Protocol summary

Study aim
Determining the effectiveness of Acceptance and commitment therapy on changing the bandwidth of delta, beta 1, beta 2, theta beta coherence, changing the asymmetry of cognitive brain waves of the right hemisphere, cognitive flexibility, cognitive fusion, blood oxytocin level, regulation Excitement in people with obsessive-compulsive disorder
Design
A clinical trial with a control group with a pre-test and post-test with three-month follow-up, single blind, randomly assigning patients to two groups using Excel software.
Settings and conduct
The statistical population includes individuals with OCD in Zanjan province. Patients who will be referred by psychiatrists and meet the inclusion criteria will be examined by the Structured Clinical Interview (SCID-I) and the Yale-Brown scale. Then, in a session before intervention, written consent will be obtained from patients, and demographic characteristics and other questionaairs will be filled. Oxytocin will be sampled subsequently.
Participants/Inclusion and exclusion criteria
Inclusion criteria: symptoms of OCD Comorbidity with other anxiety disorders 18-60 years no severe psychiatric disorders Not using drugs and alcohol in the last three months Not receiving psychological interventions not receive drug therapy in the last month written constent No chronic disease Exit criteria: Absence of more than two sessions Receive other psychological intervention simultaneously using drug at the same time no constent disorder aggreviation
Intervention groups
Intervention group: Acceptance and commitment therapy will be individually during 8 sessions as Dr. Twohing's protocol by two therapists. The aim is mostly reducing anxiety and how to deal with obsessive thoughts and compulsions. Control group: will not receive any special therapy and only use evaluation sessions.
Main outcome variables
Brain waves, OCD symptoms, psychological flexibility

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210727052000N2
Registration date: 2023-02-07, 1401/11/18
Registration timing: prospective

Last update: 2023-02-07, 1401/11/18
Update count: 0
Registration date
2023-02-07, 1401/11/18
Registrant information
Name
Fatemeh Hassani alimolk
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3566 1160
Email address
fatima.hassani75@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of acceptance and commitment therapy on electroencephalography, psychological flexibility, cognitive fusion, emotion regulation, symptom reduction, and oxytocin blood levels in people with obsessive-compulsive disorder
Public title
The effectiveness of Acceptance and Commitment Therapy on the brain waves of patients with obsessive-compulsive disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having symptoms of obsessive-compulsive disorder Coexistence with other anxiety disorders (social anxiety disorder, generalized anxiety disorder, panic disorder, specific phobia and transition phobia) Age range between 18-60 years Not suffering from severe psychiatric disorders (psychotic spectrum, bipolar disorder) Not using drugs and alcohol in the last three months Not receiving cognitive-behavioral interventions for at least 8 sessions in the last 5 years Failure to receive drug therapy within a month before the start of the intervention Interest of the participants to participate in the research based on the provisions of the written consent No chronic medical illness
Exclusion criteria:
Absence of more than two sessions Receiving another similar psychological intervention at the same time as the current research Drug therapy at the same time as intervention Lack of consent to continue treatment during the intervention process Aggravation of the person's problems during the intervention and the need to provide another intervention
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
People who meet the entry criteria are referred by professors, counseling centers, and psychiatric clinics in Zanjan province and are randomly assigned to the experimental and control groups. Random allocation is done using Excel software. For this, in the first column, we enter 20 numbers 1 and 20 numbers 2 (representing the test and control group, respectively). Then, in the second column, we generate 46 random numbers using the (RAND) function. We sort the data based on column values containing random numbers (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups.
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 Zanjan University of Medical Sciences
Street address
Shahid Beheshti hospital, Ark gate, Zanjan city, Zanjan province
City
Zanjan
Province
Zanjan
Postal code
7531974143
Approval date
2022-11-17, 1401/08/26
Ethics committee reference number
IR.zums.REC.1401.259

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
Sign and symptoms of obsessive-compulsive disorder
Timepoint
pre and post test, after 3 months follow-up
Method of measurement
Yale-Brown Obsessive-Compulsive Scale

2

Description
brain waves
Timepoint
pre, post and 3 months after intervention
Method of measurement
electroeencephalogram

Secondary outcomes

1

Description
cognitive fusion
Timepoint
pre, post and 3 months after intervention
Method of measurement
Cognitive fusion questionnaire

2

Description
cognitive emotion regulation
Timepoint
pre, post and 3 months after intervention
Method of measurement
Cognitive emotion regulation questionnaire

3

Description
psychological flexibility
Timepoint
pre, post and 3 months after intervention
Method of measurement
Acceptance and action questionnaire (II)

Intervention groups

1

Description
Intervention group: Acceptance and Commitment Therapy is third wave psychology therapy, the protocol used by Dr. Twohing was written. The said treatment, during 8 sessions of individual psychotherapy, seeks to increase the acceptance of unpleasant feelings, cognitive breakdown from disturbing annoying thoughts, and also to introduce the values of the patients in order to increase the psychological flexibility of the patients in general.
Category
Treatment - Other

2

Description
Control group: The control group will only benefit from the evaluation sessions, so they will not know whether they will be in the intervention group or the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid beheshti hospital
Full name of responsible person
Ehsan Saboory
Street address
Shahid Beheshti Hospital, Zanjan City, Ark Square
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4003
Email
fatima.hassani75@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samad Nadri
Street address
Zanjan University of medical sciences, Azadi street, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45136_15788
Phone
+98 24 3315 6141
Email
nadri_s@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
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
Zanjan University of Medical Sciences
Full name of responsible person
Seyed Elnaz Mousavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti hospital, Ark square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4003
Email
elnaz48.mousavi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Hassani alimolk
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Plaque 18, Shahed street, West Azarbayjan province, Naghadeh city
City
Zanjan
Province
Zanjan
Postal code
45136_15788
Phone
+98 44 3566 1160
Fax
Email
fatima.hassani75@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Seyed Elnaz Mousavi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti hospital, Ark square, Zanjan
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 4003
Email
elnaz48.mousavi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data will be made available to the journal and researchers only if needed, after de-identifying individuals.
When the data will become available and for how long
Researchers start accessing documents and data files after 6 months to a year after the publication of the article.
To whom data/document is available
Only the researchers and reviewers of the journal to which the article is submitted.
Under which criteria data/document could be used
The data will be sent for review studies, where all analyzes must be supervised by one of the authors of the proposal.
From where data/document is obtainable
After publishing the article, researchers can email the responsible author at elnaz48.mousavi@gmail.com to access the data. Or, if you wish, go to Shahid Beheshti Hospital to meet with Dr. Mousavi.
What processes are involved for a request to access data/document
If the reason is scientific and the email is sent after the publication of the article, the requested information will be sent to them at least one week after consultation with other authors.
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