Protocol summary

Summary
The aim of current study is examination the impact of Acceptance and Commitment Group Therapy on Obsessive-Compulsive symptom severity, depression, ruminative thought and psychological flexibility. Include criteria (being female, age between 18 and 45) and Exclude criteria (severe depression, changing dose of psychiatric medication or using other psychological methods) employed for sampling. Statistical population was all female with primary diagnosis of Obsessive-Compulsive Disorder in Kashan city. 32 outpatients female were selected. In a pilot project, they were randomly allocated to intervention group (that receive acceptance and commitment therapy as well as SSRI); n=16 and control group (that continue SSRI during study); n=16. Duration of intervention was 4 month in the spring of 2016. We expect this study show reduction in OCD symptom severity and psychological inflexibility as primary diagnosis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070528803N1
Registration date: 2016-10-23, 1395/08/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-23, 1395/08/02
Registrant information
Name
Farzane Rohani
Name of organization / entity
Kashan University Of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 31 3228 6565
Email address
rohani-fa@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University Of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-04-04, 1395/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness Of Acceptance and Commitment Group Therapy(ACT-G) on Obsessive Compulsive Symptom Severity, Depression, Ruminative thought and Psychological flexiblity in Obsessive Compulsive Outpatients
Public title
The Effectiveness of Acceptance and Commitment Group Therapy in the Treatment Of Obsessive Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: primary diagnosis of OCD according to DSM-5; being female; age between 18 and 45; consent and commitment for following study exclusion criteria: severe depression (up to 29 degree in BDI-II); bipolar or psychotic episode; intellectual disability; personality disorders; changing psychiatric medication or its dose 30 days before preceding baseline and during study; using other psychological method 30 days preceding baseline and during study
Age
From 76 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
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
Research and Technology Management
Street address
Ravand highway، Kashan University of Medical Science
City
Kashan
Postal code
00988715981151
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
IR.KAUMS.REC.1395.18

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 symptom severity
Timepoint
before intervention(baseline), after two month(post), two month after finishing intervention(follow-up)
Method of measurement
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)، Padua Inventory

Secondary outcomes

1

Description
depression severity، ruminative thought، psychological flexiblity
Timepoint
before intervention(baseline), after two month(post), two month after finishing intervention(follow-up)
Method of measurement
Beck Depression Inventory: BDI-II، Rumination Response Scale: RRS، Acceptance and Action Questionnaire: AAQ-II

Intervention groups

1

Description
intervention group: acceptance and commitment group therapy and SSRIs
Category
Behavior

2

Description
control group: SSRIs
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kargarnejad Psychiatric Hospital
Full name of responsible person
Fateme Goreishi
Street address
Ravand 5km road، Kashan University Of Medical Science
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University Of Medical Science
Full name of responsible person
Gholamali Hamidi
Street address
Ravand 5 km road, Kashan Medical Science Collection
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University Of Medical Science
Full name of responsible person
Farzane Rohani
Position
MA student
Other areas of specialty/work
Street address
Ravad 5 km road، Kashan Medical Science Collection
City
Kashan
Postal code
Phone
+98 31 3225 9843
Fax
Email
rohani.psy92@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University Of Medical Science
Full name of responsible person
Morad Rasoliazad
Position
PhD Assistant professor
Other areas of specialty/work
Street address
Rvand 5Km road, Kashan Medical Science Collection
City
Kashan
Postal code
Phone
+98 55540021
Fax
Email
mrasoliazad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University Of Medical Science
Full name of responsible person
Farzane Rohani
Position
MA student
Other areas of specialty/work
Street address
Ravand 5km Road، Medical science collection
City
Kashan
Postal code
Phone
+98 31 3225 9843
Fax
Email
rohani.psy92@gmail.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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