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.
Study Type
OBSERVATIONAL
Enrollment
40
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.
University of Turin
Turin, Turin, Italy
RECRUITINGMonitoring 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).
Time frame: 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).
Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 month)
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").
Time frame: Baseline, at study completion (an average of 18 month)
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.
Time frame: Baseline, at study completion (an average of 18 month)
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).
Time frame: Baseline, during the intervention, 6 months, 12 months, at study completion (an average of 18 month)
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").
Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 months)
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").
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
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.
Time frame: Baseline, 6 months, 12 months, through study completion (an average of 18 months)
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.
Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 month)
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").
Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 months)
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).
Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 month)
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.
Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 months)
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