Protocol summary

Study aim
Determining the Effectiveness of Acceptance and Commitment Therapy on the Sense of coherence, Locus of Control , and Post-Traumatic Growth in Patients with Spinal Cord Injury and Multiple Sclerosis
Design
Clinical trial - has a randomized control group
Settings and conduct
This research is done on the psychological problems of patients with spinal cord and multiple sclerosis in Tehran.
Participants/Inclusion and exclusion criteria
The criteria for entering patients with spinal cord injury - Have ages between 20 and 55 years old. - Have at least a diploma. - live in Tehran. - At least one year from the time of the lesion. - A maximum of five years from the time of the lesion. - Ability to use your upper extremity. Criteria for the withdrawal of patients with spinal cord injury - Their cervical spinal cord injury. - Have alcohol or drugs. - Simultaneously undergo another psychological treatment. - have more than two absentee sessions. - Have brain damage. The criteria for the entry of MS patients - Have ages between 20 and 55 years old. - Have at least a diploma. - live in Tehran. - At least one year from the time of illness. - A maximum of five years from the end of the illness. - Based on the ICF index, they have the ability to use the upper limb. MS patient exit criteria - Multiple sclerosis is benign. - Have alcohol or drugs. - Simultaneously undergo another psychological treatment. - have more than two absentee sessions. - have memory problems.
Intervention groups
The intervention group included 15 patients with spinal cord injury and 15 patients with multiple sclerosis who received acceptance and commitment for eight sessions.
Main outcome variables
Sense of coherence, Locus of Control , Post-Traumatic Growth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180710040411N1
Registration date: 2018-10-07, 1397/07/15
Registration timing: registered_while_recruiting

Last update: 2018-10-07, 1397/07/15
Update count: 0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Javad Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0061
Email address
sa.khanjani@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of acceptance and commitment therapy on the sense of coherence,Locus of Control and post-traumatic growth in patients with spinal cord injury and MS
Public title
Effectiveness of acceptance and commitment therapy on the sense of coherence,Locus of Control and post-traumatic growth in patients with spinal cord injury and MS
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria‏ for sci Aged between 20 and 55 years old have at least a diploma education . reside in Tehran At least one year has passed since the time of the lesion. Maximum five years from the time of the lesion. The ability to use your upper extremity. Inclusion Criteria‏ for ms have at least a diploma education reside in Tehran Based on the ICF indicator, the ability to Use of upper limbs at least one year from the end of the illness. maximum five years from the end of the illness Aged between 20 and 55 years old
Exclusion criteria:
Exclusion Criteria‏ for sci Have cervical spinal cord injury Simultaneously undergo another psychological treatment. Have alcohol or drugs use have more than two absentee sessions .Have brain damage Exclusion Criteria‏ for ms Have alcohol or drugs use have more than two absentee sessions have memory problems. Simultaneously undergo another psychological treatment Multiple sclerosis is benign
Age
From 20 years old to 55 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
Random sampling is used to select the samples and random assignment of the subjects to the experimental and control groups is also performed.
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
The Ethics Committee of of the Educational Deputy of the University of Welfare and Rehabilitation Sc
Street address
No.1, javadi ally., Mazandaran st., Emam Hossin sq., Tehran
City
Tehran
Province
Tehran
Postal code
1481886593
Approval date
2018-07-04, 1397/04/13
Ethics committee reference number
IR.USWR.REC.1397.019

Health conditions studied

1

Description of health condition studied
Spinal cord injury
ICD-10 code
T91.3
ICD-10 code description
Sequelae of injury of spinal cord

2

Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
The sense of coherence: the sense of mental integrity, a general orientation, a penetrating, sustainable and dynamic basis of assurance that the life events to which one is confronted is comprehensible, structured, and explainable, resources to deal with them And these events are meaningful and worthy of engagement
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
‎Antonovsky 's Sense of coherence scale

2

Description
Locus of Control: The concept of Locus of Control refers to the ability of humans to control environmental conditions and events. On the basis of this concept, people are divided into two categories: one, people with an internal Locus of Control, who perceive themselves to dominate their feelings, behavior, and living conditions, actively seek to modify and reform it, and the successes and They attribute their failures to their intrinsic factors.Second, individuals who have external control, who do not control themselves on their own circumstances and events, attribute their life events to external factors such as the chance, fate, and power of others. Indeed, it seems that these people do not rely on their abilities and efforts
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Julian Rotter's Locus of Control scale

3

Description
Post-traumatic Growth: Post-traumatic Growth As the mental experience of a positive mental change, the individual's struggle with a traumatic event is defined. An increase in the appreciation of life, the new priorities in life, the enhancement of personal self-esteem, the identification of new opportunities, the improvement of intimate relationships or spiritual change are examples of these positive psychological changes.
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Tedeschi & Calhoun post-traumatic traumatic growth scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: 15 patients with SCI receiving 8 sessions of acceptance and commitment therapy. This treatment is a type of third wave of cognitive therapy that, instead of changing the thoughts works on responses to thoughts, allows them to accept them. By accepting emotions and changing the response to Thoughts in this therapy are a form of flexibility in the individual, and this flexibility makes one committed to act in its original and intrinsic values.
Category
Rehabilitation

2

Description
intervention group 2: consists of 15 patients with MS who receive 8 sessions of acceptance and commitment therapy. This treatment is a type of third wave of cognitive therapy that, instead of changing the thoughts works on responses to thoughts, allows them to accept them. By accepting emotions and changing the response to Thoughts in this therapy are a form of flexibility in the individual, and this flexibility makes one committed to act in its original and intrinsic values.
Category
Rehabilitation

3

Description
Control group: Control group 1: has 15 patients with spinal cord injury who do not receive treatment.
Category
N/A

4

Description
Control group: Control group 2: consists of 15 patients with MS who do not receive treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shaheed Jalaypour's Spinal Cord Injury Center
Full name of responsible person
Ali Zarabi
Street address
Shaheed Jalayipour spinal cord center., behind Shaheed Akbar Abadi hospital., Mowlavi street.,Tehran
City
Tehran
Province
Tehran
Postal code
ندارد
Phone
+98 21 5515 6450
Email
sa.khanjani@uswr.ac.ir

2

Recruitment center
Name of recruitment center
Rofeideh Hospital
Full name of responsible person
Mohammad Saeed Khanjani
Street address
Rofeideh Rehabilitation Hospital., Nemati Alley., Soleimani St., Ghaytrieh.,Tehran
City
Tehran
Province
Tehran
Postal code
ندارد
Phone
+98 21 2220 5326
Email
sa.khanjani@uswr.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Mohamad Saeed Khanjani
Street address
University of Social Welfare and Rehabilitation Sciences., Khodakyar Alley., Student street.,Shahid Shahriyari Square.,Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
sa.khanjani@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
5
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Javad Kazemi
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
University of Social Welfare and Rehabilitation Sciences., Khodakyar Alley., Student street., Shahid Shahriyari Square., Tehran
City
Tehran
Province
Tehran
Postal code
65571-37347
Phone
+98 21 2218 0061
Email
kazemi012@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Javad Kazemi
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
University of Social Welfare and Rehabilitation Sciences., Khodakyar Alley., Student street., Shahid Shahriyari Square., Tehran
City
Tehran
Province
Tehran
Postal code
65571-37347
Phone
+98 21 2218 0061
Email
kazemi012@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Javad Kazemi
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
University of Social Welfare and Rehabilitation Sciences., Khodakyar Alley.,Student street.,Shahid Shahriyari Square.,Tehran
City
Tehran
Province
Tehran
Postal code
65571-37347
Phone
+98 21 2218 0061
Email
kazemi012@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results will be published without mentioning the names of the participants
When the data will become available and for how long
10 months
To whom data/document is available
Supervisors-Researchers - Journalists
Under which criteria data/document could be used
The data will be published without mentioning the names of individuals for presentation in research journals.
From where data/document is obtainable
Will be consulted by the University's Ethics Committee
What processes are involved for a request to access data/document
About three months after the completion of the project, the results of the research will be received by the applicant.
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