This study aimed to assess the efficacy of mindfulness based cognitive therapy method on dysthymic patients. For this purpose, we selected 50 clients who had referred to some of psychiatric clinics of shiraz, Iran, and had dysthymic disorder criteria; then, we assigned them into two groups of intervention and control. For the intervention group the psychotherapy method will be carried out in eight sessions of 2 to 2.5 hours and one session a week in addition to receiving medication. The control group receives only medication without any other psychotherapy method. Variables that will be assessed in this study through questionnaires are severity of depression, aggression, the ability of emotional regulation and rumination. The intervention group will fill out the questionnaires before and after the intervention, and the control group will fill out the questionnaires during a 2 month period. The results will be statistically compared with each other at the end of the therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203259330N1
Registration date:2012-04-12, 1391/01/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-12, 1391/01/24
Registrant information
Name
Sajedeh Hamidian
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 9319
Email address
hamidians@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of mindfulness-based cognitive therapy in depression, anger, rumination and the ability of emotional regulation in dysthymic patients
Public title
The effect of mindfulness based cognitive therapy on dysthymic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having at least 2 years of depression according to diagnostic criteria of DSM-VI-TR for Dysthymic Disorder; age older than 18 years; minimum diploma in education. Exclusion criteria: receiving any other psychotherapy in addition to attending in therapy sessions for intervention group; receiving any psychotherapy meanwhile using medicine for control group; having an episode of psychosis, mania or a diagnosed personality disorder; using drugs or alcohol; having thought, ideation or an active plan for suicide; having depression due to a concurrent physical problem.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Shiraz unversity of medical sciences
Street address
Central building, Shiraz university of medical sciences, Zand st.
City
Shiraz
Postal code
71345-1978
Approval date
2012-03-08, 1390/12/18
Ethics committee reference number
CT-90-5964
Health conditions studied
1
Description of health condition studied
Dysthymic Disorder
ICD-10 code
F34.1
ICD-10 code description
Dysthymia
Primary outcomes
1
Description
Depression
Timepoint
before and after the intervention
Method of measurement
BDI-II (Beck Depression Inventory-II)
Secondary outcomes
1
Description
Agression
Timepoint
before and after the intervention
Method of measurement
state-trait agression inventory spilberger
2
Description
Rumination
Timepoint
before and after the intervention
Method of measurement
Rumination questionnaire
3
Description
emotional regulation
Timepoint
before and after the intervention
Method of measurement
disturbances in emotional regulation inventory
Intervention groups
1
Description
Control group :only pharmacotherapy
Category
Treatment - Drugs
2
Description
Intervention group: the mbct (mindfulness based cognitive therapy) method that is carried out in 8 sessions, once a week, each session lasts 2 to 2.5 hours plus pharmacotherapy.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Reza
Full name of responsible person
Dr. Ali Sahraeiyan
Street address
Namazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Shiraz University of Medical Scinece, central building, next to Red cresent building ,zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz university of medical sciences
Full name of responsible person
Sajedeh Hamidian
Position
MSc student in clinical psychology
Other areas of specialty/work
Street address
Department of psychiatry and psychology , Hafez hospital, Chamran Boulevard
City
Shiraz
Postal code
7194634786
Phone
+98 71 1627 9319
Fax
Email
hamidians@sums.ac.ir , hooma65@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan university of medical sciences
Full name of responsible person
Dr. Abdollah Omidi
Position
PHD of clinical psychology, assistant professor of psychiatry department
Other areas of specialty/work
Street address
Psychiatry department , kashan university of medical sciences
City
KJashan
Postal code
Phone
+98 36 1555 0111
Fax
Email
abomidi20@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
Sajedeh Hamidian
Position
MSc student in clinical psychology
Other areas of specialty/work
Street address
Department of psychiatry and psychology , Hafez hospital, Chamran Boulevard
City
Shiraz
Postal code
Phone
Fax
Email
hooma65@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)