Augmenting efficacy of cognitive behavioral therapy with anti-disgust cognitive intervention on disgust propensity/ sensitivity, emotion acceptance, and OCD severity in patients with obsessive-compulsive disorder
Comparing the efficacy of psychological therapies on disgust propensity/ sensitivity, emotion acceptance, and OCD severity in patients with obsessive-compulsive disorder.
Design
A randomized clinical trial with a parallel group (cognitive behavioral therapy with or without anti-disgust cognitive intervention. The intervention and parallel groups each consist of 26 participants. Randomization was performed by a person who was blind to the objectives of the study.
Settings and conduct
After meeting the eligibility criteria, the enrolled participants will be randomly allocated to two intervention groups. In addition, each intervention will last 15 weekly sessions or three months. All participants will be assessed four times using research measures. Four assessment phases include 1) pre-treatment, 2) before the exposure and response prevention sessions, 3) posttreatment, and 4) three-month follow-up. Therapists, evaluators, and research assistants are different people.
Participants/Inclusion and exclusion criteria
Inclusion criteria: be at least 18 years old; equal to or more than 12 degrees education; diagnosed with contamination-based obsessive-compulsive disorder; have a fixed dose of the medication up to three months before the beginning of the study; completing informed consent.
Intervention groups
Intervention group 1: Cognitive-behavioral therapy with anti-disgust cognitive intervention.
Intervention group 2: Cognitive-behavioral therapy.
Augmenting efficacy of cognitive behavioral therapy with anti-disgust cognitive intervention on disgust propensity/ sensitivity, emotion acceptance, and OCD severity in patients with obsessive-compulsive disorder
Public title
Augmenting cognitive behavioral therapy for obsessive-compulsive disorder with anti-disgust cognitive intervention
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being at least 18 years old in the beginning of the study.
Having an education grade equal to 12 or more.
Diagnose with contamination-based obsessive-compulsive disorder as a primary diagnosis.
Having a stable dose of medication from 3 months before the beginning of the study.
Completing informed constant form.
Exclusion criteria:
Diagnose with other comorbid psychiatric disorders or conditions except for major depressive disorder.
Having a history of traumatic head injury or epilepsy.
Age
From 19 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by a research assistant through the lottery method. First, the research assistant will give a code to each participant who met the eligibility criteria. The mentioned codes will be written on paper. Then, he will be poured all papers into an opaque container and intermittently allocated each participant to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The process of evaluation, randomization, and treatment for all participants will be conducted in two separate centers. In the first center, each participant will be evaluated by a research assistant who is blind to the study's objectives. He will assign each participant to one of two groups, as described in the randomization procedure. Then, each participant will refer to the second center to start the interventions. The second center is located at a one-kilometer distance from the first center. Therapists, researchers, evaluators, and data analysts will also present at the second center and will be utterly blind to the study objectives and which participant belonged to which group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Kharazmi University
Street address
Somayyeh building, Kharazmi University, South Moffateh st, Tehran
City
Tehran
Province
Tehran
Postal code
15719-14911
Approval date
2021-09-14, 1400/06/23
Ethics committee reference number
IR.KHU.REC.1400.027
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
Disgust propensity/ sensitivity
Timepoint
Pre-treatment, before exposure and response prevention sessions, post-treatment, three-month follow-up
Method of measurement
Disgust Propensity/ Sensitivity Scale (DPSS)
2
Description
Obsessive-compulsive disorder severity
Timepoint
Pre-treatment, before exposure and response prevention sessions, post-treatment, three-month follow-up
Method of measurement
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
3
Description
Emotion acceptance
Timepoint
Pre-treatment, before exposure and response prevention sessions, post-treatment, three-month follow-up
Method of measurement
Non-judging & non-reactivity sub-scales of Five Facets Mindfulness Questionnaire
Secondary outcomes
1
Description
Acceptance rate of exposure and response prevention
Timepoint
Before exposure and response prevention sessions
Method of measurement
Percent of acceptance of exposure and response prevention
Intervention groups
1
Description
Intervention group: cognitive-behavioral therapy plus anti-disgust cognitive intervention, 15 weekly sessions, time of each session: 90 minutes, case conceptualization, disgust-related cognitive psychoeducation & intervention, exposure and response prevention, relapse prevention.
Category
Behavior
2
Description
Control group: cognitive-behavioral therapy, 15 weekly sessions, time of each session: 90 minutes, case conceptualization, exposure and response prevention, relapse prevention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Atiyeh clinic
Full name of responsible person
Davood Qasemzadeghan
Street address
Mehr cultural center, Khandayie blvd
City
Kashan
Province
Isfehan
Postal code
8739114384
Phone
+98 31 5568 3234
Email
b.salmani1365@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research & technology assistance of Kharazmi University
Full name of responsible person
Dr Jamshid Shanbeh Zadeh
Street address
Somayyeh building, Kharazmi University, South Moffateh st, Tehran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8884 8944
Email
jamshid@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research & technology assistance of Kharazmi University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr Behzad Salmani
Position
Ph.D. in Health Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iman 12 alley, Shahid Beheshti square, enghelab town, Meshkat
City
Kashan
Province
Isfehan
Postal code
87391-14384
Phone
+98 31 5568 3234
Email
b.salmani1365@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr Behzad Salmani
Position
Ph.D. in Health Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Iman 12 alley, Shahid beheshti square, enghelab town, Meshkat
City
Kashan
Province
Isfehan
Postal code
87391-14384
Phone
+98 31 5568 3234
Email
b.salmani1365@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr. Behzad Salmani
Position
Ph.D. in Health Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Maarefat 5 alley, enghelab town, Meshkat
City
Kashan
Province
Isfehan
Postal code
87391-14384
Phone
+98 983155683234
Email
b.salmani1365@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Privacy of personal information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available