At a glance
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A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress
In Brief
A clinical study evaluating Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C) and Emotion Regulation Therapy for Cancer Caregivers (ERT-C) for Cancer Patients and Family Caregivers. Active but no longer recruiting, targeting 348 participants across 5 sites.
Signals
Detailed Summary
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).
Study Details
Timeline
Arms & Interventions
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.
Interventions
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).