Resolving Early Life Stress: Psychotherapy Outcomes and Neurobiology in Complex Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Montgomery and Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The RESPOND trial explores the link between early life adversity and later life depressive symptoms. The investigators have designed a new psychological therapy tailored to address the symptoms that can be caused by difficult experiences in early life. These symptoms include low mood, emotional dysregulation, and distressing thoughts and beliefs related to difficult or traumatic experiences. The investigators would like to see if this new therapy helps people feel better. The investigators are also studying the biological changes that can occur as a result of early life adversity, and how this therapy may influence those changes. To do this, the investigators ask questions about participants' physical and mental health and take blood samples.
详细描述
Objectives of proposed study:
- Assess efficacy of a novel psychotherapy protocol:
The investigators will evaluate a new psychotherapy specifically designed to target depressive symptoms and emotional dysregulation in individuals with depressive symptoms and a history of ELA. This protocol incorporates evidence-based techniques from Dialectical Behavior Therapy (DBT), Cognitive Behavioral Therapy (CBT), and Cognitive Processing Therapy (CPT), and is tailored to the unique needs of this population. 2. Examine biological mechanisms underlying the link between ELA and depression:
To investigate the biological processes that link ELA to later-life depressive pathology, the study will explore epigenetic, inflammatory, and hormonal markers, as well as clinical mechanisms such as trauma-related factors, illness presentation, and comorbid diagnoses.
The primary outcome of this study is a change in depression symptoms as characterized by the Montgomery Åsberg Depression Rating Scale (MADRS). The secondary outcomes will be changes in emotional regulation as measured by the Difficulties in Emotional Regulation Scale (DERS), changes in trauma symptoms as measured by the PTSD Checklist for the DSM-5 (PCL-5) and the International Trauma Questionnaire (ITQ), and changes in inflammation and methylation status as measured through blood analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years old or older
- •At or above 18 on HAM-D, indicative of moderate-severe depressive symptoms
- •Any childhood (before 18 years old) adversity as indicated by scores on the CECA q and ACES q
排除标准
- •Individuals who meet for PTSD diagnosis from a criterion A trauma occurring in adulthood without a history of ELA
- •Individuals experiencing active mania or psychosis
- •Individuals with an active substance use disorder
- •Individuals presenting with active suicide risk (plan, intention, means) indicative of a need for higher level care
- •Individuals in current psychotherapeutic treatment (defined as having engaged in consistent psychotherapy within the last 3 months)
研究组 & 干预措施
Psychotherapy arm
The psychotherapy intervention will be delivered virtually over 12 weeks, 1x/week for 1 hour, 1-on-1 with a therapist
干预措施: Psychotherapy (Other)
结局指标
主要结局
Montgomery and Asberg Depression Rating Scale (MADRS)
时间窗: Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment)
The Montgomery and Asberg Depression Rating Scale is a 10-item semi-structured interview assessing the severity of depressive symptoms (Montgomery \& Åsberg, 1979). The MADRS is sensitive to changes induced my treatment, making it appropriate to implement over psychotherapeutic intervention to monitor changes in depression severity.
次要结局
- Difficulties with Emotional Regulation Scale(Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment))
- International Trauma Questionnaire(Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment))
- PTSD Checklist for the DSM-5(Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment))
- Biomarkers - Hormonal markers(Baseline (week 0), Treatment endpoint (week 12))
- Illness Intrusiveness Scale(Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment))
- Biomarkers - Epigenetic(Baseline (week 0), Treatment endpoint (week 12))
- Biomarkers - Inflammatory(Baseline (week 0), Treatment endpoint (week 12))
- Difficulties with Emotional Regulation Scale(Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment))
- International Trauma Questionnaire(Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment))
- PTSD Checklist for the DSM-5(Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment))
- Biomarkers - Hormonal markers(Baseline (week 0), Treatment endpoint (week 12))
- Illness Intrusiveness Scale(Baseline (week 0), Treatment endpoint (week 12), Follow-up (3 months post treatment))
- Biomarkers - Epigenetic(Baseline (week 0), Treatment endpoint (week 12))
- Biomarkers - Inflammatory(Baseline (week 0), Treatment endpoint (week 12))
研究者
Benicio Frey
Professor, Psychiatry & Behavioural Neurosciences; Director, Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton