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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

Protocol summary

Study aim
A Comparison of the Effectiveness of Unified Transdiagnostic Treatment (UP) and Application of Roy's adaptation model on Blood Pressure Reduction, Alexithymia ,Psychological Distress and Diet Adherence in People with Hypertension Patients Comorbid with Stress
Design
This study is a randomized Clinical trial with one control group and two parallel intervention groups, designed for 45 patients, using SPSS software to analyze the data. This is not a blinded study.
Settings and conduct
This study is performed on People with Hypertension Patients Comorbid with Stress. The patients visited the Aligoodarz 17 Shahrivar Civil Health Care Center (The location of the study: the Aligoodarz 17 Shahrivar Civil Health Care Center; It is not a blinded study).
Participants/Inclusion and exclusion criteria
Inclusion criteria: achieving at least the score of 19 in stress sub-scale of DASS – 21 scale; having more than 18 years old; hypertension equal or higher than 140 mm mercury; diastolic hypertension equal or more than 90 mm mercury; Using hypertension drugs in more than six months; be willing to participate. Non inclusion criteria: participating in the psychological interventions simultaneously; having a history of mental illness and drug abuse
Intervention groups
The intervention group 1: Treatment sessions based on Unified Transdiagnostic Treatment book of Barlow et al will be performed according to the protocol (1 session per week, each session about 90 minutes – totally 8 sessions during 2 months). The intervention group 2: Treatment sessions based on Application of Roy's adaptation model will be performed according to the protocol (1 session per week, each session about 60 minutes – totally 8 sessions during 2 months). Control group: doesn't receive any intervention.
Main outcome variables
Psychological distress, Alexithymia, Diet Adherence, Blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210717051911N1
Registration date: 2021-08-14, 1400/05/23
Registration timing: prospective

Last update: 2021-08-14, 1400/05/23
Update count: 0
Registration date
2021-08-14, 1400/05/23
Registrant information
Name
Marziyeh Kolivand
Name of organization / entity
The University of Lorestan
Country
Iran (Islamic Republic of)
Phone
+98 66 4336 2078
Email address
kolivand.mz@fh.lu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-12, 1400/09/21
Expected recruitment end date
2021-12-15, 1400/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of Unified Transdiagnostic Treatment (UP) and Roy's adaptation model in treatment of hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Participate in other psychological interventions Having a history of mental illness and taking psychotropic drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, Shahid Anooshirvan Rezaei Square, Khorramabad, Lorestan.
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2021-07-05, 1400/04/14
Ethics committee reference number
IR.LUMS.REC.1400.100

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Psychological distress
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Depression Anxiety and Stress Scale

2

Description
Alexithymia
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Toronto Alexithymia Scale

3

Description
Diet Adherence
Timepoint
Before intervention, The middle of intervention and after intervention
Method of measurement
Diet information registration form

4

Description
The amount of blood pressure systolic
Timepoint
Before intervention, The middle of intervention and after intervention
Method of measurement
Digital sphygmomanometer

5

Description
The amount of blood pressure diastolic
Timepoint
Before intervention, The middle of intervention and after intervention
Method of measurement
Digital sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Diagnosis

2

Description
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
Category
Rehabilitation

3

Description
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.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
17 Shahrivar Comprehensive Urban Health Service Center
Full name of responsible person
Marziyeh Kolivand
Street address
Mohammad Sadegh Khansari Alley, Valiasr Shomali Street
City
Aligudarz
Province
Lorestan
Postal code
6861393988
Phone
+98 66 4334 2259
Email
marzikolivand@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Lorestan
Full name of responsible person
Mohammad Feizian
Street address
5th kilometer of Tehran road , Khorramabad, Lorestan
City
Khorramabad
Province
Lorestan
Postal code
44316-68151
Phone
+98 21 3312 0097
Email
lorestanuni@lu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lorestan
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
The University of Lorestan
Full name of responsible person
Marziyeh Kolivand
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shafagh2 Alley., Alavi 1 Street
City
Azna
Province
Lorestan
Postal code
6871611111
Phone
+98 66 4336 2078
Email
marzikolivand@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lorestan
Full name of responsible person
Marziyeh Kolivand
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shafagh2 Alley., Alavi 1 Street
City
Azna
Province
Lorestan
Postal code
6871611111
Phone
+98 66 4336 2078
Email
marzikolivand@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Lorestan
Full name of responsible person
Marziyeh Kolivand
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
خیابان علوی یک، کوچه شفق دو
City
Azna
Province
Lorestan
Postal code
6871611111
Phone
+98 66 4336 2078
Email
marzikolivand@yahoo.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
After deleting participants' identifying factors details, the information about the main consequences will be shared
When the data will become available and for how long
As the results are published
To whom data/document is available
Researchers working in universities and medical centers
Under which criteria data/document could be used
In clinical and therapeutic work
From where data/document is obtainable
Lorestan University Central Library, Adress: 5th Kilometer of Khorramabad-Boroujerd Highway, Khorramabad, Lorestan. Phone:06633120661 researcher, Marziyeh Kolivand, Email marzikolivand@yahoo.com
What processes are involved for a request to access data/document
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.
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