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IRCT20220129053854N1 IRCT 2022-04-09 Rasht University of Medical Sciences Determining the Effectiveness of Acceptance and Commitment-Based Approach and Solution-Based Approach on Mental Health and Quality of Life of Burn Patients Determining the Effectiveness of Acceptance and Commitment-Based Approach and Solution-Based Approach on Mental Health and Quality of Life of Burn Patients: A clinical trial 2022-04-21 anticipated 45 Complete https://irct.ir/trial/62618 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, in order to assign patients to intervention and control groups, the limited randomization approach will be used as a block randomization method. To prevent the last allocation from being detected in the blocks under consideration, we will consider the size of the blocks to be random with a size of 6. In this study, in order to hide the allocation, the created sequences will be placed in closed envelopes. In this regard, the letter A (control group), the letter B (intervention group with an approach based on acceptance and commitment) and the letter C (Intervention group with a solution-oriented approach) will be used and to generate random numbers, we will use the Rnnif package in R software, Blinding description: Factors that cause errors in this category of studies are: patient and researcher awareness, and researcher evaluation of the type of treatment prescribed. To prevent bias and increase credibility in this study, we will use the one-blind method in which analysts Identification of control and intervention groups will be blinded. For this purpose, the treatment method and patient groups will be coded and any evidence that leads the analyst to identify patient groups will be removed. N/A Burn. Intervention 1: Intervention group: Acceptance and Commitment Group -Routine burn care is provided to patients after discharge. These cares include: answering smart questions, how to care for wounds and dressings, teaching the proper diet for burns, how to wash wounds at home, how to properly use medications at home, the date and time of the next visit, and the necessary guidance for referral to a psychologist or psychiatrist if needed. Routine care is also explained in the form of exercises, related to each component for the intervention groups. One month later, after obtaining consent, a questionnaire of quality of life and mental health will be administered. Then, the acceptance and commitment-based treatment group and the solution-oriented treatment group will be treated by a clinical psychologist in 9 sessions of 2 hours, and the control group will not receive treatment. During the sessions, assignments in accordance with the therapeutic goals of each approach will be presented to patients and will be evaluated in the next sessions. Finally, in each group, the quality of life and mental health questionnaire will be administered again and the research data will be analyzed using an appropriate statistical method. Therapeutic sessions for acceptance and commitment group compiled based on Harris therapeutic guidelines (2007). The summary of the sessions is as follows: * Session 1: Introduction and acquaintance and expression of research goals; *Session 2: Discussion about patients goals and giving information about quality of life and better life outcomes; * Session 3: Discussion about quality of life in patients lives and reviewing control strategies; Session 4: Discussion about uselessness of control strategies, explanation about avoiding painful experiences and its outcomes and introducing mindfulness and acceptance; *Session 5: Explaining cognitive fusion and expressing the common relationship between emotions, cognitive functions and visible behavior, teaching cognitive faults and distance from thoughts and observing thoughts without judgment and action independent of mental experiences; *Session 6: Investigating the effect of cognitive fault training, explaining the concepts of role, context and types of self and moving towards a valuable life with a self-accepting and observant; *Session 7: Discussing the effect of observing thoughts in the lives of therapists, explaining the concept of values, motivating change and empowering clients for a better life; *Session 8: Discussing values and barriers to action according to them, creating flexible behavioral patterns in accordance with values, and creating a commitment to act towards goals and values and passing obstacles; *Session 9: Discussing the consequences of action based on values, examining constructive changes during the treatment period and how to stabilize and consolidate them, providing a summary of treatment sessions and receiving feedback from therapists, conducting post-test and finishing treatment sessions. Intervention 2: Intervention group: solution-based Group - Routine burn care is provided to patients after discharge. These cares include: answering smart questions, how to care for wounds and dressings, teaching the proper diet for burns, how to wash wounds at home, how to properly use medications at home, the date and time of the next visit, and the necessary guidance for referral to a psychologist or psychiatrist if needed. Routine care is also explained in the form of exercises, related to each component for the intervention groups. One month later, after obtaining consent, a questionnaire of quality of life and mental health will be administered. Then, the acceptance and commitment-based treatment group and the solution-oriented treatment group will be treated by a clinical psychologist in 9 sessions of 2 hours, and the control group will not receive treatment. During the sessions, assignments in accordance with the therapeutic goals of each approach will be presented to patients and will be evaluated in the next sessions. Finally, in each group, the quality of life and mental health questionnaire will be administered again and the research data will be analyzed using an appropriate statistical method. Solution-based therapy sessions were developed according to resources related to this therapeutic approach, including Walter and Peller (1992), Maud (2000), Lipchik (2002) and Nelson and Thomas (2007).The summary of the sessions is as follows: *The first session: introduction, the expression of research objectives and how the research process, the number of meetings and rules and regulations of the department, the implementation of the pre-test, *Session 2: discussing the positive things in the life of the therapists, encouraging the therapists to express what they want instead of focusing on the problem, setting tangible, objective, positive and practical goals; * Session 3: Discussing the goals of therapists, developing solutions by examining the changes that will happen if problems are solved in the lives of the therapists; *Session 4: Using scaling to assess people's commitment and hope for solving the problem, *Session 5: Discussing how to make changes, helping therapists find exceptions to better function in life, creating hope for change and tackling the problem; *Session 6: Discussing exceptions and highlighting appropriate solutions, asking miracle questions and encouraging therapists to express their abilities and strengthening them; *Session 7: Discussing the respondents' responses to the miracle question, emphasizing on implementing solutions using the word "instead" and replacing appropriate thoughts, feelings and behaviors instead of problematic thoughts, feelings and behaviors; *Session 8: Highlighting the capabilities and capabilities of therapists, discussing how to stabilize the changes made, *Session 9: providing a summary of treatment sessions, discussing the positive points and weaknesses of the therapist and the treatment plan, and receiving feedback from the therapists, performing post-test and finishing treatment sessions. Intervention 3: Control group: Routine burn care is provided to patients after discharge. These cares include: answering smart questions, how to care for wounds and dressings, teaching the proper diet for burns, how to wash wounds at home, how to properly use medications at home, the date and time of the next visit, and the necessary guidance for referral to a psychologist or psychiatrist if needed. Routine care is also explained in the form of exercises, related to each component for the intervention groups. One month later, after obtaining consent, a questionnaire of quality of life and mental health will be administered. Then, the acceptance and commitment-based treatment group and the solution-oriented treatment group will be treated by a clinical psychologist in 9 sessions of 2 hours, and the control group will not receive treatment. During the sessions, assignments in accordance with the therapeutic goals of each approach will be presented to patients and will be evaluated in the next sessions. Finally, in each group, the quality of life and mental health questionnaire will be administered again and the research data will be analyzed using an appropriate statistical method. 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 I have not decided yet - the release schedule is still unknown
public Dr. Mohammad Reza Mobayen
Namjoo street
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences scientific Dr. Mohammad Reza Mobayen
Namjoo street
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8540 Maziar.mobayen@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Deep second, third and fourth degree burn 10 to 70% total body surface area (TBSA) At least one month after burn injury No mental illness and mental retardation Living in Rasht no limit no limit Both Simultaneous participation in other psychotherapy programs Absence in more than two sessions in classes Occurrence of stressful events such as death of relatives or divorce Unwillingness to collaborate in research T31.1 - T3 Burns involving 10 to 70% of body surface with deep second, third and fourth degrees Rehabilitation Rehabilitation Rehabilitation Intervention group: Acceptance and Commitment Group -Routine burn care is provided to patients after discharge. These cares include: answering smart questions, how to care for wounds and dressings, teaching the proper diet for burns, how to wash wounds at home, how to properly use medications at home, the date and time of the next visit, and the necessary guidance for referral to a psychologist or psychiatrist if needed. Routine care is also explained in the form of exercises, related to each component for the intervention groups. One month later, after obtaining consent, a questionnaire of quality of life and mental health will be administered. Then, the acceptance and commitment-based treatment group and the solution-oriented treatment group will be treated by a clinical psychologist in 9 sessions of 2 hours, and the control group will not receive treatment. During the sessions, assignments in accordance with the therapeutic goals of each approach will be presented to patients and will be evaluated in the next sessions. Finally, in each group, the quality of life and mental health questionnaire will be administered again and the research data will be analyzed using an appropriate statistical method. Therapeutic sessions for acceptance and commitment group compiled based on Harris therapeutic guidelines (2007). The summary of the sessions is as follows: * Session 1: Introduction and acquaintance and expression of research goals; *Session 2: Discussion about patients goals and giving information about quality of life and better life outcomes; * Session 3: Discussion about quality of life in patients lives and reviewing control strategies; Session 4: Discussion about uselessness of control strategies, explanation about avoiding painful experiences and its outcomes and introducing mindfulness and acceptance; *Session 5: Explaining cognitive fusion and expressing the common relationship between emotions, cognitive functions and visible behavior, teaching cognitive faults and distance from thoughts and observing thoughts without judgment and action independent of mental experiences; *Session 6: Investigating the effect of cognitive fault training, explaining the concepts of role, context and types of self and moving towards a valuable life with a self-accepting and observant; *Session 7: Discussing the effect of observing thoughts in the lives of therapists, explaining the concept of values, motivating change and empowering clients for a better life; *Session 8: Discussing values and barriers to action according to them, creating flexible behavioral patterns in accordance with values, and creating a commitment to act towards goals and values and passing obstacles; *Session 9: Discussing the consequences of action based on values, examining constructive changes during the treatment period and how to stabilize and consolidate them, providing a summary of treatment sessions and receiving feedback from therapists, conducting post-test and finishing treatment sessions. Intervention group: solution-based Group - Routine burn care is provided to patients after discharge. These cares include: answering smart questions, how to care for wounds and dressings, teaching the proper diet for burns, how to wash wounds at home, how to properly use medications at home, the date and time of the next visit, and the necessary guidance for referral to a psychologist or psychiatrist if needed. Routine care is also explained in the form of exercises, related to each component for the intervention groups. One month later, after obtaining consent, a questionnaire of quality of life and mental health will be administered. Then, the acceptance and commitment-based treatment group and the solution-oriented treatment group will be treated by a clinical psychologist in 9 sessions of 2 hours, and the control group will not receive treatment. During the sessions, assignments in accordance with the therapeutic goals of each approach will be presented to patients and will be evaluated in the next sessions. Finally, in each group, the quality of life and mental health questionnaire will be administered again and the research data will be analyzed using an appropriate statistical method. Solution-based therapy sessions were developed according to resources related to this therapeutic approach, including Walter and Peller (1992), Maud (2000), Lipchik (2002) and Nelson and Thomas (2007).The summary of the sessions is as follows: *The first session: introduction, the expression of research objectives and how the research process, the number of meetings and rules and regulations of the department, the implementation of the pre-test, *Session 2: discussing the positive things in the life of the therapists, encouraging the therapists to express what they want instead of focusing on the problem, setting tangible, objective, positive and practical goals; * Session 3: Discussing the goals of therapists, developing solutions by examining the changes that will happen if problems are solved in the lives of the therapists; *Session 4: Using scaling to assess people's commitment and hope for solving the problem, *Session 5: Discussing how to make changes, helping therapists find exceptions to better function in life, creating hope for change and tackling the problem; *Session 6: Discussing exceptions and highlighting appropriate solutions, asking miracle questions and encouraging therapists to express their abilities and strengthening them; *Session 7: Discussing the respondents' responses to the miracle question, emphasizing on implementing solutions using the word "instead" and replacing appropriate thoughts, feelings and behaviors instead of problematic thoughts, feelings and behaviors; *Session 8: Highlighting the capabilities and capabilities of therapists, discussing how to stabilize the changes made, *Session 9: providing a summary of treatment sessions, discussing the positive points and weaknesses of the therapist and the treatment plan, and receiving feedback from the therapists, performing post-test and finishing treatment sessions. Control group: Routine burn care is provided to patients after discharge. These cares include: answering smart questions, how to care for wounds and dressings, teaching the proper diet for burns, how to wash wounds at home, how to properly use medications at home, the date and time of the next visit, and the necessary guidance for referral to a psychologist or psychiatrist if needed. Routine care is also explained in the form of exercises, related to each component for the intervention groups. One month later, after obtaining consent, a questionnaire of quality of life and mental health will be administered. Then, the acceptance and commitment-based treatment group and the solution-oriented treatment group will be treated by a clinical psychologist in 9 sessions of 2 hours, and the control group will not receive treatment. During the sessions, assignments in accordance with the therapeutic goals of each approach will be presented to patients and will be evaluated in the next sessions. Finally, in each group, the quality of life and mental health questionnaire will be administered again and the research data will be analyzed using an appropriate statistical method. Quality of Life. Timepoint: One month after the burn ‌injury- At the end of treatment sessions. Method of measurement: WHOQOL-BREF Quality of Life Questionnaire. Mental health. Timepoint: One month after the burn ‌injury- At the end of treatment sessions. Method of measurement: Goldberg questionnaire. Rasht University of Medical Sciences Approved 2022-02-09 Research Ethic Committees of Guilan University of Medical science Guilan University of Medical science Rasht Guilan Iran (Islamic Republic of)