Protocol summary

Study aim
Definition Comparison the Effectiveness of Hypnotherapy and pharmacotherapy on Depression of Depressed Patients
Design
All clients were students of Sari Azad University and Payame Noor Sari. They were selected by available sampling. In this way, the students who took the Beck rapper depression Test were invited to participate after their depression scores were evaluated. With the approval of a psychiatrist, 15 people in the hypnosis group, 15 people in the medication group and 15 people in the control group. 15 people in the hypnosis group received hypnotherapy in 7 sessions.
Settings and conduct
The study was performed in Shari city clinic and was held once a week
Participants/Inclusion and exclusion criteria
1. Lack of under controlled Convulsions 2. Lack of serious Thoughts about Self-injury or other's 3. Lack of former allergy to fluoxetine 4. Agreements to doing the test. Exclusion criteria: 1. The unwillingness of the individual to continue in the research 2. Do not attend more than 2 sessions of hypnotherapy sessions 3. Do not take the drug for more than two weeks.
Intervention groups
21 Questions pre test questionnaire of Beck depression inven tory was given to each group. For the intervention gruop , Hypnosis therapy training sessions were held in 7 sessions of week. The Psychiatrist prescribed 20 mg of Fluxetine capsules daily for The second intervention gruop for 7 weeks.The control group only received a questionnaire during the treatment period and did not receive any treatment.
Main outcome variables
Depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131007014928N8
Registration date: 2021-11-13, 1400/08/22
Registration timing: retrospective

Last update: 2021-11-13, 1400/08/22
Update count: 0
Registration date
2021-11-13, 1400/08/22
Registrant information
Name
Mehdi Pourasghar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3327 3024
Email address
m.pourasghar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-27, 1398/07/05
Expected recruitment end date
2020-01-30, 1398/11/10
Actual recruitment start date
2019-09-27, 1398/07/05
Actual recruitment end date
2020-09-10, 1399/06/20
Trial completion date
2020-09-10, 1399/06/20
Scientific title
Comparison the affectibility of Hypnotherapy and pharmacotherapy on depression of Depressed patients
Public title
Comparison the Affectibility of Hypnotherapy and pharmacotherapy on depression of Depressed patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Earn more than 30 points in the Beck Depression Test Having a minimum age of 20 and a maximum of 60 years Agreements to doing the test
Exclusion criteria:
lack of under controlled convulsions lack of serious thoughts about self-injury or other`s lack of former allergy to Flouxetine
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling Method in this Research is the Available type. After the Initial Evaluation of Beck Depression Test, 45 People Having Scores Higher than 30 Were Selected and divided in 3 groups with simple randomization by sealed envelops.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Mazandaran university of Medical Sciences and Health Services
Street address
Mazandaran University of Medical Sciences , Vali-asr Boulvard , sari , Mazandaran , Iran
City
Sari
Province
Mazandaran
Postal code
۹۱۹۷۱_۴۸۴۷۱
Approval date
2019-09-27, 1398/07/05
Ethics committee reference number
IR.IAU.AMOL.REC.1398.556

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Depression score in BECK test
Timepoint
Before and 7 weeks after the intervention
Method of measurement
Beck Depression Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: For the intervention group, hypnosis sessions were held in 7 sessions of 45 minutes for 7 weeks.
Category
Treatment - Other

2

Description
Intervention group2: For the intervention group They received 20 mg of fluoxetine capsules daily for 7 weeks
Category
Treatment - Other

3

Description
Control group: The control group only received a questionnaire during the treatment period and did not receive any treatment
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zare Haspital
Full name of responsible person
Mehdi Pourasghar
Street address
Mazandaran University of Medical Sciences , Vali-Asr Boulevard , Sari , Mazandaran , Iran.
City
Sari
Province
Mazandaran
Postal code
4813864866
Phone
+98 11 3337 3632
Email
m.pourasghar@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sahar Eslami koulaee
Street address
Amol, km 5 of the old Road from Amol to Babol
City
Sari
Province
Mazandaran
Postal code
3358461514
Phone
+98 11 4321 7000
Email
info@iauamol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Pourasghar
Position
Associat proffessor of psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Mazandaran University of Medical Sciences, Vali-Asr Boulevard, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
m.pourasghar@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehdi Pourasghar
Position
Associat proffessor of psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Mazandaran University of Medical Sciences, Vali-Asr Boulevard, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
m.pourasghar@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sahar eslami koulaee
Position
Master of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sari, Imam Square (RA) Joibar three ways, at the beginning of Valiasr Highway
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
0098 11 ۳۳۰۴۴۰۰۰-
Email
eslamisahar698@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data is completely personal and contrary to professional ethics
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Statistical documents are available
When the data will become available and for how long
Six months after publication if manuscript
To whom data/document is available
for researcher and scientists
Under which criteria data/document could be used
no limitation
From where data/document is obtainable
me_pourasghar@yahoo.com
What processes are involved for a request to access data/document
e-mail to me_pourasghar@yahoo.com
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