The effect of group cognitive behavioral therapy on mood symptoms and temptation to substance use in male patients with bipolar disorder and substance dependence.
Determining the effect of GCBT on mood symptoms and temptation to use Substances in male patients with bipolar disorder and substance dependence.
Design
The clinical trial has a control group, randomized by random block method, one-way blind, the total of intervention and control groups are 40 people.
Settings and conduct
GCBT sessions are held in the classrooms of the psychiatry departments of Sinai Hospital in two separate closed groups of 10 people (20 people in total) in two 1.5-hour sessions per week. The people who completed the questionnaires (by interview method) and analyzed the data were blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the diagnosis of bipolar disorder has been confirmed by a psychiatrist; substances dependence; ability to communicate and answer questionnaires; literate in reading and writing; consent to participate in the study; receive usual medical care and treatment; not having a physical or mental disability; not having another psychiatric disorder; not participating in similar psychotherapy. Exclusion criteria: entering the acute phase of the disease; absence from more than 2 group therapy sessions.
Intervention groups
Eight sessions of GCBT are conducted as follows: 1: Introduction, statement of goals and structure of sessions. 2: getting to know the common cognitive errors in manic and depressive periods 3: Dealing with temptation. 4: Refusal skills, managing social situations and strengthening courage. 5: Making wise decisions 6: problem solving, anger control, stress management and emotion control. 7: modification of lifestyle, management of feelings of boredom and impatience. 8: Relaxation and breathing, prevention of relapse, maintaining stability and ending the treatment.
Main outcome variables
Mood symptoms including mania and depression; the temptation to use substances
General information
Reason for update
Acronym
GCBT
IRCT registration information
IRCT registration number:IRCT20170411033378N11
Registration date:2023-05-18, 1402/02/28
Registration timing:prospective
Last update:2023-05-18, 1402/02/28
Update count:0
Registration date
2023-05-18, 1402/02/28
Registrant information
Name
Efat Sadeghian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
sadeghian_e@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-05, 1402/03/15
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group cognitive behavioral therapy on mood symptoms and temptation to substance use in male patients with bipolar disorder and substance dependence.
Public title
The effect of group cognitive behavioral therapy on mood symptoms and temptation to substance use.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The diagnosis of bipolar disorder has been confirmed by a psychiatrist
Have drug dependence
Ability to communicate and answer questionnaires
Being literate in reading and writing
Consent to participate in the study
Receive usual medical care and treatment
Not having a physical or mental disability
Not having another psychiatric disorder along with bipolar disorder
Not participating in similar psychotherapy
Exclusion criteria:
Entering the acute phase of the disease
Absence in more than 2 sessions of group therapy sessions
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this research is block randomization method. In this method, patients who meet the study entry criteria are divided equally and randomly into two intervention and control groups. For this purpose, blocks have been formed, within each block, half of the patients are placed in the intervention group and half of them are included in the control group. The main goal in this method is to balance the number of participants in each group. Considering that it is difficult to conduct group therapy for more than ten patients, and we have two intervention groups of ten, four blocks of ten are prepared. In each of these blocks, 5 patients are randomly placed in the intervention group (A) and 5 patients in the control group (B). The randomization sequence is provided through the following website: https://www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the clarity of the intervention received by the members of the groups involved in the study, it is practically impossible to blind the study participants.Therefore, in order to blind and prevent bias in all stages, completing the questionnaires and analyzing the data are done by people who do not know whether the patients are in the intervention group or the control group (People other than cognitive behavioral therapists).
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical
Street address
In front of Mardom Park, Hamedan University of Medical Sciences,
City
Hamadan
Province
Hamadan
Postal code
38698 -65178
Approval date
2023-04-29, 1402/02/09
Ethics committee reference number
IR.UMSHA.REC.1402.082
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31.9
ICD-10 code description
Bipolar affective disorder, unspecified
2
Description of health condition studied
Substance dependence
ICD-10 code
F19.1
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances
Primary outcomes
1
Description
Mania score in Hirschfeld Mood Disorder Questionnaire (2000)
Timepoint
Measuring the mania score at the beginning of the study (before the start of the intervention), after the completion of the group cognitive behavioral therapy sessions, one month and three months after the completion of the sessions.
Method of measurement
Hirschfeld Mood Disorder Questionnaire (2000)
2
Description
Depression score in Beck Depression Questionnaire (short form with 13 questions)
Timepoint
Measuring the Depression score at the beginning of the study (before the start of the intervention), after the completion of the group cognitive behavioral therapy sessions, one month and three months after the completion of the sessions.
Method of measurement
Depression Questionnaire (short form with 13 questions)
3
Description
Temptation score in Wright's Craving Beliefs Questionnaire (2003)
Timepoint
Measuring the temptation score at the beginning of the study (before the start of the intervention), after the completion of the group cognitive behavioral therapy sessions, one month and three months after the completion of the sessions.
Method of measurement
Wright's Craving Beliefs Questionnaire (2003)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention group includes 2 closed groups of 10 people (due to the limitation in the number of people present in the therapy group). For these people, in addition to the usual care, group cognitive behavioral therapy sessions are held for 8 sessions, two sessions a week, in the evenings in the classrooms in the psychiatry departments by a trained psychiatric nursing student and with the presence of the psychiatric nursing faculty experienced in this field. Each session will last 1.5 hours and about 10 minutes between sessions will be considered for rest and a short reception. Sessions are systematic with specific content and specific assignments for patients.
Category
Rehabilitation
2
Description
Control group: does not receive intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Educational and Medical Center
Full name of responsible person
Dr. Efat Sadeghian
Street address
Farshchian educational and medical center, Mirzadeh Eshghi St.
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0150
Email
sadeghianefat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokohi
Street address
Hamedan, Shahid Fahmideh Blvd., University Headquarters, 4th Floor, Research and Technology Vice-Chancellor
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 4058
Email
sadeghianefat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamadan 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
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd.
City
Hamadan
Province
Hamadan
Postal code
6861819453
Phone
6517838736
Email
sadeghianefat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamedan University of Medical Sciences, In front of Mardom Park
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0150
Fax
Email
sadeghianefat@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Efat Sadeghian
Position
Associate Professor/Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0150
Fax
+98 81 3838 0150
Email
sadeghian_e@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
IPD briefly describe what specific participant data sets are to be shared
When the data will become available and for how long
Starting in Oct 2023
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
People working in academic institutions
From where data/document is obtainable
Via Email: sadeghianefat@gmail.com
What processes are involved for a request to access data/document