Comparing the effectiveness of cognitive-behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) on anxiety, perceived stress and coping with pain in patients with Leukemia
Comparing the effectiveness of cognitive-behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) on anxiety, perceived stress and coping with pain in patients with Leukemia
Design
A randomized controlled clinical trial with parallel groups; sample size 45
Settings and conduct
At first, the patients with leukemia were introduced to the researcher in coordination with Sayyed Shohada Hospital in Isfahan. Then, the researcher, by interviewing and examining the inclusion and exclusion criteria, selected 45 of them by available sampling method and randomly divided into three groups. Then, the researcher randomly selected two groups as the experimental group and one group as a control group. Then, one of the experimental groups received 9 sessions of Acceptance and Commitment Therapy, and the other group received 12 sessions of Cognitive-Behavioral Therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 30-80 years, Having a minimum reading and writing literacy, normal listening ability and informed consent to attend therapy sessions. Exclusion criteria: mental disorders that require urgent treatment, disruption of the normal course of treatment, lack of cooperation, and severe physical disability.
Intervention groups
In the first group, acceptance and commitment therapy, in the second group cognitive-behavioral therapy, in the third group no intervention will be performed.
Main outcome variables
anxiety; perceived stress; coping with pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191214045733N1
Registration date:2020-02-28, 1398/12/09
Registration timing:registered_while_recruiting
Last update:2020-02-28, 1398/12/09
Update count:0
Registration date
2020-02-28, 1398/12/09
Registrant information
Name
manoochehr faryabi
Name of organization / entity
Islamic azad university kish international
Country
Iran (Islamic Republic of)
Phone
+98 34 4326 4000
Email address
rafiepoor@pnu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-13, 1398/09/22
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of cognitive-behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) on anxiety, perceived stress and coping with pain in patients with Leukemia
Public title
Comparing the effectiveness of cognitive-behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) on anxiety, perceived stress and coping with pain in patients with Leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 30 to 80 years
Having a minimum reading and writing literacy
Normal listening ability
Informed consent to attend therapy sessions
Exclusion criteria:
Having any chronic diseases like diabetes, heart disease and lung disease
Having any physical or mental disability
Any drug use
Taking any sedative medication
History of psychiatric illness
Absence in more than 3 treatment sessions
Age
From 30 years old to 80 years old
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
Block randomization was performed by the statistical consultant as follows: Randomization was performed in three groups: Acceptance and Commitment Therapy, Cognitive-Behavioral Therapy, and Control group. Block randomization was done by building blocks of sequences so that the same number of participants was assigned to study groups within each group. We first coded the groups in Latin letters as follows:
A = Acceptance and Commitment Therapy, B = Cognitive-Behavioral Therapy, and C= Control Group
In this study with three groups A, B and C we created the following six groups and assign 1 to 6 each:
ABC-ACB-BAC-BCA-CAB-CBA
Then we used a random number table to select one of these blocks whenever the numbers 1, 2, 3, 4, 5 and 6 appear, and if the other number appears, considered null and go to the next choice. In fact, we obtained a random sequence of numbers with a random number table that we considered the order of assignment for each number. As such, the number of people in the groups was 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
Hormozgan University of Medical Sciences
Street address
Shahid Chamran Blvd, Bandar Abbas University of Medical Sciences
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.329
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukemia
Primary outcomes
1
Description
Anxiety
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Beck Anxiety Inventory (1988)
2
Description
Coping with pain
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Pain coping strategies Questionnaire Roseneshteil and kiev (2000)
3
Description
Perceived Stress
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Perceived Stress Scale Cohen et.al (1983)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group One: Acceptance and commitment Therapy - For the first experimental group, 9 sessions of 90-minute Acceptance and commitment Therapy will be taught in groups (Hayes, 2004).
Category
Treatment - Other
2
Description
Second Group Intervention: Cognitive Behavioral Therapy - For the second group Cognitive Behavioral Therapy (Beck, 1988) will be administered in 12 sessions and each session for 90 minutes.
Category
Treatment - Other
3
Description
Control group: No Intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Seyed al-Shohada Hospital
Full name of responsible person
Manouchehr Faryabi
Street address
No. 313, Jiroft, Azadi Street, Jiroft
City
Kerman
Province
Kerman
Postal code
7861733869
Phone
+98 34 4326 4000
Email
faryabi_m@yahoo.com
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
Kish
Province
Hormozgan
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
20
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
Manouchehr Faryabi
Position
Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 313, Azadi Street,
City
Kerman
Province
Kerman
Postal code
7861733869
Phone
+98 34 4326 4000
Email
faryabi_m@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Manouchehr Faryabi
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 313, Azadi Street,
City
Kerman
Province
Kerman
Postal code
7861733869
Phone
+98 34 4326 4000
Email
faryabi_m@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Manouchehr Faryabi
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 313, Azadi Street,
City
Kerman
Province
Kerman
Postal code
7861733869
Phone
+98 34 4326 4000
Email
faryabi_m@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
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
Manouchehr Faryabi, Postal address: Kerman, Jiroft, Azadi St., No.313
What processes are involved for a request to access data/document
The request will be sent by email to: faryabi_m@yahoo.com