HIV/AIDSNCT03848858
Efficacy of EMDR Therapy, as Compared to Treatment as Usual, in Reducing Clinical Symptoms in People With HIV
A study testing EMDR plus TAU in people with HIV/AIDS and Psychological Trauma, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV/AIDS, Psychological Trauma, PTSD
- What is being tested?
- EMDR plus TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2019to 2 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Eye Movement Desensitization and Reprocessing Therapy Versus Treatment-As-Usual in a Pilot Randomized Controlled Trial in Reducing Clinical Symptoms and Biological Markers of HIV in Patients With a Recent Diagnosis of HIV
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.
Read the detailed description
Background
The seropositive population are vulnerable to high rates of psychological trauma with 30-40% of people living with HIV having HIV-related trauma, and rates of up to 90% of trauma unrelated to HIV. HIV-related trauma is linked to various events such as receiving the diagnosis, the number of medical symptoms, receiving treatment, the level of perceived stigma related to HIV, and witnessing HIV-related deaths. The risk of suffering trauma related to HIV is higher in those with prior trauma and negative life event.
Trauma is known to not only have a serious impact on mental health, but also to be a key predictor of poor prognosis in HIV, affecting treatment outcomes and health-related quality of life. Trauma exposure and the development of trauma symptoms impair psychosocial functioning, increase vulnerability to stress and burden the physiological systems involved in coping and adaptation. Patients with posttraumatic symptoms show poorer treatment adherence, yet even in therapy-adherent individuals, posttraumatic symptoms are associated with immune dysregulation, leading to decreased CD4 cell count and thus negative health outcomes. Trauma-affected patients are also more likely to engage in risky health-related behaviors and to suffer higher functional impairment not explained by CD4 count variance.
Due to the negative impact of trauma in terms of psychological distress and poorer HIV outcomes, psychological interventions which specifically address trauma are needed as an adjunct to antiretroviral treatment, in order to reduce unnecessary mortality related to poor treatment adherence and to improve health-related quality of life and functionality. There is even potential for psychological interventions to impact directly on HIV disease progression. Limited evidence suggests that psychological interventions targeting trauma can have a positive impact on HIV symptom experience, while a small but promising body of research into Mindfulness-based interventions targeted at reducing stress show they may have a positive impact on the biological HIV marker CD4. Therefore, a brief yet effective psychological intervention at the point of diagnosis could have a significant impact in reducing psychological trauma and distress and improving treatment adherence and thus prognosis, and may even improve HIV disease progression.
One of the first-line treatments for trauma in non-HIV populations is Eye Movement Desensitization and Reprocessing (EMDR) therapy. EMDR is a psychotherapeutic approach developed in the late 80s by Francine Shapiro that aims to treat traumatic memories and their associated stress symptoms. This therapy consists of a standard protocol which includes eight phases and bilateral stimulation (usually horizontal saccadic eye movements) to desensitize the discomfort caused by traumatic memories and the aim of the therapy is to achieve their reprocessing and integration within the patient's standard biographical memories. EMDR therapy is recommended by the World Health Organization as a psychotherapy of choice in the treatment of PTSD, showing efficacy in children, teenagers, and adults. Recent studies show potential for EMDR as an efficacious treatment in non-PTSD patients, including in promoting treatment adherence in bipolar patients and as an add-on treatment in chronic pain conditions, as per a recent review. Therefore, EMDR would seem to be indicated as an interesting therapeutic tool in helping people successfully assimilate the HIV diagnosis and reduce psychological distress and psychological trauma symptoms, and as an adjuvant treatment to health-related quality of life and potentially treatment adherence and biological markers of the disease.
This study aims to be the first to test the efficacy of the EMDR therapy in people recently diagnosed with HIV. If shown to be efficacious in this population, it could open the way for future studies to test the efficacy of EMDR in reducing risk behaviors associated with HIV transmission and as a treatment adjunct in treatment-refractory patients.
Evaluation \& Diagnostic Protocol
In the baseline visit, sociodemographic data will be taken through a data collection notebook (CRD) and the validated Spanish versions of clinical scales, as well as scales related to health-related quality of life and functionality will be administered. At 6 months, the measures will be taken again, along with a measure regarding satisfaction of the treatment for participants in the EMDR group.
Side Effects and Follow Up
EMDR therapy is a safe and well tolerated psychological treatment. However, some may feel discomfort or suffer when the horizontal eye movements are carried out. If this occurs, bilateral stimulation will be achieved via tapping, which consists of small taps on the hands. Likewise, therapeutic work on difficult life experiences can accentuate psychological distress symptoms. The patient will be taught a variety of self-control techniques to be able to deal with the disturbing information which may arise during and between sessions. Any incident will be registered in the patient's clinical history as well as the CRD of the investigation project to later report the data.
Data Collection: Selection and Evaluation of Study Sample
Study participation is voluntary after being informed of the study objectives and having signed the informed consent document. The participants will be evaluated individually by specially trained health professionals (psychiatrists and psychologists qualified to make diagnoses). The project has been sent and approved to the Ethical Committee for Clinical Investigations in our Centre (number nº 2018/8199/I). Following the baseline evaluation, randomization will be carried out, stratified by age, sex and presence of prior trauma. Data will be collected post intervention. Motives for refusal to participate in the study will be collected to determine the presence of selection bias in the sample and the causes of non-participation.
Statistical Analysis
Calculation of Sample Size:
The study aims to evaluate the efficacy of the EMDR intervention protocol with TAU compared to TAU-only in terms of reduction of posttraumatic symptoms and psychological distress and an improvement in functionality, health-related quality of life, treatment adherence, and the biological markers of HIV of CD4 and the CD4/CD8 ratio. More specifically, the study will evaluate the efficacy of the EMDR therapy compared to treatment as usual in patients with HIV and psychological trauma in terms of clinical stabilization and improvement: reduction of associated trauma and affective symptoms, improvement of functioning, health-related quality of life and biological markers. This is a pilot study in order to get a signal whether or not this intervention is helpful with a planned sample size of 40. However, all patients meeting the inclusion criteria will be assigned to EMDR (n=20) or the TAU group (n=20) by two independent researchers using to the following algorithm: The first two patients will be randomly allocated to EMDR or TAU. For each subsequent patient, the treatment allocation will be identified, which a) balances the arm sizes if one arm has two patients more than the other arm, or otherwise b) decreases the largest effect-size of the between-arms differences in age, sex and trauma type. All steps of the randomization process will be automatically carried out in a central location using a computer program. Effect sizes will be estimated using Hedge's g, directly calculated in numeric variables and converted from odds ratios in binary variables.
Analysis of the main study variables
The distribution of the between-group socio-demographic and clinical characteristics at baseline will be analyzed using descriptive statistics. The continuous variables with a normal distribution will be analyzed with a Multivariate Analysis of Variance (MANOVA). The change in clinical and biological variables compared to baseline at strategic times during the intervention will be analyzed using an ANOVA with repeated measures including time factors, treatment conditions and their interaction. For cases which do not meet the normality premise, the Wilcoxon test will be used. The differences between groups, for the categorical and main clinical variables, will be analyzed using the Chi-squared test. Those variables which are statistically significant can be used as covariables in a logistical regression or lineal study of the factors associated with the significance of the effect, and to determine which variables are the best predictors of function. The effect size index will be estimated (Hedge's g or Pearson's r) for the correlation index of each analysis carried out. The statistical software used for all analyses will be the latest available version of SPSS (v. 24).
Analysis of Clinical Efficacy
For the main statistical analysis, the Intention to Treat (ITT) principal will be applied. The Last Observation Carried Forward (LOCF) will be used as the measure in cases of dropout.
Ethical Issues
The current Project will be carried out in accordance with the basic principles of protection of human rights and dignity as per the Helsinki Declaration and as per current legislation. The study will not begin until the Ethical Committee for Clinical Investigations (CEIC) gives approval and all information gathered will be treated confidentially, as per EU Regulation 2016/679. Patients will be informed verbally and need to sign the attached informed consent.
- Conditions
- HIV/AIDS, Psychological Trauma, PTSD
- Being tested
- EMDR plus TAU
- Keywords
- HIV, Psychological Trauma, Eye Movement Desensitization and Reprocessing Therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Psychological Trauma, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR plus TAUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to posttreatment at 6 months
Secondary outcomes (8)
Post-traumatic stress disorder
Post-traumatic stress disorder will be assessed using the Global Post-traumatic Stress Evaluation-DSM V (EGEP-5). This scale consists a 58-item self-report checklist of posttraumatic symptoms to enable diagnosis as per DSM-V criteria. The items are separated in three sections: events (27 items), symptoms (28 items) and functioning (7 items). The scale has been designed to obtain information about: posttraumatic stress disorder (PTSD), intensity or severity of the posttraumatic symptoms (using scales), number of current posttraumatic symptoms, intensity or gravity of the subjective clinical symptoms, disorder specification (chronic or intense PTSD and its beginning), and the level of functional damage.
Measured: From baseline to posttreatment at 6 months
Dissociative symptoms
Dissociation will be evaluated using the Dissociative Experiences Scale (DES). This scale consists a 28-item self-report scale to identify the presence of 3 main symptom clusters of dissociation: amnesia, depersonalization and absorption. Scores are obtained for each subscale from 0 (occurring 0% of times) to 100 (occurring 100% of the time). There is also a global score and can be obtained by summing all the values of the items and dividing them by 28. The higher DES score means the more likely is that the patient has a dissociative disorder.
Measured: From baseline to posttreatment at 6 months
Anxiety
Anxiety will be assessed using the Generalized Anxiety Disorder-7 scale (GAD-7). This scales consists a 7-item self-administered scale to measure the severity of anxiety symptoms over the last 2 weeks and to screen between the anxiety disorders (Generalized Anxiety Disorder, Panic Disorder, Social Phobia and Post Traumatic Stress Disorder). Each item is scored on a 3-point Likert scale, with a cut-off score of 10 indicating clinical symptoms. The global score can be obtained by summing all the answers of the items. Higher scores correlate with disability and functional impairment.
Measured: From baseline to posttreatment at 6 months
Depression
Depression will be evaluated using the Patient Health Questionnaire-9 (PHQ-9). This scale consists a self-administered depression rating scale based on 9 items. Each of the items checked as positive have to be answered in a 3-point Likert scale. The global score can be obtained by summing all the answers of the items. The cut-off score of 10 indicates clinical symptoms (1-4 scores show minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-27 severe depression).
Measured: From baseline to posttreatment at 6 months
General psychopathology
General psychopathology will be assessed using the Brief Psychiatric Rating Scale (BPRS). This scale is used to assess the gravity and sub-classification (negative or positive) of the schizophrenic disorder. Each item is scored on a 7-point Likert scale, between 1 (symptom absence) and 7 (extremely severe). The total score is obtained summing the scores of each of the 18 items, ranging between 18 and 126. The score of the negative symptoms cluster is obtained by adding the scores of the following items: 3, 13, 16 and 18. This punctuation ranges between 4 and 28. The score of the positive symptoms cluster is obtained by adding the scores of the following items: 4, 11, 12 and 15. This punctuation also ranges between 4 and 28.
Measured: From baseline to posttreatment at 6 months
Perception of quality of life
Quality of life will be evaluated using the Medical Outcomes Study-Short Form 30 items (MOS-HIV 30). This scale consists a 35-item self-report in 11 domains to assess eleven dimensions of health including General Health Perceptions, Pain, Physical Functioning, Role Functioning, Social Functioning, Mental Health, Energy/Fatigue, Health Distress, Cognitive Function, Quality of Life and Health Transition. The raw scores for each scale are transformed to a 0-100 scale, with higher scores indicating a better quality of life and functioning.
Measured: From baseline to posttreatment at 6 months
Treatment adherence
Adherence to pharmacological treatment will be evaluated using the Morisky scale. The Morisky scale is designed to estimate the risk of medication non-adherence. Scores are based on patient responses to four, Yes or No questions. The total scores are ranked from 0 to 4, where the highest scores reflect greater medication adherence.
Measured: From baseline to posttreatment at 6 months
CD4T and CD8T cells
The average levels of CD4T and in the CD4T/CD8T index will be measured using blood samples.
Measured: From baseline to posttreatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Feb 2019
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- EMDR Europe, Fundacion IMIM
- Responsible party
- Principal investigator, Ana Moreno Alcázar, Parc de Salut Mar
- Investigators
- Benedikt L Amann, PhD, Principal investigator, Parc de Salut Mar; Fundación IMIM; Universitat Autónoma de Barcelona; CIBERSAM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848858
- Sponsor's protocol ID
- 2018/8199/I
- Status last verified
- Feb 2026
- First submitted
- 7 Nov 2018
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there are no plans.
Publications
Brezing C, Ferrara M, Freudenreich O. The syndemic illness of HIV and trauma: implications for a trauma-informed model of care. Psychosomatics. 2015 Mar-Apr;56(2):107-18. doi: 10.1016/j.psym.2014.10.006. Epub 2014 Oct 8.
PubMed 25597836Brief DJ, Bollinger AR, Vielhauer MJ, Berger-Greenstein JA, Morgan EE, Brady SM, Buondonno LM, Keane TM; HIV/AIDS Treatment Adherence, Health Outcomes and Cost Study Group. Understanding the interface of HIV, trauma, post-traumatic stress disorder, and substance use and its implications for health outcomes. AIDS Care. 2004;16 Suppl 1:S97-120. doi: 10.1080/09540120412301315259.
PubMed 15736824Creswell JD, Myers HF, Cole SW, Irwin MR. Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Brain Behav Immun. 2009 Feb;23(2):184-8. doi: 10.1016/j.bbi.2008.07.004. Epub 2008 Jul 19.
PubMed 18678242Gonzalez-Garcia M, Ferrer MJ, Borras X, Munoz-Moreno JA, Miranda C, Puig J, Perez-Alvarez N, Soler J, Feliu-Soler A, Clotet B, Fumaz CR. Effectiveness of Mindfulness-Based Cognitive Therapy on the Quality of Life, Emotional Status, and CD4 Cell Count of Patients Aging with HIV Infection. AIDS Behav. 2014 Apr;18(4):676-685. doi: 10.1007/s10461-013-0612-z. Epub 2013 Sep 28.
PubMed 24077971Gonzalez A, Locicero B, Mahaffey B, Fleming C, Harris J, Vujanovic AA. Internalized HIV Stigma and Mindfulness: Associations With PTSD Symptom Severity in Trauma-Exposed Adults With HIV/AIDS. Behav Modif. 2016 Jan;40(1-2):144-63. doi: 10.1177/0145445515615354. Epub 2015 Nov 19.
PubMed 26584609Hansen NB, Brown LJ, Tsatkin E, Zelgowski B, Nightingale V. Dissociative experiences during sexual behavior among a sample of adults living with HIV infection and a history of childhood sexual abuse. J Trauma Dissociation. 2012;13(3):345-60. doi: 10.1080/15299732.2011.641710.
PubMed 22545567Jam S, Imani AH, Foroughi M, SeyedAlinaghi S, Koochak HE, Mohraz M. The effects of mindfulness-based stress reduction (MBSR) program in Iranian HIV/AIDS patients: a pilot study. Acta Med Iran. 2010 Mar-Apr;48(2):101-6.
PubMed 21133002Jonas DE, Cusack K, Forneris CA, Wilkins TM, Sonis J, Middleton JC, Feltner C, Meredith D, Cavanaugh J, Brownley KA, Olmsted KR, Greenblatt A, Weil A, Gaynes BN. Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD) [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC011-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK137702/
PubMed 23658937Siyahhan Julnes P, Auh S, Krakora R, Withers K, Nora D, Matthews L, Steinbach S, Snow J, Smith B, Nath A, Morse C, Kapetanovic S. The Association Between Post-traumatic Stress Disorder and Markers of Inflammation and Immune Activation in HIV-Infected Individuals With Controlled Viremia. Psychosomatics. 2016 Jul-Aug;57(4):423-30. doi: 10.1016/j.psym.2016.02.015. Epub 2016 Mar 2.
PubMed 27095586Katz S, Nevid JS. Risk factors associated with posttraumatic stress disorder symptomatology in HIV-infected women. AIDS Patient Care STDS. 2005 Feb;19(2):110-20. doi: 10.1089/apc.2005.19.110.
PubMed 15716642Knobel H, Carmona A, Grau S, Pedro-Botet J, Diez A. Adherence and effectiveness of highly active antiretroviral therapy. Arch Intern Med. 1998 Sep 28;158(17):1953. doi: 10.1001/archinte.158.17.1953. No abstract available.
PubMed 9759698Machtinger EL, Wilson TC, Haberer JE, Weiss DS. Psychological trauma and PTSD in HIV-positive women: a meta-analysis. AIDS Behav. 2012 Nov;16(8):2091-100. doi: 10.1007/s10461-011-0127-4.
PubMed 22249954McEwen BS, Seeman T. Protective and damaging effects of mediators of stress. Elaborating and testing the concepts of allostasis and allostatic load. Ann N Y Acad Sci. 1999;896:30-47. doi: 10.1111/j.1749-6632.1999.tb08103.x.
PubMed 10681886Moreno-Alcazar A, Treen D, Valiente-Gomez A, Sio-Eroles A, Perez V, Amann BL, Radua J. Efficacy of Eye Movement Desensitization and Reprocessing in Children and Adolescent with Post-traumatic Stress Disorder: A Meta-Analysis of Randomized Controlled Trials. Front Psychol. 2017 Oct 10;8:1750. doi: 10.3389/fpsyg.2017.01750. eCollection 2017.
PubMed 29066991Mugavero M, Ostermann J, Whetten K, Leserman J, Swartz M, Stangl D, Thielman N. Barriers to antiretroviral adherence: the importance of depression, abuse, and other traumatic events. AIDS Patient Care STDS. 2006 Jun;20(6):418-28. doi: 10.1089/apc.2006.20.418.
PubMed 16789855
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Eye Movement Desensitization and Reprocessing Therapy Versus Treatment-As-Usual in a Pilot Randomized Controlled Trial in Reducing Clinical Symptoms and Biological Markers of HIV in Patients With a Recent Diagnosis of HIV
- ClinicalTrials.gov ID
- NCT03848858
- Acronym / sponsor ID
- 2018/8199/I
- Conditions
- HIV/AIDS, Psychological Trauma, PTSD
- Keywords
- HIV, Psychological Trauma, Eye Movement Desensitization and Reprocessing Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- EMDR Europe, Fundacion IMIM
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
The seropositive population are vulnerable to high rates of psychological trauma with 30-40% of people living with HIV having HIV-related trauma, and rates of up to 90% of trauma unrelated to HIV. HIV-related trauma is linked to various events such as receiving the diagnosis, the number of medical symptoms, receiving treatment, the level of perceived stigma related to HIV, and witnessing HIV-related deaths. The risk of suffering trauma related to HIV is higher in those with prior trauma and negative life event.
Trauma is known to not only have a serious impact on mental health, but also to be a key predictor of poor prognosis in HIV, affecting treatment outcomes and health-related quality of life. Trauma exposure and the development of trauma symptoms impair psychosocial functioning, increase vulnerability to stress and burden the physiological systems involved in coping and adaptation. Patients with posttraumatic symptoms show poorer treatment adherence, yet even in therapy-adherent individuals, posttraumatic symptoms are associated with immune dysregulation, leading to decreased CD4 cell count and thus negative health outcomes. Trauma-affected patients are also more likely to engage in risky health-related behaviors and to suffer higher functional impairment not explained by CD4 count variance.
Due to the negative impact of trauma in terms of psychological distress and poorer HIV outcomes, psychological interventions which specifically address trauma are needed as an adjunct to antiretroviral treatment, in order to reduce unnecessary mortality related to poor treatment adherence and to improve health-related quality of life and functionality. There is even potential for psychological interventions to impact directly on HIV disease progression. Limited evidence suggests that psychological interventions targeting trauma can have a positive impact on HIV symptom experience, while a small but promising body of research into Mindfulness-based interventions targeted at reducing stress show they may have a positive impact on the biological HIV marker CD4. Therefore, a brief yet effective psychological intervention at the point of diagnosis could have a significant impact in reducing psychological trauma and distress and improving treatment adherence and thus prognosis, and may even improve HIV disease progression.
One of the first-line treatments for trauma in non-HIV populations is Eye Movement Desensitization and Reprocessing (EMDR) therapy. EMDR is a psychotherapeutic approach developed in the late 80s by Francine Shapiro that aims to treat traumatic memories and their associated stress symptoms. This therapy consists of a standard protocol which includes eight phases and bilateral stimulation (usually horizontal saccadic eye movements) to desensitize the discomfort caused by traumatic memories and the aim of the therapy is to achieve their reprocessing and integration within the patient's standard biographical memories. EMDR therapy is recommended by the World Health Organization as a psychotherapy of choice in the treatment of PTSD, showing efficacy in children, teenagers, and adults. Recent studies show potential for EMDR as an efficacious treatment in non-PTSD patients, including in promoting treatment adherence in bipolar patients and as an add-on treatment in chronic pain conditions, as per a recent review. Therefore, EMDR would seem to be indicated as an interesting therapeutic tool in helping people successfully assimilate the HIV diagnosis and reduce psychological distress and psychological trauma symptoms, and as an adjuvant treatment to health-related quality of life and potentially treatment adherence and biological markers of the disease.
This study aims to be the first to test the efficacy of the EMDR therapy in people recently diagnosed with HIV. If shown to be efficacious in this population, it could open the way for future studies to test the efficacy of EMDR in reducing risk behaviors associated with HIV transmission and as a treatment adjunct in treatment-refractory patients.
Evaluation \& Diagnostic Protocol
In the baseline visit, sociodemographic data will be taken through a data collection notebook (CRD) and the validated Spanish versions of clinical scales, as well as scales related to health-related quality of life and functionality will be administered. At 6 months, the measures will be taken again, along with a measure regarding satisfaction of the treatment for participants in the EMDR group.
Side Effects and Follow Up
EMDR therapy is a safe and well tolerated psychological treatment. However, some may feel discomfort or suffer when the horizontal eye movements are carried out. If this occurs, bilateral stimulation will be achieved via tapping, which consists of small taps on the hands. Likewise, therapeutic work on difficult life experiences can accentuate psychological distress symptoms. The patient will be taught a variety of self-control techniques to be able to deal with the disturbing information which may arise during and between sessions. Any incident will be registered in the patient's clinical history as well as the CRD of the investigation project to later report the data.
Data Collection: Selection and Evaluation of Study Sample
Study participation is voluntary after being informed of the study objectives and having signed the informed consent document. The participants will be evaluated individually by specially trained health professionals (psychiatrists and psychologists qualified to make diagnoses). The project has been sent and approved to the Ethical Committee for Clinical Investigations in our Centre (number nº 2018/8199/I). Following the baseline evaluation, randomization will be carried out, stratified by age, sex and presence of prior trauma. Data will be collected post intervention. Motives for refusal to participate in the study will be collected to determine the presence of selection bias in the sample and the causes of non-participation.
Statistical Analysis
Calculation of Sample Size:
The study aims to evaluate the efficacy of the EMDR intervention protocol with TAU compared to TAU-only in terms of reduction of posttraumatic symptoms and psychological distress and an improvement in functionality, health-related quality of life, treatment adherence, and the biological markers of HIV of CD4 and the CD4/CD8 ratio. More specifically, the study will evaluate the efficacy of the EMDR therapy compared to treatment as usual in patients with HIV and psychological trauma in terms of clinical stabilization and improvement: reduction of associated trauma and affective symptoms, improvement of functioning, health-related quality of life and biological markers. This is a pilot study in order to get a signal whether or not this intervention is helpful with a planned sample size of 40. However, all patients meeting the inclusion criteria will be assigned to EMDR (n=20) or the TAU group (n=20) by two independent researchers using to the following algorithm: The first two patients will be randomly allocated to EMDR or TAU. For each subsequent patient, the treatment allocation will be identified, which a) balances the arm sizes if one arm has two patients more than the other arm, or otherwise b) decreases the largest effect-size of the between-arms differences in age, sex and trauma type. All steps of the randomization process will be automatically carried out in a central location using a computer program. Effect sizes will be estimated using Hedge's g, directly calculated in numeric variables and converted from odds ratios in binary variables.
Analysis of the main study variables
The distribution of the between-group socio-demographic and clinical characteristics at baseline will be analyzed using descriptive statistics. The continuous variables with a normal distribution will be analyzed with a Multivariate Analysis of Variance (MANOVA). The change in clinical and biological variables compared to baseline at strategic times during the intervention will be analyzed using an ANOVA with repeated measures including time factors, treatment conditions and their interaction. For cases which do not meet the normality premise, the Wilcoxon test will be used. The differences between groups, for the categorical and main clinical variables, will be analyzed using the Chi-squared test. Those variables which are statistically significant can be used as covariables in a logistical regression or lineal study of the factors associated with the significance of the effect, and to determine which variables are the best predictors of function. The effect size index will be estimated (Hedge's g or Pearson's r) for the correlation index of each analysis carried out. The statistical software used for all analyses will be the latest available version of SPSS (v. 24).
Analysis of Clinical Efficacy
For the main statistical analysis, the Intention to Treat (ITT) principal will be applied. The Last Observation Carried Forward (LOCF) will be used as the measure in cases of dropout.
Ethical Issues
The current Project will be carried out in accordance with the basic principles of protection of human rights and dignity as per the Helsinki Declaration and as per current legislation. The study will not begin until the Ethical Committee for Clinical Investigations (CEIC) gives approval and all information gathered will be treated confidentially, as per EU Regulation 2016/679. Patients will be informed verbally and need to sign the attached informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EMDR plus TAU | Experimental | Behavioral: EMDR plus TAU20 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). |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDR plus TAUThe 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. | Behavioural | EMDR plus TAU |
Primary outcome
Psychological trauma
Time frame: From baseline to posttreatment at 6 months
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).
8 secondary outcomes
Post-traumatic stress disorder
Time frame: From baseline to posttreatment at 6 months
Dissociative symptoms
Time frame: From baseline to posttreatment at 6 months
Anxiety
Time frame: From baseline to posttreatment at 6 months
Depression
Time frame: From baseline to posttreatment at 6 months
General psychopathology
Time frame: From baseline to posttreatment at 6 months
Perception of quality of life
Time frame: From baseline to posttreatment at 6 months
Treatment adherence
Time frame: From baseline to posttreatment at 6 months
CD4T and CD8T cells
Time frame: From baseline to posttreatment at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 25597836Brezing C, Ferrara M, Freudenreich O. The syndemic illness of HIV and trauma: implications for a trauma-informed model of care. Psychosomatics. 2015 Mar-Apr;56(2):107-18. doi: 10.1016/j.psym.2014.10.006. Epub 2014 Oct 8.
- Background: PubMed 15736824Brief DJ, Bollinger AR, Vielhauer MJ, Berger-Greenstein JA, Morgan EE, Brady SM, Buondonno LM, Keane TM; HIV/AIDS Treatment Adherence, Health Outcomes and Cost Study Group. Understanding the interface of HIV, trauma, post-traumatic stress disorder, and substance use and its implications for health outcomes. AIDS Care. 2004;16 Suppl 1:S97-120. doi: 10.1080/09540120412301315259.
- Background: PubMed 18678242Creswell JD, Myers HF, Cole SW, Irwin MR. Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Brain Behav Immun. 2009 Feb;23(2):184-8. doi: 10.1016/j.bbi.2008.07.004. Epub 2008 Jul 19.
- Background: PubMed 24077971Gonzalez-Garcia M, Ferrer MJ, Borras X, Munoz-Moreno JA, Miranda C, Puig J, Perez-Alvarez N, Soler J, Feliu-Soler A, Clotet B, Fumaz CR. Effectiveness of Mindfulness-Based Cognitive Therapy on the Quality of Life, Emotional Status, and CD4 Cell Count of Patients Aging with HIV Infection. AIDS Behav. 2014 Apr;18(4):676-685. doi: 10.1007/s10461-013-0612-z. Epub 2013 Sep 28.
- Background: PubMed 26584609Gonzalez A, Locicero B, Mahaffey B, Fleming C, Harris J, Vujanovic AA. Internalized HIV Stigma and Mindfulness: Associations With PTSD Symptom Severity in Trauma-Exposed Adults With HIV/AIDS. Behav Modif. 2016 Jan;40(1-2):144-63. doi: 10.1177/0145445515615354. Epub 2015 Nov 19.
- Background: PubMed 22545567Hansen NB, Brown LJ, Tsatkin E, Zelgowski B, Nightingale V. Dissociative experiences during sexual behavior among a sample of adults living with HIV infection and a history of childhood sexual abuse. J Trauma Dissociation. 2012;13(3):345-60. doi: 10.1080/15299732.2011.641710.
- Background: PubMed 21133002Jam S, Imani AH, Foroughi M, SeyedAlinaghi S, Koochak HE, Mohraz M. The effects of mindfulness-based stress reduction (MBSR) program in Iranian HIV/AIDS patients: a pilot study. Acta Med Iran. 2010 Mar-Apr;48(2):101-6.
- Background: PubMed 23658937Jonas DE, Cusack K, Forneris CA, Wilkins TM, Sonis J, Middleton JC, Feltner C, Meredith D, Cavanaugh J, Brownley KA, Olmsted KR, Greenblatt A, Weil A, Gaynes BN. Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD) [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC011-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK137702/
- Background: PubMed 27095586Siyahhan Julnes P, Auh S, Krakora R, Withers K, Nora D, Matthews L, Steinbach S, Snow J, Smith B, Nath A, Morse C, Kapetanovic S. The Association Between Post-traumatic Stress Disorder and Markers of Inflammation and Immune Activation in HIV-Infected Individuals With Controlled Viremia. Psychosomatics. 2016 Jul-Aug;57(4):423-30. doi: 10.1016/j.psym.2016.02.015. Epub 2016 Mar 2.
- Background: PubMed 15716642Katz S, Nevid JS. Risk factors associated with posttraumatic stress disorder symptomatology in HIV-infected women. AIDS Patient Care STDS. 2005 Feb;19(2):110-20. doi: 10.1089/apc.2005.19.110.
- Background: PubMed 9759698Knobel H, Carmona A, Grau S, Pedro-Botet J, Diez A. Adherence and effectiveness of highly active antiretroviral therapy. Arch Intern Med. 1998 Sep 28;158(17):1953. doi: 10.1001/archinte.158.17.1953. No abstract available.
- Background: PubMed 22249954Machtinger EL, Wilson TC, Haberer JE, Weiss DS. Psychological trauma and PTSD in HIV-positive women: a meta-analysis. AIDS Behav. 2012 Nov;16(8):2091-100. doi: 10.1007/s10461-011-0127-4.
- Individual participant dataSharing planned: No. Currently there are no plans.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benedikt L Amann, PhD principal investigator
Parc de Salut Mar; Fundación IMIM; Universitat Autónoma de Barcelona; CIBERSAM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR plus TAU in people with HIV/AIDS and Psychological Trauma, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological trauma (time frame: From baseline to posttreatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03848858, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.