers: A mechanism-targeted approach to addressing caregiver distress. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Emotion Regulation Therapy for Psychologically Distressed Caregivers of Cancer Patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Moderators and mediators of emotion regulation therapy for psychologically distressed caregivers of cancer patients: secondary analyses from a randomized controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Third-wave cognitive behavioral therapies for caregivers of cancer patients: a scoping review. [2023]