NCT06730867

Brief Summary

Eye Movement Desensitization and Reprocessing therapy is a time-limited trauma-response therapy that treats symptoms of stress that result disturbing life experiences. Eye Movement Desensitization and Reprocessing therapy has been used to treat trauma-related symptoms for people living with HIV. People living with HIV tend to experience higher psychiatric morbidity rates of depression, anxiety, and post-traumatic stress symptoms than the general population. However, even with case studies of Eye Movement Desensitization and Reprocessing therapy on people living with HIV, there is no definitive protocol for the clinician as they navigate the therapy. This study aims to assess the feasibility and acceptability of delivering an Eye Movement Desensitization and Reprocessing therapy protocol tailored for people living with HIV and trauma. 20 people living with HIV will be recruited to participate in an eight-week Eye Movement Desensitization and Reprocessing therapy. The therapy will be focused on assessing the viability of an Eye Movement Desensitization and Reprocessing protocol that is specified for people living with HIV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

November 20, 2024

Last Update Submit

June 20, 2025

Conditions

Keywords

HIVEMDRtrauma

Outcome Measures

Primary Outcomes (4)

  • Recruitment of PLHIV and trauma to participate in EMDR

    Recruitment will be assessed by the rate of enrollment (participants/month).

    9 months

  • Study Retention

    Retention will be assessed by counting the number of participants who are retained throughout the study.

    10 months

  • Engagement

    Engagement will be assessed by counting the number of EMDR sessions attended by participants

    10 months

  • Intervention Fidelity

    Fidelity will be assessed by the EMDR Fidelity Rating Scale

    10 months

Secondary Outcomes (3)

  • Program Completion

    10 months

  • Data Collection Completion

    10 months

  • Intervention Evaluation

    10 months

Study Arms (1)

People Living With HIV (PLHIV)

EXPERIMENTAL
Behavioral: EMDR Therapy Protocol

Interventions

The intervention involves an eight-week program that details a specific EMDR protocol and questionnaire for people living with HIV. The EMDR sessions occur once a week for eight weeks under the supervision of the investigator.

Also known as: Eye Movement Desensitization and Reprocessing
People Living With HIV (PLHIV)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals that have lived with HIV for over a year.
  • Age 18 or older
  • Have experienced any type of trauma in their lifetime (for example: physical abuse, verbal abuse, physical neglect, emotional neglect, mental illness, substance addiction, imprisonment, witnessing or experiencing violence, natural disasters)

You may not qualify if:

  • have current suicidal ideation
  • diagnosis with schizophrenia
  • have active psychosis
  • diagnosed with dissociative identity disorder
  • have current severe major depression
  • have previously received EMDR therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Eye Movement Desensitization Reprocessing

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 20, 2024

First Posted

December 12, 2024

Study Start

July 29, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations