Efficacy of a short term computer-based cognitive remediation program on cognitive performance in people with bipolar disorder: A randomized controlled study
Efficacy of a short term computer-based cognitive remediation program on cognitive performance in people with bipolar disorder
Design
Controlled randomized clinical trial
Settings and conduct
In this study, target population includes people with bipolar mood disorder and study population is a subset of them, who are in complete or partial remission and receive services from Roozbeh Hospital. Study sample will be chosen from this population based on inclusion and exclusion criteria. ُSubjects will randomly be assigned to intervention or control group. Cognitive remediation which is going to be done in day center of Roozbeh Hospital using COGPACK software, is the intervention in order to improve different domains of cognition. Cognitive state will be assessed before and after intervention to assess its efficacy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.People with bipolar mood disorder in partial or complete remission
2.Aged 18 through 55 years
3.Education level higher than 8th grade
4.IQ level above 70
Exclusion criteria:
1.A history of substance abuse (except nicotine & caffeine) within the past month
2.A history of electroconvulsive therapy within the six weeks prior to the study
3.A history of head trauma followed by loss of consciousness
4.Comorbidity of a major neurological disorder
5.Acute episode of the disease which requires immediate intervention
Intervention groups
The intervention group, in addition to treatment as usual (TAU) which is the 1st intervention, will recieve second intervention which consists of twelve 90-minute personal sessions of cognitive remediation, using COGPACK software tasks to improve cognitive status.The control group will receive onlyTAU (1st intervention). TAU includes medication treatment and psychoeducation.
Main outcome variables
Attention, memory, executive function, quality of life, function, clinical impression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200213046485N1
Registration date:2020-04-24, 1399/02/05
Registration timing:prospective
Last update:2020-04-24, 1399/02/05
Update count:0
Registration date
2020-04-24, 1399/02/05
Registrant information
Name
mehrnoosh vahidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
vahidi-m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-02, 1399/02/13
Expected recruitment end date
2021-05-03, 1400/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of a short term computer-based cognitive remediation program on cognitive performance in people with bipolar disorder: A randomized controlled study
Public title
Cognitive remediation in people with bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
people with bipolar disorder in partial or complete remission ( Young Mania Rating Scale (Y-MRS) score less than 8 and Hamiltone Depression Rating Scale (HDRS) score less than 8)
Education level higher than 8th grade
IQ level above 70 based on Wechsler intelligence scale
Exclusion criteria:
A history of substance abuse (except nicotine and caffeine) within the past month
A history of Electroconvulsive therapy within the six weeks prior to the study
A history of head trauma followed by loss of consciousness
Comorbidity of major neurological disorders including epilepsy, Parkinson’s disease, dementia etc.
Acute episode or active phase of the disease which requires immediate intervention
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be randomly assigned into intervention or control group via Blocked randomization method (Permuted block randomization). To create a randomized sequence the following website will be used: http://www.sealedenvelpe.com.
To conceal allocations, a randomized sequence is provided only for an specific individual. Then based on the sequence of subjects entering the program, the researcher asks that individual about the group in which each subject must be included. For every intervention according to the randomized sequence a number is assigned to each case.
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 School of Medicine, Tehran University of Medical Sciences
Street address
Roozbeh hospital, South Kargar Ave., Tehran
City
Tehran
Province
Tehran
Postal code
13337159140
Approval date
2020-02-10, 1398/11/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.883
Health conditions studied
1
Description of health condition studied
Bipolar mood disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Executive function score
Timepoint
before and after intervention
Method of measurement
Stockings of Cambridge test of CANTAB battery tests
2
Description
Visual memory score
Timepoint
before and after intervention
Method of measurement
Delayed matching to sample test of CANTAB battery tests
3
Description
Spatial working Memory score
Timepoint
before and after study
Method of measurement
Spatial working memory test of CANTAB battery tests
4
Description
Attention score no.1
Timepoint
before and after study
Method of measurement
Choice Reaction time test of CANTAB battery tests
5
Description
Attention score no.2
Timepoint
Before and after intervention
Method of measurement
Rapid visual information processing test of CANTAB battery tests
Secondary outcomes
1
Description
Quality of life score
Timepoint
Before and after intervention
Method of measurement
Michalak Quality of Life in Bipolar Disorder scale
2
Description
Clinical global impression score
Timepoint
Before and after intervention
Method of measurement
Clinical global impression scale
3
Description
Global function score
Timepoint
before and after intervention
Method of measurement
Global Assessment of Functioning scale
4
Description
Hamiltone depression rating scale score
Timepoint
before and after intervention
Method of measurement
Hamiltone depression rating scale
5
Description
Young mania rating scale score
Timepoint
before and after intervention
Method of measurement
Young mania rating scale
Intervention groups
1
Description
Intervention group: In the present study, the intervention group, in addition to usual standard treatment, will receive the intervention which consists of 12 personal sessions of ninety-minute computer-based training for cognitive remediation, twice or three times a week, using the Cogpack software. Cogpack is a software composed of many exercises and tasks for improvement of different domains of cognition, like attention, memory, language, planning, etc. In this study we aim to use some of these exercises to improve attention, memory and executive function. All of the sessions are going to be conducted by an occupational therapist in day center of Roozbeh Hospital. Usual standard treatment will include medication treatment and patient and family psychoeducation.
Category
Treatment - Other
2
Description
Control group: The control group will only receive usual standard treatment including medication treatment and patient and family psychoeducation.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Mehrnoosh Vahidi
Street address
Roozbeh hospital, South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 2222
Email
mehrnoosh.vahidi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahre Mirsepasi
Street address
Roozbeh hospital, South Kargar Ave., Tehran
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 9151
Email
mirsepassizahra@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mehrnoosh vahidi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh hospital, South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 2222
Email
mehrnoosh.vahidi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Mirsepasi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh hospital, South Kargar Ave.
City
Teharn
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 2222
Email
z-mirsepassi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnoosh Vahidi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh hospital, South Kargar Ave.
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 2222
Email
mehrnoosh.vahidi@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