Evaluation the effectiveness of supportive-expressive dynamic psychotherapy in improving the treatment outcome of Bipolar Spectrum Disorders in Male Hospitalized Patients
In this randomized controlled trial, 36 men with bipolar disorder who met the inclusion criteria and admitted to the psychiatric ward were selected. They were diagnosed with bipolar disorder based on DSM-5 criteria and a clinical psychiatrist's diagnosis and selected voluntary using available sampling method. Participants were randomly assigned to the two experimental and control groups of 18.
Settings and conduct
36 patients from the psychiatric ward of men in Medical University hospital (Khorshid) of Isfahan, after acute phase of illness and discharge from the emergency department of psychiatry and transfer to the psychiatric ward of the hospital were selected by Block randomization method and then enrolled to the study.
Participants/Inclusion and exclusion criteria
1- Having bipolar mood disorder based on psychiatrist's diagnosis; 2- Hospitalized; 3. Normal IQ.4. Male gender; 5. Lack of co-morbid serious physical and organic problems (Including sensory impairments such as deafness and blindness, severe physical disabilities); 6. No cognitive impairment that interferes with understanding and participating in treatment; 7.The absence of other serious psychiatric disorders (e.g.psychotic symptoms , anxiety disorders,...)
Intervention groups
Patients in the treatment group were treated with supportive-expressive psychotherapy in addition to the maintenance phase drug treatment.The control group received only standard drug treatment and didn't receive no other intervention. Intervention sessions based on existing protocols of supportive psychotherapy-expressive therapy were held in weekly 16 sessions of 30-minutes totally for four months.
Evaluation the effectiveness of supportive-expressive dynamic psychotherapy in improving the treatment outcome of Bipolar Spectrum Disorders in Male Hospitalized Patients
Public title
Evaluation the effect of supportive-expressive dynamic psychotherapy in Bipolar Spectrum patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having bipolar mood disorder based on psychiatrist's diagnosis
Hospitalized
Normal IQ.
Male gender.
Lack of co-morbid physical and organic serious problems (Including sensory impairments such as deafness and blindness, severe physical disabilities)
No cognitive impairment that interferes with understanding and participating in treatment
The absence of other serious psychiatric disorders (e.g.psychotic symptoms , anxiety disorders,...)
Exclusion criteria:
The patient's unwillingness to continue the participation in study
Absence for more than one session and the absence in the session considered as compensated session
Hospital discharging
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method was simple and performed centrally using random numbers table. Each patient's record was assigned a number from 1 to 36 and then randomly assigned to intervention and control groups. Paired numbers were assigned to the control group and individual numbers to the intervention group. In total, 36 patients were divided into two groups of 18.
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
Institutional Research Ethics Committee Islamic Azad University- Shiraz Branch
Street address
5 km after Sadra Highway
City
Shiraz
Province
Fars
Postal code
74731 71987
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1398.002
Health conditions studied
1
Description of health condition studied
Bipolar Mood Disorders
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Bipolar disorder level
Timepoint
BDRS scores at the beginning of the study (maintenance phase), immediately after the completion of psychological interventions 1 month, 3 months and 6 months after the start of the study in the supportive-psychotic recipient group, along with drug therapies
Method of measurement
The BDRS and its subscales in the sample of Iranian patients have a construct validity, ownership, distinction, and diagnosis that can be used in surveying and clinical trials.
2
Description
Relapse Rate
Timepoint
1 Month after intervention, 3 Month After Interventions , 6 Month after Intervention
Method of measurement
Bipolar Disorder Rating Scale (BDRS)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Adult male patients with bipolar disorder treated under medical treatment
Category
Diagnosis
2
Description
Intervention group: The men patients with bipolar disorder received drug treatment in addition to supportive expressive psychotherapy .This was an insight-based psychotherapy model and a selective psychotherapy for treating patients that had adequate ego strength, but for some reason should not or could not be enroll in long term psychoanalysis sessions.The main approach of therapy was insight based. The patient's response, however, was depend on factors such as the creating judgment free and supportive and emphatic which was mostly depending on factors such as the relationship between the therapist and the patient. The treatment lasted from 12 to 25 sessions in terms of the length of the treatment, and usually the number of sessions was once a week in the early stages of treatment, but when we entered the main phase of the treatment (middle phase), the number of sessions was twice a week.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Men Inpatients Psychiatry section at Khorshid complex at Medical University of Isfahan
Full name of responsible person
َAlireza Bornamanesh
Street address
Ostandari St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 2222 2125
Email
Bornamanesh@miau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University (IAU )
Full name of responsible person
َAlireza Bornamanesh
Street address
Ostandari St
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2125
Email
Bornamanesh@gmail.com
Grant name
No Grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University (IAU )
Proportion provided by this source
2
Public or private sector
Private
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
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Bornamanesh
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.288, Saeb st, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8184813341
Phone
+98 31 3773 6684
Email
Bornamanesh@miau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Bornamanesh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 288, Saeb St
City
Isfahan
Province
Isfehan
Postal code
8184813341
Phone
+98 31 3773 6684
Email
Bornamanesh@miau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Bornamanesh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 288, Saeb St
City
Isfahan
Province
Isfehan
Postal code
8184813341
Phone
+98 31 3773 6684
Email
Bornamanesh@miau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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