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IRCT20210717051911N1 IRCT 2021-08-14 The University of Lorestan Effect of Unified Transdiagnostic Treatment (UP) and Roy's adaptation model in treatment of hypertension A Comparison of the Effectiveness of Unified Transdiagnostic Treatment (UP) and Application of Roy's adaptation model on Blood Pressure, Alexithymia, Psychological Distress and Diet Adherence in People with Hypertension Comorbid with Stress 2021-12-12 anticipated 60 Complete https://irct.ir/trial/57554 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The block randomization method is performed by the statistical consultant as follows: randomization is performed in three groups: unified transdiagnostic treatment, application of Roy's adaptation model and control. First, a list of eligible individuals is provided and coded. We first code the groups in Latin letters as follows: A = unified transdiagnostic treatment, B= application of Roy's adaptation model and C = control group. In this study with three groups A, B, and C, we create the following six groups and assign a number from 1 to 6 to each group: ABC-ACB-BAC-BCA-CAB-CBA, Then, using the table of random numbers, we contract that if the numbers 1, 2, 3, 4, 5, and 6 appear in order, one of these blocks will be selected, and if another number appears, we will assume it to be void and move on to the next selection. We have obtained a random sequence of numbers with a table of random numbers that for each number we consider the desired order of assignment. In this way, the number of people in the groups will be approximately equal. N/A Hypertension. Intervention 1: The first intervention group: after taking part in a pre-test in a separate meeting, the participants will have the Unified Transdiagnostic treatment which includes 8 basic treatment factors and targets important aspects of the processing and regulating emotions. Eight collective treatment sessions will focus on different factors and take 90 minutes long. These factors briefly include 1. Motivational development and education if needed 2. Psychological training and monitoring emotional experiences 3. Training on the awareness of the emotions 4. Re-cognitive assessment training 5. Avoidance of excitement6. Understanding and tolerance of physical sensations 7. Situation-based emotional encounters 8. Prevention of recurrence of the symptoms. Intervention 2: The second intervention group: the Roy's adaptation model is implemented according to the steps of the nursing process, which are as follow: 1. Evaluation and recognition; 2. Nursing diagnosis; 3. Planning; 4. Implementation; 5. Assessment. In addition to the implementation of pre-tests, which is carried out on both the intervention and control group. In the intervention group, the first step is the evaluation and recognition form of Roy as well as the in-person interviews. Next, according to the obtained information, identification of incompatible behaviors, associated stimulations, and prioritizing these behaviors for the maladjusted and reformable behaviors, the objectives are determined and a suitable treatment program will be provided.The participants in the Roy's adaptation model intervention will be engaged in eight weekly treatment sessions for about an hour. Treatment steps details with respect to the identified stimuli in the implementation section are: 1. Hypertension disease familiarity (trained by a general doctor).2. Evaluating the important physiological parameters related to high blood pressure, such as nutrition and its effect on hypertension, and proposing solutions and behavioral trains by nutrition expert 3. Evaluating the other physiological parameters related to high blood pressure such as exercise, BMI, their effects on hypertension and education, and conducting suitable behavioral training by the general practitioner. 4. Proposing the methods for reducing stress, anxiety, and relaxing techniques by psychologist 5. Training methods to control anger, increase self-confidence, and positive self-assumption providing by psychologist 6. Teaching issues related to roles, responsibilities, social support, and taking drugs regularly 7. Convene training sessions related to taking part in social and religious events and avoiding isolation 8. Reviewing previous meetings. Intervention 3: The control group: 15 subjects will be randomly assigned to this group and do not receive any treatment for two months. At the end of the study, the subjects will receive whether Roy's adaptation model treatment or Unified Transdiagnostic treatment. Yes - There is a plan to make this available What will be shared: After deleting participants' identifying factors details, the information about the main consequences will be shared When: As the results are published To whom: Researchers working in universities and medical centers Conditions: In clinical and therapeutic work Where to obtain: Lorestan University Central Library, Adress: 5th Kilometer of Khorramabad-Boroujerd Highway, Khorramabad, Lorestan. Phone:06633120661 researcher, Marziyeh Kolivand, Email marzikolivand@yahoo.com How to obtain: If you are working in a university or scientific institution, it is necessary to provide the relevant document, and the reason for the need for the requested information and the type of relationship with the other study is requested. Comments:
public Marziyeh Kolivand
Shafagh2 Alley., Alavi 1 Street
Azna Iran (Islamic Republic of) 6871611111 +98 66 4336 2078 marzikolivand@yahoo.com The University of Lorestan scientific Marziyeh Kolivand
Shafagh2 Alley., Alavi 1 Street
Azna Iran (Islamic Republic of) 6871611111 +98 66 4336 2078 marzikolivand@yahoo.com The University of Lorestan Iran (Islamic Republic of) Have a minimum score of 19 or higher on the stress subscale of the DASS-21 questionnaire Being over 18 years old Having the minimum physical and cognitive abilities necessary to participate in the interventions Systolic blood pressure equal to or greater than 140 and diastolic blood pressure equal to or greater than 90 mm Hg Have a history of at least six months of medication for high blood pressure treatment Tendency to participate in treatment sessions 18 years 65 years Both Participate in other psychological interventions Having a history of mental illness and taking psychotropic drugs I10 Essential (primary) hypertension Diagnosis Rehabilitation N/A The first intervention group: after taking part in a pre-test in a separate meeting, the participants will have the Unified Transdiagnostic treatment which includes 8 basic treatment factors and targets important aspects of the processing and regulating emotions. Eight collective treatment sessions will focus on different factors and take 90 minutes long. These factors briefly include 1. Motivational development and education if needed 2. Psychological training and monitoring emotional experiences 3. Training on the awareness of the emotions 4. Re-cognitive assessment training 5. Avoidance of excitement6. Understanding and tolerance of physical sensations 7. Situation-based emotional encounters 8. Prevention of recurrence of the symptoms. The second intervention group: the Roy's adaptation model is implemented according to the steps of the nursing process, which are as follow: 1. Evaluation and recognition; 2. Nursing diagnosis; 3. Planning; 4. Implementation; 5. Assessment. In addition to the implementation of pre-tests, which is carried out on both the intervention and control group. In the intervention group, the first step is the evaluation and recognition form of Roy as well as the in-person interviews. Next, according to the obtained information, identification of incompatible behaviors, associated stimulations, and prioritizing these behaviors for the maladjusted and reformable behaviors, the objectives are determined and a suitable treatment program will be provided.The participants in the Roy's adaptation model intervention will be engaged in eight weekly treatment sessions for about an hour. Treatment steps details with respect to the identified stimuli in the implementation section are: 1. Hypertension disease familiarity (trained by a general doctor).2. Evaluating the important physiological parameters related to high blood pressure, such as nutrition and its effect on hypertension, and proposing solutions and behavioral trains by nutrition expert 3. Evaluating the other physiological parameters related to high blood pressure such as exercise, BMI, their effects on hypertension and education, and conducting suitable behavioral training by the general practitioner. 4. Proposing the methods for reducing stress, anxiety, and relaxing techniques by psychologist 5. Training methods to control anger, increase self-confidence, and positive self-assumption providing by psychologist 6. Teaching issues related to roles, responsibilities, social support, and taking drugs regularly 7. Convene training sessions related to taking part in social and religious events and avoiding isolation 8. Reviewing previous meetings The control group: 15 subjects will be randomly assigned to this group and do not receive any treatment for two months. At the end of the study, the subjects will receive whether Roy's adaptation model treatment or Unified Transdiagnostic treatment. Psychological distress. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Depression Anxiety and Stress Scale. Alexithymia. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Toronto Alexithymia Scale. Diet Adherence. Timepoint: Before intervention, The middle of intervention and after intervention. Method of measurement: Diet information registration form. The amount of blood pressure systolic. Timepoint: Before intervention, The middle of intervention and after intervention. Method of measurement: Digital sphygmomanometer. The amount of blood pressure diastolic. Timepoint: Before intervention, The middle of intervention and after intervention. Method of measurement: Digital sphygmomanometer. The University of Lorestan Approved 2021-07-05 Ethics committee of Lorestan University of Medical Sciences Lorestan University of Medical Sciences, Shahid Anooshirvan Rezaei Square, Khorramabad, Lorestan. Khorramabad Lorestan Iran (Islamic Republic of)