Symptoms and General Pathology

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Behaviors and Mental Disorders

Inflammation

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Depressive Disorder

Depression

Caregiver Burden

Behavioral Symptoms

Stress, Psychological

8 sessions of Emotion Regulation Therapy.

Emotion Regulation Therapy

Mia S O'Toole, MSc

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).

PURPOSE:

The primary purpose of the study is to test the efficacy of Emotion Regulation Therapy (ERT) for informal caregivers (ICs) of cancer patients. ERT is a manualized treatment for ICs and consists of 8 weekly sessions.

AIMS AND HYPOTHESES:

Intervention and mediation effects. In an RCT, the investigators will investigate the efficacy of an 8 session ERT for ICs on psychological and physical distress and a number of other health outcomes in both ICs and cancer patients. Outcomes in the ERT group will be compared to outcomes in a group of ICs and patients receiving usual medical care (UMC) (see Figure 1). ICs receiving ERT compared to ICs receiving UMC are expected to exhibit 1a) significant reductions in psychological distress and perceived caregiving burden, 1b) improvements in quality of life; and 1c) improvements in pro-inflammatory markers of stress/immune functioning. Likewise, patients whose ICs receive ERT are expected to report 2a) reduced anxiety and depression, 2b) improved quality of life and 2c) less chronic inflammation. Due to the design, these effects will be considered following the acute treatment period (pre, mid and post therapy). In addition to this, gains are expected to be maintained over the follow-up-period. In addition, 3) improvements are exptected to be maintained over the follow-up period. Finally, 4) improvements in adaptive emotion regulation (mindfulness, acceptance, and cognitive reappraisal) are expected to mediate the effect of ERT.

PARTICIPANTS AND PROCEDURES:

ICs of cancer patients with various cancer types will be consecutively recruited from Aarhus University Hospital, Denmark. Staff at the Outpatient Clinic at the Department of Oncology, Aarhus University Hospital, Denmark, will screen ICs at the department. Initially the investigators wanted to include caregivers of patients with lung and colorectal cancer only. However, in order to be able to include caregivers at a faster pace, it was decided - after one month during which only two caregivers were included - to broaden the patient group. Furthermore, it was decided that more than one IC per patient could participate.

After giving informed consent, participants will be randomized to Emotion Regulation Therapy (ERT) or usual medical care (UMC) in a ratio of 1:1 by means of computer-generated randomization lists. Outcome measures will be obtained pre-, mid-, and post-therapy as well as at 3 and 6-month follow-up. At every ERT session, ICs and clinicians will fill out a number of self-report the process measures. Cancer patients will be assessed pre- and post ERT, and at 3 and 6-months follow-up. Every IC and patient will provide blood samples before and after the intervention as well as at follow-ups.

Based on a power calculation (alpha=0.0125, beta=0.90), a dropout rate of 35%, and an intraclass correlation between ICs of the same patient of 0.20, the inclusion of 80 ICs will allow for an interaction effect between group (ERT vs. UMC) and time (acute treatment, thats is, pre, mid and post) of a medium effect size (d=0.5) to be significant.

Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial

Cancer Caregiver Burden: Targeting Emotion Regulation in a Randomized Controlled Trial

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

Questionnaire measuring anxiety and depression

Questionnaire measuring emotion regulation

Questionnaire measuring psychological distancing

Serum-derived pro-inflammatory markers (only pre and post therapy)

2 items (actual and wanted emotional closeness) rated on a 0-10 scale

University of Aarhus

Psychotropic Drugs

All Drugs and Chemicals

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.

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.

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

The sessions are outlined as follow:

1. psychoeducation, goal-setting, and describing the rationale for CBT (Session 1);
2. coping effectiveness training (Session 2);
3. identifying unhelpful cognitions and dysfunctional beliefs (Session 3);
4. challenging and restructuring unhelpful cognitions (Session 4);
5. behavioral activation within the limitations of the caregiving context (Session 5);
6. problem-solving (Session 6);
7. communication strategies and assertiveness training (Session 7);
8. consolidating gains, maintenance, and relapse prevention (Session 8).

Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C)

The sessions are outlined as follow:

1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1);
2. attention regulation skills training (Sessions 1-2);
3. training in metacognitive skills (Sessions 3-4);
4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7);
5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).

Emotion Regulation Therapy for Cancer Caregivers (ERT-C)

Allison Applebaum, PhD

William Breitbart, MD

Jamie Jacobs, PhD

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).

CBT-C and ERT-C are each 8-session, individual, caregivers-directed interventions delivered by a trained study therapist listed on the face page and facilitated by a manualized workbook with between-session practice exercises. To accommodate caregivers and reduce compliance issues with attendance of sessions, the 8 sessions are to be completed within 8 to 16 weeks from initiation of the first session. Each session is 60 minutes in length and will be audio and video recorded for MSK participants; sessions will only be audio recorded for MGH participants. Specific modules and intervention components are described below. To accommodate as many caregivers as possible and in response to the restrictions placed on caregivers currently in the context of the COVID-19 pandemic, sessions will be offered via telepsychiatry (using WebEx , Zoom, Teams).

Training case participants will be identified and consented onto the study for training purposes only. Participants who are consented as training cases will not be randomized and will not complete any assessments. Data collected on training cases will be used for training and supervision purposes on this study only. These records will not be shown outside of the study supervisors, therapist in training, and staff.

This study will utilize a randomized, controlled, repeated measures design to investigate the efficacy of Emotion Regulation Therapy for Cancer Caregivers (ERT-C) vs. Cognitive Behavioral Therapy for Cancer Caregivers.

A Study Comparing Two Types of Supportive Interventions for Caregivers of Patients With Cancer

A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

as assessed via the HADS Developed by Zigmond and Snaith in 1983, the HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Items of the overall severity of anxiety and depression are rated on a five-point (0-4) severity scales (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cancer Caregiver Burden: Targeting Emotion Regulation in a Trial	NCT02322905	Anxiety Depress...	Emotion Regulat...	18 Years - 69 Years	University of Aarhus
A Study Comparing Two Types of Supportive Interventions for Caregivers of Patients With Cancer	NCT04802720	Cancer Patients Family Caregive...	Cognitive Behav... Emotion Regulat...	18 Years -	Memorial Sloan Kettering Cancer Center

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