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IRCT20150427021965N10 IRCT 2019-07-31 Rasht University of Medical Sciences The effect of cognitive-behavioral intervention and psycho educational training in patients with colorectal cancer Clinical trial of evaluating and comparing the effectiveness of cognitive-behavioral and psychoeducation intervention on quality of life in patients with colon cancer 2019-07-23 anticipated 20 Complete https://irct.ir/trial/40599 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After the convenience sampling method, the resident of psychiatry will randomly divide them into two intervention groups. Samples will be assigned by block randomization method one by one samples by using closed envelopes in two groups of 10 (With cognitive-behavioral intervention and psycho educational training). Given that the total number of samples is 20, people will be divided into 5 blocks of 4. Then assistant assigns patients to each group by closed envelopes. The first group is subjected to a cognitive-behavioral group for 6 weeks per week for a 1.5 hour session. The second group is subjected to a group of psycho educational training in six sessions per week, one 1.5 hour session. 3 Colorectal cancer. Intervention 1: Intervention group: People in the first intervention group will receive cognitive-behavioral group therapy/ First session: Running pre-test, introduction, discussing the importance of non-pharmacological treatments, introducing the cognitive-behavioral pattern. Second session: Reviewing the tasks of the previous session, teaching behavioral techniques to control the severity of complications from cancer, teaching some ways to cope with fatigue, teaching relaxation, teaching cognitive-behavioral techniques, expressing negative emotions (such as avoiding absolutism and generalization, Analysis of profits and losses and expressing feelings along with expressing expectations) and presentation of tasks. Third Session: Reviewing the tasks of the previous session, getting to know ways to deal with problems such as denial, projection, zoom Out, magnification, catastrophizing and Intellectual ruminations , Familiarity with problem solving techniques, regular planning for activity and planning for positive affairs on a daily basis and the presentation of tasks. Fourth session: Reviewing the tasks of the previous session, familiarizing with negative thoughts including negative thinking, mind Reading and negative predictive, preparing a list of negative thoughts. Fifth session: Reviewing the tasks of the previous session, familiarizing with How to deal with negative thoughts, presenting tasks for coping with negative thoughts in everyday life. Sixth session: Reviewing to use of problem-solving interventions on everyday issues, Reviewing the past contents and summaries, providing feedback on progress and receiving feedback from the patient about successful and unsuccessful aspects of treatment, post-test implementation, and appreciation of participants. The treatment process will be 6 sessions per 90 minutes. Intervention 2: Intervention group: People in the second group of intervention will receive group therapy for psychoeducational training. The process of treatments will be set up during 6 sessions of 90 minutes./ First session: Running pre-test , introduction, general description about the psycho educational training model, presentation of medical explanations for colorectal cancer, treatments and follow-up, presentation of educational pamphlet to patients. Second session: Reviewing the previous session, Teaching on how to be aware of stress and recognizing the sources of stress and recognizing personal responses to it including physical, psychological, and behavioral responses. Third session: Reviewing the previous session, practical training of stress management Includes: changing attitudes toward existing stress and then changing physical responses to it through relaxation methods. Fourth session: Reviewing the previous session, training key components of coping methods includes: optimism, ability to do, flexibility, adding information and awareness. Familiarity with the three common coping strategies: Behavioral - Active, Cognitive - Active, avoidance. Fifth session: Review of previous sessions, Training five steps of problem solving, including of relaxation, problem identification, thinking about possible solutions , choosing an appropriate solution to the circumstances, evaluation and action. Sixth session: Reviewing the previous session, explaining the importance of mental support and help patients to express their emotions and excitements (Positive or Negative) and sharing it with other members of the group, Summing up the sessions and answers to patient questions. Yes - There is a plan to make this available What will be shared: All data will be coded and unidentifiable, will be shared. When: Start the access period 3-6 months after printing the results To whom: All physicians and paramedics in the field of psychology Conditions: For further information on rehabilitation methods for patients with severe medical conditions, such as cancer Where to obtain: Email address How to obtain: The demandant will be responded to by the moderator after 3-5 days. Comments:
public Aida Yahyazadeh
15 khordad avenue, Shafa Hospital
Rasht Iran (Islamic Republic of) 41939-55599 +98 13 3366 6268 aidayahyazadeh@yahoo.com Rasht University of Medical Sciences scientific Homa Zarrabi
15 khordad avenue, Shafa Hospital.
Rasht Iran (Islamic Republic of) 41939-55599 +98 13 3366 6268 kavosh1400@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Diagnosis of colorectal cancer by specialist Age between 20 and 65 years old Minimum five primary educations Consent to participate in the study 20 years 65 years Both Having neurological diseases Third stage of disease and above Getting Beck depression and anxiety questioners score higher than 28 Having psychiatric disorders C19 Malignant neoplasm of rectosigmoid junction Rehabilitation Rehabilitation Intervention group: People in the first intervention group will receive cognitive-behavioral group therapy/ First session: Running pre-test, introduction, discussing the importance of non-pharmacological treatments, introducing the cognitive-behavioral pattern. Second session: Reviewing the tasks of the previous session, teaching behavioral techniques to control the severity of complications from cancer, teaching some ways to cope with fatigue, teaching relaxation, teaching cognitive-behavioral techniques, expressing negative emotions (such as avoiding absolutism and generalization, Analysis of profits and losses and expressing feelings along with expressing expectations) and presentation of tasks. Third Session: Reviewing the tasks of the previous session, getting to know ways to deal with problems such as denial, projection, zoom Out, magnification, catastrophizing and Intellectual ruminations , Familiarity with problem solving techniques, regular planning for activity and planning for positive affairs on a daily basis and the presentation of tasks. Fourth session: Reviewing the tasks of the previous session, familiarizing with negative thoughts including negative thinking, mind Reading and negative predictive, preparing a list of negative thoughts. Fifth session: Reviewing the tasks of the previous session, familiarizing with How to deal with negative thoughts, presenting tasks for coping with negative thoughts in everyday life. Sixth session: Reviewing to use of problem-solving interventions on everyday issues, Reviewing the past contents and summaries, providing feedback on progress and receiving feedback from the patient about successful and unsuccessful aspects of treatment, post-test implementation, and appreciation of participants. The treatment process will be 6 sessions per 90 minutes. Intervention group: People in the second group of intervention will receive group therapy for psychoeducational training. The process of treatments will be set up during 6 sessions of 90 minutes./ First session: Running pre-test , introduction, general description about the psycho educational training model, presentation of medical explanations for colorectal cancer, treatments and follow-up, presentation of educational pamphlet to patients. Second session: Reviewing the previous session, Teaching on how to be aware of stress and recognizing the sources of stress and recognizing personal responses to it including physical, psychological, and behavioral responses. Third session: Reviewing the previous session, practical training of stress management Includes: changing attitudes toward existing stress and then changing physical responses to it through relaxation methods. Fourth session: Reviewing the previous session, training key components of coping methods includes: optimism, ability to do, flexibility, adding information and awareness. Familiarity with the three common coping strategies: Behavioral - Active, Cognitive - Active, avoidance. Fifth session: Review of previous sessions, Training five steps of problem solving, including of relaxation, problem identification, thinking about possible solutions , choosing an appropriate solution to the circumstances, evaluation and action. Sixth session: Reviewing the previous session, explaining the importance of mental support and help patients to express their emotions and excitements (Positive or Negative) and sharing it with other members of the group, Summing up the sessions and answers to patient questions. Quality of Life. Timepoint: At baseline, after the intervention and one month later, they will be evaluated by the WHOQOL quality of life test. Method of measurement: All participants are assessed by WHOQOL Quality of Life Test. Depression. Timepoint: All participants in the baseline period, after the intervention, and one month later, are evaluated by Beck Depression Psychology Test. Method of measurement: All participants are evaluated by Beck Depression Psychology Test. Anxiety. Timepoint: All participants at baseline, after intervention, and one month later, are evaluated by Beck Anxiety Test. Method of measurement: All participants are evaluated by Beck Anxiety Test. Rasht University of Medical Sciences Approved 2019-06-26 Ethics committee of Guilan University of Medical Sciences Old Building of School of Health, In front of the 17th Shahrivar Hospital, Shahid Siadati Avenue, Namjoo St. Rasht Guilan Iran (Islamic Republic of)