Protocol summary

Summary
This study aims to compare the effectiveness of Acceptance and Commitment Therapy and Cognitive-Behavior Therapy in experience avoidance, values, and reducing symptoms in adolescent Obsessive-Compulsive Disorder patients. This study serves as a clinical trial and involves pre-and post-testing with control group assessment of effects. The population of study consists of all adolescent patients with Obsessive-Compulsive Disorder in Kashan. A non-random sample of 60 adolescent patients with primary diagnosis of OCD will be selected and randomly divided into two interventions (ACT and CBT) and one control groups. Assessment tools for this study include Obsessive Compulsive Inventory-Child Version (OCI-CV), The Avoidance and Fusion Questionnaire for Youth (AFQ-Y), and Valued Living Questionnaire (VLQ). The main outcome variables are experience avoidance, values, and OCD symptoms.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017032633144N1
Registration date: 2017-09-02, 1396/06/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-02, 1396/06/11
Registrant information
Name
Mohammad Javad Shabani
Name of organization / entity
Department of Clinical Psychology, Faculty of Medicine, Kashan University of Medical Sciences, Kasha
Country
Iran (Islamic Republic of)
Phone
+98 77 3325 3153
Email address
shabani-mj@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Acceptance and Commitment Therapy and Cognitive-Behavior Therapy on experiential avoidance, values and symptom in adolescent Obsessive-Compulsive Disorder
Public title
Comparison of the Efficacy of Acceptance and Commitment Therapy and Cognitive-Behavior Therapy on experiential avoidance, values and symptom in adolescent Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a diagnosis of obsessive-compulsive disorder according to DSM-5; age range of 12-18 y/o; formal consent to participate in the study ;no history of brain trauma; major disabilities like mental retardation; no drug abuse history; absence of severe psychiatric conditions (e.g. schizophrenia and bipolar disorder). Exclusion criteria: past (1 year) and present history of psychological therapeutic interventions; absence in more than 2 sessions.
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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 Kashan University of Medical Sciences and Health Services
Street address
Ravand highway، Kashan University of Medical Sciences
City
kashan
Postal code
Approval date
2017-01-18, 1395/10/29
Ethics committee reference number
IR.KAUMS.REC.1395.124

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
experiential avoidance
Timepoint
Before intervention (baseline), after two month (post)
Method of measurement
Avoidance and Fusion Questionnaire for Youth (AFQ-Y)

2

Description
values
Timepoint
Before intervention (baseline), after two month (post)
Method of measurement
Valued Living Questionnaire (VLQ)

3

Description
OCD symptoms
Timepoint
Before intervention (baseline), after two month (post)
Method of measurement
Obsessive Compulsive Inventory (OCI-CV) AND Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

Secondary outcomes

1

Description
therapeutic alliance
Timepoint
after intervention on experimental group
Method of measurement
Therapeutic Alliance Scale for Children: Youth Version

Intervention groups

1

Description
acceptance and commitment group therapy for 8 sessions of 1 hours on the intervention group + routine medical treatment
Category
Behavior

2

Description
Cognitive behavioural therapy (CBT) for 12 sessions of 1 hours on the intervention group+routine medical treatment
Category
Behavior

3

Description
Routine medical treatment + psychological training for 12 sessions of one hours for control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kargarnejad Hospital
Full name of responsible person
hamidmohsenabadi
Street address
Ravand highway، Kashan University of Medical Sciences
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
Department of Clinical Psychology, Faculty of Medicine, Kashan University of Medical Sciences, Kasha
Full name of responsible person
Mohammad Javad Shabani
Position
MSc
Other areas of specialty/work
Street address
Rvand 5Km road, Kashan Medical Science Collection
City
Kashan
Postal code
Phone
+98 31 5554 2305
Fax
Email
shabani-mj@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Clinical Psychology, Faculty of Medicine, Kashan University of Medical Sciences, Kasha
Full name of responsible person
Zahra Zanjani
Position
assistant professor
Other areas of specialty/work
Street address
Rvand 5Km road, Kashan Medical Science Collection
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
z_zanjani2005@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Clinical Psychology, Faculty of Medicine, Kashan University of Medical Sciences, Kasha
Full name of responsible person
Mohammad Javad Shabani
Position
MSc
Other areas of specialty/work
Street address
Rvand 5Km road, Kashan Medical Science Collection
City
Kashan
Postal code
Phone
00
Fax
Email
shabani-mj@kaums.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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