Protocol summary

Summary
The objective of this research study is a randomized clinical trial with control group. Compare the effect of cognitive behavior therapy - rich with culture and religious teachings and cognitive behavior therapy to reduce depression, anxiety, and relapse rates of opioid-dependent patients. Inclusion criteria: individuals who, based on clinical interview and the Diagnostic and Statistical Mental Disorders criteria (America Psychiatric Association) affiliated with one of the opioid compounds (substance abuse) that had depression and anxiety. If you had missed three sessions of the study were excluded The study population was patients: the addiction treatment center for addiction treatment Welfare visited the city of Yazd. And among them 30 people who were entering the main criteria were randomized into three treatment groups. The first group (Group cognitive behavioral therapy - with a religious attitude), the second group (group cognitive - behavioral) the third group (control group). Group cognitive behavioral protocols for enriched with spiritual and religious learning, cognitive-behavioral protocol commonly performed for the second group, each group of 8 had a 2-hour group therapy session. The findings showed: Cognitive behavior therapy with a spiritual approach and cognitive - behavioral therapy compared to control group in reducing depression, anxiety has been effective. But spirituality-based therapy in reducing depression, anxiety, and prevention of recurrence has been more effective.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206089973N1
Registration date: 2012-07-25, 1391/05/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-07-25, 1391/05/04
Registrant information
Name
Mostafa Arab-Varnousfaderani
Name of organization / entity
Department of Counseling Faculty of Education and Psychology, University of Isfahan,
Country
Iran (Islamic Republic of)
Phone
+98 31 3362 6245
Email address
arabashrafi@gmail.com
Recruitment status
Recruitment complete
Funding source
Islamic Azad University roodhen
Expected recruitment start date
1997-10-07, 1376/07/15
Expected recruitment end date
1998-09-21, 1377/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cognitive - behavioral therapy and cognitive behavior therapy with spiritual approach on depression, anxiety symptoms and rate of relapse in self-referral addicts
Public title
Cognitive behavior therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria Subjects: All subjects are Substance abuse and The Beck Depression Inventory and Zung Anxiety scores are above the cut-off point Exclusion criteria from the study: Risk of severe psychiatric disorders and Not present in therapy sessions.
Age
From 25 years old to 46 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Islamic Azad University
Street address
Roodehen - Islamic Azad University
City
Roodehen
Postal code
3973188981
Approval date
1999-03-13, 1377/12/22
Ethics committee reference number
1132070176108

2

Ethics committee
Name of ethics committee
Islamic Azad University Roodehen
Street address
Roodehen,Islamic Azad University
City
Roodehen
Postal code
9373188981
Approval date
1999-03-13, 1377/12/22
Ethics committee reference number
1132070176108

3

Ethics committee
Name of ethics committee
Islamic Azad University
Street address
Roodehen - Islamic Azad University
City
Roodehen
Postal code
3973188981
Approval date
1999-03-13, 1377/12/22
Ethics committee reference number
1132070176108

Health conditions studied

1

Description of health condition studied
Substance abuse
ICD-10 code
F11
ICD-10 code description
behavioural disorders due to use of opioids Mental and

Primary outcomes

1

Description
Substance abuse
Timepoint
Before treatment, after treatment, three months after treatment
Method of measurement
Urinalysis

Secondary outcomes

1

Description
Depression, Anxiety
Timepoint
Before treatment - after treatment - three months after treatment.
Method of measurement
The Beck Depression Inventory standard. Zung standard questionnaire for anxiety

Intervention groups

1

Description
for group A Cognitive behavioral group therapy protocol enriched with spiritual and religious teachings
Category
Behavior

2

Description
For group B: 8 sessions of cognitive behavior group therapy
Category
Behavior

3

Description
The control group received only the drug
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Outpatient treatment center for self-referred Mtadn,Yazd
Full name of responsible person
Mostafa Arab Varnousfaderany clinical psychologist
Street address
yazd sazman bahzisty
City
yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Roodehen
Full name of responsible person
mostafa arab varnousfaderani
Street address
Roodehen - Islamic Azad University
City
Roodrhan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Roodehen
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
isfahan education organization
Full name of responsible person
mostafa arab varnousfaderani
Position
MA / Clinical Psychology / Consultant
Other areas of specialty/work
Street address
isfahan education organization Secondary literature, eight of Paradise Street,
City
isfahan
Postal code
8414884937
Phone
+98 31 1362 6245
Fax
Email
arabebrahimi@isfedu.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
amrollah ebrahimi
Position
PHD/Assistant professor
Other areas of specialty/work
Street address
Psychiatry department, NOOR medical center, OSTANDARI St. Isfahan
City
Isfahan
Postal code
Phone
+98 31 1625 8818
Fax
Email
a_ebrahimi@med.mui.acarabebrahimi@isfedu.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
isfahan education organization
Full name of responsible person
mostafa arab varnousfaderani
Position
MA/educational consuitant
Other areas of specialty/work
Street address
Hashtbahasht St. ADAB high school, Isfaha
City
Isfahan
Postal code
Phone
+98 31 1222 2286
Fax
Email
arabebrahimi@isfedu.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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