NCT06955845

Brief Summary

This randomized controlled trial aims to compare the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) therapy versus Selective Serotonin Reuptake Inhibitors (SSRIs) in the treatment of Post-Traumatic Stress Disorder (PTSD). Adult patients diagnosed with PTSD will be randomly assigned to receive either EMDR therapy or SSRIs for a period of six weeks. The primary outcome is the rate of remission as measured by validated PTSD symptom severity scales at Week 6. Secondary outcomes include changes in functional impairment and patient-reported quality of life. The study seeks to determine whether EMDR therapy is a non-pharmacological alternative to SSRIs for achieving symptom remission in PTSD.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not 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

First Submitted

Initial submission to the registry

April 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

April 25, 2025

Last Update Submit

July 4, 2025

Conditions

Keywords

PTSDEMDRSSRIsTraumaMental HealthRandomized controlled trialPost-traumatic stress disorderEye Movement Desensitization and Reprocessing

Outcome Measures

Primary Outcomes (1)

  • Remission rate at Week 6

    Each group's proportion of participants achieving remission from PTSD is defined as having a score below 22 on the PTSD Checklist for DSM-5 (PCL-5; range 0-80, where higher scores indicate worse PTSD symptoms), a validated PTSD scale.

    6 weeks

Secondary Outcomes (1)

  • Change in functional impairment score

    6 weeks

Study Arms (2)

EMDR Therapy

EXPERIMENTAL

Participants will receive Eye Movement Desensitization and Reprocessing (EMDR) therapy over six weeks.

Behavioral: Eye Movement Desensitization and Reprocessing Therapy

Selective Serotonin Reuptake Inhibitors (SSRIs)Treatment

ACTIVE COMPARATOR

Participants will receive selective serotonin reuptake inhibitors (SSRIs) such as Sertraline over six weeks.

Drug: Selective serotonin reuptake inhibitors

Interventions

Patients in this arm will receive weekly EMDR sessions for 6 weeks

Also known as: EMDR Therapy
EMDR Therapy

The patients will receive an SSRI medication daily for 6 weeks. The dose will be titrated by the clinician.

Selective Serotonin Reuptake Inhibitors (SSRIs)Treatment

Eligibility Criteria

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

You may qualify if:

  • Age 18-60 years
  • Clinical diagnosis of Post-Traumatic Stress Disorder (PTSD)
  • Duration of illness ≥ 6 months
  • Able to provide informed consent

You may not qualify if:

  • Current substance abuse or dependence
  • History of psychotic disorder or bipolar disorder
  • Active suicidal ideation
  • Concurrent psychotherapy or psychiatric medication (except study-assigned SSRI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Combined Military Hospital

Nowshera, KPK, 25770, Pakistan

Location

Department of Psychiatry, Combined Military Hospital Nowshera

Nowshera, Kpk, 25770, Pakistan

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticCombat DisordersWounds and InjuriesPsychological Well-Being

Interventions

Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPersonal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

Study Officials

  • Asad Ullah Jan, MBBS,FCPS

    CMH Nowshera

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Psychiatrist

Study Record Dates

First Submitted

April 25, 2025

First Posted

May 2, 2025

Study Start

May 6, 2025

Primary Completion

November 30, 2025

Study Completion

December 31, 2025

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

No plans to share IPD at this time.

Locations