Cognitive Behavior Therapy (CBT) and Psychological Status and Immune Function
NCT ID: NCT04741308
Last Updated: 2022-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2021-03-01
2023-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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CBT group
Patients randomly assigned to CBT group will receive 8 times of CBT treatment during chemotherapy.
cognitive behavior therapy
The CBT intervention is a 8-times group-based intervention that meets 2-3 weeks.Each session will be performed during chemotherapy and will last for 60 min, including 45 min cognitive behavior therapy and 15 min relaxation training.Our CBT intervention is designed to be conducted in groups of 3 to 6 patients led by two group facilitators. Group leaders will: guide participants relaxation training, develop a supportive group environment, encourage emotional expression, assist participants develop a sense of self-confidence, identify maladaptive coping and encourage adaptive coping responses.
non-CBT group
Patients randomly assigned to non-CBT group will receive four sessions of health education in a month after surgery.
Each session will last 1 hour, including lectures and Q\&A . The content of each session is different, including: diagnosis and treatment of colorectal cancer, adverse reactions and management of chemotherapy, nutritional support during chemotherapy and physical exercise during chemotherapy.
No interventions assigned to this group
Interventions
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cognitive behavior therapy
The CBT intervention is a 8-times group-based intervention that meets 2-3 weeks.Each session will be performed during chemotherapy and will last for 60 min, including 45 min cognitive behavior therapy and 15 min relaxation training.Our CBT intervention is designed to be conducted in groups of 3 to 6 patients led by two group facilitators. Group leaders will: guide participants relaxation training, develop a supportive group environment, encourage emotional expression, assist participants develop a sense of self-confidence, identify maladaptive coping and encourage adaptive coping responses.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Having severe depression and anxiety currently;
3. Having alcohol dependence or other substance dependence;
4. Having serious physical illness;
5. Participating in other clinical studies.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai 10th People's Hospital
OTHER
Responsible Party
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Yuan Shen, MD, PhD
Chief of Psychiatry
Locations
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Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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References
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Wang M, Xu Y, Shi J, Zhuang C, Zhuang Y, Li J, Cashin PH. The effect of cognitive behavioral therapy on chemotherapy-induced side effects and immune function in colorectal cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial. J Gastrointest Oncol. 2023 Aug 31;14(4):1869-1877. doi: 10.21037/jgo-23-625. Epub 2023 Aug 30.
Other Identifiers
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dsyy006
Identifier Type: -
Identifier Source: org_study_id
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