(1) Objectives: The main objective of this study is examining the effect of therapeutic relationship in schizophrenic patients on medication regimens compliance in Razi psychiatric hospital of Tabriz. (2) Design: This research is an experimental study with “pre-test and post-test with control group" design. (3) Setting and conduct: First pilot study will be done to determine sample size. The estimated sample size will be allocated randomly to interventional and control groups. Instruments for data gathering and measuring are Health Belief Model Scale and Observational Checklist for Medication Compliance. (4) Participants including major eligibility criteria: Schizophrenic patients who have ability and willingness to answer interview questions; are not residual schizophrenic type; have at least one history of recurrence; have at least 18 years old; have not co-disorders; and are not in acute phase of disorder. Exclusion criteria: Discharging the patient before the completion of relationship therapy sessions and not participating in the post- test. (5) Interventions: Firstly, the pre-test will be done in both groups. The experimental group will attend 7-12 sessions of relationship therapy. The control group will not receive any intervention in this duration. Finally, the post-test will be done in both groups and the results of two groups will be compared with together. (6) The main outcome variable: Increasing of medication regimen compliance.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206206834N5
Registration date:2012-11-14, 1391/08/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-14, 1391/08/24
Registrant information
Name
Hossein Ebrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1475 1709
Email address
ebrahimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-11-05, 1391/08/15
Expected recruitment end date
2013-02-03, 1391/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nurses' therapeutic relationship in schizophrenic patients on medication regimens compliance
Public title
The effect of nurses' therapeutic relationship in schizophrenic patients on medication regimens compliance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Schizophrenic patients who have ability and willingness to answer interview questions; are not residual schizophrenic type; have at least one history of recurrence; have at least 18 years old; have not co-disorders; and are not in acute phase of disorder. Exclusion criteria: Discharging the patient before the completion of relationship therapy sessions and not participating in the post- test.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Sciences, Vice chancellor for research
Street address
Third floor, Central Building- No 2, Golgasht Street
City
Tabriz
Postal code
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
91116
Health conditions studied
1
Description of health condition studied
Noncompliance with medical treatment and regimen, Schizophrenia
ICD-10 code
Z91.1, F20
ICD-10 code description
Personal history of noncompliance with medical treatment and regimeny; Paranoid schizophrenia, Hebephrenic schizophrenia, Catatonic schizophrenia, Undifferentiated schizophrenia, Post-schizophrenic depression, Simple schizophrenia, Other schizophrenia and
Primary outcomes
1
Description
Compliance with medication regimen
Timepoint
Before intervention and one week after finishing intervention
Method of measurement
Observational Checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Firstly, the pre-test will be done. Intervention group will be receiving 7-12 sessions about relationship therapy. Then, the post-test will be done. Finally, the differences of compliance in pre-test and post-test will be compared with each other.
Category
Behavior
2
Description
Control group: This group will be not receiving any intervention. The differences of compliance in pre-test and post-test will be measured and will be compared with each other.