IRCT | 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.

Protocol summary

Study aim: The aim of this study was to 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.
Design: A randomized clinical trial with 1month follow up with parallel groups and Double blinded
Settings and conduct: Participants were selected from patients coming to the Heshmat Cardiovascular hospital of Rasht. 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 by Web-based Randomization and according to allocation concealment by using SNOSE. Interventions will be performed in Heshmat Hospital.
Participants/Inclusion and exclusion criteria: Hypertension, Males and females between 30 to 60, have the ability to read and write, without any other physical and psychological illness, without addiction, or consumption of psychoactive drugs.
Intervention groups: group 1. 10 sessions of 1.5hour cognitive rehabilitation (once a week). group 2. Eight 1.5hours sessions of education based on mindfulness (once a week). group 3. 18 sessions of integrated intervention (twice a week). group 4. Control group, No intervention.
Main outcome variables: To gather pre-test, post-test and follow-up information, the following items will be considered, performed, and calculated. anxiety variable according to the Beck anxiety Inventory. executive functions variable as follows. Wisconsin Card Sorting, Stroop Color and Word, Continuous Performance, N-BACK tests 1 & 2. Cardiovascular indexes variable including heart rate, Systolic and diastolic blood pressure and pulse pressure with a digital bronchial sphygmomanometer and stethoscope.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20210531051454N1

Registration date: 2021-06-26, 1400/04/05

Registration timing: retrospective

Last update: 2021-06-26, 1400/04/05

Update count: 0
Registration date: 2021-06-26, 1400/04/05

Registrant information: Name

Fatemeh Rabipour

Name of organization / entity

Tabriz Azad University

Country

Iran (Islamic Republic of)

Phone

+98 13 3323 5433

Email address

stu.rabipour.f@iaut.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2021-05-05, 1400/02/15
Expected recruitment end date: 2021-06-20, 1400/03/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: 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.

Public title: Survey of psychological interventions effect on hypertension patients’ improvement
Purpose: Education/Guidance
Inclusion/Exclusion criteria: Inclusion criteria:

Hypertension Males and females between 30 to 60 have the ability to read and write

Exclusion criteria:

Other physical illnesses Other psychiatric illnesses addiction, or consumption of Psychotropic and psychoactive drugs
Age: From 30 years old to 60 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Data analyser

Sample size

Target sample size: 80

Randomization (investigator's opinion)

Randomized

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 (investigator's opinion)

Double blinded

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.

Placebo

Not used

Assignment

Parallel

Other design features

Evaluation of Executive functions variable and anxiety variable are being done using computer.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of Islamic Azad University-Tabriz Branch

Street address

East side of Pasdaran Highway

City

Tabriz

Province

East Azarbaijan

Postal code

5157944533
Approval date: 2021-04-27, 1400/02/07
Ethics committee reference number: IR.IAU.TABRIZ.REC.1400.020

Health conditions studied

1

Description of health condition studied: Hypertension
ICD-10 code: 110
ICD-10 code description: Essential (primary) hypertension. High blood pressure.

Primary outcomes

1

Description: 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)

2

Description: 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

3

Description: 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.

Secondary outcomes

empty

Intervention groups

1

Description: 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.
Category: Rehabilitation

2

Description: 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.
Category: Behavior

3

Description: 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
Category: Behavior

4

Description: 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.
Category: N/A

Recruitment centers

1

Recruitment center: Name of recruitment center

Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medic

Full name of responsible person

Dr. Arsalan Salari

Street address

The beginning of the Bayani alley, Mosalla street (15 Khordad)

City

Rasht

Province

Guilan

Postal code

4193955588

Phone

+98 13 3361 8177

Fax

+98 13 3361 8177

Email

gums.icrc@gmail.com

Web page address

https://www.gums.ac.ir/gicrc/Default.aspx?tabid=7054

1

Sponsor: Name of organization / entity

Rasht University of Medical Sciences

Full name of responsible person

Dr. Arsalan Salari

Street address

The beginning of the Bayani alley, Mosalla street (15 Khordad)

City

Rasht

Province

Guilan

Postal code

4193955588

Phone

+98 13 3361 8177

Fax

+98 13 3361 8177

Email

gums.icrc@gmail.com

Web page address

https://www.gums.ac.ir/gicrc/Default.aspx?tabid=7054
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: Cardiovascular Diseases Research Center, Department of Cardiology, Heshmat Hospital, School of Medicine, Guilan University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Islamic Azad University of Tabriz

Full name of responsible person

Fatemeh Rabipour

Position

PHD student

Latest degree

Master

Other areas of specialty/work

Psychology

Street address

The Counseling and Psychology Center (Negaheno), Tirazhe Building, Lakani street, Rasht

City

Rasht

Province

Guilan

Postal code

4178795355

Phone

+98 13 3323 5433

Email

Rabipour.f@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Islamic Azad University of Tabriz

Full name of responsible person

Dr.Davood Hosseini Nasab

Position

professor

Latest degree

Ph.D.

Other areas of specialty/work

Psychology

Street address

East side of Pasdaran Highway

City

Tabriz

Province

East Azarbaijan

Postal code

5157944533

Phone

+98 41 3196 6052

Email

davoodhosseininasab@Gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Tabriz Azad University

Full name of responsible person

Fatemeh Rabipour

Position

PHD student

Latest degree

Master

Other areas of specialty/work

Psychology

Street address

The Counseling and Psychology Center (Negaheno), Tirazhe Building, Lakani street, Rasht

City

Rasht

Province

Guilan

Postal code

4178795355

Phone

+98 13 3323 5433

Fax

Email

Rabipour.f@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: If there is a scientifically demonstrated research by a relevant study, all of our data after Id concealment can be shared.
When the data will become available and for how long: 6 months availability for the articles releasing after the study
To whom data/document is available: Occupied researchers in the universal and scientific institutes
Under which criteria data/document could be used: 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.
From where data/document is obtainable: Communication with the researcher Fatemeh Rabipour by Email: Rabipour.f@gmail.com
What processes are involved for a request to access data/document: 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

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.