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Effectiveness of Internet-based Cognitive Behavioral Therapy in Weight Loss and Outcome of Virtual Group Therapy

Protocol summary

Study aim
Determining the effectiveness of Internet-based cognitive-behavioral therapy in weight loss and treatment outcome through virtual group
Design
This research is a quasi-experimental applied foundation with pre- and post-test between three intervention groups, routine obesity treatment and control group. The sample size based on G-Power is 90 people (30 people in the intervention group (iCBT), 30 people in the usual treatment of obesity (diet therapy) and 30 people in the waiting list control group) who are randomly placed in groups. The intervention group receives Internet-based cognitive-behavioral therapy, the as usual group undergoes a treatment regimen, and the control group's waiting list treatment is delayed until the end of the intervention group treatment.
Settings and conduct
This research does not require a physical location and only the initial interview is done at the Call of Life Counseling Center located in Neishabour.
Participants/Inclusion and exclusion criteria
Inclusion criteria include BMI≥ 25, age 18 to 50 years, having at least a ninth grade degree Fluency in Persian language, internet access and skill in using it. Exclusion criteria include menopause or pregnancy, lactation, psychosis and bipolar disorder diagnosed by a PhD student in psychology, certain diseases such as diabetes, thyroid, cancer, cardiovascular disease, and the use of psychotropic drugs or drugs that affect weight.
Intervention groups
The intervention group receives Internet-based cognitive-behavioral therapy, the as usual group undergoes a treatment regimen, and the control group's waiting list treatment is delayed until the end of the intervention group treatment.
Main outcome variables
Reducing body mass index Improve lifestyle self-efficacy Satisfaction with body image Improve eating-related behaviors Depression, anxiety, stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210306050594N1
Registration date: 2021-03-09, 1399/12/19
Registration timing: prospective

Last update: 2021-03-09, 1399/12/19
Update count: 0
Registration date
2021-03-09, 1399/12/19
Registrant information
Name
NAJME ABEDI SHARGH
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4263 6798
Email address
abede.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-13, 1399/12/23
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Internet-based Cognitive Behavioral Therapy in Weight Loss and Outcome of Virtual Group Therapy
Public title
Internet-based Cognitive Behavioral Therapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years Have at least a ninth grade degree Internet access and skills in using it Fluency in Persian BMI≥ 25
Exclusion criteria:
Menopause or pregnancy, lactation Psychosis and bipolar disorder diagnosed by a PhD student in psychology Certain diseases such as diabetes, thyroid, cancer, cardiovascular disease Taking psychotropic drugs or drugs that affect weight
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The present research in the category is applied basic research in terms of purpose and semi-experimental in terms of collection method. The pre-test and post-test design template was between three groups of iCBT intervention, routine treatment (TAU) and waiting list control group (WL). The population of this study is overweight women with a body mass index of more than 25, Neishabour city in 1300-00. Of these, 82 are selected based on G * Power analysis to determine the size of the medium to large effect (alpha .05; power .80) and due to the possibility of shedding according to the research, which is online, 90 people are considered. شد. How to replace people after structured diagnostic interview based on DSM-5 (SCID-5) by a PhD student in psychology and review the inclusion and exclusion criteria in the first stage using the available sample of 90 people selected and replacing subjects in each intervention and control group It is simple random using a table of random numbers and is an individual randomization unit.
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
Iran University of Medical Sciences
Street address
Sattarkhan St., Maziar Mansouri St., Iran Psychiatric Institute
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-09-28, 1398/07/06
Ethics committee reference number
IR.IUMS.REC.1398.667

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Weight Loss
Timepoint
two months
Method of measurement
Body mass index is calculated

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group :receive cognitive-behavioral therapy for weight loss. Cognitive-behavioral therapy sessions are based on Judith Beck's treatment plan for weight loss in 42 two-hour sessions over six weeks. This protocol is a treatment package that has been proven to be effective. Setsu and Zerwas research was also modeled on the correct implementation of ICBT. The content of the sessions used in the present study includes familiarity with the logic of treatment, familiarity with destructive thoughts and challenges with them, familiarity with the ABC pattern, setting goals, starting a diet, examining destructive thoughts related to dieting and responding to them, overcoming challenges The remaining destructive thoughts are adjusting and creating new skills, how to stop weight loss and stabilize new weight, and evaluate and summarize. CBT treatment is performed by a PhD student in clinical psychology who completed a CBT training course at the Tehran Psychiatric Institute. In this way, the therapist first forms two groups called psychotherapy in weight loss in WhatsApp (one intervention group 30 people, one control group waiting list 30 people) every morning audio file explaining psychotherapy sessions with exercise related to each session according to The goals of the program are recorded by a psychotherapist and placed in the virtual space created by the WhatsApp application, as well as the techniques are explained online. And to understand and perform correctly, the exercises of each person are examined (people have the opportunity to listen to the treatment file and perform the exercise and share it in the group until the evening) and for the exercises, feedback and answering questions for one hour. Every day from 6 to 7 pm, a consultation session can be held using online chat and WhatsApp voice and video calls. During the course, people communicate with each other and the therapist through online chat and support and give feedback to each other.
Category
Treatment - Other

2

Description
Control group 2: The control group did not apply any psychological treatment.
Category
N/A

3

Description
Control group 2: The as usual group undergoes treatment regimen once a week under the supervision of a nutritionist.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Neishabour, Counseling Center
Full name of responsible person
Najmeh Abedi Sharghا
Street address
Iran Square, Attar St. 10
City
نیشابور
Province
Razavi Khorasan
Postal code
9319737711
Phone
+98 51 4263 6798
Email
najme.abedi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abbas Motavlian
Street address
Sattar Khan St., Maziar Mansouri St., Tehran Psychiatric Institute
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Najmeh Abedi Shargh
Position
tutor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Qods City
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319363333
Phone
+98 51 4262 1060
Email
NAJME.ABEDI@GMAIL.COM

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Najme Abedi Shargh
Position
Tutor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Neishabour, Quds Town, No. 141
City
نیشابور
Province
Razavi Khorasan
Postal code
9319363333
Phone
+98 51 4263 6798
Fax
Email
abede.n@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Najme Abedi Shargh
Position
Tutor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Neishabour, Quds Town, No. 141
City
نیشابور
Province
Razavi Khorasan
Postal code
9319363333
Phone
+98 51 4263 6798
Fax
Email
abede.n@iums.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
Descriptive statistics information of all participants in the study Research results
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Be a research person in the field of research with the code of ethics
From where data/document is obtainable
Email address: NAJME.ABBEDI@GMAIL.COM
What processes are involved for a request to access data/document
Submit your request via email. One week to one month
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