Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) with Cognitive-Behavioral Therapy (CBT) in Improving Psychological Symptoms in Multiple Sclerosis Patients
Abstract
Present research attributions mapped at the comparative scrutiny of Acceptance and Commitment Therapy (ACT) and Cognitive Behavior Therapy (CBT) impacts on psychological symptoms (tiredness, anxiety, stress and depression), resiliency and life quality amongst the Multiple Sclerosis (MS) patients.
Present study counted as a clinical trials or treatment trials with pretest, post test and also 1.5 and 3 months two phase follow up that for sample selection population after the list preparation of an outpatient clinic of Baqiyatallah hospital visitors and call on them, 66 persons who were interested in therapy selected via convenience sampling method and randomly put in order as three groups (22 patients in ACT group, 22 patients in CBT group and 22 patients in control group). The input criteria such as; 20-40 years old-rage, ability of orderly participation in therapy sessions and conscious satisfaction of participation in research plan. And output criteria similar to; having serious signs of MS, affliction to or suffering from extreme or serious physical or mental disease and not intend to participation in therapy process. Not only in order to present study attributions; the first experimental group received 90 minutes Acceptance and Commitment Therapy per 8 sessions and the second one; received 90 minutes Cognitive Behavior Therapy per 10 sessions, but also there was no intervention about control group. Variables of primary consequence; tiredness, anxiety, stress and depression and Variables of secondary or afterthought consequence; resiliency and life quality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112631115N1
Registration date:2017-09-13, 1396/06/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-13, 1396/06/22
Registrant information
Name
mohsen karimi
Name of organization / entity
Baqiyatallah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 5264 3283
Email address
moh3en.karimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Science
Expected recruitment start date
2016-12-20, 1395/09/30
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Acceptance and Commitment Therapy (ACT) with Cognitive-Behavioral Therapy (CBT) in Improving Psychological Symptoms in Multiple Sclerosis Patients
Public title
The Effectiveness of Psychological Therapy on Improving Psychological Symptoms in Patients with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-20-40 years old-rage
2-Ability of orderly participation in therapy sessions
3-Conscious satisfaction of participation in research plan
1-Having serious signs of MS
2-Affliction to or suffering from extreme or serious physical or mental disease
3-Not intend to participation in therapy process
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
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 Baqiatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Science, Molla Sadra Avenue, Vanak Squre, Tehran, Iran
City
Tehran
Postal code
7485114591
Approval date
2017-03-17, 1395/12/27
Ethics committee reference number
IR.BMSU.REC.1395.308
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
2
Description of health condition studied
Fatigue
ICD-10 code
R53
ICD-10 code description
General physical deterioration, Lethargy, Tiredness
3
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Two or three of the above symptoms are usually present. The patient is usually distressed by these but will probably be able to continue with most activities.
4
Description of health condition studied
Stress
ICD-10 code
ّّّّF43.0
ICD-10 code description
A transient disorder that develops in an individual without any other apparent mental disorder in response to exceptional physical and mental stress and that usually subsides within hours or days. Individual vulnerability and coping capacity play a role i
5
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is
Primary outcomes
1
Description
Fatigue
Timepoint
Before the intervention (pre-test), immediately after the intervention (post-test), after one month and half of the intervention (follow-up 1), after three month of the intervention(follow-up 2)
Method of measurement
Based on Fatigue in M.S patient Questionnaire
2
Description
Depresiion
Timepoint
Before the intervention (pre-test), immediately after the intervention (post-test), after one month and half of the intervention (follow-up 1), after three month of the intervention(follow-up 2)
Method of measurement
Depression, Anxiety & Stress Scale(DASS)
3
Description
Anxiety
Timepoint
Before the intervention (pre-test), immediately after the intervention (post-test), after one month and half of the intervention (follow-up 1), after three month of the intervention(follow-up 2)
Method of measurement
Depression, Anxiety & Stress Scale(DASS)
4
Description
Stress
Timepoint
Before the intervention (pre-test), immediately after the intervention (post-test), after one month and half of the intervention (follow-up 1), after three month of the intervention(follow-up 2)
Method of measurement
Depression, Anxiety & Stress Scale(DASS)
Secondary outcomes
1
Description
Resilience
Timepoint
Before the intervention (pre-test), immediately after the intervention (post-test), after one month and half of the intervention (follow-up 1), after three month of the intervention(follow-up 2)
Method of measurement
Connor- Davidson Resilience Scale
2
Description
Quality of Life
Timepoint
Before the intervention (pre-test), immediately after the intervention (post-test), after one month and half of the intervention (follow-up 1), after three month of the intervention(follow-up 2)
Method of measurement
M.s Quality of Life scale
Intervention groups
1
Description
Acceptance & Commitment Therapy(ACT)
Category
Behavior
2
Description
Cognitive-Behavior Therapy(CBT)
Category
Behavior
3
Description
No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr Gholamhosain Alishiri
Street address
Baqiyatallah University of Medical Science, Molla Sadra Avenue, Vanak Squre, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Baqiatallah University of Medical Sciences
Full name of responsible person
Dr Gholamhosain Alishiri
Street address
Baqiatallah University of Medical Science, Molla Sadra Avenue, Vanak Squre, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Baqiatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
mohsen karimi
Position
MS Clinical Psychology
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science, Molla Sadra Avenue, Vanak Squre, Tehran, Iran
City
Tehran
Postal code
7485114591
Phone
+98 31 5264 3283
Fax
Email
moh3en.karimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
mohsen karimi
Position
MS Clinical Psychology
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science, Molla Sadra Avenue, Vanak Squre, Tehran, Iran
City
Tehran
Postal code
7485114591
Phone
+98 31 5264 3283
Fax
Email
moh3en.karimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiatallah University of Medical Sciences
Full name of responsible person
mohsen karimi
Position
MS Clinical Psychology
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Science, Molla Sadra Avenue, Vanak Squre, Tehran, Iran Tehran
City
Tehran
Postal code
7485114591
Phone
+98 31 5264 3283
Fax
Email
moh3en.karimi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)