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A Rater-blinded RCT to Compare Effectiveness of EMDR vs TAU in Patients With First Episode Psychosis and History of Psychological Trauma

Sponsor
Parc de Salut Mar (Other)
Overall Status
Recruiting
CT.gov ID
NCT03991377
Collaborator
Consorci Hospitalari de Vic (Other), Hospital Mutua de Terrassa (Other), Althaia Xarxa Assistencial Universitària de Manresa (Other)
71
Enrollment
1
Location
2
Arms
44.2
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of this project is to analyze whether EMDR therapy, as an adjuvant to usual treatment, is effective in reducing post-traumatic stress and psychotic/affective symptoms in patients with a FEP and comorbid psychological trauma associated with first hospital admission and / or previous stressful life event.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Eye movement desensitization and reprocessing therapy
  • Drug: Treatment as usual
 N/A

Detailed Description

Background: The experience of psychosis and hospitalization may be highly distressing. In fact, a significant proportion of FEP patients show posttraumatic stress symptoms during their recovery, which has been conceptualized as a posttraumatic postpsychotic syndrome (PPS). Moreover, the prevalence of childhood trauma in psychotic patients is four times higher than in general population. It is currently recognized the clinical implications of trauma in psychosis, as well as the need for treatment. Eye Movement Desensitization and Reprocessing (EMDR) therapy is a well stablished trauma treatment. EMDR is an eight- phase treatment protocol that includes bilateral stimulation to desensitize the discomfort caused by traumatic memories. Initial evidence suggests that EMDR is safe, well tolerated and beneficial in chronic patients with severe mental illness and comorbid psychological trauma.

Objectives: To assess if EMDR therapy leads to: 1) reduce post-traumatic stress symptoms; 2) reduce positive, negative and affective symptoms; 3) improve overall functioning; and 4) improve quality of life.

The hypothesis of this trial is that subjects of the EMDR group will experience an overall clinical improvement after therapy and will suffer from less admissions and relapses at 12 months of follow-up.

Design:

This is a multicenter phase II rater-blinded randomized controlled trial in which 80 FEP patients and psychological trauma will be randomly assigned to EMDR (n=40) or to TAU (n=40). Patients in the EMDR condition will receive up to 20 psychotherapeutic sessions of 60 minutes,

Clinical and diagnostic variables:

  1. Traumatic events will be measured by Global Assessment of Posttraumatic Stress Questionnaire, Cumulative Trauma Screening, the Impact of Event Scale-Revised, the Dissociative Experiences Scale, Childhood Trauma Questionnaire, The Holmes-Rahe Life Stress Inventory and the Dissociative Experiences Questionnaire.

  2. Clinical symptomatology will be assessed by using:

  • Suicide and Drug Consumption module of the International Neuropsychiatric Interview

  • Structured Clinical Interview for Positive and Negative Syndrome Scale

  • Young's Scale for Mania Evaluation

  • Beck Depression II Questionnaire.

  1. Functionality will be assessed with the Global Assessment of Functioning questionnaire.

  2. Cognitive insight and adherence to the treatment will be measured using the Beck Cognitive Insight Scale and the Drug Attitude Inventory.

  3. Quality of Life will be assessed with the Standardized Instrument developed by the EuroQol Group.

All variables will be measured at baseline, post-treatment and 12 months of follow-up.

Randomization procedure All patients meeting the inclusion criteria will receive the baseline (T0) assessment. After T0, participants will be assigned to the EMDR or TAU group following a biased coin procedure: (1) the first two patients will be randomly allocated to EMDR with p = 0.5, (2) the next patient will be allocated as follows: (b1) if one group already includes at least two more patients than the other group, the patient will be randomly allocated to EMDR with p = 0.8 is this is the smallest group and with p = 0.2 if it is the largest group, (b2) otherwise, we will first simulate that the patient is allocated to EMDR and calculate the sum of the between-group square standardized differences in site, age, sex, diagnosis and before the clinical trial between groups, we will then simulate that the patient is allocated to TAU and recalculate the sum, and finally randomly allocate the patient to EMDR with p = 0.8 if this was associated to the smallest sum and with p = 0.2 if not. For example, if we had already included 10 patients to the EMDR group and 8 patients to the TAU group, the 19th patient would be randomly allocated with p = 0.2 for EMDR and p = 0.8 for TAU. If he/she was allocated to TAU, for the 20th patient we would calculate the above sum of covariates after simulating that the he/she is allocated to EMDR and after simulating that he/she is allocated to TAU, and if the sum of the EMDR simulation was larger than the sum of the TAU simulation, we would randomly allocate the 20th patient with p = 0.2 for EMDR and p = 0.8 for TAU. Following this procedure, the final groups should be balanced in size and matched in site, age, sex and diagnosis. All steps of the randomization process will be automatically carried out by an independent researcher in a central location using a computer program.

Computation of sample size The study aims to assess the relative efficacy of an EMDR intervention protocol for patients with PEP versus TAU mainly in stabilization and clinical improvement - reduction of anxious, depressive, somatic and/or psychotic symptoms, among others. For this reason, the main variable used is the number of clinical relapses after the intervention, with a follow-up of up to 12 months. Taking into account previous studies, the calculation of the sample size has been calculated based on a survival analysis with the statistical package "powerSurvEpi" for R, using an alpha = 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 alpha = 0.005 is n = 36 per intervention group (two groups, total n = 72). According to Chambless and Hollon, a sample of this size should show clinically relevant differences. Assuming a loss percentage of approximately 10-15% of the patients in the study, it would be necessary to recruit approximately 80 patients, 40 for each branch of intervention.

Statistical analysis:
Dropouts and follow-up:

If a participant requires an inpatient stay due to an acute episode of a psychotic disorder during the 6-month intervention period, the patient will be excluded from the trial and considered as dropout because the hospital admission will mean the patient cannot continue with the EMDR psychotherapy during the acute phase. In the case of relapse during follow-up, patients will be maintained in the trial to obtain maximum information on the course of the illness.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a multicenter phase II rater-blinded randomized controlled trial with two parallel branches, EMDR + TAU and TAU, of 80 FEP patients who have a history of psychological trauma, even if they do not currently meet DSM-V criteria for PTSD.This is a multicenter phase II rater-blinded randomized controlled trial with two parallel branches, EMDR + TAU and TAU, of 80 FEP patients who have a history of psychological trauma, even if they do not currently meet DSM-V criteria for PTSD.
Masking:
Single (Outcomes Assessor)
Masking Description:
Clinical raters carrying out evaluations will be blind to the participants' research condition. Patients will not be blind to treatment as a sham alternative to EMDR therapy is impossible due to its use of bilateral stimulation.
Primary Purpose:
Treatment
Official Title:
A Multicenter Phase II Rater-blinded Randomized Controlled Trial (RCT) to Compare Effectiveness of Eye Movement Desensitization Reprocessing Therapy (EMDR) vs Treatment as Usual (TAU) in First Episode Psychosis and History of Trauma.
Actual Study Start Date :
Apr 25, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: EMDR therapy

Patients in the psychotherapy intervention will receive up to 20 individual sessions of EMDR, weekly sessions, of 60 minutes each, using the standard EMDR therapy protocol developed by Shapiro to treat both current and past trauma-related symptom.

Behavioral: Eye movement desensitization and reprocessing therapy
EMDR is an integrative psychotherapy that uses standardized protocols and elements of cognitive-behavioral, interpersonal, and body-centered therapies, as well as dual stimulation (e.g., side-to-side eye movements). The current standard protocol includes eight phases: Patient history. Patient preparation. Patient assessment. Memory desensitization. Installing the positive cognition. Body scan. Closure. Reevaluation.
Other Names:
  • EMDR

    • Drug: Treatment as usual
    Once patients are discharged from hospital, they will be treated by the multidisciplinary team of the Specialized Early Intervention Programme for Incipient Psychosis (PAE-TPI) as part of their usual treatment, which consists of a multidisciplinary approach that includes pharmacological treatment and psychological support, from social workers or nursing staff. An individual care plan is drawn up depending on individual needs and may include follow-up psychiatric visits to evaluate clinical status and, if necessary, readjust pharmacological treatment, and psychological visits to assess and detect risk situations and prevent relapses using a non-trauma focused CBT. In no case will psychological treatment focus on PTSD.
    Other Names:
  • TAU

    		•
    Active Comparator: Treatment as usual

    Multidisciplinary approach that includes pharmacological treatment and psychological support.

    Drug: Treatment as usual
    Once patients are discharged from hospital, they will be treated by the multidisciplinary team of the Specialized Early Intervention Programme for Incipient Psychosis (PAE-TPI) as part of their usual treatment, which consists of a multidisciplinary approach that includes pharmacological treatment and psychological support, from social workers or nursing staff. An individual care plan is drawn up depending on individual needs and may include follow-up psychiatric visits to evaluate clinical status and, if necessary, readjust pharmacological treatment, and psychological visits to assess and detect risk situations and prevent relapses using a non-trauma focused CBT. In no case will psychological treatment focus on PTSD.
    Other Names:
  • TAU

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reduction of the severity of trauma-related symptoms [Change from baseline to visits at 6 and 12 months]

      To measure severity and changes in trauma-related symptoms with the Impact of Event Scale - Revised. Items are rated on a 5-point Likert scale ranging from 0 and 4, yielding a total score ranging from 0 to 88.

    Secondary Outcome Measures

    1. Making a PTSD diagnosis [Change from baseline to visits at 6 and 12 months]

      To diagnose PTSD with the Global Assessment of Posttraumatic Stress Questionnaire. Higher scores indicate more severity in trauma-related symptoms.

    2. Detection of dissociative symptoms [Change from baseline to visits at 6 and 12 months]

      To assess dissociative symptoms with the Dissociative Experiences Scale. An overall mean score ranging from 0 to 100. The higher score, the higher the severity of the dissociative symptoms.

    3. Detection of Childhood life traumatic events [Childhood period. It is administered only during the baseline visit.]

      To assess life events with the Childhood Trauma Questionnaire. A 5-point Likert scale is used, ranging from "Never True" to "Very Often True".

    4. Detection of traumatic events in the last year [The last year. It is administered only during the baseline visit.]

      To assess events with The Holmes-Rahe Life Stress Inventory. Scores below 150 reflect low levels of stress, scores between 150 and 299 represent a 50% risk of a stress-related illness in the near future and scores above 300 represent an 80% risk.

    5. Reduction of positive psychotic symptoms [Change from baseline to visits at 6 and 12 months]

      To measure changes in the Positive and Negative Syndrome Scale (PANSS) . It ranges from 7 to 49: the higher the score, the worse the positive psychotic symptoms.

    6. Reduction in depressive symptoms [Change from baseline to visits at 6 and 12 months]

      To measure changes in the Beck Depression II Questionnaire. Total scores range from 0 to 52: the higher the score, the worse the depressive symptoms.

    7. Reduction of (hypo) manic symptoms [Change from baseline to visits at 6 and 12 months]

      To measure changes in the Young Mania Rating Scale. It ranges from 0 to 130: the higher the score, the worse the manic symptoms.

    8. Improvement of global functioning [Change from baseline to visits at 6 and 12 months]

      To measure changes with the Global Assessment of Functioning Scale. The global score ranges from 0 to 100. The higher the score, the higher the functional status.

    9. Improving of the quality of life associated with health [Change from baseline to visits at 6 and 12 months]

      To measure changes with the Standardized Instrument for Evaluating Quality of Life Associated with Health.The global score ranging from 0 to 100. The lower scores indicate poorer awareness of the quality of life associated with health.

    10. Improving awareness of having a mental disorder and of their need for treatment [Change from baseline to visits at 6 and 12 months]

      To measure changes in the with the Beck Cognitive Insight Scale. The total score ranging from 0 to 45. The higher score on the scale, the lower severity of negative symptomatology.

    11. Improving adherence to pharmacological treatment [Change from baseline to visits at 6 and 12 months]

      To measure changes in the attitude towards medication with the Drug Attitude Inventory. The total score can oscillate between 10 and 20. The higher the score, the more positive the perceived effect of the medication.

    12. Reducing in the number of relapses [Change from baseline to visits at 6 and 12 months]

      To measure relapses with the register of the number hospital admissions and/or emergency visits

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age ≥16 years old

    • presence of one or more traumatic events, causing symptoms associated with the trauma (Impact of Event Scale-Revised >0 and Subjective Units of Distress >5), but it is not necessary that traumatic events meet DSM-5 criteria for PTSD

    • psychotic symptoms/psychiatric hospitalization will be considered a traumatic event when the criteria for a trauma-related disorder or stress factors according to DSM-V (Post-Traumatic Stress Disorder, Acute Stress Disorder, and Other Trauma-related Disorder and unspecified stress factors) are also met

    • ability to read and write in Spanish.

    Exclusion Criteria:

    • suicidal risk, to be operated on the basis of: suicide risk scale - suicidal risk module scale MINI≥ 1 or suicide attempt in the last six months

    • presence of organic brain diseases

    • have received trauma-focused therapy in the past 2 years.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Parc de Salut Mar Barcelona Spain 08003

    Sponsors and Collaborators

    • Parc de Salut Mar
    • Consorci Hospitalari de Vic
    • Hospital Mutua de Terrassa
    • Althaia Xarxa Assistencial Universitària de Manresa

    Investigators

    • Principal Investigator: BENEDIKT L AMANN, PhD, Parc de Salut Mar

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Parc de Salut Mar
    ClinicalTrials.gov Identifier:
    NCT03991377
    Other Study ID Numbers:
    • PI18/00009
    First Posted:
    Jun 19, 2019
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Parc de Salut Mar
    First psychotic episode, psychological trauma, EMDR therapy, Treatment as usual
    Additional relevant MeSH terms:
    Wounds and Injuries
    Psychotic Disorders
    Mental Disorders
    Psychological Trauma

    Study Results

    No Results Posted as of Mar 31, 2022