Comparing of the effectiveness of acceptance & commitment therapy and Schema therapy based on acceptance and commitment to body image, Self-Compassion, sexual self-esteem and couple burnout in dialysis women
Comparison of the effectiveness of acceptance and commitment therapy and schema therapy based on acceptance and commitment on the body image of dialysis women
Design
Clinical trial with control group, with parallel groups, blinded, randomized, on 45 patients. The rand function of Excel software was used for randomization.
Settings and conduct
The statistical population of this research consists of all married dialysis women who referred to Khorasan Razavi Dialysis Patients Support Association in 1400-1401. Blinding has not been done and available sampling will be selected and randomly replaced in two groups. The current research is a semi-experimental research with a pre-test-post-test design and a follow-up test with a control group.
Participants/Inclusion and exclusion criteria
Being married, more than 20 years old, passing at least 3 months of chronic kidney disease, having literacy and willing and informed consent to participate in the research;
Exit criteria:
From patients who had cognitive problems or psychotic disorders, patients who received other psychotherapy at the same time, as well as patients who had kidney transplant experience and missed more than two treatment sessions.
Intervention groups
They will be selected by available sampling and randomly replaced in two groups. The first group includes a group of 15 married women on dialysis who will receive acceptance and commitment treatment. The second group includes a group of 15 married women on dialysis, 15 married women who will be on the waiting list and will not receive treatment.
Main outcome variables
The effectiveness of acceptance and commitment therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N60
Registration date:2023-01-01, 1401/10/11
Registration timing:prospective
Last update:2023-01-01, 1401/10/11
Update count:0
Registration date
2023-01-01, 1401/10/11
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-04-09, 1402/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing of the effectiveness of acceptance & commitment therapy and Schema therapy based on acceptance and commitment to body image, Self-Compassion, sexual self-esteem and couple burnout in dialysis women
Public title
Comparison of the effectiveness of treatment of acceptance and commitment and marital burnout of dialysis women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being married
Age more than 20 years
Passing at least 3 months of chronic kidney disease and the need for dialysis
Having literacy and willing and informed consent to participate in research.
Exclusion criteria:
Patients with cognitive problems or psychotic disorders
Patients receiving other psychotherapy at the same time
Patients who have kidney transplant experience and absent more than two treatment sessions.
Age
From 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, permutation block method was used to generate a sequence of random allocation of individuals to the study groups. Random allocation sequence was performed using random allocation software and block size four. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied.
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 Islamic Azad University Mashhad Medical Sciences Unit
Street address
Qasim Abad (Gharb city, Khorasan, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Approval date
2022-08-24, 1401/06/02
Ethics committee reference number
IR.IAU.MSHD.REC.1401.118
Health conditions studied
1
Description of health condition studied
Sexual self-esteem and marital dissatisfaction of dialysis women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effectiveness of acceptance therapy
Timepoint
One day before the intervention and one day after
Method of measurement
Pre-test - post-test and follow-up test plan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, they are subjected to a pre-test, then they are put into a treatment schema based on acceptance and commitment,(8 sessions, one hour and a half each session during two months) and after the end of the test period, all tow groups will be subjected to a post-test.
Category
Diagnosis
2
Description
First, they undergo the pre-test, they are only placed on the waiting list, and after completing the intervention group, they complete the post-test.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorasan Razavi Dialysis Patients Support Association