The objective of this study was to compare the efficacy of physical training and counter token behavior therapy on the level of negative symptoms in schizophrenia patients. A total of 45 randomly selected patients were put in two experimental groups and one control group (15 patients in each). One of the experimental groups received 16 sessions of physical training and the other received counter token behavior therapy. No intervention was used for the control group. The primary outcome in this study was the negative symptoms of schizophrenia that was measured by the scale for the assessment of negative symptoms (SANS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011085133N1
Registration date:2011-01-03, 1389/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-03, 1389/10/13
Registrant information
Name
Kamran Gholonia
Name of organization / entity
Azad univercity tonekabon
Country
Iran (Islamic Republic of)
Phone
+98 14 2322 6329
Email address
abolghasemi@tonekaboniau.ac.ir
Recruitment status
Recruitment complete
Funding source
Tonekabon Azad University
Expected recruitment start date
2010-05-05, 1389/02/15
Expected recruitment end date
2010-06-21, 1389/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of physical exercise to token behavior therapy on the rate of negative symptoms in schizophrenic patients
Public title
The efficacy of physical exercise and token behavior therapy on reducing the negative symptoms in schizophrenic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: at least 3 years passed from disorder outset, male gender, age 20-50 years, no mental illness and disorders along with schizophrenia, no mental retardation or brain damage, having active case in Organizing Committee for Chronic Psychiatric Patients
Exclusion criteria: displaying severe physical illness, change of diagnosis within the period or displaying other prominent psychiatric symptoms, death, moving from the Care Center
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Tonekabon Azad University
Street address
Tonekabon Azad University, Vali Abad Educational Complex, 2nd kilometer of Chaloos road
City
Tonekabon
Postal code
Approval date
2010-10-29, 1389/08/07
Ethics committee reference number
23320
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
negative symptoms
Timepoint
Before the intervention, three months after intervention, the end of intervention
Method of measurement
The Scale for Assessment of Negative Symptoms (SANS)
Secondary outcomes
empty
Intervention groups
1
Description
Physical exercise was carried out within 16 sessions, including physical movements with 7 minute-running, 3 minute-in situ running, 7 minute-stretching starting from upper body to lower body, 10 minute-dynamic exercise, 3 minute-cooling down
Category
Behavior
2
Description
Control group: No intervention
Category
N/A
3
Description
Token behavior therapy: token economics was applied aimed at reducing negative symptoms in schizophrenic patients. Schizophrenic patients were awarded tokens on account of displaying positive behaviors such as: 1) participating in therapeutic activities, 2) properly washing face after waking up, 3) tooth brushing, 4) being tidy and organized, 5) responding to the questions and taking part in conversations. These patients lost tokens due to displaying negative behaviors such as: 1) not participating in therapeutic activities, 2) not properly washing face after waking up, 3) shouting at other people, 4) not being tidy and organized, 5) not responding to the questions asked and not taking part in conversations
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Asayesh Chronic Psychiatric Care Center
Full name of responsible person
Kamran Gholinia
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tonekabon Azad University
Full name of responsible person
Khalil Pourshamsian
Street address
Tonekabon Azad University, Vali Abad Educational Complex, 2nd kilometer of Chaloos road
City
Tonekabon
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tonekabon Azad University
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
Tonekabon Azad University
Full name of responsible person
Kamran Gholinia
Position
M.A. student
Other areas of specialty/work
Street address
Tonekabon Azad University, Vali Abad Educational Complex, 2nd kilometer of Chaloos road
City
Tonekabon
Postal code
Phone
+98 911 130 9728
Fax
Email
kgolinia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tonekabon Azad University
Full name of responsible person
Shahnam Abolghasemi
Position
PHD Psycologe
Other areas of specialty/work
Street address
Tonekabon Azad University, Vali Abad Educational Complex, 2nd kilometer of Chaloos road
City
Tonekabon
Postal code
Phone
+98 911 391 3907
Fax
Email
abolghasemi@tonekaboniau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tonekabon Azad University
Full name of responsible person
Kamran Gholinia
Position
M.A. Student
Other areas of specialty/work
Street address
Tonekabon Azad University, Vali Abad Educational Complex, 2nd kilometer of Chaloos road
City
Tonekabon
Postal code
Phone
Fax
Email
kgolinia@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)