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The Comparison of The effectiveness of Acceptance and commitment therapy(ACT) and cognitive psycho rehabilitation (CPRT) on psychological well-being and self-efficacy of low vision students

Protocol summary

Study aim
The Comparison of The effectiveness of Acceptance and commitment therapy(ACT) and cognitive psycho rehabilitation (CPRT) on psychological well-being and self-efficacy of low vision students
Design
A randomized controlled clinical trial with parallel groups, Randomized block, sample size 45 (15 persons per group)
Settings and conduct
Both groups completed self-efficacy and psychological well-being questionnaires before beginning the sessions and obtaining permission. Experimental group A (Acceptance and Commitment Therapy) and experimental group B (Cognitive Rehabilitation) were trained weekly in high school students respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria included secondary education and partially sighted. Exclusion criteria were diseases that lead to hospitalization, absence of more than two sessions in therapeutic sessions and the occurrence of major stress from unforeseen events.
Intervention groups
In the first group, acceptance and commitment based therapy, in the second group cognitive rehabilitation and in the third group no intervention will be performed.
Main outcome variables
self-efficacy and psychological well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200223046596N1
Registration date: 2020-03-17, 1398/12/27
Registration timing: retrospective

Last update: 2020-03-17, 1398/12/27
Update count: 0
Registration date
2020-03-17, 1398/12/27
Registrant information
Name
Miroun Mousavi Tilehbeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4490 0143
Email address
m.mousavi@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-15, 1398/09/24
Expected recruitment end date
2020-03-11, 1398/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of The effectiveness of Acceptance and commitment therapy(ACT) and cognitive psycho rehabilitation (CPRT) on psychological well-being and self-efficacy of low vision students
Public title
The Comparison of The effectiveness of Acceptance and commitment therapy(ACT) and cognitive psycho rehabilitation (CPRT) on psychological well-being and self-efficacy of low vision students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ٍEducating in in Tehran secondary schools partially sighted
Exclusion criteria:
Diseases that lead to hospitalization Absence of more than two sessions in therapeutic sessions The occurrence of major stress from unforeseen events
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
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: Acceptance and Commitment therapy, cognitive psycho rehabilitation and control: First, a list of eligible individuals is provided and coded. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows: A = Acceptance and Commitment therapy, B = cognitive psycho rehabilitation, and C control group In this study with three groups A, B and C we create the following six groups and assign 1 to 6 each: ABC-ACB-BAC-BCA-CAB-CBA Then, using the random number table, we choose one of these blocks whenever the numbers 1, 2, 3, 4, 5, 6 appear, and if the other number appears, consider null and go to the next choice. . In fact, we have obtained a random sequence of numbers with a random number table that we consider the order of assignment for each number. 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 Hormozgan University Of Medical Sciences
Street address
No. 64, Janbazan Ave., North Karegar Street
City
Tehran
Province
Tehran
Postal code
1437697419
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.332

Health conditions studied

1

Description of health condition studied
partially sighted
ICD-10 code
H54
ICD-10 code description
Blindness and low vision

Primary outcomes

1

Description
Psychological Well-being
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Ryff Psychological Well-being Scale

2

Description
Self-efficacy
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Schwartz & Jeroselm Self-efficacy Questionnaire (1995)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In the present study, the purpose of cognitive rehabilitation therapy is 12 sessions based on cognitive rehabilitation intervention that were held twice weekly (for one month and a half) and each session for 45 minutes.
Category
Treatment - Other

2

Description
Intervention group II: Acceptance and commitment therapy and a 90-minute 9-session treatment plan twice a week (for a month and a half) based on ACT Hayes (2004) protocol and designed as a group experimental group subjects are provided.
Category
Treatment - Other

3

Description
Control group: No Intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Secondary schools in Tehran
Full name of responsible person
Miroun Mousavi Tolebani
Street address
No 1., Block 6, Phase 6, Tehran University Town
City
Tehran
Province
Tehran
Postal code
1414616183
Phone
+98 21 8839 6380
Email
m.mousavi@iaukishint.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Roosta
Street address
Islamic Azad University of Kish International Branch, Free Zone Organization Square, Sana'i Boulevard, Kish Island.
City
Tehran
Province
Tehran
Postal code
7941775883
Phone
+98 76 4442 2720
Email
Info@Iaukishint.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Full name of responsible person
Miroun Mousavi Tilehbeni
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran - 12 km Special Road - Karaj University of Tehran - Phase 6 - Block 6 - Unit 1
City
Tehran
Province
Tehran
Postal code
1414616183
Phone
+98 21 4490 0143
Fax
Email
M.Mousavi@iaukishint.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Miroun Mousavi Tilehbeni
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran - 12 km Special Road - Karaj University of Tehran - Phase 6 - Block 6 - Unit 1
City
Tehran
Province
Tehran
Postal code
1414616183
Phone
+98 21 4490 0143
Fax
Email
M.Mousavi@iaukishint.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Miroun Mousavi Tilehbeni
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran - 12 km Special Road - Karaj University of Tehran - Phase 6 - Block 6 - Unit 1
City
Tehran
Province
Tehran
Postal code
1414616183
Phone
+98 21 4490 0143
Fax
Email
M.Mousavi@iaukishint.ac.ir

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
Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Any type of analysis on the data delivered is permitted
From where data/document is obtainable
Miroun Mousavi Tilebani No 1., Block 6, Phase 6, Tehran University Town +98 21 8839 6380
What processes are involved for a request to access data/document
The request will be sent by email to: m.mousavi@iaukishint.ac.ir
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