Predictors and Process Moderators of EMDR Therapy for Depressive Symptoms

NCT ID: NCT07033741

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Depression, Anxiety; Post-traumatic Stress Symptoms; Dissociation; Psychotherapy Research and Outcome Measures

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

EMDR Therapy Group

Participants receive Eye Movement Desensitization and Reprocessing (EMDR) therapy in accordance with standardized clinical protocol. The assessment of clinically significant symptoms will be conducted using validated screening tools and diagnostic measures aligned with the study 's objectives. The initial session (Timepoint 0a \[T0a\]) will consist of a thorough baseline evaluation, in which participants will fill out a set of baseline self-report questionnaires. A second baseline assessment (T0b) will take place after the completion of four therapy sessions, focusing on changes in emotional regulation, personal beliefs, attachment style, and the processing of traumatic memories. Both the patient and therapist will evaluate the therapeutic alliance at T0b, offering insights into the evolving dynamics of the therapeutic process. After baseline assessments (T0a and T0b), additional assessments will occur at six (T6), twelve (T12), with a maximum follow-up period of eighteen months (T18).

EMDR

Intervention Type: BEHAVIORAL

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: ensuring patient's stability at the end of the session, and (8) revaluation: assessing effectiveness of the session and future planning.

Interventions

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: ensuring patient's stability at the end of the session, and (8) revaluation: assessing effectiveness of the session and future planning.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• certified members of the Italian Eye Movement Desensitization and Reprocessing (EMDR) Association
• 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

• inability or unwillingness to comply with study protocols or schedules Patient
• history of psychotic symptoms or schizophrenia
• dementia
• severe personality disorders
• a serious, unstable medical condition
• acute suicidality that needs hospitalization.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

luca ostacoli

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Turin

Turin, Turin, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesca Cotardo, Psychologist, PhD Student

Role: CONTACT

francesca.cotardo@unito.it

+39 3293826487

Facility Contacts

Luca Ostacoli, Full Professor

Role: primary

luca.ostacoli@unito.it

+39 3351772575

Francesca Cotardo, Psychologist, PhD Student

Role: backup

francesca.cotardo@unito.it

+39 3293826487

Other Identifiers

PROCESS-EMDR/0565145

Identifier Type: -

Identifier Source: org_study_id