The Effectiveness of Acceptance and Commitment Therapy on Cognitive Flexibility and Emotional Regulation of Patients with Spinal Cord Injury and MS Patients
Determining the effectiveness of acceptance and commitment therapy on psychological flexibility and emotional regulation in patients with spinal cord injury and multiple sclerosis
Design
Clinical trial, randomized, with 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 inclusion criteria for patients with spinal cord injury:
- age between 20 and 55 years.
- education at least diploma.
- live in Tehran.
- At least one year after lesion.
- A maximum of five years from the time of the lesion.
- Ability to use upper extremity.
Exclusion criteria for patients with spinal cord injury:
- 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 treatment for eight sessions.
Main outcome variables
Psychological flexibility and emotional regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180710040411N3
Registration date:2018-11-24, 1397/09/03
Registration timing:registered_while_recruiting
Last update:2018-11-24, 1397/09/03
Update count:0
Registration date
2018-11-24, 1397/09/03
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
The Effectiveness of Acceptance and Commitment Therapy on Cognitive Flexibility and Emotional Regulation of Patients with Spinal Cord Injury and MS Patients
Public title
The Effectiveness of Acceptance and Commitment Therapy on Cognitive Flexibility and Emotional Regulation of Patients with Spinal Cord Injury and MS Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria for sci
have at least a diploma education
reside in Tehran
Aged between 20 and 55 years old
At least one year has passed since the time of the lesion.
Maximum five years from the time of the lesion.
Inclusion criteria for MS
have at least a diploma education
reside in Tehran
Aged between 20 and 55 years old
at least one year pass from the end of the illness
maximum five years passed from the illness
Based on the ICF indicator, the ability to Use of upper limbs
Exclusion criteria:
Exclusion criteria for sci
Have cervical spinal cord injury
Simultaneously undergo another psychological treatment
Have alcohol or drugs use.
Have brain damage
have more than two absentee sessions
Exclusion criteria for MS
Multiple sclerosis is benign
Using alcohol or drugs
have more than two absent sessions
have memory problems
Simultaneously undergo another psychological treatment
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
In order to select the samples in the experimental and control groups, simple random method with Using random numbers, was used. Randomizing unit was individually. Therefore, according to the inclusion and exclusion criteria among the patients with spinal cord and MS which were referred to the center of the SCI in Shahid Jalayipoor in Tehran and the MS Society of Iran in 2018, 60 patients (30 patients with sci and 30 MS patients) were selected.
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
Cognitive Flexibility: Cognitive Flexibility refers to the ability of individuals to focus on the present situation and to take advantage of opportunities to position them in pursuit of intrinsic goals and values, despite the presence of challenging or unwanted psychological events (for example, thoughts, feelings , Physiological emotions, mental images and memories).
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Questionnaire
2
Description
The emotional setting is a unique process that modifies the emotional experience to achieve social acceptance and relates to physical and psychological states in response to internal or external demands.
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Questionnaire
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: 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.