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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

NCT03991377 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-02-23

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Consorci Hospitalari de Vic

    collaborator OTHER

  • Hospital Mutua de Terrassa

    collaborator OTHER

  • Althaia Xarxa Assistencial Universitària de Manresa

    collaborator OTHER

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • BENEDIKT L AMANN, PhD · Parc de Salut Mar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991377 on ClinicalTrials.gov