Randomized controlled trial comparing the effect of Dialectical Behavior Therapy and Transdiagnostic Treatment on binge eating, difficulties in emotion regulation and BMI in obese and overweight patients with binge-eating disorder
(1) Objectives: This study aimed to compare the effec of Dialectical Behavior Therapy (DBT) and Trans-diagnostic Treatment on binge eating, difficulties in emotion regulation and BMI in obese and overweight patients with binge-eating disorder at Kashan. (2) Design: General plan of this study is consisted of experimental pre-test and post-test with control group and follow-up period. (3) Setting and conduct: Ninety subjects who met the criteria for binge eating and overweight or obesity were selected by convenient sampling and were randomly assigned in three groups (DBT, Trans-diagnostic Treatment and Control group). After measuring height and weight and calculated BMI of participants, each of the three groups filled out Gormally’s Binge Eating Scale and Gratz’s Difficulties in Emotion Regulation Scale (DERS) as pre-test and post- test and one month after intervention. The data were analyzed by SPSS-19 using the ANOVA with repeated measure. (4) Inclusion criteria: Binge eating disorder; Overweight or obesity. Exclusion criteria: Obesity associated with physical disease; Diabetes; Pregnancy or lactation; Drug abuse. (5) Interventions: The first intervention is consisted of 10 sessions (each session is 120 minutes) of Dialectical behavior therapy and Advised usual diet for the first experimental group. The second intervention is consisted of 8 sessions (each session is 120 minutes) of Trans-diagnostic therapy and Advised usual diet for the second experimental group. Control group just get Advised usual diet. (6) Main outcome measures variables in this research are binge eating, difficulties in emotion regulation, and BMI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061422709N1
Registration date:2015-08-11, 1394/05/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-11, 1394/05/20
Registrant information
Name
Maliheh Rahmani
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2305
Email address
rahmani-ma@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized controlled trial comparing the effect of Dialectical Behavior Therapy and Transdiagnostic Treatment on binge eating, difficulties in emotion regulation and BMI in obese and overweight patients with binge-eating disorder
Public title
comparing the effect of Dialectical Behavior Therapy and Transdiagnostic Treatment on Binge-Eating Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Binge eating disorder; Overweight or obesity; Willingness and able to participate in the research
Exclusion criteria: Other early psychiatric diagnoses; Obesity associated with physical disease; Diabetes; Pregnancy or lactation, Drug abuse; Absence more than 3 times; Get a history of psychological interventions during the past month
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics committee of Kashan University of Medical Sciences and Health Services
Street address
Ethics committee, Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
8715988141
Approval date
2015-06-24, 1394/04/03
Ethics committee reference number
IR.KAUMS.REC.1394.46
Health conditions studied
1
Description of health condition studied
Binge Eating
ICD-10 code
F50.4
ICD-10 code description
Overeating associated with other psychological disturbances
2
Description of health condition studied
Overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified
3
Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
Binge Eating
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Structured Clinical Interview for DSM Disorders (SCID), Binge Eating Scale (Gormally et al. 1982)
2
Description
Difficulties in Emotion Regulation
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Difficulties in Emotion Regulation Scale (DERS) (Gratz & Roemer 2004)
3
Description
body mass index (BMI)
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Quetelet index (Lambert Adolphe Jacques Quetelet)
Secondary outcomes
empty
Intervention groups
1
Description
dialectical behavior therapy; 10 sessions; 2 hours; Advised usual diet; First intervention group
Category
Behavior
2
Description
Transdiagnostic therapy; 8 sessions; 2 hours; Advised usual diet; First intervention group
Category
Behavior
3
Description
Advised usual diet; Control group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Hospital
Full name of responsible person
Maliheh Rahmani
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Full name of responsible person
Dr Qolam Ali Hamidi
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Maliheh Rahmani
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 2305
Fax
Email
rahmani-ma@kaums.ac.ir, rahmani1300@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Maliheh Rahmani
Position
postgraduate
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 2305
Fax
Email
rahmani-ma@kaums.ac.ir, rahmani1300@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Maliheh Rahmani
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 2305
Fax
Email
rahmani-ma@kaums.ac.ir, rahmani1300@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)