Predictors and Process Moderators of EMDR Therapy for Depressive Symptoms

Official title

Predictors and Process Moderators of EMDR Therapy for Depressive Symptoms: Protocol for a Real-world Prospective Observational Study

Overview

The goal of this clinical trial is to evaluate which factors influence the effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) therapy for depressive symptoms in real-world settings in Italy. The main questions the study seeks to answer are: * Which key factors influence EMDR outcomes in terms of mediators, moderators, and predictors of its effectiveness for depressive symptoms? * Do lower levels of individual psychological functioning at baseline, including high co-occurrence of personality domains and pathogenic personal beliefs, predict the effects of EMDR in treating depressive symptoms? * Are baseline psychological comorbidities (anxiety, dissociation, post-traumatic symptoms, emotional dysregulation, and sleep difficulties) and the quality of the therapeutic alliance related to the effectiveness of EMDR therapy for depressive symptoms? Participants will be both therapists and patients. * Eligible therapists must be certified members of the EMDR Italian National Association to ensure adherence to established standards in the practice of EMDR therapy and consistency in therapeutic delivery. Therapists will identify patients from their routine clinical practice who meet the study inclusion criteria and facilitate their enrollment. * Eligible patients must meet the following criteria: 1. Being 18 years of age or older. 2. being able to give informed consent. 3. presenting clinically significant symptoms in at least one of the following domains: anxiety, depression, dissociative, or post-traumatic stress symptoms. Individuals presenting with severe neurological impairment or other severe psychiatric conditions were excluded. Researchers will combine data from multiple N-of-1 trials (N-of-1 or single-subject clinical trials studies) using a Bayesian multilevel random-effects meta-analysis and meta-regression to generate robust estimates of treatment efficacy.

Interventions

• Behavioral EMDR
  The EMDR process follows an eight-phase protocol that includes (1) history taking: gathering patient's background information and planning treatment, (2) preparation: preparing the patient for processing target, (3) assessment: accessing target of the traumatic memories, (4) desensitization: processing target memories using dual task , (5) installation: strengthening the alternative positive cognition, (6) body scan: noting any physical sensations related to the target memory, (7) closure: ensur

Primary outcome measures

• Monitoring depressive symptoms [Time frame: Baseline, during the intervention, 6 months, 12 months, through study completion (an average of 18 months)]
• Depressive symptoms [Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 month)]

Secondary outcome measures (10)

• Personal beliefs [Time frame: Baseline, at study completion (an average of 18 month)]
• Personality domains [Time frame: Baseline, at study completion (an average of 18 month)]
• Anxiety symptoms [Time frame: Baseline, during the intervention, 6 months, 12 months, at study completion (an average of 18 month)]
• Dissociative symptoms [Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 months)]
• Assessing dissociative phenomena [Time frame: At second baseline timepoint (after four therapy sessions), after six months from the first baseline assessment, after twelve months from the first baseline assessment, and at end of data collection (after eighteen month)]
• Therapeutic progress and outcomes for individuals [Time frame: Baseline, 6 months, 12 months, through study completion (an average of 18 months)]
• Post-traumatic Stress symptoms [Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 month)]
• Emotion regulation [Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 months)]
• Quality of sleep [Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 month)]
• Therapeutic alliance [Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 months)]

Eligibility criteria

Participants:

Therapist

• Inclusion Criteria:
• certified members of the Italian Eye Movement Desensitization and Reprocessing (EMDR) Association
• Exclusion Criteria:
• inability or unwillingness to comply with study protocols or schedules Patient
• Inclusion Criteria:
• age 18 years or older
• capacity of providing informed consent
• presenting with clinically significant symptoms in at least one of the following domains: anxiety, depression, post-traumatic stress symptoms, or dissociative symptoms.
• Exclusion Criteria:
• history of psychotic symptoms or schizophrenia
• dementia
• severe personality disorders
• a serious, unstable medical condition
• acute suicidality that needs hospitalization.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-only

Study locations

Italy · 1 center

• University of Turin — Turin

Publications

• Cotardo F, Koumantakis E, Rossini PG, Malandrone F, Berchialla P, Ostacoli L, Carletto S. Predictors and process moderators of EMDR therapy for depressive symptoms: protocol for a series of observational N-of-1 trials. Front Psychol. 2026 Jan 6;16:1688526. doi: 10.3389/fpsyg.2025.1688526. eCollection 2025. PMID 41567443

Identifiers

NCT: NCT07033741 · PROCESS-EMDR/0565145

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗