Protocol summary

Study aim
The use of Short-term and cost-effective Treatment with a quick Effect in reducing the Mood and Anxiety Symptoms of Patients during Hospitalization.
Design
This Research is a Semi-experimental Design, with a Pre-test and Post-test with a Control Group. The Sample size includes 30 Patients and each Group includes 15 People. In order to place Patients in the Intervention and Control Groups, a Simple Randomization Method using lottery is used.
Settings and conduct
The Study is conducted in the Psychiatry Department of Kausar Semnan Hospital.
Participants/Inclusion and exclusion criteria
Entry Requirements: Patients aged 18 to 60, Patients with Anxiety and Depression disorders. Non-entry conditions: Psychotic and Mania Patients, Patients with Personality Disorders, Substance abuse Patients, mentally retarded Patients
Intervention groups
In this Study, Kim Berg's Solution-oriented Short-term Group Therapy Protocol (SFBT) is used in Six Sessions and for Three Weeks. Instead of solving the Problem, this Therapy focuses on the Solution and the Person's Strengths. The intervention group includes Patients with Anxiety and Depression Disorders admitted to the Psychiatric Department of the Hospital. The Control group includes Patients with Anxiety and Depression who do not receive Psychological Intervention. Both Groups are under Medical Treatment during Hospitalization.
Main outcome variables
Anxiety and Depression.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220706055395N1
Registration date: 2022-07-19, 1401/04/28
Registration timing: prospective

Last update: 2022-07-19, 1401/04/28
Update count: 0
Registration date
2022-07-19, 1401/04/28
Registrant information
Name
masoumeh abdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3142 2391
Email address
abdollahi.mahsa631@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-11, 1401/05/20
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Solution-Focused Brief Group Therapy (SFBT) on reducing Anxiety and Depression in Patients admitted to the Neuropsychiatric Department Compared to the Control Group.
Public title
Evaluation of the Effectiveness of Solution-Focused Brief group Therapy on reducing Anxiety and Depression.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Anxiety and Depression Disorders admitted to the Psychiatric Ward Patients 18 to 60 years old
Exclusion criteria:
Psychotic or Mania Patients Patients with Personality Disorders Substance Abuse Patients Mentally Retarded Patients
Age
From 18 years old to 60 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
Simple randomization, Using the Lottery Method. In this Method, a Number or Code is prepared for each Patient admitted to the Psychiatric Ward. Then the Numbers are written on a piece of Paper. The pieces of Paper are placed in a Container and mixed well. Then a sample of 30 People is selected. The first 15 Numbers include control Group Patients and the next 15 numbers are intervention Group Patients.
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 of Semnan Islamic Azad University
Street address
Kosar Hospital., Amin Blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.IAU.SEMNAN.REC.1401.011

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

2

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known Physiological condition

Primary outcomes

1

Description
The Percentage of People who Score higher than 21 in the Depression Subscale of the DASS-21 Questionnaire.
Timepoint
Depression in the intervention Group is measured at the beginning of Hospitalization (before the intervention) and after the intervention (after three weeks). In the Control group, it is measured from the beginning of Hospitalization and after three Weeks.
Method of measurement
Depression is measured by the Depression Subscale of the Depression- Anxiety- Stress Scale(DASS-21) Questionnaire.

2

Description
The Percentage of People who Score higher than 15 in the Anxiety-Stress Subscale of the DASS-21 Questionnaire.
Timepoint
Anxiety in the intervention Group is measured at the beginning of Hospitalization (before the intervention) and after the intervention (after three weeks). In the Control group, it is measured from the beginning of Hospitalization and after three Weeks.
Method of measurement
Anxiety is measured by the Anxiety Subscale of the DASS-21 qQuestionnaire.

Secondary outcomes

1

Description
.
Timepoint
.
Method of measurement
.

Intervention groups

1

Description
In the Experimental Group, the Intervention with Short-term Solution-oriented Treatment is carried out for six 45-minute Sessions (two Sessions per Week) in the Psychiatric Department of Kausar Hospital in a Group setting. In this Group, before and after the Implementation of the Intervention, In order to measure the level of Anxiety and Depression, the DASS-21 Anxiety-Depression Scale will be used. In order to perform the Intervention, Kim-Berg's Solution-oriented Short-term Group Therapy Protocol (SFBT) is used. The Principles of Solution-oriented Group Therapy include focusing on change and possibilities, setting Goals, focusing on People's Capabilities and Skills, creating Participation and Cooperation, using Humor and Creativity. The Intervention Group includes Patients with Anxiety and Depression Disorders admitted to the Psychiatric Department of the Hospital.
Category
Treatment - Other

2

Description
Control Group: Control group: no intervention is done in the Control Group. The level of Anxiety and Depression is evaluated on the first day of Hospitalization and after three Weeks. This Group is only under Medical Treatment during Hospitalization.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kausar Semnan Hospital
Full name of responsible person
Masoumeh Abdollahi
Street address
Kausar Hospital, Amin Blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2391
Email
abdollahi.mahsa631@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Behnaz Behnaz
Street address
Kausar Hospital, Amin Blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2391
Email
abdollahi.mahsa631@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoumeh Abdollahi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kosar Hospital., Amin Blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2391
Email
abdollahi.mahsa631@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoumeh Abdollahi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kosar Hospital., Amin Blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2391
Email
abdollahi.mahsa631@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Masoumeh Abdollahi
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kosar Hospital., Amin Blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2391
Email
abdollahi.mahsa631@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the Main outcome can be shared.
When the data will become available and for how long
The access Period starts 6 months after the Results are Published
To whom data/document is available
People working in Medical and Academic institutions
Under which criteria data/document could be used
It is allowed for Therapeutic and Research use
From where data/document is obtainable
People can refer to Masoume Abdullahi, who works at Kausar Semnan Hospital, to receive the data.
What processes are involved for a request to access data/document
After submitting an application to the President of the University of Medical Sciences and obtaining permission
Comments
Loading...