Predictors and Process Moderators of EMDR Therapy for Depressive Symptoms

NCT07033741 | Recruiting

• 1 other identifier: PROCESS-EMDR/0565145
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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:
• Being 18 years of age or older.
• being able to give informed consent.
• presenting clinically significant symptoms in at least one of the following domains: anxiety, depression, dissociative, or post-traumatic stress symptoms.

Conditions

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

Keywords

Eye Movement Desensitization and Reprocessing; depressive symptoms; predictors; moderators; psychotherapy; study protocol

Outcome Measures

Primary Outcomes (2)

• Monitoring depressive symptoms

  The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool used to measure depressive symptoms. Participants rate the frequency of symptoms over the previous 2-week period on a scale from 0 ("not at all") to 3 ("nearly every day"), with total scores indicating no symptoms (0-5 points), mild symptoms (6-10 points), moderate symptoms (11-15 points), or severe symptoms (greater than 15 points).

  Baseline, during the intervention, 6 months, 12 months, through study completion (an average of 18 months)

• Depressive symptoms

  The Beck Depression Inventory (BDI-II) is a 21-item self-report instrument that assesses the severity of depressive symptoms based on DSM-IV criteria. The total score ranges from 0 to 63, with higher scores indicating greater levels of depression. A score above 13 is considered the cut-off for depressive symptoms (14-19: mild depression; 20-28: moderate depression; ≥29: severe depression).

  Baseline, 6 months, 12 months, at study completion (an average of 18 month)

Secondary Outcomes (10)

• Personal beliefs

  Baseline, at study completion (an average of 18 month)

• Personality domains

  Baseline, at study completion (an average of 18 month)

• Anxiety symptoms

  Baseline, during the intervention, 6 months, 12 months, at study completion (an average of 18 month)

• Dissociative symptoms

  Baseline, 6 months, 12 months, at study completion (an average of 18 months)

• Assessing dissociative phenomena

  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)

Other Outcomes (6)

• Exposure to traumatic or stressful life events

  Baseline

• Compassion

  Baseline, during the intervention, 6 months, 12 months, at study completion (an average of 18 months)

• Experience of Mindfulness

  Baseline, 6 months, 12 months, at study completion (an average of 18 months)

Study Arms (1)

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).

Behavioral: EMDR

Interventions

EMDR 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.

EMDR Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include members of the Italian National EMDR Association who are in private practice. Each therapist will select one of their patients to participate in the study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

University of Turin

Turin, Turin, 10123, Italy

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Dissociative Disorders

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Francesca Cotardo, Psychologist, PhD Student

CONTACT

+39 3293826487; francesca.cotardo@unito.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 24, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

IT (1)