EMDR Therapy for People with HIV

Overseen By Bethany Rhoten

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Suicidal ideation, Schizophrenia, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a therapy called Eye Movement Desensitization and Reprocessing (EMDR) to assist people living with HIV who have experienced trauma. The researchers aim to determine if this therapy can be specifically adapted for them, as they often face higher levels of stress-related conditions such as depression and anxiety. The trial seeks individuals who have lived with HIV for over a year and have encountered any past trauma, such as abuse or witnessing violence. Participants will undergo an eight-week EMDR therapy program to assess its feasibility and acceptability. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance mental health support for people with HIV.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this EMDR therapy protocol is safe for people living with HIV?

Research has shown that EMDR (Eye Movement Desensitization and Reprocessing) therapy is generally safe and well tolerated. Some people might feel a bit uncomfortable during the eye movements, but most manage the therapy well. Other studies indicate that EMDR can help reduce symptoms like anxiety and stress for many people, regardless of age or background. It has also been used to help individuals with HIV cope with trauma-related symptoms. Overall, EMDR therapy is considered safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EMDR (Eye Movement Desensitization and Reprocessing) Therapy for people living with HIV because it offers a novel approach to addressing the psychological challenges associated with the condition. Unlike standard treatments that focus primarily on the medical management of HIV, EMDR Therapy targets the emotional and psychological well-being of individuals, aiming to reduce trauma and stress-related symptoms. This therapy uses a unique mechanism involving guided eye movements to help process distressing memories, which could lead to improved mental health outcomes and overall quality of life for those affected by HIV.

What evidence suggests that EMDR Therapy is effective for people living with HIV?

Research has shown that Eye Movement Desensitization and Reprocessing (EMDR) therapy effectively treats trauma-related symptoms. Studies indicate that EMDR often outperforms no treatment and some medications in reducing PTSD symptoms. Although specific data for people living with HIV is limited, EMDR has successfully helped similar groups. This trial will evaluate EMDR therapy for people living with HIV, aiming to help them process and reduce stress from upsetting experiences, a common issue for those with HIV. Early findings suggest it might relieve symptoms like depression and anxiety in this group. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people living with HIV who also have experienced trauma. It's designed to see if a special therapy called EMDR, which helps with stress from bad life experiences, can be tailored specifically for them.

Inclusion Criteria

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)

Individuals that have lived with HIV for over a year

Exclusion Criteria

Have active psychosis

I am currently experiencing thoughts of harming myself.

I have been diagnosed with dissociative identity disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants undergo an eight-week Eye Movement Desensitization and Reprocessing therapy tailored for people living with HIV and trauma

8 weeks

8 visits (in-person or virtual)

Follow-up

Participants complete post-intervention assessment measures and a 20-30 minute interview addressing barriers and facilitators of study participation

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• EMDR Therapy Protocol

Trial Overview The study tests an eight-week Eye Movement Desensitization and Reprocessing (EMDR) therapy protocol on 20 participants. The focus is to determine how well this specific approach works for individuals living with HIV and trauma.

How Is the Trial Designed?

Group I: People Living With HIV (PLHIV) Experimental Treatment 1 Intervention

EMDR Therapy Protocol is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as EMDR Therapy for:

• Post-Traumatic Stress Disorder (PTSD)
• Anxiety
• Depression

Approved in United States as EMDR Therapy for:

• Post-Traumatic Stress Disorder (PTSD)
• Anxiety
• Depression
• Trauma-related symptoms

Approved in United Kingdom as EMDR Therapy for:

• Post-Traumatic Stress Disorder (PTSD)
• Anxiety
• Depression

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Published Research Related to This Trial

EMDR therapy is effective in reducing distress in various anxiety conditions, including PTSD, panic disorder, and public-speaking anxiety, especially when compared to no treatment.

There is no strong evidence that the eye movements used in EMDR significantly enhance treatment outcomes, suggesting that other factors may be more important in its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does EMDR work? And if so, why?: a critical review of controlled outcome and dismantling research. Cahill, SP., Carrigan, MH., Frueh, BC.[2019]

In a study comparing the tolerability of zidovudine/lamivudine/indinavir in HIV-negative post-exposure prophylaxis (PEP) subjects and HIV-positive patients, the frequency of adverse events was significantly higher in PEP subjects (70.3%) compared to HIV-infected patients (11.1%).

Treatment interruptions due to adverse events were eight times more common in HIV-negative subjects (56.7%) than in HIV-positive patients (7%), although most adverse events were not severe, with only one severe case in the PEP group versus 12 in the treatment group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HAART tolerability: post-exposure prophylaxis in healthcare workers versus treatment in HIV-infected patients. Quirino, T., Niero, F., Ricci, E., et al.[2013]

Eye Movement Desensitization and Reprocessing (EMDR) is an effective psychotherapy technique that uses bilateral stimulation, such as eye movements or tapping, to help individuals process trauma, particularly in treating post-traumatic stress disorder (PTSD).

Research suggests that EMDR may also be beneficial for other mental health issues beyond PTSD, including bipolar disorder, substance use disorders, and depressive disorders, indicating its potential as a versatile therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A FLASH OF HOPE: Eye Movement Desensitization and Reprocessing (EMDR) Therapy. Gainer, D., Alam, S., Alam, H., et al.[2021]

EMDR is recognized as a first-line treatment for trauma, particularly effective for combat veterans, as it can reduce symptoms of anxiety, depression, anger, and physical pain without requiring detailed discussions of traumatic events.

The therapy's design allows for consecutive daily sessions, making it particularly beneficial in urgent combat situations where traditional therapies may not be feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye movement desensitization and reprocessing (EMDR) in the treatment of war veterans. Silver, SM., Rogers, S., Russell, M.[2022]

Eye Movement Desensitization and Reprocessing (EMDR) has been shown to significantly reduce reported distress in patients, according to various studies, but the evidence for its effectiveness on physiological measures and behavioral outcomes is limited.

The eye movements used in EMDR do not seem to be a crucial part of the treatment's success, and there is a need for better-controlled studies to differentiate the specific effects of EMDR from placebo effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The empirical status of the clinical application of eye movement desensitization and reprocessing. Lohr, JM., Kleinknecht, RA., Tolin, DF., et al.[2019]

In a preliminary evaluation of Eye-movement Desensitization Reprocessing (EMDR) therapy conducted in 1990, only 3 out of 8 cases showed successful outcomes, indicating mixed efficacy for this treatment approach.

The study found that cases with more severe pathology tended to improve the least, suggesting that EMDR may not be as effective for individuals with complex or severe trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the one-session Eye-movement Desensitization Reprocessing procedure for eliminating traumatic memories. Oswalt, R., Anderson, M., Hagstrom, K., et al.[2006]

In a study involving eight patients with PTSD, EMDR treatment over four sessions led to significant improvements in PTSD symptoms, as measured by structured interviews and self-report inventories.

The study suggests that EMDR may be more efficient than other PTSD treatments, achieving meaningful changes in symptoms in fewer sessions, although some residual symptoms remained at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye movement desensitization and reprocessing in posttraumatic stress disorder: a pilot study using assessment measures. Forbes, D., Creamer, M., Rycroft, P.[2019]

A meta-analysis of 34 studies found that Eye Movement Desensitization and Reprocessing (EMDR) is effective in reducing symptoms of PTSD compared to no treatment and non-exposure therapies, but it does not show significant advantages over other exposure techniques.

The analysis suggests that the eye movements used in EMDR may not provide any additional benefit, indicating that the core therapeutic elements of EMDR could be effective without this specific component.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye movement desensitization and reprocessing (EMDR): a meta-analysis. Davidson, PR., Parker, KC.[2022]

Eye Movement Desensitization and Reprocessing (EMDR) is an effective therapy for reprocessing disturbing memories, particularly beneficial for individuals with posttraumatic stress disorder (PTSD).

EMDR is time-efficient, often requiring only 3 to 5 hours of treatment, and its effectiveness may be attributed to various mechanisms, including cognitive and biological factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye movement desensitization and reprocessing. A brief and effective treatment for stress. Lee, GK., Beaton, RD., Ensign, J.[2022]

In a study of people living with HIV/AIDS in Brazil, 25.7% of patients modified their antiretroviral therapy (ART) within the first year due to adverse events, with the median time to modification being 70.5 days after starting treatment.

The most common adverse events leading to ART modification were dermatological, neuropsychiatric, and gastrointestinal issues, with patients on a specific combination of zidovudine, lamivudine, and efavirenz being twice as likely to switch therapies compared to those on tenofovir with lamivudine and efavirenz.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. Azevedo, LN., Ximenes, RAA., Monteiro, P., et al.[2022]

In a study of healthcare workers and individuals receiving HIV postexposure prophylaxis (PEP), the combination of zidovudine, lamivudine, and tenofovir (ZDV-3TC-TDF) was associated with increased rates of nausea, particularly in females.

The study suggests that preventive measures for managing nausea may be important to improve adherence to HIV PEP, as those on a different regimen (ZDV-3TC-IDV) were more likely to complete their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of adverse events associated with antiretroviral regimens for postexposure prophylaxis for occupational and nonoccupational exposures to prevent transmission of human immunodeficiency virus. Luque, A., Hulse, S., Wang, D., et al.[2022]

The Healing Our Women Program, an 11-week intervention for HIV-positive women with histories of child sexual abuse, effectively reduced psychological distress in participants compared to those on a wait-list, with 78 women receiving the active treatment.

Improvements in psychological distress were significantly associated with total trauma burden at both post-test and six-month follow-up, suggesting that the program is particularly beneficial for women with higher levels of trauma, highlighting the need for tailored interventions in HIV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Improved in a Trauma Intervention for HIV-Positive Women with Child Sexual Abuse Histories? Chin, D., Myers, HF., Zhang, M., et al.[2021]

In a study of 474 adults with HIV receiving Tenofovir, Lamivudine, and Efavirenz as their first-line treatment, an overwhelming 99.6% experienced at least one adverse event (AE) within the first year, highlighting the high incidence of ART-related AEs.

Factors such as a baseline body mass index (BMI) greater than 24 kg/m2, pre-existing multiple AEs, and pre-existing severe AEs significantly increased the risk of developing severe AEs, indicating the need for careful monitoring of these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in Chinese human immunodeficiency virus (HIV) patients receiving first line antiretroviral therapy. Dai, L., Su, B., Liu, A., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03848858

Study Details | NCT03848858 | Efficacy of EMDR Therapy, ... One of the first-line treatments for trauma in non-HIV populations is Eye Movement Desensitization and Reprocessing (EMDR) therapy. EMDR is a psychotherapeutic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11111257/

Revisiting Eye Movement Desensitization and Reprocessing ... Most studies found that EMDR was superior in relieving PTSD when compared to controls. Eleven of the 16 selected studies demonstrated ...

3. ctv.veeva.com ctv.veeva.com/study/piloting-eye-movement-desensitization-and-reprocessing-emdr-therapy-in-people-living-with-hiv-and

Piloting Eye Movement Desensitization and Reprocessing ... This study aims to assess the feasibility and acceptability of delivering an Eye Movement Desensitization and Reprocessing therapy protocol ...

4. link.springer.com link.springer.com/article/10.1007/s11904-012-0139-3

Interventions to Improve Psychological Functioning and ... In HIV-negative trauma survivors there is good evidence for the effectiveness of cognitive-behavior therapy (CBT) (in particular prolonged ...

5. mdpi.com mdpi.com/2077-0383/13/18/5633

The Efficacy of Eye Movement Desensitization and ... EMDR has been shown to be more effective than a waitlist control [46,52,57,58,59,60,61,65,67], no treatment [64], and even more effective than pharmacotherapy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8581955/

An evaluation of eye movement desensitization and ... Using real world data, we have shown that EMDR can reduce symptomatology regardless of the age, gender or clinical presentation of the client.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06730867

Piloting Eye Movement Desensitization and Reprocessing ... Eye Movement Desensitization and Reprocessing therapy has been used to treat trauma-related symptoms for people living with HIV.

8. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/emdr_pro.asp

Eye Movement Desensitization and Reprocessing (EMDR) for ... A large number of studies demonstrate it is effective to treat PTSD when administered over approximately 3 months.

9. ctv.veeva.com ctv.veeva.com/study/efficacy-of-emdr-therapy-as-compared-to-treatment-as-usual-in-reducing-clinical-symptoms-in-people

Efficacy of EMDR Therapy, as Compared to Treatment as ... If this study shows that a psychological trauma-focused therapy can help people adjust to a recent HIV diagnosis and have better outcomes, this ...