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Comparing the efficacy of Trans-diagnostic Cognitive Behavior therapy versus pharmacological therapy on reducing symptoms severity of OCD with co-occurring anxiety and mood disorders

Protocol summary

Summary
Objectives: The aim of the study was to comparing the efficacy of transdiagnostic CBT VS pharmacotherapy on reducing severity of OCD patients with co-occurring anxiety and mood disorders. Design: Sample of 36 patients recruited from 4 psychiatric and psychological centers from Zanjan, Iran. The participants assigned randomly on three groups (TCBT, Pharmacotherapy, and Control). Setting and conduct: Psychological instruments was administrated in four episodes: pretest, midtest, posttest, and a month follow up by two trained professional assistants. The instruments included clinical severity scale from Anxiety Disorders Interview Schedule for DSM-IV (ADIS) and self-reported diagnosis-specific scales. Participants: Qualified criteria for the sample included a principal diagnosis of OCD, an age requirement of 18 years or more, and confirm the informed consent. Exclusion criteria included the presence of any clinical conditions comprised current DSM-IV diagnosis of psychotic disorders, bipolar disorder, recent history of substance abuse, cognitive and personality disorders and absented in two and more psychotherapeutic sessions and drug cessation across implementing the study. Intervention: Psychological interventions was contained 20 session 1 hour based on Barlow UP, and pharmacotherapy was included SSRIs drugs that prescribed by psychiatrist. Control group didn't receive any intervention. Main outcome measures: OCD severity, frequency, and dimensions from principle diagnose and anxiety, depression, worry, and social anxiety scores from comorbid diagnosis were included in main outcome measures.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015072523333N1
Registration date: 2016-02-02, 1394/11/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-02, 1394/11/13
Registrant information
Name
Omid Saed
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
o.saed@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Reseacher (Omid Saed)
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2015-05-30, 1394/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Trans-diagnostic Cognitive Behavior therapy versus pharmacological therapy on reducing symptoms severity of OCD with co-occurring anxiety and mood disorders
Public title
Comparing the efficacy of Trans-diagnostic Cognitive Behavior therapy versus pharmacological therapy on reducing symptoms severity of OCD with co-occurring anxiety and mood disorders
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria is included: 1. age between 18-45 years 2. presence of one of the anxiety and unipolar mood disorders 3. eduction at least in 10 years 4. commitement to therapeutic sessions. exclusion criteria: 1. Absence of two or more session 2. presnce of other diagnoses such as SUD, cognitive disorders, and somatoform disorders. 3. not participating on one of the four assessments
Age
From 76 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
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 of Shahid Behesti University of Medical Sciences
Street address
Next to Ayatollah Taleghani Hospital ,Evin
City
Tehran
Postal code
Approval date
2015-05-17, 1394/02/27
Ethics committee reference number
SBMU.REC.1394.28

Health conditions studied

1

Description of health condition studied
Obsessive Compulsive Disorder
ICD-10 code
F42, F41.9
ICD-10 code description
, Depressive episode unspecified ,Anxiety disorder unspecified, ,Obsessive-compulsive disorder, Social phobias, Generalized anxiety disorder, Recurrent depressive disorder

Primary outcomes

1

Description
disorder severity, OC amount, OC dimesion, work and social function
Timepoint
before the intervention, mid test, posttest, a month follow up
Method of measurement
clinical severity rating, obsessive compulsive inventory, dimensional obsessive compulsive scale, work and social adjustment scale

Secondary outcomes

1

Description
anxiety sensetivity
Timepoint
after ending the intervention
Method of measurement
anxiety sensetivity scale

Intervention groups

1

Description
Intervention group 1:Intervention in transdiagnostic cognitive behavior therapy (TCBT group) included 20 one hour sessions of psychotherapy that designed based on Balow's Unified Protocol (2011).
Category
Behavior

2

Description
Intervention 2: Pharmacotherapt intervention included 0.5 mg Haloperidol a time per day, and 50 mg serteraline a time per day to 100 mg two time per day after four weeks that prescribed by professional Psychiatrist.
Category
Treatment - Drugs

3

Description
Control Group: Participants from control group didn't receive any intervetion and they were in wait list.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Zendegi counseling and psychological Service Center
Full name of responsible person
Omid Saed
Street address
Floor 2, Sina Clinin, Shariyar Street, Zanjan, Iran
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Omid Saed
Street address
Floor 2, Sina Clinic, Shahriyar Street, Zanjan, Iran
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Zanjan University of Medical Sciences
Full name of responsible person
Dr Farhad Taremian
Position
assistant professor
Other areas of specialty/work
Street address
Psychiatry and Clinical Psychology Dep, Beheshti Hospital, Ark Street, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3353 4500
Fax
Email
taremian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr Abbas Masjedi Arani
Position
assistant professor
Other areas of specialty/work
Street address
Clinical Psychology Dep, Floor 4, Taheghani Hospital, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21223031548
Fax
Email
doctormasjedi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Omid Saed
Position
Ph.D Student
Other areas of specialty/work
Street address
Behesti Hospital, Zanjan, Iran
City
Zanjan
Postal code
Phone
+98 24 3375 5993
Fax
Email
o.saed@sbmu.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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