A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to Occupational Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Feasibility Indicator: Recruitment (Phase II)
研究概览
简要总结
It is expected that large numbers of healthcare workers experience a broad range of psychological reactions and symptoms including anxiety, depression, moral distress, and trauma symptoms that will cause both significant suffering as well as occupational and social impairment. The purpose of this study is to find interventions which are helpful in treating psychological distress in healthcare workers adversely affected by occupational-related trauma.
There are two phases of the study. All participants will take part in Phase I, which consists of 4 sessions over a two-week period of either a narrative writing intervention or a medical music intervention. Participants will be randomly assigned to the narrative writing intervention or medical music intervention.
After Phase I, participants will be re-assessed. Healthcare workers who meet criteria for PTSD will be given the option to participate in Phase II of the study, in which they will be offered a choice between one of two evidence-based treatments for PTSD: Interpersonal Therapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minute sessions scheduled twice weekly. Participants will be allowed to choose a preferred treatment in Phase II. After Phase II participants will complete a final assessment concluding the study. All interventions will be offered using distance technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will not be aware of the condition for Phase 1 or Phase 2 of the study.
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
- •Any healthcare worker providing medical care or support who has experienced occupational-related trauma
- •English-speaking
- •Medically stable
- •Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
- •If on psychotropic medication stable for prior 60 days
- •For phase II additional inclusion criteria:
- •- Current diagnosis of PTSD
排除标准
- •Current significant unstable medical illness precluding regular session attendance or assessment completion
- •Participants who in the investigator's judgment pose a current homicidal, suicidal, or other risk
- •Lifetime or current diagnosis of schizophrenia or other psychotic disorder
- •Participation in a clinical trial or concurrent evidence-based treatment for psychiatric conditions or PTSD during the previous 3 months.
研究组 & 干预措施
Medical Music (Phase I)
Participants will complete four medical music sessions that are 20 minutes in length each.
干预措施: Medical Music (Behavioral)
Narrative Writing (Phase I)
Participants will complete four narrative writing sessions that are 20 minutes in length each.
干预措施: Narrative Writing (Behavioral)
Interpersonal Psychotherapy (Phase II)
IPT is comprised of ten 75-minute sessions scheduled twice weekly.
干预措施: Interpersonal Psychotherapy (Behavioral)
Prolonged Exposure Therapy (Phase II)
ET is comprised of ten 75-minute sessions scheduled twice weekly.
干预措施: Prolonged Exposure Therapy (Behavioral)
结局指标
主要结局
Feasibility Indicator: Recruitment (Phase II)
时间窗: Post-Phase I Assessment at week 2
Feasibility assessment will include: recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Enrollment (Phase I)
时间窗: Baseline
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Feasibility Indicator: Retention (Phase I)
时间窗: Post-Phase I Assessment at approximately week 2
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase I interventions.
Feasibility Indicator: Retention (Phase II)
时间窗: Post-Phase II Assessment at approximately week 7
Feasibility assessment will include retention defined as the number of participants completing the full course of Phase II interventions.
Acceptability Indicator: Satisfaction (Phase I)
时间窗: Post-Phase I Assessment at approximately week 2
Acceptability and treatment satisfaction will be rated with a Likert scale.
Feasibility Indicator: Recruitment (Phase I)
时间窗: Baseline
Feasibility assessment will include recruitment defined as number of individuals interested in the intervention.
Feasibility Indicator: Enrollment (Phase II)
时间窗: Post-Phase I Assessment at approximately week 2
Feasibility assessment will include enrollment defined as number of individuals beginning phase II.
Acceptability Indicator: Satisfaction (Phase II)
时间窗: Post-Phase II Assessment at approximately week 7
Acceptability and treatment satisfaction will be rated with a Likert scale.
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I)
时间窗: Start of Phase I to approximately 2 weeks
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)
时间窗: Start of Phase II to approximately 5 weeks
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.
次要结局
- Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Moral Injury Symptom Scale: Healthcare Professionals Version (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in score on the Work and Social Adjustment Scale (WSAS) (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Posttraumatic Cognitions Inventory (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Posttraumatic Cognitions Inventory (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in score on the Difficulties in Emotion Regulation Scale-18 (DERS-18) (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Difficulties in Emotion Regulation Scale-18 (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)(Start of Phase II to approximately 5 weeks)
- Change in Depressive Symptoms measured by the Quick Inventory of Depressive Symptomology (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in Anxiety Symptoms measured by the Generalized Anxiety Disorder 7-Item Scale (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the World Health Organization Quality of Life Scale - Brief (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Modified Moral Injury Events Scale (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Modified Moral Injury Events Scale (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in score on the Pittsburgh Sleep Quality Index (PSQI) (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the World Health Organization Quality of Life Scale - Brief (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in score on the PTSD Checklist for DSM-5 (PCL-5) (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in score on the Sheehan Disability Scale (SDS) (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Sheehan Disability Scale (SDS) (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in score on the Work and Social Adjustment Scale (WSAS) (Phase II)(Start of Phase II to approximately 5 weeks)
- Change in Score on the Occupational Stress Inventory Revised (OSI-R) (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in Score on the Multidimensional Scale of Perceived Social Support (MSPSS) (Phase I)(Start of Phase I to approximately 2 weeks)
- Change in score on the Pittsburgh Insomnia Rating Scale-20 Item Version (PIRS_20)(Start of Phase I to approximately 2 weeks)