Efficacy of EMDR Therapy, as Compared to Treatment as Usual, in Reducing Clinical Symptoms in People With HIV
Condition: HIV/AIDS; Psychological Trauma; PTSD
MeSH terms: Psychological Trauma
Study type: Interventional

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 within the last month. 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 recent 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.
    

Intervention name(s): EMDR plus TAU
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; Psychological Trauma; Eye Movement Desensitization and Reprocessing Therapy