Major Depressive Disorder Clinical Trial
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*
Verified date | March 2023 |
Source | Khushal Khan Khattak Univeristy, Karak, Pakistan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | August 1, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Months to 50 Years |
Eligibility | Inclusion Criteria: 1. Both male and female patients. 2. Patients between the age of 18 to 50 years (since this study is neither on children nor on old patients). 3. Patients who have basic knowledge & skills of computer, mobile and internet (although the recruited patients will be given training for using the online EMDR). 4. Patients do not suffer from severe neuropsychological and cognitive impairments. 5. Patients have not received any pharmacological therapy in the last three months. 6. Patients have not received any other psychotherapy like Cognitive Behavioral Therapy. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Kushal Khan University | Lakki Marwat | Khyber Pakhtunkhwa |
Lead Sponsor | Collaborator |
---|---|
Khushal Khan Khattak Univeristy, Karak, Pakistan |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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) | |
Primary | 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 | 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) | |
Primary | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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) |
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