University of Turin
Turin, 10123, Italy
Location status: Recruiting
Location contact
Francesca Cotardo, Psychologist, PhD Student
CONTACT
Luca Ostacoli, Full Professor
CONTACT
Sara Carletto, Post-doc research fellow
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07033741
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Turin, 10123, Italy
Location status: Recruiting
Francesca Cotardo, Psychologist, PhD Student
CONTACT
Luca Ostacoli, Full Professor
CONTACT
Sara Carletto, Post-doc research fellow
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Participants:
Therapist
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.
Time frame: Baseline, during the intervention, 6 months, 12 months, through study completion (an average of 18 months)
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, 6 months, 12 months, at study completion (an average of 18 month)
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, at study completion (an average of 18 month)
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)
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, during the intervention, 6 months, 12 months, at study completion (an average of 18 month)
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, 6 months, 12 months, at study completion (an average of 18 months)
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: 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)
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: Baseline, 6 months, 12 months, through study completion (an average of 18 months)
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, at study completion (an average of 18 month)
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 months)
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 month)
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 months)
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
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.
Time frame: Baseline, during the intervention, 6 months, 12 months, at study completion (an average of 18 months)
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.
Time frame: Baseline, 6 months, 12 months, at study completion (an average of 18 months)
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.
Time frame: Baseline, at study completion (an average of 18 months)
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.
Time frame: During the intervention, 6 months, 12 months, through study completion (an average of 18 months)
The Processing Difficulties Scale (PDS) is a 17-item self-report instrument designed to evaluate challenges encountered during memory processing in EMDR therapy, following the standard protocol. Clinicians rate each item on a 5-point Likert scale ranging from 0 ("never") to 4 ("always"), assessing specific processing styles. These styles include indicators of poor processing characterized by a lack of generalization, effective general processing, unproductive emotional processing, and signs of loss of dual attention during sessions. The PDS provides valuable insights into the quality and style of processing, aiding clinicians in identifying potential barriers to therapeutic progress.
Time frame: During the intervention, 6 months, 12 months, at study completion (an average of 18 months)
The Recalled Memory Evaluation is a 14-item self-report instrument designed to assess the emotional, cognitive, and sensory aspects of memory recall after EMDR sessions (e.g., clarity, vividness, sounds, and smells). Patients rate their experience on an 11-point Likert scale ranging from 0 ("not at all") to 10 ("completely"). The form provides key insights into changes in memory processing over time, helping to share and deepen understanding of patients lived experiences of EMDR.
Contact information is provided by the study sponsor or research team.
University of Turin, Italy
Other
Predictors and Process Moderators of EMDR Therapy for Depressive Symptoms: Protocol for a Real-world Prospective Observational Study
Acronym: PROCESS-EMDR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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