Protocol summary

Study aim
The effectiveness of computer-based cognitive rehabilitation on the improvement of cognitive deficits in patients with bipolar disorder
Design
The clinical trial has three intervention control groups, three groups of thirty are prepared for randomization with the help of Randomaize.com, with parallel groups, double-blind, randomized,
Settings and conduct
Clinic of Ibn Sina Hospital, Mashhad. Assessment tests are taken to enter the study
Participants/Inclusion and exclusion criteria
People with bipolar disorder, ranging in age from 18 to 40, both men and women The patient has no other psychiatric disorder or problem. The patient has an intelligence score above 90. The patient has not received shock therapy in the past year. Exclusion criteria: The emergence of serious physiological or psychiatric problems. Cancel the continuation of the plan Pregnancy and lactation Creating thoughts of active suicide or episodes of psychotic depression while studying
Intervention groups
After the psychiatric specialist's approval to diagnose the patient in the euthymic phase, and conduct cognitive-behavioral assessment tests to confirm the entry criteria, the patients are placed in 3 groups of 30 people using available sampling and after obtaining consent. In the control group, only drug treatment is performed. In addition to drug treatment, the other two groups are treated with computer-based cognitive rehabilitation. Before and after interventions in all three groups, cognitive evaluation tests were performed, the results and effectiveness of each are compared. Also, quantitative electroencephalography (qEEG) will be performed in an improved form of EEG before and after treatment. In order to compare and evaluate QEEG and Cognitive Test series, 30 matched healthy people will also participate.
Main outcome variables
Patients' cognitive deficits

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101130005280N59
Registration date: 2022-10-15, 1401/07/23
Registration timing: prospective

Last update: 2022-10-15, 1401/07/23
Update count: 0
Registration date
2022-10-15, 1401/07/23
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of cognitive rehabilitation based on computer tasks on cognitive dysfunction in remitted patients with bipolar disorder
Public title
Effects of cognitive rehabilitation on the improvement of cognitive deficits
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with bipolar disorder Age range 18 to 40 years Of both sexes The patient has no other psychiatric disorder or problem The patient has an intelligence score above 90 The patient has not received shock therapy in the past year
Exclusion criteria:
Emergence of serious physiological or psychiatric problems that are effective in the intervention. Cancel the continuation of the plan Creating thoughts of active suicide or episodes of psychotic depression while studying
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
This is how random numbers are prepared with the help of Randomaize.com. As per the sample size of the research, a number of envelopes with envelopes Aluminum (in the sense of the lack of clarity of the contents of the envelopes), preparation and each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes in order. In order to preserve the random sequence, on the outer surface of the envelopes. Numbering is done in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order At the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes is opened in order, the envelopes containing the odd number of the control group and the envelopes containing the even number of the intervention group.
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 Mashhad University of Medical Science
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9117699199
Approval date
2019-05-23, 1398/03/02
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.032

Health conditions studied

1

Description of health condition studied
Bipolar disorder
ICD-10 code
F30.3
ICD-10 code description
Manic episode in partial remission

Primary outcomes

1

Description
Patients' cognitive deficits
Timepoint
One week before and one week after interventions
Method of measurement
Cognitive assessment tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: they are subjected to computer-based cognitive rehabilitation therapy. Exercises with computer programs are scheduled for an average of 2 to 3 months. The rehabilitation sessions are 2 months or eight weeks, two sessions a week and each session is 60 minutes with Captain Lagast software. Psychological and compensatory training programs are involved in these interventions. Before and after the interventions, cognitive evaluation tests will be performed.
Category
Treatment - Other

2

Description
Control group: In the control group, only drug treatment is done. Cognitive evaluation tests will be done before and after the interventions.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibn Sina Psychiatric Hospital
Full name of responsible person
Ali Talaei
Street address
Mashhad, Bu Ali Square, Ibn Sina Psychiatric Hospital
City
Mashhd
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 937 315 8877
Email
ma.sarafrazavi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
345 -91357
Phone
+98 937 315 8877
Email
ma.sarafrazavi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
ali Talaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mashhad, Bu Ali Square, Ibn Sina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 903 926 4520
Email
raikaravan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Talaei
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mashhad, Bu Ali Square, Ibn Sina Psychiatric Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
raikaravan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Talaei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Mashhad, Bu Ali Square, Ibn Sina Psychiatric Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3841 3492
Email
raikaravan@gmail.com

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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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