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

NCT03991377 | Active Not Recruiting

• 1 other identifier: PI18/00009
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Episode; Psychological Trauma

Keywords

First psychotic episode, psychological trauma, EMDR therapy, Treatment as usual

Outcome Measures

Primary Outcomes (1)

• Reduction of the severity of trauma-related symptoms

  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.

  Change from baseline to visits at 6 and 12 months

Secondary Outcomes (12)

• Making a PTSD diagnosis

  Change from baseline to visits at 6 and 12 months

• Detection of dissociative symptoms

  Change from baseline to visits at 6 and 12 months

• Detection of Childhood life traumatic events

  Childhood period. It is administered only during the baseline visit.

• Detection of traumatic events in the last year

  The last year. It is administered only during the baseline visit.

• Reduction of positive psychotic symptoms

  Change from baseline to visits at 6 and 12 months

Study Arms (2)

EMDR therapy

EXPERIMENTAL

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; Drug: Treatment as usual

Treatment as usual

ACTIVE COMPARATOR

Multidisciplinary approach that includes pharmacological treatment and psychological support.

Drug: Treatment as usual

Interventions

Eye movement desensitization and reprocessing therapy BEHAVIORAL

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: 1. Patient history. 2. Patient preparation. 3. Patient assessment. 4. Memory desensitization. 5. Installing the positive cognition. 6. Body scan. 7. Closure. 8. Reevaluation.

Also known as: EMDR

EMDR therapy

Treatment as usual DRUG

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.

Also known as: TAU

EMDR therapy; Treatment as usual

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• current suicidal risk
• presence of organic brain diseases
• have received trauma-focused therapy in the past 2 years.

Sponsors & Collaborators

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

Study Sites (1)

Parc de Salut Mar

Barcelona, 08003, Spain

Location

Related Publications (61)

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  PMID: 32116827 DERIVED

MeSH Terms

Conditions

Psychological Trauma

Interventions

Eye Movement Desensitization Reprocessing; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• BENEDIKT L AMANN, PhD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: June 19, 2019
• Study Start: April 25, 2019
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

ES (1)