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IRCT20230102057023N1 IRCT 2023-01-21 Esfahan University of Medical Sciences Comparison of the Effectiveness of Emotion Regulation Therapy for Cancer Caregivers and Cognitive Behavioral Therapy ERT-C, CBT Comparison of the Effectiveness of Emotion Regulation Therapy for Cancer Caregivers (ERT-C) and Cognitive Behavioral Therapy (CBT) on Depression and anxiety symptoms, Emotion Regulation Deficits, Perseverative Negative Thinking 2023-02-09 anticipated 44 Complete https://irct.ir/trial/67964 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The randomization of this study was done by limited randomization method and block randomization type with random block sizes with individual randomization unit and through random allocation software. Opaque sealed envelopes with a random sequence were used to conceal the random allocation, Blinding description: In this study, the person providing the treatment is unaware of the outcome variables. The person who evaluates the outcome variables is unaware of the objectives and hypotheses of the study, and the data analyst is unaware of the intervention groups. N/A Condition 1: Anxiety. Condition 2: Depression. Condition 3: Cancer. Condition 4: Caregiving. Intervention 1: First Intervention group: This group receives emotion regulation therapy for cancer caregivers in 8 sessions in a group setting. This treatment includes psychoeducation for a better understanding of emotions and their underlying motivations, training in cue detection and self-monitoring skills , training in identifying reactive responses to emotions, training in self-regulation skills including "orienting and allowing", training in metacognitive skills in emotion regulation. "Courageous and Compassionate reframing", Courage and Compassion meditation training, imaginative confrontation technique for facing perceived fears and frustrations and practicing conflicting voices. Intervention 2: Second Intervention group: This group receives cognitive behavioral therapy in 8 sessions in a group setting. This treatment includes psychoeducation, goal direction and explaining the principles of cognitive behavioral therapy, effective coping training, identifying maladaptive cognitions and ineffective beliefs, challenging and reconstructing maladaptive cognitions, behavioral activation, problem solving, training communication and assertiveness skills. Yes - There is a plan to make this available What will be shared: All participant data can be shared after de-identification. When: Start of the access period: 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Providing the data is only for a better understanding of the method of this research. Therefore, analysis on the data is not allowed. Where to obtain: Kimia Kasaei nasab: kimia.kn@resident.mui.ac.ir , shirin_kasa@yahoo.com Phone: +989113548069 Dr. Reza Bagherian : bagherian@med.mui.ac.ir , Isfahan, Hezar Jarib Street, Isfahan University of Medical Sciences, Medical School, Department of Health Psychology, Postal Code: 8174673461 How to obtain: First, send an email to Mrs. Kesai Nesab, if you do not receive a response from the university email, send a message to the personal email. And otherwise, send a message to Dr. Reza Bagharian's email. We try to respond within a week Comments:
public Kimia Kasaei nasab
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 9313 kimia.kn@resident.mui.ac.ir Esfahan University of Medical Sciences scientific Reza Bagherian
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 9313 bagherian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Being at least 18 years of age A self-report of caregiving of a cancer patient with any stage of any type of cancer 18 years no limit Both History of hospitalization due to mental disorder Participation in other psychosocial trials Scoring lower than cutoff criteria on the Distress Thermometer measure (DT<4) Scoring lower than cutoff criteria on the Brief Penn State Worry Questionnaire (<15) Z63.7 F32 Z85.9 Y93.F Other stressful life events affecting family and household Major depressive disorder, single episode Personal history of malignant neoplasm, unspecified Activities involving caregiving Behavior Behavior First Intervention group: This group receives emotion regulation therapy for cancer caregivers in 8 sessions in a group setting. This treatment includes psychoeducation for a better understanding of emotions and their underlying motivations, training in cue detection and self-monitoring skills , training in identifying reactive responses to emotions, training in self-regulation skills including "orienting and allowing", training in metacognitive skills in emotion regulation. "Courageous and Compassionate reframing", Courage and Compassion meditation training, imaginative confrontation technique for facing perceived fears and frustrations and practicing conflicting voices. Second Intervention group: This group receives cognitive behavioral therapy in 8 sessions in a group setting. This treatment includes psychoeducation, goal direction and explaining the principles of cognitive behavioral therapy, effective coping training, identifying maladaptive cognitions and ineffective beliefs, challenging and reconstructing maladaptive cognitions, behavioral activation, problem solving, training communication and assertiveness skills. Depression and anxiety Symptoms Score in Hospital Anxiety and Depression Scale. Timepoint: Before intervention, After intervention, 3 months after intervention. Method of measurement: Distress thermometer, and Hospital Anxiety and Depression Scale. Emotion Regulation Deficits score in Difficulties in Emotion Regulation Scale. Timepoint: Before intervention, After intervention, and 3 months after intervention. Method of measurement: Difficulties in Emotion Regulation Scale. Perseverative Negative Thinking score in Penn State Worry Questionnaire and Ruminative Response Scale. Timepoint: Before intervention, After intervention, and 3 months after intervention. Method of measurement: Penn State Worry Questionnaire and Ruminative Response Scale. Esfahan University of Medical Sciences Approved 2022-11-15 Ethics committee of Isfahan University of Medical Sciences Hezar Jarib Isfahan Isfehan Iran (Islamic Republic of)