Effectiveness of acceptance and commitment therapy (ACT) with and without transcranial direct current stimulation (tDCS) on craving and problematic use of pornography: A single subject design
Comparing the effectiveness of acceptance and commitment therapy (ACT) and transcranial direct current stimulation (tDCS) on reducing the craving and problematic use of pornography
Design
A1-B-A2 single-subject design was used. Nine subjects participated in three types of ACT, tDCS and combined interventions. The baseline phase (A1) consisted of 3 data collection points at 10-day intervals for 1 month before the intervention. Phase B, the intervention phase, included 7 data collection points over 3 months. Phase A2 was the second baseline or follow-up phase consisting of 3 data collection points within 1 month.
Settings and conduct
The population studied in this research includes all men aged 18 to 24 in 1401 who referred to the specialized counseling and psychology clinic of Ferdowsi University of Mashhad, who are diagnosed with problematic pornography use by a clinical psychologist.After selecting the statistical sample based on the entry and exit criteria, the participants will be divided into three groups of ACT, tDCS, and a combination of 3 people through the random allocation rule.
Participants/Inclusion and exclusion criteria
Being between 18 and 24 years old
Absence of intellectual problems
Minimum elementary school education
No substance abuse
Having symptoms of problematic use of pornography based on a questionnaire
Not receiving other psychological or drug treatment at the same time
Intervention groups
Three groups: ACT, tDCS and combined
Main outcome variables
Comparing the effectiveness of acceptance and commitment therapy andtranscranial direct current stimulation on reducing the craving and problematic pornography use
General information
Reason for update
Acronym
ACT, tDCS
IRCT registration information
IRCT registration number:IRCT20190731044397N1
Registration date:2023-06-03, 1402/03/13
Registration timing:registered_while_recruiting
Last update:2023-06-03, 1402/03/13
Update count:0
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Seyed Iman Seyedzadeh Dalooyi
Name of organization / entity
Ferdowsi university of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 7931
Email address
iman.seyedzadeh@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-15, 1402/02/25
Expected recruitment end date
2023-07-16, 1402/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of acceptance and commitment therapy (ACT) with and without transcranial direct current stimulation (tDCS) on craving and problematic use of pornography: A single subject design
Public title
Effectiveness of ACT with and without tDCS on craving and problematic use of pornography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 18 and 24 years old
Absence of intellectual problems
Minimum elementary school education
No substance abuse
Having symptoms of problematic use of pornography based on a questionnaire
Not receiving other psychological or drug treatment at the same time
Exclusion criteria:
Diagnosing mental disorders that are effective in the treatment process
Concurrent participation in other psychological courses or interventions
Failure to attend more than three consecutive sessions
Reluctance to continue treatment
Age
From 18 years old to 24 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
3
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method
Unit of randomization: individual
Tool used in randomization and building of random sequence by SAS software
Allocation concealment: SNOSE method
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants assumed that all participants would receive the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Ferdowsi University of Mashhad
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
09188355827
Approval date
2021-09-11, 1400/06/20
Ethics committee reference number
IR.UM.REC.1400.125
Health conditions studied
1
Description of health condition studied
problematic use of pornography
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Problematic use of pornography
Timepoint
Every 2 weeks for three months
Method of measurement
Problematic pornography use scale, Pornography craving questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention: transcranial direct current stimulation, during 24 sessions (3 times a week) in each session, anodal and cathodal currents with an intensity of 2 milliamps for 20 minutes.
Category
Treatment - Devices
2
Description
The second intervention: treatment based on acceptance and commitment, 8 sessions of 45 minutes in a group, protocol and steps based on the proposed protocol (Twohig and Crosby, 2010)
Category
Treatment - Other
3
Description
The third intervention: the combination of the first and second intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Counseling and Psychology Clinic of Ferdowsi University of Mashhad
Full name of responsible person
Seyed Iman Seyedzadeh Dalooyi
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
09188355827
Phone
+98 915 158 6793
Email
imansdz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ferdowsi university of Mashhad
Full name of responsible person
Hamidreza Aghamohammadian Sharbaaf
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
09188355827
Phone
+98 51 1878 3008
Email
aghamohammadian@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ferdowsi university of Mashhad
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
Ferdowsi university of Mashhad
Full name of responsible person
Hamidreza Aghamohammadian Sharbaaf
Position
Professor and Head of Psychology Department
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
09188355827
Phone
+98 51 3880 5865
Email
aghamohammadian@um.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi university of Mashhad
Full name of responsible person
Hamidreza Aghamohammadian Sharbaaf
Position
Professor and Head of Psychology Department
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
09188355827
Phone
+98 51 3880 5865
Email
aghamohammadian@um.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi university of Mashhad
Full name of responsible person
Seyed Iman Seyedzadeh Dalooyi
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 10, Kalantari Blvd, Azadi Sq, Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
09188355827
Phone
+98 51 3868 0489
Fax
Email
imansdz@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
All potential data can be shared after de-identifying individuals
When the data will become available and for how long
The data will become available 3 months after the results are published
To whom data/document is available
There is no specific limitation and it will be accessible to all researchers in this field
Under which criteria data/document could be used
Currently, there are no special conditions and restrictions
From where data/document is obtainable
We will respond to applicants via email
What processes are involved for a request to access data/document
The aims and objectives of the research should be clearly explained.