Protocol summary

Study aim
The purpose of this study was to investigate the effectiveness of emotion-focused therapy on depression, anxiety, and difficulty in emotion regulation in women with binge eating disorder.
Design
The study was a quasi-experimental clinical trial with a pre- post-test design and 6 weeks of follow up with control group.After identifying Binge eating disorder and determining the criteria for Inclusion and exclusion criteria and selecting 40 patients and randomly assigning coins to the experimental (n = 20) and control (n = 20) groups, the research tools were pretest, posttest and follow up on the two groups. Was executed.
Settings and conduct
After selecting the sample and randomly assigning them to the experimental and control groups, both groups were administered a pretest (Emotion Regulation Difficulty Questionnaire and Beck Depression Anxiety Inventory). After pre-test group program with emotion-centered treatment approach was performed in 10 90-minute sessions weekly for experimental group in a weight loss clinic. The control group also received placebo during this period. The treatment program was performed in eight stages.
Participants/Inclusion and exclusion criteria
Participants' inclusion criteria: 1- Over 18 years of age 2- Being female 3- Not participating in other treatment programs during the study. Exclusion criteria: 1- Imminent suicide risk 2- Any substance abuse or dependence To Materials and Alcohol 3 - Body Mass Index (IBM = Weight in kg divided by the square of height in cm) above 40.
Intervention groups
The experimental group received EFT treatment (emotion-centered treatment approach) in 10 90-minute sessions weekly. The control group also received placebo during this period.
Main outcome variables
depression, anxiety, and difficulty in emotion regulation and binge eating disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200222046583N1
Registration date: 2020-03-11, 1398/12/21
Registration timing: retrospective

Last update: 2020-03-11, 1398/12/21
Update count: 0
Registration date
2020-03-11, 1398/12/21
Registrant information
Name
yousef asmaribardezard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 4742
Email address
asmariyousef@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-31, 1398/06/09
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
2019-08-31, 1398/06/09
Actual recruitment end date
2020-01-30, 1398/11/10
Trial completion date
2020-01-31, 1398/11/11
Scientific title
The Effectiveness of Emotion-Focused Therapy On Anxiety, Depression and Difficulty in Emotion Regulation in Binge Eating Disorder
Public title
The Effectiveness of Emotion-Focused Therapy On Anxiety, Depression and Difficulty in Emotion Regulation in Binge Eating Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women with overeating disorder, overeating disorder diagnosed by a clinical specialist (non-therapist) based on the Structured Clinical Interview for DSM-5 (SCID-5), and a cut-off point of the questionnaire (above 16).
Exclusion criteria:
Imminent suicide risk Any substance abuse or dependence on alcohol & alcohol Body mass index (IBM = Weight in kg divided by square of height in cm) above 40.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty patients were selected after being interviewed and filtered by inclusion and exclusion criteria. Members of the control group and the experimental group were chosen through the toss of coin. Coin was tossed as many times as need to complete the number of control and experimental groups.
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
IR.USWR.REC :
Street address
University of Social Welfare and Rehabilitation Sciences, kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2017-07-25, 1396/05/03
Ethics committee reference number
IR.USWR.REC.1397.78

Health conditions studied

1

Description of health condition studied
Binge eating disorder
ICD-10 code
F50.81
ICD-10 code description
ICD-10 Code: F50.81.

Primary outcomes

1

Description
Overeating intensity courses
Timepoint
Before intervention (pre-test), after intervention (one week after intervention as post-test), 1 month later (Follow-up)
Method of measurement
Research tools included Beck Depression and Anxiety Inventory, Difficulty in Emotion Regulation and Gormal Eating Intensity Scale.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The group-based program of emotion-focused treatment was performed in 10 weight sessions weekly for the experimental group in a weight loss clinic.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital Obesity Center
Full name of responsible person
Sajad Khanjani
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Fateme Amiri
Street address
Evin, boulevard student, Dead-end babysitting
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
yo.asmari@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Support
Proportion provided by this source
30
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Usef Asmari Bardezard
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Social Welfare and Rehabilitation Sciences kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
asmariyousef@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sajjad Khanjani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 2, Nayayesh Alley, Nayayesh Alley, Sattarkhan St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
khanjanis23@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sajjad Khanjani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 2, Nayayesh Alley, Nayayesh Alley, Sattarkhan St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6651 1655
Email
usefasmari1991@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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