The effectiveness of acceptance and commitment based therapy on some mental health indices and quality of life in patients who live with maintenance dialysis.
The aim of this study is to determine the effectiveness of acceptance and commitment based therapy on some mental health indices and quality of life in patients who live with maintenance dialysis. This is a clinical trial with a randomized sampling in groups with the control group. The study population of patients with Chronic Kidney Disease that refer to dialysis unit in Bu-Ali Hospital of Qazvin city. 60 qualified applicants are selected and then randomly divided into three experimental group acceptance and commitment therapy, cognitive-behavioral treatment group and the control group. exclusion criteria: acute or chronic physical illness that cause hardships to endure long meetings. Severe side effects of kidney failure requiring hospitalization or surgery. Report of having any mental disorder (eg, psychosis) that need to be hospitalized. Psychotropic drugs or substance abuse currently. And finally absence of more than three sessions of therapy.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016082729551N1
Registration date:2017-01-01, 1395/10/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-01, 1395/10/12
Registrant information
Name
Monireh Nazari
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
m_nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-12-09, 1395/09/19
Expected recruitment end date
2017-01-09, 1395/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment based therapy on some mental health indices and quality of life in patients who live with maintenance dialysis.
Public title
The effectiveness of acceptance and commitment based therapy (ACT) on quality of life in patients who live with maintenance dialysis.
Purpose
Treatment
Inclusion/Exclusion criteria
Participants must have end stage renal failure treated with maintenance dialysis. Minimum education that is considering is elementary and also participants should not have experience of being treated with acceptance and commitment based therapy .Also, Individuals should not have a history of substance abuse, psychotic disorders and mental retardation .Exclusion criteria :acute or chronic physical illness that cause hardships to endure long meetings. Severe side effects of kidney failure requiring hospitalization or surgery. Report of having any mental disorder (eg, psychosis) that need to be hospitalized. Psychotropic drugs or substance abuse currently. And finally absence of more than three sessions of therapy.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization model is block design.
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University Of Medical Sciences
Street address
Shahid Beheshti University Of Medical Sciences, near Taleghani Hospital, Arabi street, Daneshjo Blvd. , Evin, Chamran Highway, Tehran
City
Tehran
Postal code
Approval date
2016-04-24, 1395/02/05
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.92
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Quality Of Life
Timepoint
pretest before the inervention, post test after the intervention and follow up after 2 month
Method of measurement
Kidney Disease Quality of Life – Short Form version 1.3 for use with Iranian patients
Secondary outcomes
1
Description
depression
Timepoint
pretest before the intervention, post test after the intervention and follow up 2 month later
Method of measurement
Hospital Anxiety and Depression Scale
2
Description
anxiety
Timepoint
pretest before the intervention, post test after the intervention and follow up 2 month later
Method of measurement
Hospital Anxiety and Depression Scale
3
Description
Mental health
Timepoint
pretest before the intervention, post test after the intervention and follow up 2 month later
Method of measurement
Hospital Anxiety and Depression Scale Kidney Disease Quality of Life – Short Form
Intervention groups
1
Description
The second group will receive cognitive behavioral therapy in 8 session. they will continue their previous medications.
Category
Lifestyle
2
Description
The third group is, control group. They will not receive psychological treatment. They just will take their previous medications.
Category
Treatment - Drugs
3
Description
The first group is the ACT group. they will experience acceptance and commitment based therapy in 8 Sessions.Their previous medications will continue as before.