Protocol summary

Summary
The aim of this study will be the comparison of the efficacy of acceptance and commitment therapy (ACT) and Cognitive therapy in treating patients with MDD. Method: Twenty outpatients meeting DAM-IV-TR criteria for MDD will be randomly assigned to one of two treatment conditions: ACT and CT treatment. The Beck Depression Inventory-II-Second Edition (BDI-II) and Ruminative Response Scale (RRS) will be administered before treatment and after treatment. Data will be analyzed by repeated measure ANOVA.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013032612857N1
Registration date: 2013-06-14, 1392/03/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-06-14, 1392/03/24
Registrant information
Name
Shima Tamannaei
Name of organization / entity
Tehran Psychiatry Institute, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 6899
Email address
sh-tamannaeifar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Acceptance and Commitment Therapy (ACT) Effectiveness and Cognitive Therapy (CT) in Patients with Major Depressive Disorder (MDD)
Public title
psychotherapy for depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having diagnosis criteria for MDD based on the psychiatrist and psychologist's findings; diagnoses through diagnostic interview and results of the SCID-I/CV test; receiving no psychological therapies during three months before participation in the study; being at least 18 aged to 35; having at least diploma education; signing the letter of satisfaction by the patients for participating in the study; exclusion criteria: Having psychotic symptoms; drug abuse and serious suicidal thoughts as they could not receive and maintain medications; having complete criteria of cluster B personality disorder at Axis II by psychiatrist and psychologist through diagnostic interview and results of the SCID-II test.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods St. Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-12-30, 1391/10/10
Ethics committee reference number
2081/ص/91

Health conditions studied

1

Description of health condition studied
Major Depressive Disorder
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode

Primary outcomes

1

Description
Depression
Timepoint
Before treatment, after treatment
Method of measurement
Beck Depressive Inventory

2

Description
Rumination
Timepoint
Before treatment, after treatment
Method of measurement
Ruminative Response Test

Secondary outcomes

empty

Intervention groups

1

Description
The subjects will attend two-hour sessions twice a week for a total of six weeks meeting in Consulting Center of Tehran University in Tehran. As for group cognitive treatment,. During the sessions of cognitive therapy, the participants will be acquainted with the cognitive techniques including teaching ABC technique, describing negative automatic thoughts and cognitive distortions, downward arrow, testing beliefs, logical analysis, self-reward and self punishment.
Category
Behavior

2

Description
Acceptance and Commitment Therapy sessions will include: Introduction to ACT, obtaining client’s life story, identification of therapeutic goals and relationship to values, increase client awareness of the pervasiveness of emotional control, defusing automatic thoughts, managing barriers to commitment and assignment of homework.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Consulting Center of Tehran University
Full name of responsible person
Hamid Peiravi
Street address
6th Floor, No.15, Eghelab Ave., Edward brown Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Fotouhi
Street address
Shahid Hemmat Campus, Shahid Chamran and Sheikh Fazlullah Nuri Intersection, Shahid Hemmat West Highway
City
Tehran
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, Tehran University of Medical Sciences
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
Tehran psychiatric institute
Full name of responsible person
Shima Tamannaei Far
Position
Ph.D student in clinical psychology
Other areas of specialty/work
Street address
No 1, Shahid Mansouri Alley, niayesh St, Sattarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6650 6853
Fax
Email
psychshima@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran Psychiatry Institute
Full name of responsible person
Dr Bannafsheh Gharaee
Position
Ph.D in clinical psychology
Other areas of specialty/work
Street address
No 1, Shahid Mansouri Alley, niayesh St, Sattarkhan Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 6655 1655
Fax
Email
Banafshehgh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Psychiatry Institute
Full name of responsible person
Shima Tamannaei Far
Position
Phd Student in Clinical Psychology
Other areas of specialty/work
Street address
No 1, Shahid Mansouri Alley, Niayesh St, Sattarkhan Ave, Tehran
City
Tehran
Postal code
Phone
Fax
Email
psychshima@gmail.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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