Protocol summary

Summary
The aim of this study was to compare the effectiveness of Spiritual Integrated Psychotherapy( SIPT),Cognitive- Behavioral Therapy (CBT) and Medication in reducing dysfunctional attitudes and depressive symptoms in patients with dysthymic disorder. Sixty two patients with dysthymic disorder were recruited from Health and Academic Centers in Isfahan (Iran) on 2007. Main inclusion criteria were diagnosis of dysthymic disorder according to DSM-IV-TR criteria, age20-65 and Persian language. Exclusion criteria were suffering from one of serious neurological disorder, mental retardation, psychosis disorders and risk of suicide. The subjects were then randomly assigned into three experimental groups and one control group. Medication was consisted of antidepressants prescribed by psychiatrist, the SIPT and CBT were presented in 8 sessions. Beck Depression Inventory and Dysfunctional Attitudes Scale were completed by all of the subjects, prior, during, and after intervention, and in a 3 month follow-up as well. Results revealed that SIPT was found to be more effective than medication on the reduction of depressive symptoms and dysfunctional attitude (P < 0.01), And was also found to be more effective than CBT on the reduction of the dysfunctional attitude (P < 0.01), but not on the reduction of depressive symptoms. SIPT and CBT were found to have more consistent effects than medication in the follow-up (p<0.01).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108157339N1
Registration date: 2012-08-19, 1391/05/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-08-19, 1391/05/29
Registrant information
Name
Amrollah Ebrahimi
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 8818
Email address
a_ebrahimi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Department of Psychology, Isfahan University
Expected recruitment start date
2006-09-11, 1385/06/20
Expected recruitment end date
2007-09-29, 1386/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of Spirituality Integrated Psychotherapy (SIPT), Cognitive-Behavioral Therapy (CBT) and Medication Intervention on reduction of Depressive Symptoms and Dysfunctional Attitudes in Patients with Dysthymic Disorder
Public title
Spirituality Psychotherapy (SIPT), Cognitive-behavioral Therapy (CBT) and Medication Intervention on Depressive Symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included dysthymic disorder diagnosis according to DSM-IV-TR; age between 20 and 65 years old; Persian language; Exclusion comorbidity with severe physical diseases; serious neurology; mental retardation; psychosis disorders or symptoms; bipolar disorder; depression disorders resulting from drug and alcohol abuse and other psychiatric disorders with depression as their secondary symptoms; reluctance of the patient to continue the therapy; serious suicide ideation and risk of suicide which require emergency intervention.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University
Street address
Isfahan University,Hejarjerib bolvar,Isfahan, Iran
City
Isfahan
Postal code
Approval date
2006-05-10, 1385/02/20
Ethics committee reference number
5888/82

Health conditions studied

1

Description of health condition studied
Dysthimic Disorder
ICD-10 code
F34.1
ICD-10 code description
Dysthymia

Primary outcomes

1

Description
severity of depressive symptoms (self-report)
Timepoint
before intervention,after 4week,after intervention,3month afterintervention(follow out)
Method of measurement
Beck Depression Inventory(BDI-II)

2

Description
severity of anxiety symptoms(clinician rating)
Timepoint
before intervention,after 4week,after intervention,3month afterintervention(follow out)
Method of measurement
Hamilton Rating Scale for Depression(HRSD)

3

Description
dysfunctional attitude
Timepoint
before intervention,after 4week,after intervention,3month afterintervention(follow out)
Method of measurement
Dysfunctional Attitude Scale (DAS-26)

Secondary outcomes

empty

Intervention groups

1

Description
Group1:Spritually Integrated psychotherapy include cognitive, behavioral,emotional,spritual strategies based on religious sources. SIPT were presented in 8 sessions, each week, a 45-minute individualTreatment session
Category
Other

2

Description
Group2: cognitive behavior therapy with using a standard protocol in the form of eight 45-minute sessions, one session per week,Individually
Category
Other

3

Description
Group3:routin antidepressant medication therapy, Citalopram was initiated at 20 mg/day, and increased to a maximum of 60 mg/day
Category
Treatment - Drugs

4

Description
Control Group: no any intervention ( waiting list )
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor Medical Center
Full name of responsible person
Dr.Ghorban Ali Asadollahi
Street address
Noor Medical Center, Ostandari Avn, Isfahan,Iran
City
Isfahan

2

Recruitment center
Name of recruitment center
Counseling Center of Isfahan University of Medical Sciences
Full name of responsible person
Raheleh Samoei
Street address
Counseling Center, Isfahan University of Medical Sciences, Hejarjirib Bolvar, Isfahan, Iran
City
Isfahan

3

Recruitment center
Name of recruitment center
counseling Center of Iranian Oil Company(Goldis)
Full name of responsible person
Dr. Said Sadeghi
Street address
counseling Center of Iranian Oil Company(Goldis), Goldasteh Gourden Street, Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University
Full name of responsible person
Dr.Hamid Taher Neshatdost
Street address
Hejarjerib Bolvar
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University
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
Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Amrollah Ebrahimi
Position
assistant professor of Department of Psychiatry
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hejarjirib abolvar, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1222 2135
Fax
Email
a_ebrahimi@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Amrollah Ebrahimi
Position
Assistant Professor of Department of Psychiatry
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hejaarjerib Bolvar, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1222 2135
Fax
Email
a_ebrahimi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Psychosomatic Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
Full name of responsible person
Amrollah Ebrahimi
Position
assistant professor of Department of Psychiatry
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Hezarjerib Bolvar, Isfahan, Iran
City
ISFAHAN
Postal code
Phone
Fax
Email
a_ebrahimi@med.mui.ac.ir
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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