NCT06435052

Brief Summary

This Randomized Controlled Trial will check the efficacy of Eye Movement Desensitization \& Reprocessing vs Cognitive Behavioral Therapy in Post-Traumatic Stress and Comorbid Disorders in Pakistan

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

February 1, 2023

Last Update Submit

May 23, 2024

Conditions

Keywords

Post Traumatic Stress DisorderEMDRCBTPakistan

Outcome Measures

Primary Outcomes (1)

  • Post-traumatic stress disorder

    Post-traumatic stress disorder (PTSD) will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 scores will be utilized to determine the severity of PTSD symptoms. Typically, a CAPS-5 score of 40 or above will serve as the cutoff point for diagnosing PTSD.

    2 years

Secondary Outcomes (1)

  • Depressive and Anxiety Symptoms

    2 years

Study Arms (2)

Eye Movement Desensitization & Reprocessing Therapy

EXPERIMENTAL

Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered face-to-face by a psychotherapist in a total of 12 sessions, with one session per week. The efficacy of EMDR therapy will be compared with Cognitive Behavioral Therapy (CBT) in the treatment of Post-Traumatic Stress Disorder (PTSD) in Pakistan.

Behavioral: Eye Movement Desensitization & Reprocessing Therapy

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

Cognitive Behavioral Therapy (CBT) will be delivered face-to-face by a psychotherapist in a total of 14 sessions, with one session per week. The efficacy of CBT will be compared with Eye Movement Desensitization and Reprocessing therapy in the treatment of Post-Traumatic Stress Disorder in Pakistan.

Behavioral: Cognitive Behavioral Therapy

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) therapy will be administered face-to-face by a psychotherapist in a total of 12 sessions, with one session per week. The efficacy of EMDR therapy will be compared with Cognitive Behavioral Therapy in the treatment of Post-Traumatic Stress Disorder in Pakistan.

Eye Movement Desensitization & Reprocessing Therapy

Cognitive Behavioral Therapy will be comparatively checked with Eye Movement Desensitization \& Reprocessing Therapy for its efficacy. It will be administered by psychotherapist in 14 sessions (each session per week)

Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • The following patients will be excluded:
  • Patients below the age of 15 years and above 60 years, since this study is neither on children nor on old aged 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anwar Khan

Karak, 27200, Pakistan

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Anwar Khan, Assistant Professor of Organizational Psychology

Study Record Dates

First Submitted

February 1, 2023

First Posted

May 30, 2024

Study Start

August 15, 2022

Primary Completion

August 15, 2024

Study Completion

August 15, 2025

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations