About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
certified members of the Italian Eye Movement Desensitization and Reprocessing (EMDR) Association
Disqualifiers
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.
Trial 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.
Trial design
Case-only
Prospective
Treatments tested in this trial
EMDR
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
Secondary outcomes
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").
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.
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).
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").
Other outcomes
Exposure to traumatic or stressful life events
The Life Stressor Checklist-Revised (LSC-R, Wolfe et al., 2012), is a self-report measure used to assess exposure to traumatic or stressful life events throughout the lifespan, such as natural disasters, interpersonal violence, and the sudden death of a loved one. Respondents use a dichotomous response format (yes/no) to indicate whether they have experienced each event. For endorsed events, participants provide additional details, including the age of occurrence, whether they felt in harm's way or helpless ("yes" or "no"), and rate the event's impact and associated emotional distress on a 5-point Likert scale (1 = "not at all" to 5 = "extremely"). Respondents are also asked to identify up to three events that currently have the greatest impact on their lives. The LSC-R is widely used in clinical and research contexts to evaluate the cumulative effects of life stressors and their psychological impact.
Compassion
The Compassionate Action and Engagement Scales (CAES) is a self-report instrument designed to assess three key dimensions of compassion: (1) the compassion one experiences for others, (2) the compassion one perceives from others, and (3) self-compassion. The scales are based on a standard definition of compassion as "a sensitivity to suffering in self and others, coupled with a commitment to alleviate and prevent it". The instructions for each scale define compassion and invite participants to reflect on their responses when confronted with their own suffering, the suffering of others, or the experience of compassion from others. Responses are recorded using a 10-point Likert scale ranging from "never" to "always". Higher scores reflect greater levels of sensitivity and commitment within each dimension of compassion.
Experience of Mindfulness
The Philadelphia Mindfulness Scale (PHLMS-I) is a 20-item self-report inventory designed to measure two core components of mindfulness: awareness (attentiveness to present-moment experiences) and acceptance (a non-judgmental attitude toward thoughts and emotions). Each subscale comprises 10 items rated on a 5-point Likert scale ranging from 1 ("never") to 5 ("very often"), reflecting the frequency of the subjective experiences. Subscale scores are calculated as the sum of their respective items, with higher scores indicating greater mindfulness abilities.
Evaluating adult attachment style
The Relationships Questionnaire (RQ), is a 4-item self-report tool used to assess an individual's adult attachment style. Respondents rate their agreement or disagreement with four statements on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The RQ identifies whether an individual has a secure, anxious, or avoidant attachment style and provides insights into how they approach and experience interpersonal relationships.
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