1. Home
  2. Approved trials
  3. » فارسی

Effectiveness of acceptance and commitment therapy on depression, social function and fatigue in hemodialysis patients

Protocol summary

Study aim
The purpose of this study was to determine the efficacy of acceptance and commitment therapy on self-care and fatigue and role impairment due to physical health of hemodialysis patients.
Design
In this study, 60 hemodialysis patients who were admitted to hospital were selected. The participants were divided into intervention and control groups.
Settings and conduct
The research method was pretest-posttest with control group. The statistical population of this study was all hemodialysis patients who referred to dialysis department of Bou-Ali hospital in Ardebil in the second half of 1394. The sample size was 60 people who were selected by available sampling method and were randomly assigned into two experimental and control groups
Participants/Inclusion and exclusion criteria
Inclusion criteria include the age of patients aged 20-70 years, the absence of a history of an accident or an illness in the last six months, the absence of history of depression, or admission to psychiatric causes before kidney failure, and hemodialysis, lack of physical or mental disability, minimum hemodialysis For 6 months and above the cut-off point "14" based on the BDI-II Depression Inventory, the outcomes included: reluctance to continue cooperation, the occurrence of any illness or severe disability, and transplantation
Intervention groups
Effectiveness of treatment based on admission and commitment to care, fatigue and role impairment due to physical health of hemodialysis patients
Main outcome variables
According to the results of this study, acceptance and commitment therapy to increase self-care, decreasing fatigue and role impairment have a significant effect on physical health in hemodialysis patients, and in increasing self-care, decreasing fatigue and role impairment due to physical health of patients, this study yielded significant improvements.

General information

Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number: IRCT20171027037028N2
Registration date: 2018-06-15, 1397/03/25
Registration timing: retrospective

Last update: 2018-06-15, 1397/03/25
Update count: 0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 1669
Email address
parisapari070@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-01-01, 1394/10/11
Actual recruitment start date
2015-12-01, 1394/09/10
Actual recruitment end date
2016-01-01, 1394/10/11
Trial completion date
empty
Scientific title
Effectiveness of acceptance and commitment therapy on depression, social function and fatigue in hemodialysis patients
Public title
The Effectiveness of Acceptance and Commitment Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of patients aged 20-70, No history of incident or bad experience during the last six months Not having history of depression or hospitalization for psychological causes before kidney failure and hemodialysis Not having physical or mental disabilities Perform hemodialysis for at least 6 months and counting above the cut-off point "14" based on the BDI-II Depression Inventory
Exclusion criteria:
Unwillingness to continue cooperation It was the onset of any serious illness or disability and transplantation.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 3
60 people-30 received 30 treatment recipients.
Actual sample size reached: 60
More than 1 sample in each individual
Actual sample size in each individual: 3
Self-care Depression Quality of Life
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, members of the community are numbered from 1 to N, then a table row and column are randomly selected. The point of the intersection of the selected row and column is the starting point for sampling, from this point one to plus and a multiplicity is drawn. All numbers that are added on or over to it are selected as sample members. It should be remembered that instead of drawing a multiplicity or addition, the hand can be moved on this table continuously and continues until the sample is selected
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the experimental group received 8 consecutive 90-minute treatment groups based on acceptance and approval. Patients in the control group received another training in 8 sessions of 90 minutes to control the effect of Huthorn and placebo
Placebo
Used
Assignment
Single
Other design features
NO

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil Azad university
Street address
Ardabil NAYEBI SQUARE
City
Ardabil
Province
Ardabil
Postal code
5614773895
Approval date
2016-02-17, 1394/11/28
Ethics committee reference number
11920701932112

Health conditions studied

1

Description of health condition studied
Self-care, fatigue and role impairment due to physical well-being of hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
According to the results of this study, acceptance and commitment therapy to increase self-care, decreasing fatigue and role impairment have a significant effect on physical health in hemodialysis patients, and in increasing self-care, decreasing fatigue and role impairment due to physical health of patients, this study yielded significant improvements I was born.
Timepoint
3MOUNTS
Method of measurement
Beck depression questionnaire-Adjusted self-care questionnaire-Chinese version-Quality of life SF-36

Secondary outcomes

empty

Intervention groups

1

Description
Thirty-one had a placebo-controlled study and 30 received acceptance and commitment-based treatment
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
dialysis unit of Bu-Ali hospital in Ardabil
Full name of responsible person
Akram Azemi Zeinal
Street address
Ardebil Street Naibi
City
Ardebil
Province
Ardabil
Postal code
5614773895
Phone
+98 45 3323 1669
Email
parisapari070@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Akram Azemi Zeinal
Street address
Ardebil Street Naibi
City
Ardebil
Province
Ardabil
Postal code
5614773895
Phone
+98 45 3323 1669
Fax
Email
parisapari070@gmail.com
Web page address
Grant name
Author responsible for the budget
Grant code / Reference number
کد بودجه وجود ندارد
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
akram azemi zeynal
Position
نیروی طرحی
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Street Naibi-alley Mullah Hadi-Kouleh Aghahan Khan-plaque 48
City
ardebil
Province
Ardabil
Postal code
5614783895
Phone
+98 45 3323 1669
Email
parisapari070@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad university
Full name of responsible person
akram azemi zeinal
Position
M.A
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
nayebi square mollahadi alley aghagan khan alley n:48
City
Ardabil
Province
Ardabil
Postal code
5614773895
Phone
+98 45 3323 1669
Fax
Email
parisapari070@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
akram azemi zeynal
Position
Psychology master
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Street Naibi-alley Mullah Hadi-Kouleh Aghahan Khan-plaque 48
City
ardebil
Province
Ardabil
Postal code
5614773895
Phone
+98 45 3323 1669
Email
parisapari070@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
scientific theft
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...