NCT06957210

Brief Summary

This randomized controlled trial investigates the comparative effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy and selective serotonin reuptake inhibitors (SSRIs) in fostering post-traumatic growth among patients diagnosed with post-traumatic stress disorder (PTSD). Participants will be randomized to receive either EMDR therapy or standard SSRI pharmacotherapy. The primary objective is to evaluate the extent of psychological growth and recovery achieved through each intervention, aiming to guide future therapeutic strategies for PTSD.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 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 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2025

Completed
2 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 26, 2025

Last Update Submit

July 4, 2025

Conditions

Keywords

PTSDPost-traumatic Stress DisorderPost-traumatic GrowthEMDREye Movement Desensitization and Reprocessing

Outcome Measures

Primary Outcomes (1)

  • Post-Traumatic Growth (PTG) measured by Post-Traumatic Growth Inventory (PTGI)

    Change in PTGI total score from baseline to 6 weeks.

    6 weeks

Secondary Outcomes (1)

  • PTSD symptom severity measured by PTSD Checklist

    6 weeks

Study Arms (2)

EMDR

EXPERIMENTAL

EMDR therapy

Behavioral: EMDR

SSRIs

ACTIVE COMPARATOR

Acting as control group

Drug: SSRIs

Interventions

EMDRBEHAVIORAL

Participants will receive structured EMDR therapy sessions conducted by trained therapists following standard EMDR protocols. Sessions will occur weekly over a 6 week period.

EMDR
SSRIsDRUG

Participants will receive pharmacotherapy with an SSRI prescribed according to standard clinical guidelines for PTSD, monitored by a psychiatrist over a 6-week period.

SSRIs

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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

Combat DisordersStress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization ReprocessingSelective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesNeurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

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
Head Department of Psychiatry

Study Record Dates

First Submitted

April 26, 2025

First Posted

May 4, 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

Privacy concerns and confidentiality protections for participants limit the feasibility of public data sharing.

Locations