- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04021329
Efficacy of Eye Movement Desensitization & Reprocessing Versus Cognitive Behavioral Therapy in Post-Traumatic Stress and Depressive Disorders
Efficacy of Eye Movement Desensitization & Reprocessing Versus Cognitive Behavioral Therapy in Post-Traumatic Stress and Depressive Disorders: Study Protocol for a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anwar Khan, post doc
- Phone Number: 03345606406
- Email: akpashtoon1981@gmail.com
Study Locations
-
-
KPK
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Karak, KPK, Pakistan, 27200
- Anwar Khan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Exclusion Criteria:
The following patients will be excluded:
- Patients below the age of 18 years and above 60 years as this study is not on children or older patients;
- Patients who can't move their hands and eyes/or can't perform basic movements;
- Patients who are unconscious for longer periods and unable to recover consciousness;
- Patients not meeting the basic screening criteria of PTSD/ PTSD is not the main problem;
- Patients with severe intellectual impairments, since such patients are difficult to communicate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: EMDR Therapy
One arm will be a group subjected to EMDR Therapy
|
information added previously
Other Names:
|
Other: CBT Therapy
other arm will be a group subjected to CBT Therapy
|
information added previously
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Change in the symptoms of Post Traumatic Stress Disorder
Time Frame: 1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4).
|
Clinician-Administered Post Traumatic Stress Disorder Scale-5 (Weathers, Blake, et al., 2013) These diagnostic tools will be used to assess the symptoms of Post Traumatic Stress Disorder. Any changes in the level of PTSD will be noted with respect to Pre, Mid and Post treatment stages The total symptom severity score is calculated by summing severity scores for the 20
|
1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4).
|
Measurement of Socio Demographic Profile
Time Frame: 1st week at start of treatment, i.e, from date of randomization
|
Socio-demographic characteristics of the patients, like age, gender, marital status, occupation and social background
|
1st week at start of treatment, i.e, from date of randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Change in the symptoms of major depression
Time Frame: 1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4).
|
Beck Depression Inventory-II (Steer, Ball, Ranieri, & Beck, 1999; Beck, Ward, Mendelson, Mock, & Erbaugh, 1961) This Inventory will be used to assess the symptoms of Major Depressive Disorder.
Any changes in the level of Major Depression will be noted with respect to Pre, Mid and Post treatment stages Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the Beck Depression Inventory-II.
There is a four-point scale for each item ranging from 0 to 3. On two items (16 and 18) there are seven options to indicate either an increase or decrease of appetite and sleep.
Cut-off score guidelines for the BDI-II are given with the recommendation that thresholds be adjusted based on the characteristics of the sample, and the purpose for use of the Beck Depression Inventory-II.
Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe
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1st week (Baseline/pre-treatment screening, T-1); six weeks (during treatment screening, T-2); 12 weeks (post-treatment assessment, T-3). Finally, three months (follow up assessment, T-4).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KhushalKhanKhattakU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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