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

14 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is EMDR therapy safe for people with HIV?

There is no specific safety data available for EMDR therapy in people with HIV, but EMDR therapy is generally considered safe for treating various psychological conditions in humans. ^{1 2 3 4 5}

How is EMDR therapy different from other treatments for people with HIV?

EMDR therapy is unique because it uses bilateral stimulation, like eye movements or tapping, to help process and reduce the impact of traumatic memories, which can be done in a few sessions without needing to discuss the trauma in detail. This approach is different from other treatments that may require more extensive talking or homework assignments. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment EMDR Therapy for people with HIV?

Research shows that EMDR therapy can help reduce distress in anxiety conditions like PTSD and panic disorder. Although the eye movements in EMDR may not be essential, the therapy itself has been found effective in reducing distress compared to no treatment or nonvalidated treatments. ^{6 10 11 12 13}

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Does EMDR work? And if so, why?: a critical review of controlled outcome and dismantling research. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The empirical status of the clinical application of eye movement desensitization and reprocessing. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the one-session Eye-movement Desensitization Reprocessing procedure for eliminating traumatic memories. [2006]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Eye movement desensitization and reprocessing in posttraumatic stress disorder: a pilot study using assessment measures. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Eye movement desensitization and reprocessing (EMDR): a meta-analysis. [2022]

6. Brazil pubmed.ncbi.nlm.nih.gov

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS. [2022]

7. England pubmed.ncbi.nlm.nih.gov

HAART tolerability: post-exposure prophylaxis in healthcare workers versus treatment in HIV-infected patients. [2013]

8. United States 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events in Chinese human immunodeficiency virus (HIV) patients receiving first line antiretroviral therapy. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Who Improved in a Trauma Intervention for HIV-Positive Women with Child Sexual Abuse Histories? [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Eye movement desensitization and reprocessing. A brief and effective treatment for stress. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

A FLASH OF HOPE: Eye Movement Desensitization and Reprocessing (EMDR) Therapy. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Eye movement desensitization and reprocessing (EMDR) in the treatment of war veterans. [2022]