Protocol summary
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Study aim
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Comparison of effectiveness of Emotion Regulation Therapy for Cancer Caregivers and Cognitive Behavioral Therapy on Depression and Anxiety Symptoms, Emotion Regulation Difficulties, and Perseverative Negative Thinking in these persons
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Design
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A concealed, randomized, double-blinded controlled clinical trial with a parallel group design of 44 patients.
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Settings and conduct
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The trial will be conducted on family caregivers of cancer patients. Samples will be collected from the chemotherapy department of Seyed al-Shohda Hospital, Isfahan. The therapist will be unaware of the outcome variables. The person who evaluates the outcome variables will be unaware of the objectives and hypotheses of the study.
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Participants/Inclusion and exclusion criteria
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Being at least 18 years of age
A self-report of caregiving of a cancer patient with any stage of any type of cancer
No history of hospitalization due to mental disorder
Non-participation in other psychosocial trials
Scoring lower than cutoff criteria on Distress Thermometer measure (DT<4)
Scoring lower than cutoff criteria on the Brief Penn State Worry Questionnaire (<15)
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Intervention groups
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The first intervention group receives emotion regulation therapy for cancer caregivers. This treatment includes 8 online group therapy sessions.
The second intervention group receives cognitive behavioral therapy. This treatment also includes 8 group therapy sessions and will be provided online.
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Main outcome variables
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anxiety and depression symptoms; emotion regulation difficulties; perseverative negative thinking
General information
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Reason for update
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In the outcome variables section, for the "emotion regulation deficits" variable, the "Five-facet mindfulness questionnaire" was removed; And for the "perseverative negative thinking" variable, the "Ruminative Response Scale" was added.
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Acronym
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ERT-C, CBT
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IRCT registration information
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IRCT registration number:
IRCT20230102057023N1
Registration date:
2023-01-21, 1401/11/01
Registration timing:
prospective
Last update:
2023-02-22, 1401/12/03
Update count:
1
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Registration date
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2023-01-21, 1401/11/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-02-09, 1401/11/20
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Expected recruitment end date
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2023-03-11, 1401/12/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Comparison of the Effectiveness of Emotion Regulation Therapy for Cancer Caregivers and Cognitive Behavioral Therapy
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Being at least 18 years of age
A self-report of caregiving of a cancer patient with any stage of any type of cancer
Exclusion criteria:
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)
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-15, 1401/08/24
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Ethics committee reference number
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IR.MUI.MED.REC.1401.296
Health conditions studied
1
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Description of health condition studied
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Anxiety
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ICD-10 code
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Z63.7
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ICD-10 code description
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Other stressful life events affecting family and household
2
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Description of health condition studied
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Depression
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ICD-10 code
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F32
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ICD-10 code description
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Major depressive disorder, single episode
3
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Description of health condition studied
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Cancer
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ICD-10 code
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Z85.9
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ICD-10 code description
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Personal history of malignant neoplasm, unspecified
4
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Description of health condition studied
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Caregiving
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ICD-10 code
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Y93.F
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ICD-10 code description
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Activities involving caregiving
Primary outcomes
1
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Description
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Depression and anxiety Symptoms Score in Hospital Anxiety and Depression Scale
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Timepoint
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Before intervention, After intervention, 3 months after intervention
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Method of measurement
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Distress thermometer, and Hospital Anxiety and Depression Scale
2
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Description
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Emotion Regulation Deficits score in Difficulties in Emotion Regulation Scale
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Timepoint
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Before intervention, After intervention, and 3 months after intervention
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Method of measurement
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Difficulties in Emotion Regulation Scale
3
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Description
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Perseverative Negative Thinking score in Penn State Worry Questionnaire and Ruminative Response Scale
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Timepoint
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Before intervention, After intervention, and 3 months after intervention
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Method of measurement
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Penn State Worry Questionnaire and Ruminative Response Scale
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All participant data can be shared after de-identification.
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When the data will become available and for how long
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Start of the access period: 6 months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Providing the data is only for a better understanding of the method of this research. Therefore, analysis on the data is not allowed.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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
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Comments
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