Effect of Transcranial Direct Current Stimulation along with Affective Expectations Manipulation on Affective Experience and Anhedonia among Anhedonic Patients Suffering from Major Depression Disorder
effect of transcranial direct current stimulation along with affective expectations manipulation on affective experience and anhedonia among anhedonic patients suffering from major depression disorder
Design
The clinical trial will be conducted on 45 patients with parallel groups, double-blind and simple randomization through lottery.
Settings and conduct
Anhedonic patients suffering from Major Depressive Disorder who refer to Hafez and Ebne Sina hospitals in Shiraz City throughout the performing phase of the study will be randomized to the experimental groups through the lottery method. For blinding, some subjects receive actual stimulation, while others receive sham stimulation. The effect of the intervention on anhedonia symptom will be investigated by Using objective and subjective tools.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Obtaining the initial diagnosis of major depressive disorder with anhedonia using a structured clinical interview and questionnaire,
The patient should be able to perform the behavioral test and answer the questionnaires.
Exclusion criteria: The presence of comorbid disorders such as substance abuse, psychotic disorders, bipolar disorder, anxiety disorders and psychotic symptoms, the presence of metal parts in the head.
Intervention groups
Intervention group 1: In this group, during one session the participants through the tDCS device first receive electrical stimulation of 2 milliamps for 20 minutes on the head, Then positive emotions are induced through positive explanations about a movie.
Intervention group 2: During a session, the participants receive sham stimulation through the tDCS device and then induction of positive emotions through positive explanations about a movie.
Intervention group 3: transcranial electrical stimulation and then induction of neutral emotions.
Main outcome variables
Anhedonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230513058161N2
Registration date:2023-08-11, 1402/05/20
Registration timing:registered_while_recruiting
Last update:2023-08-11, 1402/05/20
Update count:0
Registration date
2023-08-11, 1402/05/20
Registrant information
Name
Somayeh Daneshvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 8351
Email address
somayedaneshvar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Transcranial Direct Current Stimulation along with Affective Expectations Manipulation on Affective Experience and Anhedonia among Anhedonic Patients Suffering from Major Depression Disorder
Public title
Effect of Stimulation along with Affective Expectations Manipulation on Anhedonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining the initial diagnosis of major depressive disorder with anhedonia using a structured clinical interview and questionnaire.
The patient should be able to perform the behavioral test and answer the questionnaires.
Exclusion criteria:
The presence of comorbid disorders such as substance abuse, psychotic disorders, bipolar disorder, anxiety disorders, and psychotic symptoms.
The presence of metal parts in the head
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of people to desired groups by simple random method and by lottery. For this purpose, we prepare three sheets on which we write the experimental groups. Then, with each patient's visit, one of the sheets is randomly removed and the patient is assigned to the selected group.
Blinding (investigator's opinion)
Double blinded
Blinding description
All the participants will be explained how the device works, and all individuals who participate in the study think that they will receive the intervention, however, some do not. In this way, after placing the transcranial direct current stimulation device on the subjects' heads, some receive actual stimulation, while others receive fake or sham stimulation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
5th floor, Shiraz University Central Building, Islamic Republic Blv, Shiraz
City
Shiraz
Province
Fars
Postal code
7194684471
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.SUMS.REC.1402.088
Health conditions studied
1
Description of health condition studied
Major Depression Disorder
ICD-10 code
F32.2
ICD-10 code description
Severe depressive episode without psychotic symptoms
Primary outcomes
1
Description
Anhedonia
Timepoint
Before and after the intervention
Method of measurement
Positive Valence Systems Scale-21 questionnaire
Secondary outcomes
1
Description
Probabilistic reward
Timepoint
Before and after the intervention
Method of measurement
Probabilistic reward task
Intervention groups
1
Description
Intervention group 1: transcranial direct current stimulation and then induction of positive emotions. In this group, the participants first receive electrical stimulation through one session, at the rate of 2 milliamps for 20 minutes, on the dorsomedial prefrontal cortex via the tDCS device, and then positive emotions will be induced. In this way, the short pleasurable video clip will be shown to the subject at the end of the stimulation. Before playing the movie, the positive emotional information about the movie will be presented to the subjects in order to manipulate the emotional expectations of the individuals.
Category
Treatment - Other
2
Description
Intervention group 2: Sham transcranial electrical stimulation then induction of positive emotions. In this group, during a session the participants first receive sham stimulation on the dorsomedial prefrontal cortex through the tDCS device, and then positive emotions are induced. In this way, at the end of the stimulation, the person will be shown the desired short pleasurable movie, and before playing the movie, in order to manipulate the emotional expectations of the person, positive emotional information about the movie will be presented to the person.
Category
Treatment - Other
3
Description
Intervention group 3: In this group, during a session the participants first receive electrical stimulation at the rate of 2 milliamps for 20 minutes on the dorsomedial prefrontal cortex through the tDCS device, and then neutral emotions are induced. In this way, at the end of the stimulation, the person will be shown the desired short pleasurable movie, and before playing the movie, neutral emotional information about the movie will be presented to the person.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Babak Hosseini
Street address
Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9080
Email
rcpsych1@sums.ac.ir
2
Recruitment center
Name of recruitment center
Ebne sina Hospital
Full name of responsible person
Ebrahim Moghimi Sarani
Street address
Eighth Ave, Hafez Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7654971466
Phone
+98 71 3228 9604
Email
sinahosp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
7th floor, central building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶- ۷۱۳۴۸
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Somayeh Daneshvar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hafez Hospital, Chamran Blv
City
Shiraz
Province
Fars
Postal code
71946-34786
Phone
+98 71 3647 9080
Email
somayedaneshvar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Somayeh Daneshvar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hafez Hospital, Chamran Blv
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9080
Email
somayedaneshvar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Somayeh Daneshvar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hafez Hospital, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9080
Email
somayedaneshvar@sums.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared in spss file format
When the data will become available and for how long
One month after results publication
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used for any statistical analysis, subject to permission from the researchers
From where data/document is obtainable
E-mail address of the corresponding author
What processes are involved for a request to access data/document
After request, the responsible author will send the data within a maximum period of one month.