Protocol summary

Study aim
Comparison of the effectiveness of group supportive counseling and group existential psychotherapy on improving the feeling of social exclusion and anxiety in patients with comorbid psychiatric disorders and substance abuse
Design
In this research, two experimental groups and one control group will be used.
Settings and conduct
To carry out the research, the pre-test phase will be done first for both the experimental and control groups. So that after obtaining written consent and necessary permits, the researcher will invite the qualified people to Razi Psychiatric Hospital on a certain date through a phone call. Then, based on the intervention protocol, supportive counseling intervention sessions for members of one experimental group and existential psychotherapy intervention sessions for the other experimental group will be held separately in Razi Psychiatric Hospital by a social worker and a psychiatrist.
Participants/Inclusion and exclusion criteria
Research participants will be selected by available sampling from among patients with comorbid psychiatric disorder and drug use. The criteria for entering the study are: 1-Age over 18 years old 2-Having the required ability to participate in group meetings 3-Diagnosis of psychiatric disorder by a psychiatrist 4-Diagnosis of drug use history by hospital specialists and the exclusion criteria from this study were: 1- Absence of more than two meetings and 2- Unwillingness to continue cooperation.
Intervention groups
Based on the intervention protocol, supportive counseling intervention sessions for the members of one of the test groups and existential psychotherapy intervention sessions for the other test group will be held separately in the psychiatric hospital.
Main outcome variables
Feeling of social exclusion and anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230411057882N1
Registration date: 2024-03-01, 1402/12/11
Registration timing: prospective

Last update: 2024-03-01, 1402/12/11
Update count: 0
Registration date
2024-03-01, 1402/12/11
Registrant information
Name
Maryam Latifian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7173 2000
Email address
maryamlatifian1993@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-08-21, 1403/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of group supportive counseling and group existential psychotherapy on improving the feeling of social exclusion and anxiety in patients with comorbid psychiatric disorders and substance abuse
Public title
Feeling of social exclusion and anxiety in patients with comorbid psychiatric disorders and substance abuse
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old Having the required ability to participate in group meetings Diagnosis of psychiatric disorder by a psychiatrist Diagnosis of drug use history by hospital specialists
Exclusion criteria:
Not being able to read and write Unwillingness to participate in the study
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are non-randomly divided into case and control groups. The control group receives routine hospital services, and the case group receives relevant interventions. Due to the fact that the implementation of the interventions is done by specialists based in the hospital, therefore, the researcher, the outcome assessor, the data analyst, and the data safety and monitoring committee are completely unaware of these divisions.
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of university of social welfare and rehabilitation science
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
IR.USWR.REC.1402.216

Health conditions studied

1

Description of health condition studied
Psychiatric disorder
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified

Primary outcomes

1

Description
Feeling of social exclusion
Timepoint
Pre-test - post-test - follow-up after 3 months
Method of measurement
Exclusion Perception Scale

2

Description
Anxiety
Timepoint
Pre-test - post-test - follow-up after 3 months
Method of measurement
DASS-21 anxiety questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Supportive counseling: Supportive counseling sessions based on self-compassion will be done in a group based on a protocol with the components of a supportive counseling approach. The content of this educational protocol includes things such as teaching empathy, teaching sympathy, teaching forgiveness and accepting mistakes, teaching acceptance of problems, and teaching the development of valuable and sublime feelings. This protocol will be implemented in 8 1-hour sessions (weekly) by a trained social worker with a doctorate in social work.
Category
Other

2

Description
Group existential psychotherapy: group meaning therapy sessions will be conducted based on a protocol with components of the existential therapy approach based on the framework of Hotzel's treatment plan. The content of this educational protocol includes things such as philosophical education of the nature of being human, education of meaning and inner self-exploration, education of the concepts of loneliness, interpersonal, intrapersonal and existential types in very simple language, education of recognition of responsibility and accountability as an inevitable part of the human condition and responsibility. that man is responsible for the difficult conditions of life, training to control negative thoughts and ruminations; It is searching and trying to find meaning in various aspects of life and in the worst conditions of life and rebuilding oneself and getting familiar with all kinds of experimental, attitudinal and creative values. This protocol will be implemented in 10 1-hour sessions (weekly) by a trained social worker with a doctorate in social work.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Maryam Latifian
Street address
Shahid Rostgar Blvd., Taghi Abad, Ray city
City
Tehran
Province
Tehran
Postal code
7612016186
Phone
+98 21 3340 1220
Email
razi@uswr.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Kianoush Abdi
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
pr@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Latifian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Social Services
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2230 7421
Email
maryamlatifian1993@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Latifian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Social Services
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2230 7421
Email
maryamlatifian1993@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Maryam Latifian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Social Services
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2230 7421
Email
maryamlatifian1993@gmail.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
Due to the principle of confidentiality, the data file of the participants will not be published.
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
Undecided - It is not yet known if there will be 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
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