Generalized Anxiety DisorderNCT05785312
Development of Online EMDR Therapy System and Its Comparative Testing With Face-to-Face EMDR Therapy for Treatment of Anxiety and Depressive Disorders in Pakistan
A study testing Online EMDR Therapy System and Face to Face Eye Movement Desensitization & Reprocessing Therapy in people with Generalized Anxiety Disorder and Major Depressive Disorder, run by Khushal Khan Khattak Univeristy, Karak, Pakistan at 1 site in Pakistan.
Trial summary
This study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan. Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy. Read more about this study
- Who is it for?
- Ages 18 months to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder, Major Depressive Disorder, Social Anxiety Disorder
- What is being tested?
- Online EMDR Therapy System and Face to Face Eye Movement Desensitization & Reprocessing Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Both male and female patients.
- Patients between the age of 18 to 50 years (since this study is neither on children nor on old patients).
- Patients who have basic knowledge \& skills of computer, mobile and internet (although the recruited patients will be given training for using the online EMDR).
- Patients do not suffer from severe neuropsychological and cognitive impairments.
- Patients have not received any pharmacological therapy in the last three months.
- Patients have not received any other psychotherapy like Cognitive Behavioral Therapy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Kushal Khan University
Lakki, Khyber Pakhtunkhwa, 28420
Anwar Khan, PhD, +92334560433, akpashtoon1981@gmail.com
About this study
Official title: Development of Online EMDR Therapy System and Its Comparative Testing With Face-to-Face EMDR Therapy for Treatment of Anxiety and Depressive Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study*
This study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan. Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy.
Read the detailed description
Depressive and Anxiety disorders have higher global prevalence. Moreover, they are leading causes of global burden of mental diseases (i.e., 24th leading cause of global Disability-adjusted Life Years). Such increase in the global prevalence of Depression and Anxiety disorders is due to the complexities of modern life. Nowadays various evidence-based psychotherapies, like e.g., EMDR therapy are available. Therapists have been using face-to-face modes for a long time, but with the expansion of Computer Technologies, online psychotherapies have been developed. The need for online psychotherapies was further increased due to Corona Virus-19 pandemic. Scientists have developed online modes of Cognitive Behavioral Therapy, Prolonged Exposure Therapy and Mindfulness Therapy, etc., but there are limited research studies on the online EMDR therapy, especially in the Asian countries. Therefore, questions arises a) Is it possible to treat Anxiety \& Depressive disorders through online EMDR therapy? b) What adaptations would be required to be made in the face-to-face protocols of EMDR therapy? c) Whether the online EMDR therapy will be: i) fit and safe for use; ii) usable; iii) operable \& practicable; and iv) efficient in delivering a timely treatment? The existing online programs of EMDR Therapy, e.g., VirtualEMDR have been built in the western-developed countries, hence may not be accessible to the local patients in Pakistan. Moreover, these programs might not be compatible with the requirements of patients in Pakistan. Keeping in view such facts, this study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan. Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy. For this purpose, patients will be recruited through a consecutive sampling technique, with a sample size of n=30. Data on symptomology and other technical data will be collected through standard scales. Qualitative data were analyzed by qualitative techniques, while the quantitative data were analyzed by descriptive and multivariate statistics. This study will be unique in its nature since a) an online EMDR therapy will be developed for Pakistani patients, b) this online system will be scientifically validated, c) and its efficacy will be compared with face-to-face EMDR therapy. This study will provide a base for the future researchers to design and implement online psychotherapies in Pakistan. In this way, the mental healthcare system of Pakistan could be ultimately revolutionized through the online treatment facilities.
- Conditions
- Generalized Anxiety Disorder, Major Depressive Disorder, Social Anxiety Disorder, Somatic Symptom, Panic Attacks, Obsessive-Compulsive Disorder and Symptoms
- Being tested
- Online EMDR Therapy System, Face to Face Eye Movement Desensitization & Reprocessing Therapy
- Keywords
- EMDR, Online EMDR, Depression, Anxiety, Pakistan, Pilot Study
- Medical subject headings
- Generalized Anxiety Disorder, Depressive Disorder, Major, Phobia, Social, Medically Unexplained Symptoms, Panic Disorder, Obsessive-Compulsive Disorder, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online EMDR Therapy SystemDevice
Online EMDR Therapy System will be delivered through online computer system that will be specifically designed for delivering EMDR therapy online
Face to Face Eye Movement Desensitization & Reprocessing TherapyOther
The Face to Face Eye Movement Desensitization \& Reprocessing Therapy will be delivered in person inside clinician's room by following standard EMDR therapy protocol
| Study group | Role | What they receive |
|---|---|---|
| Face to Face Eye Movement Desensitization & Reprocessing Therapy | Experimental | The standard Face to Face Eye Movement Desensitization \& Reprocessing Therapy will be applied by a trained clinical psychologist through in person face to face sessions. Receives: Other: Face to Face Eye Movement Desensitization & Reprocessing Therapy |
| Online Eye Movement Desensitization & Reprocessing Therapy | Active comparator | The Online Eye Movement Desensitization \& Reprocessing Therapy will be applied by a trained clinical psychologist through computer system by connecting through internet. For this purpose the online EMDR therapy application software will be installed Receives: Device: Online EMDR Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing changes in symptom of Generalized Anxiety Disorder with time (i.e., treatment course)
Generalized Anxiety Disorder by Generalized Anxiety Disorder Questionnaire-IV. Score of 5.7 or above will indicate that the patient is suffering from Generalized Anxiety Disorder.
Measured: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Assessing changes in symptom of Major Depressive Disorder with time (i.e., treatment course)
Major Depressive Disorder by Beck Depression Inventory-II. Score of 30 or above will indicate that the patient is suffering from major depressive disorder
Measured: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Assessing changes in symptom of Social Anxiety Disorder with time (i.e., treatment course)
Social Anxiety Disorder will be assed by Social Anxiety Scale. Score of 60 or above will indicate that the patient is suffering from Social Anxiety Disorder.
Measured: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Secondary outcomes (3)
Assessing changes in Panic symptoms with time (i.e., treatment course)
Panic Attacks by Panic Disorder Severity Scale. Score of 20 or above will indicate that the patient is suffering form panic symptoms.
Measured: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Assessing changes in Somatic symptoms
Somatic Symptoms by the Somatic Symptom Scale-8. Score of 11 or above will indicate that the patient is suffering from somatic symptoms.
Measured: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Assessing changes in Obsessive symptoms with time (i.e., treatment course)
Obsessive Compulsive Symptoms by Dimensional Obsessive-Compulsive Scale. Score of 15 or above on each dimension will indicate that the patient is having Obsessive Compulsive Symptoms.
Measured: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Since this a comparative study, therefore after recruiting patients, the patients will be randomly allocated parallelly to the two arms. Arm One will will be Face-to-Face EMDR Therapy, in which the patients will receive standard EMDR therapy in a face-to-face meeting with the therapist. Arm two will be the online EMDR Therapy, in which the patients will receive EMDR therapy online via video conferencing. The patient will be randomly selected assigned to each arm with 1:1 allocation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khushal Khan Khattak Univeristy, Karak, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anwar Khan, Khushal Khan Khattak Univeristy, Karak, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785312
- Sponsor's protocol ID
- 12321
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: will only be shared after placing valid request
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Online EMDR Therapy System and Its Comparative Testing With Face-to-Face EMDR Therapy for Treatment of Anxiety and Depressive Disorders in Pakistan: A Randomized Controlled Feasibility-Pilot Study*
- ClinicalTrials.gov ID
- NCT05785312
- Acronym / sponsor ID
- 12321
- Conditions
- Generalized Anxiety Disorder, Major Depressive Disorder, Social Anxiety Disorder, Somatic Symptom, Panic Attacks, Obsessive-Compulsive Disorder and Symptoms
- Keywords
- EMDR, Online EMDR, Depression, Anxiety, Pakistan, Pilot Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Khushal Khan Khattak Univeristy, Karak, PakistanUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan. Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy.
Detailed description
Depressive and Anxiety disorders have higher global prevalence. Moreover, they are leading causes of global burden of mental diseases (i.e., 24th leading cause of global Disability-adjusted Life Years). Such increase in the global prevalence of Depression and Anxiety disorders is due to the complexities of modern life. Nowadays various evidence-based psychotherapies, like e.g., EMDR therapy are available. Therapists have been using face-to-face modes for a long time, but with the expansion of Computer Technologies, online psychotherapies have been developed. The need for online psychotherapies was further increased due to Corona Virus-19 pandemic. Scientists have developed online modes of Cognitive Behavioral Therapy, Prolonged Exposure Therapy and Mindfulness Therapy, etc., but there are limited research studies on the online EMDR therapy, especially in the Asian countries. Therefore, questions arises a) Is it possible to treat Anxiety \& Depressive disorders through online EMDR therapy? b) What adaptations would be required to be made in the face-to-face protocols of EMDR therapy? c) Whether the online EMDR therapy will be: i) fit and safe for use; ii) usable; iii) operable \& practicable; and iv) efficient in delivering a timely treatment? The existing online programs of EMDR Therapy, e.g., VirtualEMDR have been built in the western-developed countries, hence may not be accessible to the local patients in Pakistan. Moreover, these programs might not be compatible with the requirements of patients in Pakistan. Keeping in view such facts, this study aims at developing an online system for the remote delivery of EMDR therapy in Pakistan. Moreover, this study will compare the efficacy of online EMDR therapy with face-to-face EMDR therapy. For this purpose, patients will be recruited through a consecutive sampling technique, with a sample size of n=30. Data on symptomology and other technical data will be collected through standard scales. Qualitative data were analyzed by qualitative techniques, while the quantitative data were analyzed by descriptive and multivariate statistics. This study will be unique in its nature since a) an online EMDR therapy will be developed for Pakistani patients, b) this online system will be scientifically validated, c) and its efficacy will be compared with face-to-face EMDR therapy. This study will provide a base for the future researchers to design and implement online psychotherapies in Pakistan. In this way, the mental healthcare system of Pakistan could be ultimately revolutionized through the online treatment facilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Since this a comparative study, therefore after recruiting patients, the patients will be randomly allocated parallelly to the two arms. Arm One will will be Face-to-Face EMDR Therapy, in which the patients will receive standard EMDR therapy in a face-to-face meeting with the therapist. Arm two will be the online EMDR Therapy, in which the patients will receive EMDR therapy online via video conferencing. The patient will be randomly selected assigned to each arm with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Face to Face Eye Movement Desensitization & Reprocessing Therapy | Experimental | Other: Face to Face Eye Movement Desensitization & Reprocessing TherapyThe standard Face to Face Eye Movement Desensitization \& Reprocessing Therapy will be applied by a trained clinical psychologist through in person face to face sessions. |
| Online Eye Movement Desensitization & Reprocessing Therapy | Active comparator | Device: Online EMDR Therapy SystemThe Online Eye Movement Desensitization \& Reprocessing Therapy will be applied by a trained clinical psychologist through computer system by connecting through internet. For this purpose the online EMDR therapy application software will be installed |
Who may qualify
- Ages
- 18 months to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Both male and female patients.
- Patients between the age of 18 to 50 years (since this study is neither on children nor on old patients).
- Patients who have basic knowledge \& skills of computer, mobile and internet (although the recruited patients will be given training for using the online EMDR).
- Patients do not suffer from severe neuropsychological and cognitive impairments.
- Patients have not received any pharmacological therapy in the last three months.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online EMDR Therapy SystemOnline EMDR Therapy System will be delivered through online computer system that will be specifically designed for delivering EMDR therapy online | Device | Online Eye Movement Desensitization & Reprocessing Therapy |
| Face to Face Eye Movement Desensitization & Reprocessing TherapyThe Face to Face Eye Movement Desensitization \& Reprocessing Therapy will be delivered in person inside clinician's room by following standard EMDR therapy protocol | Other | Face to Face Eye Movement Desensitization & Reprocessing Therapy |
Primary outcome
Assessing changes in symptom of Generalized Anxiety Disorder with time (i.e., treatment course)
Time frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Generalized Anxiety Disorder by Generalized Anxiety Disorder Questionnaire-IV. Score of 5.7 or above will indicate that the patient is suffering from Generalized Anxiety Disorder.
Assessing changes in symptom of Major Depressive Disorder with time (i.e., treatment course)
Time frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Major Depressive Disorder by Beck Depression Inventory-II. Score of 30 or above will indicate that the patient is suffering from major depressive disorder
Assessing changes in symptom of Social Anxiety Disorder with time (i.e., treatment course)
Time frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Social Anxiety Disorder will be assed by Social Anxiety Scale. Score of 60 or above will indicate that the patient is suffering from Social Anxiety Disorder.
3 secondary outcomes
Assessing changes in Panic symptoms with time (i.e., treatment course)
Time frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Assessing changes in Somatic symptoms
Time frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Assessing changes in Obsessive symptoms with time (i.e., treatment course)
Time frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No. will only be shared after placing valid request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online EMDR Therapy System and Face to Face Eye Movement Desensitization & Reprocessing Therapy in people with Generalized Anxiety Disorder and Major Depressive Disorder, run by Khushal Khan Khattak Univeristy, Karak, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing changes in symptom of Generalized Anxiety Disorder with time (i.e., treatment course) (time frame: A total of 40 patients will be selected. Symptoms will be screened for 06 months in such a way that symptoms will be assessed first during base line (T1), then during mid of treatment (T2), and finally at the end of treatment (T3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.