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Comparison of the Effectiveness of EEG-Based Neurofeedback Therapy Versus Conventional Therapies (Medication and Mindfulness-Based Cognitive Behavioral Therapy) in Improving Symptoms of Obsessive-Compulsive Disorder Patients: A Randomized Controlled Trial

Protocol summary

Study aim
To investigate the effectiveness of EEG-based neurofeedback (NFB) treatment versus current treatments for the improvement in symptoms among OCD patient
Design
Randomised, parallel group, superiority trial with four arms. Sample size: 80 OCD patients. Randomisation: Centralised and computerised using random number generator software.
Settings and conduct
The trial will be conducted in the Psychiatry Unit at Lady Reading Hospital, Peshawar.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1. OCD patients diagnosed according to DSM-V criteria. 2. Age range: 18–40 years. Exclusion Criteria: 1. Neurological conditions such as stroke, head injury, epilepsy, or dementia. 2. Severe medical conditions (e.g., hepatic or renal failure). 3. History of psycho-surgery or neurosurgical procedures. 4. Substance abuse or drug dependence. 5. Psychiatric comorbidities including schizophrenia, psychosis, or delusional disorders.
Intervention groups
There will be four intervention groups with equal participants (n=20 each), randomly assigned: Group A: Treatment as usual (psychopharmacological treatment only). Group B: Mindfulness-Based Cognitive Behavioral Therapy (MBCT) + psychopharmacological treatment. Group C: EEG-based Neurofeedback (NFB) + psychopharmacological treatment. Group D: Combined MBCT and NFB treatment. All participants, except Group A, will undergo 12 weekly sessions of therapy (MBCT: 50 mins; NFB: 30 mins + prep time).
Main outcome variables
Primary Outcome: 1. Reduction in OCD symptom severity, assessed using the Yale Brown Obsessive Compulsive Scale (YBOCS). Secondary Outcomes: 1. Levels of depression, anxiety, and stress (DASS-21). 2. Insight and belief delusionality (Brown Assessment of Belief Scale). 3. Childhood trauma severity (MACE). 4. Biomarker levels (IL-6, IL-Iβ, C-reactive protein).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250304064931N1
Registration date: 2025-05-29, 1404/03/08
Registration timing: registered_while_recruiting

Last update: 2025-05-29, 1404/03/08
Update count: 0
Registration date
2025-05-29, 1404/03/08
Registrant information
Name
Sumaira Mehreen
Name of organization / entity
Lady Reading Hospital Peshawar
Country
Pakistan
Phone
+92 345 9093113
Email address
sumaira.mehreen@lrh.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-28, 1404/02/08
Expected recruitment end date
2025-08-27, 1404/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of EEG-Based Neurofeedback Therapy Versus Conventional Therapies (Medication and Mindfulness-Based Cognitive Behavioral Therapy) in Improving Symptoms of Obsessive-Compulsive Disorder Patients: A Randomized Controlled Trial
Public title
Comparison of the Effectiveness of EEG-Based Neurofeedback Therapy Versus Conventional Therapies (Medication and Mindfulness-Based Cognitive Behavioral Therapy) in Improving Symptoms of Obsessive-Compulsive Disorder Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with Obsessive-Compulsive Disorder (OCD) according to DSM-5 criteria. Aged between 18 and 40 years. No neurological disorder (stroke, head injury, epilepsy, dementia). No severe medical conditions (e.g., hepatic failure, renal failure). No history of psycho-surgery or neurosurgical procedures.
Exclusion criteria:
Psychiatric comorbidity (schizophrenia, psychosis, delusional disorders). Substance abuse or drug dependence.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
To implement random allocation, we will use OpenEpi software to generate a list of random numbers corresponding to participant IDs. Each eligible participant will be assigned a unique identifier, and based on the random number sequence, they will be allocated to either the intervention or control group in a 1:1 ratio. Allocation will be performed using a simple randomization approach without stratification or blocking. The randomization list will be prepared in advance by an independent statistician not involved in participant recruitment to maintain allocation concealment. The group assignments will be placed in sequentially numbered, opaque, sealed envelopes, which will be opened only after participant enrollment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized controlled trial (RCT) design

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Institutional Review Board- Lady Reading Hospital Peshawar
Street address
Soekarno Rd, Pipal Mandi, Peshawar, 25000
City
Peshawar
Postal code
25000
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
283/LRH/MTI

Health conditions studied

1

Description of health condition studied
Obsessive-Compulsive Disorder (OCD) is a chronic mental health condition characterized by persistent, intrusive thoughts (obsessions) and repetitive behaviors or mental acts (compulsions) that an individual feels compelled to perform. These symptoms can cause significant distress, interfere with daily functioning, and diminish quality of life. The study focused on understanding the clinical presentation, underlying mechanisms, and potential interventions for individuals affected by OCD. Emphasis was placed on early diagnosis, treatment outcomes, and the socio-cultural context influencing symptom expression and treatment adherence.
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
Obsessive compulsive disorder
Timepoint
Before intervention (baseline), and on every follow up (monthly in group A for 3 months which is treatment as usual group, and weekly in treatment group B, C and D for 12weeks
Method of measurement
Yale brown obsessive compulsive scale (YBOCS)

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Group A (treatment as usual)
Category
Treatment - Drugs

2

Description
Intervention group: Group B (mindfulness based cognitive therapy with medication)
Category
Treatment - Other

3

Description
Intervention group: roup C (electroencephalogram based neurofeedback with medication)
Category
Treatment - Other

4

Description
Intervention group: Group D (Mindfulness based cognitive therapy/Electroencephalogram based neurofeedback without medication)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Lady Reading Hospital, Medical Teaching Institute
Full name of responsible person
Sumaira Mehreen
Street address
Soekarno Rd, Pipal Mandi, Peshawar,
City
Peshawar
Postal code
25000
Phone
+92 345 9093113
Email
sumaira.mehreen@lrh.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khyber Medical University Peshawar
Full name of responsible person
Dr. Syed Muhammad Shabbir Ali Naqvi
Street address
F1 Phase-6 Rd, Phase 5 Hayatabad
City
Peshawar
Postal code
25000
Phone
+92 315 6569401
Email
coordinator.ctu@kmu.edu.pk
Web page address
https://kmu.edu.pk/
Grant name
N/A
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
N/A
Proportion provided by this source
1
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

2

Sponsor
Name of organization / entity
Lady Reading Hospital Peshawar
Full name of responsible person
Dr Sumaira Mehreen
Street address
Soekarno Rd, Pipal Mandi, Peshawar
City
Peshawar
Postal code
25000
Phone
+92 345 9093113
Email
sumairapsy@gmail.com
Grant name
N.A
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
N/A
Proportion provided by this source
1
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
University of Peshawar
Full name of responsible person
Sumaira Mehreen
Position
PhD scholar
Latest degree
Master
Other areas of specialty/work
Clinical psychology
Street address
Department of Psychology, university of Peshawar, Khyber Pakhtunkhwa, Peshawar
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 345 9093113
Email
sumaira.mehreen@lrh.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Peshawar
Full name of responsible person
Sumaira Mehreen
Position
PhD scholar
Latest degree
Master
Other areas of specialty/work
Clinical psychology
Street address
Department of Psychology, university of Peshawar, Khyber Pakhtunkhwa, Peshawar
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 91 9211430
Email
sumaira.mehreen@lrh.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Lady Reading Hospital Peshawar
Full name of responsible person
Sumaira Mehreen
Position
PhD scholar
Latest degree
Master
Other areas of specialty/work
Clinical psychology
Street address
Department of Psychology, university of Peshawar, Khyber Pakhtunkhwa, Peshawar
City
Peshawar
Province
Khyber Pakhtunkhwa
Postal code
25000
Phone
+92 311 0992703
Email
sumaira.mehreen@lrh.edu.pk

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
No - There is not 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
I will provide study protocols, data analysis, and codes
When the data will become available and for how long
After the completion of my thesis, I will provide for a long time.
To whom data/document is available
To IRCT and other members
Under which criteria data/document could be used
For research and educational purposes
From where data/document is obtainable
from websites and journals
What processes are involved for a request to access data/document
online
Comments
N/A
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