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IRCT20210531051454N1 IRCT 2021-06-26 Rasht University of Medical Sciences Survey of psychological interventions effect on hypertension patients’ improvement Comparison between the effectiveness of attentive rehabilitation of attention & memory, mindfulness-based education and integrated intervention on executive functions, anxiety and cardiovascular indices in patients with hypertension. 2021-05-05 anticipated 80 Complete https://irct.ir/trial/56601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Evaluation of Executive functions variable and anxiety variable are being done using computer, Randomization description: Participants were selected from patients coming to the Heshmat Cardiovascular hospital of Rasht. In the first session, the goal and method of the study were described to the patients and demographic characteristics questionnaires were filled. Then according to inclusion criteria and with study participation consent, 80 patients were selected and randomized into four 20-members groups of cognitive rehabilitation, mindfulness, combined and, control by Web-based Randomization (https://www.randomizer.org/) and according to allocation concealment by using Sequentially numbered, sealed, opaque envelopes (SNOSE). based on the research sample size, several aluminum envelopes were prepared and each random sequence were recorded on a card. the cards were placed into the separate envelopes respectively. To maintain the random sequence, the envelopes were numbered in the same way on their outer surface. In the end, the flaps of envelopes were glued and orderly placed in a box. At the beginning of the participants’ registration, envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: In this study, participants after obtaining informed consent and being randomly placed in the groups, will not receive any information about how the other groups is intervened, as well as how they themselves are positioned as the experimental group or the control group; and also the statistical analyzer is unaware of each step of randomization, participants grouping and, study setting, and method. N/A Hypertension. Intervention 1: Intervention group. 10 sessions of 1.5hour cognitive rehabilitation (once a week). First session. Explanation of the intended study, All the exercises below with difficulty level 1. Colored Home Task, faces Task, similar windows Task, marked table Task, Segmanted images Task, Acronym Making Task, last colored Task, Animal Tracing Task, Repetitive Images Task, Letter Matching Task and, Delay color Matching Task. Second session. All the first session exercises with difficulty level 2.Third session. All the first session exercises with difficulty level 3. fourth Session. All the first session exercises with difficulty level 4. fifth session. All the first session exercises with difficulty level 5. Sixth session. All the first session exercises with difficulty level 6. Seventh session. All the first session exercises with difficulty level 7. Eighth session. All the first session exercises with difficulty level 8. ninth session. All the first session exercises with difficulty level 9. Tenth session. All the first session exercises with difficulty level 10. Post-test. within the next 1 to 3 days. Follow up. One month later. Hint. Exercises with different stimulants are designed as a hierarchy with different difficulty levels and are presented in 10 graded levels. Stimulants' complexity increase, speed of the presentation, and advancing processing needs were used to progress the exercises. All exercises have a limited time and options like feedback presentation and calculation and smart observation of the scores. The therapist can increase the difficulty level due to the obtained score. Intervention 2: Intervention group. Eight 1.5hours sessions of education based on mindfulness (once a week). First session. Explanation of the intended study, the introduction of the group members to each other, inform the members about their disease and the role of the psychological factors in appearance and aggravation of the symptoms, determination of the goals and the patient expectation from the therapy, building a nice relationship, having raisin, body scan meditation, distributing CDs and pamphlets and an explanation of the mindfulness therapy method and providing home exercises. Second session. mindfulness of thoughts and emotions, recording pleasant events and providing home exercises. Third session. Sitting meditation, mindful walking, Three-minute mindfulness breathing space and providing home exercises. fourth Session. Looking and hearing meditation and providing home exercises. fifth session. Sitting meditation and providing home exercises. Sixth session. Meditative visualization, explain ambiguous scenarios and providing home exercises. Seventh session. Explain to the relation between mind and activity, discussion about the recurrence symptoms and providing home exercises. Eighth session. Review of the previous contents, reflection, feedback, Mindfulness Reminder Tools, goals survey and providing home exercises. Post-test. within the next 1 to 3 days. Follow up. One month later. Intervention 3: Intervention group. 18 sessions of integrated intervention (twice a week), Including 10 sessions of 1.5hour cognitive rehabilitation And Eight 1.5hours sessions of education based on mindfulness. First session. Explanation of the intended study, All the exercises below with difficulty level 1. Colored Home Task, faces Task, similar windows Task, marked table Task, Segmanted images Task, Acronym Making Task, last colored Task, Animal Tracing Task, Repetitive Images Task, Letter Matching Task and, Delay color Matching Task. Second session. Introduction of the group members to each other, inform the members about their disease and the role of the psychological factors in appearance and aggravation of the symptoms, determination of the goals and the patient expectation from the therapy, building a nice relationship, having raisin, body scan meditation, distributing CDs and pamphlets and an explanation of the mindfulness therapy method and providing home exercises. Third session. All the first session exercises with difficulty level 2. fourth Session. mindfulness of thoughts and emotions, recording pleasant events and providing home exercises. fifth session. All the first session exercises with difficulty level 3. Sixth session. Sitting meditation, mindful walking, Three-minute mindfulness breathing space and providing home exercises. Seventh session. All the first session exercises with difficulty level 4.Eighth session. Looking and hearing meditation and providing home exercises.ninth session. All the first session exercises with difficulty level 5. Tenth session. Sitting meditation and providing home exercises. Session 11. All the first session exercises with difficulty level 6. Session 12. Meditative visualization, explain ambiguous scenarios and providing home exercises. Session 13. All the first session exercises with difficulty level 7. Session 14. Explain to the relation between mind and activity, discussion about the recurrence symptoms and providing home exercises. Session 15. All the first session exercises with difficulty level 8. Session 16. Review of the previous contents, reflection, feedback, Mindfulness Reminder Tools, goals survey and providing home exercises. Session 17. All the first session exercises with difficulty level 9. Session 18. All the first session exercises with difficulty level 10. Post-test. within the next 1 to 3 days. Follow up. One month later. Intervention 4: Control group. No intervention. Post-test. simultaneous with the intervention groups. Follow up. simultaneous with the intervention groups.Hint. According to the charter of ethics in research, the control group (waiting list) will receive one of the interventions after the follow-up. Yes - There is a plan to make this available What will be shared: If there is a scientifically demonstrated research by a relevant study, all of our data after Id concealment can be shared. When: 6 months availability for the articles releasing after the study To whom: Occupied researchers in the universal and scientific institutes Conditions: The study should not be a repetition for current researches. City changes or minor variables variations are not acceptable. Practical changes in the method of the study, duration, and the way of intervention along with theoretical and research background are acceptable. Where to obtain: Communication with the researcher Fatemeh Rabipour by Email: Rabipour.f@gmail.com How to obtain: The data will be released in less than a month of contacting the researcher and presentation of the personal and scientific profile and registered information of the study such as ethical code &… . Comments:
public Fatemeh Rabipour
The Counseling and Psychology Center (Negaheno), Tirazhe Building, Lakani street, Rasht
Rasht Iran (Islamic Republic of) 4178795355 +98 13 3323 5433 Rabipour.f@gmail.com Islamic Azad University of Tabriz scientific Dr.Davood Hosseini Nasab
East side of Pasdaran Highway
Tabriz Iran (Islamic Republic of) 5157944533 +98 41 3196 6052 davoodhosseininasab@Gmail.com Islamic Azad University of Tabriz Iran (Islamic Republic of) Hypertension Males and females between 30 to 60 have the ability to read and write 30 years 60 years Both Other physical illnesses Other psychiatric illnesses addiction, or consumption of Psychotropic and psychoactive drugs 110 Essential (primary) hypertension. High blood pressure. Rehabilitation Behavior Behavior N/A Intervention group. 10 sessions of 1.5hour cognitive rehabilitation (once a week). First session. Explanation of the intended study, All the exercises below with difficulty level 1. Colored Home Task, faces Task, similar windows Task, marked table Task, Segmanted images Task, Acronym Making Task, last colored Task, Animal Tracing Task, Repetitive Images Task, Letter Matching Task and, Delay color Matching Task. Second session. All the first session exercises with difficulty level 2.Third session. All the first session exercises with difficulty level 3. fourth Session. All the first session exercises with difficulty level 4. fifth session. All the first session exercises with difficulty level 5. Sixth session. All the first session exercises with difficulty level 6. Seventh session. All the first session exercises with difficulty level 7. Eighth session. All the first session exercises with difficulty level 8. ninth session. All the first session exercises with difficulty level 9. Tenth session. All the first session exercises with difficulty level 10. Post-test. within the next 1 to 3 days. Follow up. One month later. Hint. Exercises with different stimulants are designed as a hierarchy with different difficulty levels and are presented in 10 graded levels. Stimulants' complexity increase, speed of the presentation, and advancing processing needs were used to progress the exercises. All exercises have a limited time and options like feedback presentation and calculation and smart observation of the scores. The therapist can increase the difficulty level due to the obtained score. Intervention group. Eight 1.5hours sessions of education based on mindfulness (once a week). First session. Explanation of the intended study, the introduction of the group members to each other, inform the members about their disease and the role of the psychological factors in appearance and aggravation of the symptoms, determination of the goals and the patient expectation from the therapy, building a nice relationship, having raisin, body scan meditation, distributing CDs and pamphlets and an explanation of the mindfulness therapy method and providing home exercises. Second session. mindfulness of thoughts and emotions, recording pleasant events and providing home exercises. Third session. Sitting meditation, mindful walking, Three-minute mindfulness breathing space and providing home exercises. fourth Session. Looking and hearing meditation and providing home exercises. fifth session. Sitting meditation and providing home exercises. Sixth session. Meditative visualization, explain ambiguous scenarios and providing home exercises. Seventh session. Explain to the relation between mind and activity, discussion about the recurrence symptoms and providing home exercises. Eighth session. Review of the previous contents, reflection, feedback, Mindfulness Reminder Tools, goals survey and providing home exercises. Post-test. within the next 1 to 3 days. Follow up. One month later. Intervention group. 18 sessions of integrated intervention (twice a week), Including 10 sessions of 1.5hour cognitive rehabilitation And Eight 1.5hours sessions of education based on mindfulness. First session. Explanation of the intended study, All the exercises below with difficulty level 1. Colored Home Task, faces Task, similar windows Task, marked table Task, Segmanted images Task, Acronym Making Task, last colored Task, Animal Tracing Task, Repetitive Images Task, Letter Matching Task and, Delay color Matching Task. Second session. Introduction of the group members to each other, inform the members about their disease and the role of the psychological factors in appearance and aggravation of the symptoms, determination of the goals and the patient expectation from the therapy, building a nice relationship, having raisin, body scan meditation, distributing CDs and pamphlets and an explanation of the mindfulness therapy method and providing home exercises. Third session. All the first session exercises with difficulty level 2. fourth Session. mindfulness of thoughts and emotions, recording pleasant events and providing home exercises. fifth session. All the first session exercises with difficulty level 3. Sixth session. Sitting meditation, mindful walking, Three-minute mindfulness breathing space and providing home exercises. Seventh session. All the first session exercises with difficulty level 4.Eighth session. Looking and hearing meditation and providing home exercises.ninth session. All the first session exercises with difficulty level 5. Tenth session. Sitting meditation and providing home exercises. Session 11. All the first session exercises with difficulty level 6. Session 12. Meditative visualization, explain ambiguous scenarios and providing home exercises. Session 13. All the first session exercises with difficulty level 7. Session 14. Explain to the relation between mind and activity, discussion about the recurrence symptoms and providing home exercises. Session 15. All the first session exercises with difficulty level 8. Session 16. Review of the previous contents, reflection, feedback, Mindfulness Reminder Tools, goals survey and providing home exercises. Session 17. All the first session exercises with difficulty level 9. Session 18. All the first session exercises with difficulty level 10. Post-test. within the next 1 to 3 days. Follow up. One month later Control group. No intervention. Post-test. simultaneous with the intervention groups. Follow up. simultaneous with the intervention groups.Hint. According to the charter of ethics in research, the control group (waiting list) will receive one of the interventions after the follow-up. Anxiety. Timepoint: Before and within 1 to 3 days after the end of intervention and a month after the end of intervention. Method of measurement: Beck Anxiety Inventory (BAI). Executive Functions. Timepoint: Before and within 1 to 3 days after the end of intervention and a month after the end of intervention. Method of measurement: Stroop Color and Word Test, Wisconsin Card Sorting Test (WCST), The Continuous Performance Test (CPT), N-BACK 1 & 2. Cardiovascular indices. Timepoint: Before and within 1 to 3 days after the end of intervention and a month after the end of intervention. Method of measurement: Cardiovascular indices variable including heart rate, Systolic and diastolic blood pressure and pulse pressure with a digital brachial sphygmomanometer and stethoscope were taken and calculated by a cardiovascular specialist. Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences Approved 2021-04-27 Research Ethics Committees of Islamic Azad University-Tabriz Branch East side of Pasdaran Highway Tabriz East Azarbaijan Iran (Islamic Republic of)