The effectiveness of group therapy based on acceptance and commitment to reduce anxiety and improve the quality of life in patients with dialysis and kidney transplant
The comparative evaluation of the effectiveness of group therapy based on acceptance and commitment to reduce anxiety and improve the quality of life in patients with dialysis and kidney transplant.
Design
The study population will be included all patients with dialysis and kidney transplant from 5 to 15 years old. The sample size will be 60 patients. Intervention will be included: the first group treatment of hemodialysis patients based on acceptance and commitment, the second group Treatment of kidney transplant patients based on acceptance and commitment and third group patients without acceptance and commitment therapy (control).
Settings and conduct
The study is designed to reduce the anxiety and improve the quality of life of patients undergoing dialysis and kidney transplantation. The location of the study is Zanjan health centers. The study is interventional.
Participants/Inclusion and exclusion criteria
Inclusion criteria will be included: the maximum age 50 years; having literacy; hemodialysis and kidney transplant and no problem in writing and listening. Exclusion criteria will be included: the presence of psychiatric disorders requiring to the emergency treatment such as psychosis symptoms and suicide; under treatment with anti-anxiety and anti-depressant drugs and severe physical inability.
Intervention groups
Intervention will be included: the first group treatment of hemodialysis patients based on acceptance and commitment, the second group Treatment of kidney transplant patients based on acceptance and commitment and third group patients without acceptance and commitment therapy (control). Intervention time will be six weeks (one session a week).
Main outcome variables
The primary outcome variables will be included: quality of life (physical health, psychological health, social and environmental relationships), Beck anxiety, acceptance and commitment.
General information
Reason for update
Acronym
ACT
IRCT registration information
IRCT registration number:IRCT20171104037210N1
Registration date:2017-12-26, 1396/10/05
Registration timing:retrospective
Last update:2017-12-26, 1396/10/05
Update count:0
Registration date
2017-12-26, 1396/10/05
Registrant information
Name
Soheila Azari
Name of organization / entity
Islamic Azad University of Zanjan
Country
Iran (Islamic Republic of)
Phone
+98 24 3333 0443
Email address
soheila.azari@iauz.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University of Zanjan
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group therapy based on acceptance and commitment to reduce anxiety and improve the quality of life in patients with dialysis and kidney transplant
Public title
Group therapy based on acceptance and commitment in patients with dialysis and kidney transplant
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The maximum age 50 years
Having literacy;
hemodialysis and kidney transplant
no problem in writing and listening
Exclusion criteria:
The presence of psychiatric disorders requiring to the emergency treatment such as psychosis symptoms and suicide
Under treatment with anti-anxiety and anti-depressant drugs
Severe physical inability
Age
From 15 years old to 50 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
Simple randomization using random numbers table.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Does not have.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Zanjan
Street address
Emam Khomeini Site, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515658145
Approval date
2017-07-31, 1396/05/09
Ethics committee reference number
IR.IAU.Z.REC.1396,63
Health conditions studied
1
Description of health condition studied
Kidney transplant
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
2
Description of health condition studied
Renal dialysis
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis
Primary outcomes
1
Description
Quality of life
Timepoint
Six month
Method of measurement
WHO quality of life
2
Description
Anxiety
Timepoint
Six month
Method of measurement
Beck anxiety
3
Description
Acceptance
Timepoint
Six month
Method of measurement
ACT acceptance criteria
4
Description
Commitment
Timepoint
Six month
Method of measurement
ACT commitment criteria
Secondary outcomes
empty
Intervention groups
1
Description
Treatment of hemodialysis patients based on acceptance and commitment
Category
Prevention
2
Description
Treatment of kidney transplant patients based on acceptance and commitment
Category
Prevention
3
Description
Control
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kidney Foundation of Zanjan
Full name of responsible person
Soheila Azari
Street address
Farvardin St., Azadegan Town, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4571964186
Phone
+98 24 3341 1203
Fax
+98 24 3341 1205
Email
soheila.azari@iauz.ac.ir
Web page address
http://zanjankf.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Zanjan
Full name of responsible person
Ahmad Taqiloo
Street address
Emam Khomeini Site, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515658145
Phone
+98 24 3342 1001
Fax
+98 24 3342 1007
Email
Amoozesh@iauz.ac.ir
Web page address
http://www.iauz.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 of Zanjan
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kidney Foundation of Zanjan
Full name of responsible person
Soheila Azari
Position
M.Sc. Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Farvardi St., Azadegan Town
City
Zanjan
Province
Zanjan
Postal code
4513733678
Phone
+98 24 3341 1203
Fax
Email
soheila.azari@iauz.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kidney foundation of Zanjan
Full name of responsible person
Soheila Azari
Position
M.Sc. Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Farvardin St., Azadegan Town
City
Zanjan
Province
Zanjan
Postal code
4513733678
Phone
+98 24 3341 1203
Fax
Email
soheila.azari@iauz.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kidney Foundation of Zanjan
Full name of responsible person
Soheila Azari
Position
M.Sc. Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Farvardin St., Azadegan Town
City
Zanjan
Province
Zanjan
Postal code
4513733678
Phone
+98 24 3341 1203
Fax
Email
soheila.azari@iauz.ac.ir
Web page address
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
Not allowed from the University viewpoint
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available