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IRCT20200209046424N1 IRCT 2020-03-14 Islamic Azad University The Effect of Acceptance and Commitment Therapy on prostate cancer Developing of Acceptance and Commitment Therapy (ACT) protocol based on psychological problems in people with prostate cancer and its effectiveness on health-related quality of life and psychological distress of them. 2020-01-01 anticipated 40 Complete https://irct.ir/trial/45669 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: Based on the inclusion criteria and a pre-test session, 40 men who scored lower than average after completing the Depression, Anxiety and Stress Questionnaire (DASS 21) had health-related quality of life (SF 36). Since the study groups have equal sample size, we use simple random allocation law which is one of the limited randomization methods and we divide people into two groups of intervention and control. Keep notes of patients on 40 separate sheets and place the sheets inside the draw container and then we randomly record the 20 sheets out of the container into the intervention group and place the remaining 20 sheets in the control group. If there is a loss in treatment sessions, the sample size will be randomly eliminated in order to equalize the sample size and eventually the number of subjects in both groups should be the same. The experimental group (n=20) will have 8 sessions of 120-minute Acceptance and Commitment therapy and the control group will receive no intervention. N/A Prostate Cancer. Intervention 1: Acceptance and Commitment Therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "Acceptance, Faulting, self as context, present-day communication, recognizing values ​​and committed action Intervention group". In fact the purpose of Acceptance and Commitment therapy, is not to make a direct change in the client. Rather, its purpose is to help clientele communicate their experiences in different ways and be able to engage completely with meaningful, value-based life. The proposed protocol is based on the Acceptance and Commitment Book by Hayes, Straussell and Wilson. In the intervention group: Twenty patients have prostate cancer before the protocol is implemented In the pre-test, they completed the Short Form of Depression, Anxiety and Stress Questionnaire (DASS-21) and Health-Related Quality of Life (SF-36) with full specifications. In the intervention group, the Acceptance and Commitment Therapy protocol (ACT) will be conducted in eight consecutive 90-minute sessions in 4 consecutive weeks. Intervention 2: Control group:Twenty patients with prostate cancer who complete the pre-test questionnaire of depression, anxiety and stress (DASS-21) and health-related quality of life (SF-36) with complete the specification. The group will receive routine care during this 4-week period and will not perform any additional work. After 4 weeks post-test this group will also complete the questionnaires. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Upon completion of the dissertation the expected outcome will be decided upon.
public Fatemeh Baniasadi
No. 4, Alley 16, Dehkade Olympic Blvd.
Tehran Iran (Islamic Republic of) 1489653143 +98 21 4471 9445 f.baniasadi@iaukishint.ac.ir Islamic Azad University scientific Hamid Poursharifi, Ph.D.
kodakyar Ave., daneshjo Blvd.,Evin
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۳۸۳۴ +98 21 2218 0045 ha.poursharifi@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Willingness to participate in the research project Age 75 - 50 years Minimum literacy At least one year under treatment (with expert approval) No addiction to any drug Completion of consent to participate in the research Low score of health related quality of life questionnaire and psychological problems scale 50 years 75 years Male Kidney and liver diseases Use of psychoactive drugs C61 Malignant neoplasm of prostate Behavior Behavior Acceptance and Commitment Therapy (ACT) has six central processes that lead to psychological flexibility. These six processes are: "Acceptance, Faulting, self as context, present-day communication, recognizing values ​​and committed action Intervention group". In fact the purpose of Acceptance and Commitment therapy, is not to make a direct change in the client. Rather, its purpose is to help clientele communicate their experiences in different ways and be able to engage completely with meaningful, value-based life. The proposed protocol is based on the Acceptance and Commitment Book by Hayes, Straussell and Wilson. In the intervention group: Twenty patients have prostate cancer before the protocol is implemented In the pre-test, they completed the Short Form of Depression, Anxiety and Stress Questionnaire (DASS-21) and Health-Related Quality of Life (SF-36) with full specifications. In the intervention group, the Acceptance and Commitment Therapy protocol (ACT) will be conducted in eight consecutive 90-minute sessions in 4 consecutive weeks. Control group:Twenty patients with prostate cancer who complete the pre-test questionnaire of depression, anxiety and stress (DASS-21) and health-related quality of life (SF-36) with complete the specification. The group will receive routine care during this 4-week period and will not perform any additional work. After 4 weeks post-test this group will also complete the questionnaires. Psychological Problem Score on the Short Form of Depression, Anxiety and Stress Scale (DASS 21); Physical and Mental Health Score in Health Related Quality of Life Questionnaire (SF 36). Timepoint: At the beginning of the study (before the intervention) and after 8 sessions of acceptance and commitment group therapy. Method of measurement: The Short Form of Depression, Anxiety and Stress Scale (DASS 21); Health Related Quality of Life Questionnaire (SF 36). Health-related quality of life score and psychological problems score. Timepoint: Health-related Quality of Life Questionnaires (SF 36) and Depression, Anxiety and Stress Short Form (DASS 21) at baseline (before intervention) and after treatment protocol. Method of measurement: The Depression, Anxiety and Stress Questionnaire (DASS 21) Health-related quality of life (SF 36). Islamic Azad University Approved 2019-12-07 Ethics committee of Hormozgan University of Medical Sciences Shahid Chamran Blvd., Hormozgan University of Medical Sciences Bandar Abbas Hormozgan Iran (Islamic Republic of)