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comparing the effectiveness of acceptance and commitment therapy (ACT), selective serotonin reuptake inhibitors (SSRIs), and the combination of ACT and SSRIs in the treatment of adults with OCD.

Protocol summary

Summary
The aim of this study was to compare the effectiveness of acceptance and commitment therapy , selective serotonin reuptake inhibitors, and the combination of acceptance and commitment therapy and selective serotonin reuptake inhibitors in the treatment of adults with Obsessive Compulsive Disorder. Thirty-two outpatients with Obsessive Compulsive Disorder were randomly assigned to one of three treatment conditions:acceptance and commitment therapy , selective serotonin reuptake inhibitors, and combined treatment. The Yale-Brown Obsessive-Compulsive Scale , Beck Depression Inventory-II-Second Edition , Beck Anxiety Inventory , World Health Organization Quality of Life-BREF , and Acceptance and Action Questionnaire were administered at pre - and post-treatment. The Yale-Brown Obsessive-Compulsive Scale , Beck Depression Inventory-II-Second Edition , Beck Anxiety Inventory , and Acceptance and Action Questionnaire were also administered in the middle treatment. Twenty-seven patients completed the study.Acceptance and commitment therapy was based on an acceptance and commitment therapy manual for OCD developed by Twohig (2007).The patients in drug group received a different selective serotonin reuptake inhibitor (sertraline=50-200 mg/d;fluoxetine=20-80 mg/d) for 10 weeks, which was monitored by two psychiatrist. The combination group received both ACT and a different selective serotonin reuptake inhibitor (sertraline=50-200 mg/d;fluoxetine=20-80 mg/d) for 10 weeks.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013042713145N1
Registration date: 2013-05-17, 1392/02/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-17, 1392/02/27
Registrant information
Name
Yaghoob Vakili
Name of organization / entity
Tehran University of Medical Sciences,Tehran psychiatric institute
Country
Iran (Islamic Republic of)
Phone
+98 936 664 4146
Email address
y-vakili@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-02-04, 1390/11/15
Expected recruitment end date
2013-03-16, 1391/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the effectiveness of acceptance and commitment therapy (ACT), selective serotonin reuptake inhibitors (SSRIs), and the combination of ACT and SSRIs in the treatment of adults with OCD.
Public title
Comparing The Effectiveness of Acceptance and Commitment Therapy,Pharmacotherapy.and their combination in the Treatment of Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : a primary diagnosis of OCD according to DSM-IV-TR ; age between 18 to 50 years; OCD symptoms duration of at least 1year; Exclusion criteria: having a current or past psychotic disorder ; suicidal tendencies; medical illness ; substance abuse disorder ; personality disorder; had been treated with either pharmacotherapy or psychotherapy in the 1month preceding baseline;patients with other axis I disorders (except anxiety disorders and major depression disorder and dysthymia disorder) and axis II disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Science, Sixth Floor, Ghods St, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-08-18, 1391/05/28
Ethics committee reference number
60101179621210291

Health conditions studied

1

Description of health condition studied
Obsessive Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
obsessive - compulsive symptoms
Timepoint
pre-middle and post-treatment
Method of measurement
The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

Secondary outcomes

1

Description
Depression
Timepoint
pre-middle and post treatment(tenth week)
Method of measurement
Beck Depression Inventory-II-Second Edition (BDI-II)

2

Description
Anxiety
Timepoint
pre-middle and post treatment(tenth week)
Method of measurement
Beck Anxiety Inventory (BAI)

3

Description
experiential avoidance
Timepoint
pre-middle and post treatment(tenth week)
Method of measurement
Acceptance and Action Questionnaire (AAQ)

4

Description
Quality of Life
Timepoint
pre-and post treatment(tenth week)
Method of measurement
World Health Organization Quality of Life-BREF (WHOQOL-BREF)

Intervention groups

1

Description
ACT was based on an ACT manual for OCD developed by Twohig (10). A Ph.D. clinical psychologist (first author) under the supervision of an experienced clinical psychologist in treating OCD provided ACT. The ACT program included evaluating the patient's obsessions and compulsions (session 1); The "Man in the hole" metaphor was used to illustrate how the patient's efforts to regulate obsessions are ineffective (session 2); The " Tow scales " metaphor was used to illustrate the possible benefits of acceptance of obsessions and anxiety rather than attempting to control or reduce them ( sessions 3 and 4 ); using defusion, contact with the present or mindfulness, and self as context exercises ( sessions 5 and 6 ); recognize his values; and preventing relapse ( sessions 7 and 8 ).
Category
Behavior

2

Description
The patients in drug group received a different SSRI (sertraline=50-200 mg/d;fluoxetine=20-80 mg/d) for 10 weeks, which was monitored by two psychiatrist.
Category
Treatment - Drugs

3

Description
The combination group received both ACT and a different SSRI (sertraline=50-200 mg/d;fluoxetine=20-80 mg/d) for 10 weeks.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran psychiatric institute
Full name of responsible person
banafsheh gharraee
Street address
No 1, Shahid Mansouri Alley, niayesh St, Sattarkhan Ave
City
Tehran

2

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr Rahimnia
Street address
Shahid Hemmat Campus, Shahid Chamran and Sheikh Fazlullah Nuri Intersection, Shahid Hemmat West Highway
City
Tehran
Grant name
02/123700/91
Grant code / Reference number
30121
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science
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
yaghoob vakili
Position
Ph.D student in clinical psychology
Other areas of specialty/work
Street address
No 1, Shahid Mansouri Alley, niayesh St, Sattarkhan Ave, Postal تهران
City
Tehran
Postal code
1443813444
Phone
+98 21 6655 1515
Fax
Email
y-vakili@razi.tums.ac.iryaghoobvakili@yahoo.com
Web page address
ندارد

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical science , Tehran psychiatric 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,
City
Tehran
Postal code
1443813444
Phone
+98 21 6655 1655
Fax
Email
Banafshehgh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Psychiatric Iinstitute,Tehran university of medical science
Full name of responsible person
Yaghoob Vakili
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
1443813444
Phone
+98 21 6655 1655
Fax
Email
y-vakili@razi.tums.ac.ir and yaghoobvakili@yahoo.com
Web page address
ندارد

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
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