The effects of affective expectations on affective experience and anhedonia among anhedonic patients suffering from major depression disorder
Design
Clinical trial with control group, with parallel groups, single-blind, randomized. For randomization, people are placed in the control or intervention group through lottery.
Settings and conduct
The research will be conducted in Hafez and Ebne Sina hospitals in Shiraz. The participants will be randomly divided into two groups of inducing positive and neutral expectations. participants in the positive expectancy induction group are given very positive explanations about the movie that will be played for them. While the subjects of the neutral emotion induction group will be given explanations about the movie that only explain the events that happened in the movie without using any special emotional charge. The participants are aware of the study as a whole, but they are unaware of which group they belong to.
Participants/Inclusion and exclusion criteria
Inclusion criteria: initial diagnosis of major depressive disorder with anhedonia, Age range from 18 to 65 years.
Exclusion criteria: The presence of comorbid disorders, including substance abuse, psychotic disorders, bipolar disorder, anxiety disorders, and psychotic symptoms, active suicidal ideation, History of head injury or neurological diseases.
Intervention groups
Intervention group: induction of positive expectations. participants in the positive expectancy induction group are given very positive explanations about the movie that will be played for them.
Control group: induction of neutral expectations. Explanations about the film will be provided, which only explain the events and happenings in the film without using any special emotional load.
Main outcome variables
Affective Experience
Anhedonia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230513058161N1
Registration date:2023-07-19, 1402/04/28
Registration timing:registered_while_recruiting
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
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
2023-02-09, 1401/11/20
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of affective expectations on affective experience and anhedonia among anhedonic patients suffering from major depression disorder
Public title
The effects of affective expectations on anhedonia among patients suffering from major depression disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Initial diagnosis of major depressive disorder with anhedonia
Age range from 18 to 65 years
Exclusion criteria:
The presence of comorbid disorders, including substance abuse, psychotic disorders, bipolar disorder, anxiety disorders, and psychotic symptoms.
Active suicidal ideation
History of head injury or neurological diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets and write "intervention" on one and "control" on the other. Then, upon each patient's visit, he/she is asked to pick one of the sheets randomly, and based on this, the patient is assigned to the intervention or control group. It is continued in the same way for other patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
The general design of the experiment is explained to the participants, but the subject does not know which group will be placed in. In this way, the general objectives of the research are explained to the subjects before the implementation of the research: In this research, we intend to investigate the symptom of anhedonia in major depressive disorder using psychological interventions. However, subjects are not told which of the experimental or control groups they have been placed in.
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 Blvd,
City
Shiraz
Province
Fars
Postal code
7194684471
Approval date
2022-12-04, 1401/09/13
Ethics committee reference number
IR.SUMS.REC.1401.573
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
2
Description
Affective Experience
Timepoint
Before and after the intervention
Method of measurement
Affective Experience questionnaire
Secondary outcomes
1
Description
Probabilistic reward Learning
Timepoint
Before and after the intervention
Method of measurement
Probabilistic reward task
Intervention groups
1
Description
Intervention group: induction of positive expectations. Individuals in this group will be given a very positive description of the movie they are about to see, on the basis that the movie will be very enjoyable, such as: "This movie you are about to see is one of the best movies I've ever seen." It is a popular comedy that is very enjoyable. The aim of this statement is to induce excitement and positive emotion towards watching the clip in order to increase the interest of the person in watching the clip.
Category
Treatment - Other
2
Description
Control group: The people of this group will be given an explanation about the movie, which only explains the events and happenings in the movie without using any special emotional load.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Babak Hosseini
Street address
Hafez Hospital, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9080
Email
Hafez@sums.ac.ir
2
Recruitment center
Name of recruitment center
Ebne Sina Hospital
Full name of responsible person
Ebrahim Moghimi Sarani
Street address
Hafez Ave, 8th Ave
City
Shiraz
Province
Fars
Postal code
7146676541
Phone
+98 71 3228 9601
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
7194684471
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 Blvd
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3612 8351
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 Blvd
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3612 8351
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 41 3612 8351
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 potential data can be shared in SPSS file format after de-identifying people.
When the data will become available and for how long
Access start 6 months after the results publication
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
The necessary conditions for sending a request to access data or documents are email to the corresponding author. Only statistical analyzes similar to those performed in the present study are allowed, including independent t-student tests and multivariate analysis of variance tests.
From where data/document is obtainable
Email to the corresponding author
What processes are involved for a request to access data/document
Applicants can send their request via e-mail to the responsible author, then within a maximum period of one month, the corresponding author will send them the required documents or files.