- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06957210
Post-Traumatic Growth Following Eye Movement Desensitization and Reprocessing Therapy Versus SSRIs in Patients With Post-Traumatic Stress Disorder
Post-Traumatic Growth Following Eye Movement Desensitization and Reprocessing Therapy Versus SSRIs in Patients With Post-Traumatic Stress Disorder: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KPK
-
Nowshera, KPK, Pakistan, 25770
- Combined Military Hospital
-
Nowshera, KPK, Pakistan, 25770
- Department of Psychiatry, Combined Military Hospital Nowshera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Clinical diagnosis of Post-Traumatic Stress Disorder (PTSD) based on DSM-5 criteria
Willingness to participate and provide informed consent
Ability to comply with study procedures
Exclusion Criteria:
Current diagnosis of psychotic disorder, bipolar disorder, or severe major depressive episode with psychotic features
Active substance use disorder within the past 6 months
Severe cognitive impairment or inability to complete study assessments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMDR
EMDR therapy
|
Participants will receive structured EMDR therapy sessions conducted by trained therapists following standard EMDR protocols.
Sessions will occur weekly over a 6 week period.
|
|
Active Comparator: SSRIs
Acting as control group
|
Participants will receive pharmacotherapy with an SSRI prescribed according to standard clinical guidelines for PTSD, monitored by a psychiatrist over a 6-week period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Traumatic Growth (PTG) measured by Post-Traumatic Growth Inventory (PTGI)
Time Frame: 6 weeks
|
Change in PTGI total score from baseline to 6 weeks.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD symptom severity measured by PTSD Checklist
Time Frame: 6 weeks
|
Change in PTSD Checklist total score from baseline to 6 weeks.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Trauma and Stressor Related Disorders
- Mental Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Combat Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Agents
- Membrane Transport Modulators
- Neurotransmitter Uptake Inhibitors
- Serotonin Agents
- Pharmacologic Actions
- Chemical Actions and Uses
- Behavior Therapy
- Psychotherapy
- Behavioral Disciplines and Activities
- Desensitization, Psychologic
- Selective Serotonin Reuptake Inhibitors
- Eye Movement Desensitization Reprocessing
Other Study ID Numbers
- CMHNSR-REF-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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