Objective: The effectiveness of group therapy on the quality of life and mental welfare based on the acceptance and commitment in kidney patients.
Study design: Randomized, convenience sampling, with the controlled group and without placebo, single-center.
Study population: All kidney diseases patients referred to Kowsar hospital in Semnan city.
Inclusion criteria: At least 18 years; at least diploma in education.
Exclusion criteria: cognitive problems, psychotic disorders.
Sample size, intervention, time of intervention, outcomes studied: 30 cases of kidney disease patients referred to hospital Kowsar that their sampling process is performed by convenience sampling from April to June 2016 are selected and randomly divided into two group of intervention (n=15) and control (n=15) groups.
Intervention group: Therapy sessions are done based on acceptance and commitment Hayes and Strosahl and Wilson books (every week one 90-minute session - 8 sessions during 2 months) according to the protocol.
Control group: in control group, no intervention is performed on them and it is used only to compare the results with the intervention group.
Before and after the intervention, quality of life in kidney disease patients is evaluated using questionnaire (KDQOL-SF).
General information
Acronym
Acceptance and Commitment Therapy (ACT)
IRCT registration information
IRCT registration number:IRCT2017012725732N12
Registration date:2017-06-20, 1396/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-20, 1396/03/30
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University
Expected recruitment start date
2016-04-12, 1395/01/24
Expected recruitment end date
2016-06-13, 1395/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group therapy on the quality of life and mental welfare based on the acceptance and commitment in kidney patients
Public title
The effectiveness of group therapy on the quality of life and mental welfare based on the acceptance and commitment in kidney patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: At least 18 years; at least diploma in education.
Exclusion criteria: cognitive problems; psychotic disorders.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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, Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
IR.SEMUMS.REC.1395.6
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Quality of Life
Timepoint
Baseline and end of study
Method of measurement
Kidney patients' quality of life questionnaire (KDQOL-SF)
2
Description
Anxiety
Timepoint
Baseline and end of study
Method of measurement
Kidney patients' quality of life questionnaire (KDQOL-SF)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: in control group, no intervention is performed on them and it is used only to compare the results with the intervention group.
Category
Behavior
2
Description
Intervention group: Therapy sessions are done based on acceptance and commitment Hayes and Strosahl and Wilson books (every week one 90-minute session - 8 sessions during 2 months) according to the protocol.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital, Semnan University of Medical Sciences
Full name of responsible person
Parvin Rafienia
Street address
Kosar Hospital, Street Amin, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University, Vice Chancellor for Research and Technology
Full name of responsible person
Ali Haghighi Asl
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University, Vice Chancellor for Research and Technology
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
Semnan University
Full name of responsible person
Parvin Rafienia
Position
Ph.D. in Psychology
Other areas of specialty/work
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Parvin Rafienia
Position
Ph.D. in Psychology
Other areas of specialty/work
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Parvin Rafienia
Position
Ph.D. in Psychology
Other areas of specialty/work
Street address
Semnan University, Damghan 5 km Road, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)