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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
348
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).
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).
University of California, Irvine (Data and Specimen Analysis Only)
Irvine, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mount Sinai Hospital (Data Analysis Only)
New York, New York, United States
Columbia University (Data and Specimen Analysis Only)
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
changes in anxiety symptoms
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
Time frame: up to 6 months
changes in depressive symptoms
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
Time frame: up to 6 months
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