Predictors and Process Moderators of EMDR Therapy for Depressive Symptoms: Protocol for a Real-world Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Monitoring depressive symptoms
研究概览
简要总结
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.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •certified members of the Italian Eye Movement Desensitization and Reprocessing (EMDR) Association
排除标准
- •inability or unwillingness to comply with study protocols or schedules Patient
- •Inclusion Criteria:
- •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.
- •Exclusion Criteria:
- •history of psychotic symptoms or schizophrenia
- •severe personality disorders
- •a serious, unstable medical condition
- •acute suicidality that needs hospitalization.
结局指标
主要结局
Monitoring depressive symptoms
时间窗: 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).
Depressive symptoms
时间窗: 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).
次要结局
- 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))
- Therapeutic progress and outcomes for individuals(Baseline, 6 months, 12 months, through study completion (an average of 18 months))
- Post-traumatic Stress symptoms(Baseline, 6 months, 12 months, at study completion (an average of 18 month))
- Emotion regulation(Baseline, 6 months, 12 months, at study completion (an average of 18 months))
- Quality of sleep(Baseline, 6 months, 12 months, at study completion (an average of 18 month))
- Therapeutic alliance(Baseline, 6 months, 12 months, at study completion (an average of 18 months))
研究者
luca ostacoli
Full Professor
University of Turin, Italy