Protocol summary

Summary
The purpose of this study was to investigate the effect of problem solving skills training on the severity of aggression in type 1 bipolar disorder patients. Entry criteria: aged 18 to 60 years. Earning the minimum score of 75 from the Bass and Prisons questionnaire in Mashhad. Exit criteria: Absence in problem solving skills training group in more than 25% of its sessions. Failure to perform assignments in the problem solving skill group or lack of accountability for the follow-up required. Method: In this study, 60 patients with type 1 bipolar disorder admitted to Avicenna Hospital in Mashhad were selected by convenience sampling and randomly assigned to two groups of control and intervention. Both groups completed the bass and perry aggression questionnaire as a pretest in the beginning of the treatment plan. Both the intervention and control groups, routine patient training continued, and the intervention group received routine training, received training on problem solving skills in four sessions of 60 minutes for one month. Two months after the completion of the training, both groups completed the Bass and Perry questionnaires as post-tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051633994N1
Registration date: 2017-09-19, 1396/06/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Malihe Eshaghzadeh
Name of organization / entity
Mashhad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3853 1511
Email address
eshaghzadehm931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University Of Medical Scienes
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Problem-Solving Skills Training on the Aggression Severity in Patients with Type 1 Bipolar Disorders
Public title
Investigating the Impact of Problem-Solving Skills Training on the Aggression Severity in Patients with Type 1 Bipolar Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Entry criteria: aged 18 to 60 years. Earning the minimum score of 75 from the Bass and Prisons questionnaire in Mashhad. Exit criteria: Absence in problem solving skills training group in more than 25% of its time. Failure to perform assignments in the problem solving skill group or lack of accountability for the follow-up required.
Age
No age limit
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University Of Medical Sciences
Street address
Daneshgah AVE
City
Mashhad
Postal code
Approval date
2017-03-11, 1395/12/21
Ethics committee reference number
IR.MUMS.REC.1395.619

Health conditions studied

1

Description of health condition studied
Bipolar disorder
ICD-10 code
F31.1
ICD-10 code description
The patient is currently manic, without psychotic symptoms (as in F30.1), and has had at least one other affective episode (hypomanic, manic, depressive, or mixed) in the past.

Primary outcomes

1

Description
Aggression
Timepoint
Before the intervention. Two months after intervention
Method of measurement
Buss-Perry Aggression Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients received problem solving skills in 4 sessions, 60 minutes each week with routine training sessions.
Category
Behavior

2

Description
Control group: Patients received only routine training.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Ebne Sina Psychiatr Hospital
Full name of responsible person
Mrs Azghandi
Street address
Street Hurr Ameli
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Mashhad University of Medical sciences
Full name of responsible person
Vaghee Saeed
Street address
Nursing Collage
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Mashhad University of Medical sciences
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
Mashah University Of Medical
Full name of responsible person
Vaghee Saeed
Position
MSc
Other areas of specialty/work
Street address
Nussin Collage
City
Mashhad
Postal code
Phone
+98 51 3859 7313
Fax
Email
Vaghees@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Malihe Eshaghzadeh
Position
MSc Student
Other areas of specialty/work
Street address
Nursing collage
City
Mashhad
Postal code
Phone
+98 51 3859 7313
Fax
Email
vaghees@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Malihe Eshaghzadeh
Position
MSc Student
Other areas of specialty/work
Street address
Nursing collage
City
Mashhad
Postal code
Phone
+98 51 3859 7313
Fax
Email
m.eshaghzadeh93@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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