Protocol summary

Summary
Objectives: Depression is one of the most common psychological disorders with developmental growth. Considering to the role of emotional regulation in psychological disorders such as depression, this study aimed to assess the effectiveness of dialectical behavior therapy based on emotion regulation training (main variable) on the regulation of emotion difficulties and depression symptoms (dependent variables) among referred patients to a psychology clinic in Mashhad city. Main variable: Dialectical behavior therapy based on emotion regulation training, Dependent variables: Regulation of emotion difficulties and depression symptoms. Design: This clinical trial designed as pre-test, post-test and one month follow-up. Participants: The population of this clinical trial including all persons who had referred to the one of the Mashhad psychology clinics from January to March 2013 and were selected by available sampling method. The inclusion criteria was receiving 20 or more scores in Beck Depression Inventory-II and the exclusion criteria included another intervention, including any medicine and psychotherapy during this project. Setting and conduct: 40 participants were divided randomly to experimental and control group, equally. The tools of this study were BDI-II and Difficulties of Emotion Regulation Scale (DERS). Data were analyzed by repeated measurement-analysis of variance in SPSS software. Interventions: Dialectical behavior therapy based on emotion regulation training in 8 sessions, twice a week

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013110515284N1
Registration date: 2013-12-26, 1392/10/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-12-26, 1392/10/05
Registrant information
Name
Nadia Shamloo
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 51 1711 2540
Email address
borhanimm3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2013-03-31, 1392/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assess the effectiveness of dialectical behavior therapy based on emotion regulation training on the depression symptoms among referred patients to a psychology clinic in Mashhad city
Public title
The effectiveness of dialectical behavior therapy based on emotion regulation training on depression symptom
Purpose
Treatment
Inclusion/Exclusion criteria
The main condition of inclusion criteria was receiving 20 or more scores in Beck Depression Inventory-II; and the main condition of exclusion criteria included another intervention including any medicine and psychotherapy during this project
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
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, Azad Univercity, branch of Saveh
Street address
1st-floor, Agriculture faculty, City University of Khatam-Al-Anbiya, Km 3 of Noor-Alibeyk road
City
Saveh
Postal code
Approval date
2012-08-12, 1391/05/22
Ethics committee reference number
35011

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Depression
Timepoint
One week before intervention-The end point of intervention-One month after the end of intervention
Method of measurement
BDI-II

2

Description
Difficulties of Emotion Regulation
Timepoint
One week before intervention-the end point of intevention-one month after the end of intervention
Method of measurement
Difficulties of Emotion Regulation Scale (DERS)

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group (dialectical behavior therapy based on emotion regulation training in 8 sessions, twice a week)
Category
Behavior

2

Description
Control group which takes part in free discussion meetings without special structure
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Saba Clinic
Full name of responsible person
Nadia Shamloo
Street address
Vakil abad 30
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Azad Univercity branch of Saveh, Vice chancellor for research
Full name of responsible person
Anoosh Eghdami
Street address
1st-floor, Agriculture faculty, City University of Khatam-Al-Anbiya, Km 3 of Noor-Alibeyk road
City
Saveh
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad Univercity branch of Saveh, Vice chancellor for research
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
Azad Univercity, branch of Saveh
Full name of responsible person
Nadia Shamloo
Position
Ms in clinical psychology
Other areas of specialty/work
Street address
Number16, Hashemieh10
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
borhanimm3@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Azad Univercity,branch of Saveh
Full name of responsible person
Nadia Shamloo
Position
Ms in clinical psychology
Other areas of specialty/work
Street address
Number16, Hashemieh10
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
borhanimm3@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Azad Univercity, branch Of Saveh
Full name of responsible person
Nadia Shamloo
Position
Ms in clinical psychology
Other areas of specialty/work
Street address
Number16, Hashemieh10
City
Mashhad
Postal code
Phone
+98 51 1711 2540
Fax
Email
borhanimm3@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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