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Depression, AnxietyPROCESS-EMDRNCT07033741

Predictors and Process Moderators of EMDR Therapy for Depressive Symptoms

An observational study of Depression, Anxiety and Post-traumatic Stress Symptoms, run by University of Turin, Italy at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
EMDR
How many people
40 participants
Where
1 siteItaly
Study dates
8 Jan 2025to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Francesca Cotardo, Psychologist, PhD Student contact

+39 3293826487

francesca.cotardo@unito.it

Italy1 site, 1 recruiting
  • University of Turin

    Turin, Turin, 10123

    Luca Ostacoli, Full Professor, +39 3351772575, luca.ostacoli@unito.it

    Francesca Cotardo, Psychologist, PhD Student, +39 3293826487, francesca.cotardo@unito.it

    Recruiting

Other trials in Italy

About this study

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

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:

Read more
  • 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.

Being tested
EMDR
Keywords
Eye Movement Desensitization and Reprocessing, depressive symptoms, predictors, moderators, psychotherapy, study protocol
Medical subject headings
Depression, Anxiety Disorders, Dissociative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMDRBehavioural

    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.

Study groups in NCT07033741
Study groupRoleWhat they receive
EMDR Therapy GroupParticipants 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).
Receives: Behavioral: EMDR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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).

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

Secondary outcomes (10)
  1. Personal beliefs

    The Personal Beliefs Scale-Revised (PBS-R) is a 44-item self-report measure designed to evaluate maladaptive personal beliefs across domains such as self-worth, interpersonal relationships, and personal agency. Respondents first indicate whether each belief applies to them by selecting "yes" or "no". For beliefs marked as applicable, participants then rate the degree to which each belief is problematic or distressing on a 4-point Likert scale, ranging from 1 ("not at all") to 4 ("very problematic").

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

  2. Personality domains

    The Personality Inventory for DSM-5 - Brief Form (PID-5-BF) is a 25-item self-report measure designed to assess five personality trait domains: negative affect, detachment, antagonism, disinhibition, and psychoticism. Each domain consists of 5 items rated on a 4-point scale ranging from 0 ("very false or often false") to 3 ("very true or often true"). The total score ranges from 0 to 75, with higher scores indicating greater personality dysfunction, while individual domain scores range from 0 to 15. Consistently high scores in a particular domain may indicate significant and challenging areas for the patient that may warrant further assessment, treatment, or follow-up.

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

  3. Anxiety symptoms

    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report instrument designed to measure the frequency of generalized anxiety symptoms over the previous 2-week period on a scale from 0 ("not at all") to 3 ("nearly every day"). Total scores indicate no symptoms (0-5 points), mild symptoms (6-10 points), moderate symptoms (11-15 points), or severe symptoms (greater than 15 points).

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

  4. Dissociative symptoms

    The Dissociative Experiences Scale (DES-II) is a 28-item, self-report assessment tool designed to measure dissociative experiences, including emotional involvement, depersonalization, derealization, compartmentalization, and amnesia. Each item on the scale evaluates the proportion of time an individual experiences the specific symptom. The overall score is calculated as the average of all item scores, ranging from 0% ("never") to 100% ("always").

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

  5. Assessing dissociative phenomena

    The Multidimensional Dissociation Inventory (MDI) is a 30-item self-report tool designed to assess dissociative phenomena across six domains: Disengagement, Depersonalization/Derealization, Emotional Constriction, Memory Disturbance, and Identity Dissociation. Each item is rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("very often").

    Measured: 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)

  6. Therapeutic progress and outcomes for individuals

    The Progress in Treatment Questionnaire - Patient (PITQ-p) is a 32-item self-report measure completed by patients, focusing on their ability to manage emotions, symptoms, relationships, safety, and overall well-being. Patients report the percentage of time they exhibit specific behaviors during the previous week, using a scale ranging from 0% ("never") to 100% ("always"). Item.

    The Progress in Treatment Questionnaire - Therapist (PITQ-t) is a 29-item measure designed to assess the percentage of time patients demonstrate treatment target behaviors over the prior 6 months. Each item is rated on a scale ranging from 0% ("never") to 100% ("always"). The questionnaire includes six specific items (items 24-29) for patients exhibiting dissociative self-states. Higher scores reflect greater adaptive functioning. The PITQ-t helps therapists evaluate multiple areas of patient functioning, providing a structured approach to monitoring progress and refining treatment plans.

    Measured: Baseline, 6 months, 12 months, through study completion (an average of 18 months)

  7. Post-traumatic Stress symptoms

    The Post-traumatic Stress Disorder Checklist (PCL-5) is a 20-item self-report assessment designed to evaluate the presence and severity of PTSD symptoms. Each item is rated on a 5-point Likert scale, where 0 indicates the absence of symptoms and 4 indicates extreme severity. The items of the PCL-5 are designed to be aligned with the DSM-5 diagnostic criteria for PTSD. The total score ranges from 0 to 80, with higher scores indicating greater levels of PTSD symptoms. A cutoff score of 33 is considered a reasonable threshold for provisional PTSD diagnosis.

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

  8. Emotion regulation

    The Difficulties in Emotion Regulation Scale (DERS) is a 36-item, self-report questionnaire to assess how individuals perceive and manage relevant difficulties in their emotional experiences. It is related to various aspects of emotion regulation, including acceptance of emotional responses, impulse control, emotional clarity, and the use of emotion regulation strategies. Respondents are asked to rate their agreement on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree").

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

  9. Quality of sleep

    The Mini Sleep Questionnaire (MSQ) is a 10-item self-report instrument designed to assess sleep quality and sleep disorders. Each item is rated on a 7-point Likert scale, ranging from 1 ("never") to 7 ("always"). Four levels of sleep quality are identified: 10-24 (good sleep quality), 25-27 (mild sleep difficulties), 28-30 (moderate sleep difficulties), and ≥31 (severe sleep difficulties).

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

  10. Therapeutic alliance

    The Working Alliance Inventory (WAI) is a 36-item self-report measure designed to assess the quality of the therapeutic alliance available in both therapist (WAI-T) and patient (WAI-P) versions. The scale evaluates three fundamental dimensions of the therapeutic relationship: goals (agreement on therapy objectives), tasks (agreement on the steps or methods to achieve these goals), and bond (the emotional connection and mutual trust between therapist and patient). Each item is rated on a 7-point Likert scale ranging from 1 ("never") to 7 ("always"), with higher scores reflecting a stronger working alliance. Subscale scores provide detailed insights into the specific components of the alliance, while the total score represents the overall strength of the therapeutic relationship.

    The study also includes study-specific evaluation forms designed to gather targeted information on therapeutic processes and clinical outcomes.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study start8 Jan 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07033741
Sponsor's protocol ID
PROCESS-EMDR/0565145
Acronym
PROCESS-EMDR
Status last verified
Nov 2025
First submitted
30 Apr 2025
Last updated
25 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 41567443

Questions about this trial

What is this clinical trial studying?

An observational study of Depression, Anxiety and Post-traumatic Stress Symptoms, run by University of Turin, Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Francesca Cotardo, Psychologist, PhD Student (+39 3293826487, francesca.cotardo@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Monitoring depressive symptoms (time frame: Baseline, during the intervention, 6 months, 12 months, through study completion (an average of 18 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07033741, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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