Desensitizing Distressing Recollections in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Post traumatic Cognitions Inventory
研究概览
简要总结
The major goal of this study is to determine whether Neuro-Emotional Technique is a viable treatment option for decreasing distress in cancer patients. The potential advantages of NET are: 1) it is designed specifically to address distressing stimuli and unresolved emotional memories; 2) it is a brief, time-limited intervention; and 3) its multi-modal design may appeal to and benefit a broader range of patients than a single mode intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years of age
- •Distressing cancer-related recollection that has persisted for at least six months
- •Distressing cancer-related recollection that causes physiological reactivity (i.e., increased heart rate and/or increased skin conductance level - SCL), as described in section 4.2.
- •Received a cancer diagnosis at least 6 months prior to being contacted for participation in this study
排除标准
- •Any current Major Mental Disorder, as assessed by Structured Clinical Interview for DSM IV Axis I Disorders (SCID - Clinical Version, First et al, 1997)
- •History of Post-traumatic Stress Disorder
- •Current active mood primary disorder prior to the cancer diagnosis (as per PI or designate)
- •History or current diagnosis of substance or alcohol abuse or dependence (as per PI or designate)
- •Use of psychotropic medications within the past month or current use of medications that would interfere with autonomic nervous system measures (benzodiazepines, barbiturates, major tranquilizers).
- •Use of some psychotropic medications are allowed such as SSRIs and certain sleep aids, but dosages must be stable from six weeks prior to enrollment and throughout study period
- •Any psychological or musculoskeletal problems that would interfere with psychophysiological assessments and treatment
- •Currently receiving chemotherapy or radiation
- •Are in the terminal stages of illness
研究组 & 干预措施
Intervention
Subjects will receive NET intervention treatment immediately
干预措施: NET Intervention (Behavioral)
Control
Subjects will receive NET intervention treatment and serve as a wait-list control
干预措施: NET Intervention (Behavioral)
结局指标
主要结局
Post traumatic Cognitions Inventory
时间窗: baseline/ 4 weeks/6 months follow up
change from baseline Post Traumatic Cognitions Inventory score
State Trait Anxiety Inventory
时间窗: baseline/4 weeks/6 months follow up
change from baseline State Trait Anxiety Inventory score
Brief Symptom Inventory
时间窗: baseline/4 weeks/6 month follow up
change from baseline Brief Symptom Inventory
次要结局
- Autonomal response to distressing recollections(baseline/4 weeks follow up)
- Genomic testing(baseline/ 4 weeks follow up)
