Efficacy of EMDR Therapy, as Compared to Treatment as Usual, in Reducing Clinical Symptoms in People With HIV

NCT03848858 | Completed

• 1 other identifier: 2018/8199/I
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

People living with HIV may suffer HIV-related psychological trauma. Studies also show that this group is vulnerable to non-HIV-related trauma. Trauma can increase vulnerability to stress and reducing the ability to cope. It can have a negative impact on treatment adherence, treatment outcomes, functioning and health-related quality of life. However, despite evidence showing psychological trauma can contribute to poor outcomes in HIV, little research has been carried out to assess whether psychological trauma-focused therapy can help people living with HIV. A first-line treatment for psychological trauma is Eye Movement Desensitization and Reprocessing (EMDR) therapy. This therapy is recommended by the World Health Organization for treating Post-Traumatic Stress Disorder, with many studies showing this treatment is safe and effective for this disorder. However, it has not to our knowledge been specifically tested in the population of people living with HIV. This project will test whether EMDR therapy, in addition to the standard medical treatment received at the Infectious Diseases Unit, is more effective than standard medical treatment alone in reducing psychological trauma, improving health-related quality of life and improving HIV outcomes in people recently diagnosed with HIV. To test this, the investigators will recruit 40 people who have received a diagnosis of HIV. 20 will be offered the possibility to receive EMDR treatment for one hour weekly for up to 6 months, in addition to the standard medical treatment, while the other 20 will be offered only the standard medical treatment. The hypotheses of the present study are that the participants who receive EMDR therapy on top of their standard medical treatment will show a reduction in psychological trauma and related symptoms such as anxiety, depression and global distress, as compared to those who did not. The investigators also predict that the EMDR group will show improved functioning and health-related quality of life. The final hypotheses are that the EMDR group will show improved treatment adherence and HIV outcomes. If this study shows that a psychological trauma-focused therapy can help people adjust to a HIV diagnosis and have better outcomes, this will have important implications for improving care for people living with HIV.

Conditions

Psychological Trauma; PTSD; HIV/AIDS

Keywords

HIV; Psychological Trauma; Eye Movement Desensitization and Reprocessing Therapy

Outcome Measures

Primary Outcomes (1)

• Psychological trauma

  Psychological trauma will be evaluated using the Impact of Events Scale-Revised. This scale consists in 22-item to determine frequency and impact of posttraumatic symptoms experienced, with subscales of intrusion, avoidance and hyperarousal, each scored on a 5-point Likert scale, yielding a score for each subscale and a total score. This scale has a scoring range of 0 to 88. On this test, scores that exceed 24 can be quite meaningful. High scores have the following associations: 24 or more PTSD is a clinical concern. Those with scores this high who do not have full PTSD will have partial PTSD or at least some of the symptoms; 33 and above represents the best cutoff for a probable diagnosis of PTSD; 37 or more this is high enough to suppress your immune system's functioning (even 10 years after an impact event).

  From baseline to posttreatment at 6 months

Secondary Outcomes (8)

• Post-traumatic stress disorder

  From baseline to posttreatment at 6 months

• Dissociative symptoms

  From baseline to posttreatment at 6 months

• Anxiety

  From baseline to posttreatment at 6 months

• Depression

  From baseline to posttreatment at 6 months

• General psychopathology

  From baseline to posttreatment at 6 months

Study Arms (2)

EMDR plus TAU

EXPERIMENTAL

20 individual weekly sessions of 60 minutes each of Eye Movement Desensitization and Reprocessing Therapy (EMDR), plus Treatment as Usual (TAU), applying first the standard EMDR protocol (Shapiro, 2005), and then a specific protocol for the sequelae of somatic illness and medical trauma (Hase, 2018).

Behavioral: EMDR plus TAU

TAU only

NO INTERVENTION

The patients in this condition are newly diagnosed and will be introduced to the study in their first appointment with the Infectious Diseases Unit, in which analyses of HIV-related biological markers are taken. In a follow up appointment between 1 and 2 weeks later, antiretroviral treatment is initiated. There is a further check-up 1-2 months after initiating antiretroviral treatment, and then 6-monthly check-ups. In these checkups, measures of CD4 and the CD4/CD8 ratio are taken and treatment adherence is reviewed. The patients receiving EMDR therapy will also participate in these activities.

Interventions

EMDR plus TAU BEHAVIORAL

The standard EMDR protocol will first be applied, consisting of 8 phases: 1) Patient history; 2) Patient preparation; 3) Evaluation of the main aspects of the traumatic memory; 4) Desensitization of the memory; 5) Installation of the positive cognition; 6) Body scan; 7) Close and 8) Reevaluation. The specific protocol for the sequelae of somatic illness and medical trauma is next applied. It first focuses on processing past memories related to diagnosis, symptom development, medical procedures and unjust or stressful behaviour with the medical system. Once these are processed, the intervention addresses current symptoms, impairments and triggers. Finally, the patient is helped to face the future and reduce avoidance of medical procedures, avoidance of social life and fear of dying.

EMDR plus TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with HIV within last 1 month
• Aged 18 - 65
• Impact of Events Scale-Revised score of higher than 0 related to HIV diagnosis
• Fluency in Spanish
• Initiating antiretroviral medication

You may not qualify if:

• Diagnosis of severe mental disorder or neurological disorder
• Current suicidal ideation
• Current substance use disorder
• Have received a structured therapy for trauma in the past 2 years (for part 2 of the study only)
• Clinical diagnosis of AIDS.

Sponsors & Collaborators

• EMDR Europe: collaborator
• Fundacion IMIM: collaborator
• Parc de Salut Mar: lead

Study Sites (1)

Parc de Salut Mar

Barcelona, 08019, Spain

Location

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Psychological Trauma; Stress Disorders, Post-Traumatic

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Benedikt L Amann, PhD

  Parc de Salut Mar; Fundación IMIM; Universitat Autónoma de Barcelona; CIBERSAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluators will be blind to treatment. Participants cannot be blind to treatment due to the impossibility of creating a sham alternative to EMDR therapy, due to its use of bilateral stimulation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Patients will be recruited from the Infectious Diseases Unit of the Hospital del Mar, Barcelona, Spain, and evaluations and therapy sessions will be carried in the Hospital del Mar and in the Hospital del Mar Research Institute. The study consists of a single-blind RCT with two parallel branches, 1) individual therapy with EMDR and TAU, and 2) TAU only, with participants matched by age, sex, and prior trauma burden. Following the initial evaluation, participants will be randomized to either receive up to 6 months of weekly 1 hour EMDR sessions (20 sessions) in addition to the standard medical treatment, or standard medical treatment only. The participants will be evaluated pre- and post- treatment.

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: February 21, 2019
• Study Start: February 1, 2019
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)