EMDR in Psychiatric Inpatients With Severe Mental Disorder
Condition: Severe Mental Disorder; Psychological Trauma
MeSH terms: Wounds and Injuries; Mental Disorders; Psychotic Disorders; Psychological Trauma
Study type: Interventional

Summary: 
      The study of psychological trauma has become increasingly important in the field of mental
      health research due to the strong negative impact it has on the course and prognosis of
      psychiatric pathologies. However, from a clinical point of view it is still an overlooked and
      even ignored component. There is scientific evidence that treating traumatic events at
      outpatient hospital services in patients with severe mental disorder improves both
      trauma-related symptoms and clinical symptoms. 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 and
      which has obtained promising first results in patients with severe mental disorder. This
      project proposes to test whether EMDR therapy in addition to standard treatment is more
      effective than standard treatment alone in psychiatric in-patients with severe mental
      disorder, in terms of reducing symptoms related to psychopathology and trauma, and in terms
      of improving functioning. Our first hypothesis is that EMDR will be more effective than
      standard treatment alone in reducing the severity of psychiatric symptoms. Our second
      hypothesis is that EMDR will be more effective than standard treatment alone in reducing the
      severity of trauma-related symptoms. Our third hypothesis is that EMDR will be more effective
      than standard treatment alone in improving functioning.
    

Detailed description: 
      Background

      Severe mental disorders (SMD) are a group of diverse conditions which principally affect
      perception, cognition, emotion and behavioural control (Hyman et al. 2016). SMD has a
      significant health impact worldwide, both in economic terms as well as in mortality rate due
      to suicide or associated medical illnesses (Charlson et al. 2016), due to its high
      prevalence, frequent early age of onset, and its clinical course (usually chronic or with
      temporary improvements followed by relapse), and the cognitive deterioration of important
      mental capabilities.

      The results of the different meta-analyses have shown that suffering adverse events in
      infancy significantly increases the risk of developing SMD in adult life (Bortolato et al.,
      2017; Palmier-Claus, Berry, Bucci, Mansell, & Varese, 2016). What is more, it is important to
      take into account that the presence of this comorbidity has important clinical implications,
      such as an increase in suicides, greater severity of symptoms, an increase in risky sexual
      behaviours, more hospital admissions, a worse disease course and a greater risk of being
      retraumatized (Rosenberg et al. 2007; Ford et al. 2007; Oquendo et al. 2005). However, at
      clinical level it is still an element which receives very little focus and may interfere in
      the correct evolution of the disease (Mauritz et al. 2013).

      Two recently published studies in the severe psychiatric population have shown that the
      specific treatment of trauma improves in all cases the symptoms related to it in patients
      diagnoses with schizophrenia (van den Berg et al. 2015) and bipolar disorder (Novo et al.
      2014), as well as showing an improvement in other clinical symptoms such as psychotic
      symptoms, paranoid ideation and hallucinations in the case of schizophrenia, and
      sub-syndromic symptoms in the case of bipolar disorder. In both studies, the intervention
      strategy used to treat traumatic events was EMDR (Eye Movement Desensitization and
      Reprocessing), a psychotherapeutic approach whose use in recent years has grown exponentially
      in clinical practice due to its great efficacy and safety, as well as being recommended by
      the World Health Organisation (WHO) and the American Psychiatric Association (APA) as a first
      line treatment for Post-traumatic Stress Disorder (PTSD) (Shapiro, 2014). It was developed at
      the beginning of the nineties by the North American psychologist Francine Shapiro to treat
      the consequences of psychological trauma. EMDR is an 8-phase psychological treatment composed
      of protocols and standardized procedures applicable to both adults and children. The eight
      phases (patient history, patient preparation, evaluation of the main aspects of the memory,
      desensitization of the traumatic memory, installation of the positive cognition, body scan,
      close and re-evaluation) and the protocol of the time line of past-present-future, allow a
      holistic evaluation of the image of the traumatic memory, and allow for the patient to be
      well-prepared before processing past events which underlie current pathology, current
      situations which cause perturbation, and challenges and possible future stimuli which might
      lead to the appearance of symptoms (Shapiro, 2014). The distinctive feature of this technique
      is the incorporation of bilateral stimulation, in the majority of cases through horizontal
      saccadic eye movements, into the combination of different theoretical and practical
      psychological orientations, in order to desensitize the suffering cause by traumatic memories
      and, as a consequence, achieve the reprocessing and the integration of these memories into
      the normalized biographic memories of the patient (Shapiro 2001). One of the main advantages
      of EMDR is that all protocols, both the standard and more specific ones, are standardized and
      scientifically validated both for clinical use and scientific scrutiny (Novo et al. 2016).

      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, neuropsychological and trauma-related
      scales will be administered. Prior to discharge from the unit, the measures will be taken
      again, along with a measure regarding satisfaction of the treatment. Finally, all measures
      will be repeated at 6 and 12 months post-discharge as follow-up.

      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 to the Ethical Committee for Clinical Investigations in
      Parc de Salut Mar for approval. Following the baseline evaluation, randomization will be
      carried out, stratified by age, sex and presence of prior trauma. Data will be collected
      after the EMDR sessions are finished, and participants will be contacted again at 6 months
      and 12 months follow up. 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 principally of clinical stabilization and
      improvement - a reduction in psychotic, anxiety, depressive and somatic symptoms amongst
      others. For this reason, the main variable will be the number of clinical relapses following
      the intervention, with a 12 month follow-up. Taking previous studies into account (Meyer &
      Hautzinger, 2012), the calculation of the size of the sample has been calculated based on a
      survival analysis with the statistical package "powerSurvEpi" for R
      (http://www.r-project.org) using an alpha of 0.005 instead of 0.05 to allow correction for
      multiple comparisons. The number of patients required to detect a hazard ratio = 2 in a Cox
      regression with a statistical power of 80% and an alpha of 0.005 is n=36 per intervention
      group (two groups: total n = 72). According to Chambless & Hollon (NO REFERENCE), a sample of
      this size should show clinically relevant differences. Assuming a dropout percentage of
      approximately 10-15% in trial patients, it will be necessary to recruit approximately 132
      patients, 66 for each intervention condition.

      Analysis of the main study variables The distribution of the between-group socio-demographic
      and clinical characteristics at baseline will be analysed using descriptive statistics. The
      continuous variables with a normal distribution will be analysed 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 analysed 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 analysed using the
      Chi-squared test. Those variables which are statistically significant can be used as
      covariables in a logistic or linear regression of the factors associated with the effect
      size, 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 Law 14/2007 of Biomedical Investigation (LIB) will be followed for the biological
      samples. 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
      constitutional law 15/1999, 13th December. Patients will be informed verbally and need to
      sign the attached informed consent.

      Study limitations The fact that pharmacological treatment is not controlled for is a
      potential source of bias. To partially counteract this limitation, in the statistical
      analysis of the results the variable of pharmacological treatment will be taken into account.

      Implications

      The growing scientific interest in recent years regarding the impact of the presence of
      psychological trauma in the course and prognosis of mental disorders has demonstrated the
      great need to treat this risk factor from a clinical viewpoint, given the important negative
      consequences it means for patients. For this reason, and given the limited interest currently
      shown by the majority of mental health professionals, the investigators believe that proving
      the efficacy of implementing a trauma-focused treatment in an in-patient psychiatric setting
      is an innovative and pioneering proposal which can bring benefits not only to patients with
      psychotic symptoms, but also to the public health system through being cost-effective. This
      study has the potential to demonstrate the usefulness and the benefits of treating
      psychological trauma in psychiatric in-patients with clinical symptoms in a safe and
      effective way.
    

Intervention name(s): Eye Movement Desensitization and Reprocessing (EMDR) Therapy
Intervention type(s): Behavioral
Intervention description(s): EMDR is an 8-phase psychological treatment composed of protocols and standardized procedures applicable to both adults and children. The eight phases (patient history, patient preparation, evaluation of the main aspects of the memory, desensitization of the traumatic memory, installation of the positive cognition, body scan, close and re-evaluation) and the protocol of the time line of past-present-future, allow a holistic evaluation of the image of the traumatic memory, and allow for the patient to be well-prepared before processing past events which underlie current pathology, current situations which cause perturbation, and challenges and possible future stimuli which might lead to the appearance of symptoms. (Shapiro, 2014)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The project will be carried out in the sub-acute and long-stay inpatient wards of Parc de Salut Mar, Institute of Neuropsychiatry and Addiction (INAD), located in the Centre Forum. It consists of a single-blind RCT with two parallel branches, 1) individual therapy with EMDR and TAU, and 2) TAU only, with patients matched by age, sex, psychiatric diagnosis and premorbid IQ. Once the patient has been stabilized with psychotropic medication and has begun taking part in the psychosocial activities proposed by the unit, they will be offered the chance to receive 25 individual EMDR therapy sessions, each lasting 60 minutes. The patients will be evaluated at the beginning of their hospital stay, again when discharged from the unit and then at 6 and 12 month follow up.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe Mental Disorder; Psychological Trauma; Eye Movement Desensitization and Reprocessing Therapy