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临床试验/NCT04124380
NCT04124380已完成不适用

Understanding and Testing Recovery Processes for PTSD and Alcohol Use Following Sexual Assault

University of Washington2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2021年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Alcohol Use Interview

研究概览

简要总结

Sexual assault can lead to devastating consequences including the development of chronic conditions including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Interventions delivered soon after exposure to assault can decrease the long-term negative consequences of sexual assault but existing interventions are limited in their ability to target concurrent PTSD symptoms and alcohol use and little is known about how to make best practice treatment decisions in the early period following sexual assault. A greater emphasis on transdiagnostic processes that are related to both PTSD and alcohol use, such as fear and reward systems, can elucidate mechanisms of recovery, lead to the development of more effective intervention approaches, and guide clinical decision making for patients recently exposed to sexual assault.

详细描述

Following sexual assault, many individuals will develop chronic problems including posttraumatic stress disorder (PTSD) and alcohol use disorders (AUD). Intervention provided soon after assault can decrease the risk of developing chronic psychopathology and associated negative consequences. Interventions that address common underlying mechanisms of PTSD and alcohol use, such as fear and reward systems, have strong potential utility as efficacious and accessible interventions for clinicians treating patients recently exposed to sexual assault. This proposal is designed to test fear and reward as crucial processes underlying recovery following sexual assault and elucidate the most efficacious treatment targets. Employing experimental tasks (safety-signal learning paradigm and probabilistic reward task) to capture baseline underlying vulnerabilities in fear and reward systems respectively will allow for exploration of how these processes impact recovery. A randomized clinical trial (N = 180) will be conducted to test efficacy of intervention approaches that target PTSD or alcohol use compared to supportive telehealth. In addition, a phased study design will allow for exploration of efficacy of primary and secondary intervention approaches to test the questions of 1) whether it is more efficacious to target PTSD or alcohol use first; and 2) whether it is necessary to target both PTSD and alcohol use to facilitate recovery or if one is sufficient. This proposal is significant in exploring transdiagnostic mechanisms implicated in recovery following sexual assault, fear and reward, and using a novel design to compare efficacy, ordering, and necessity of two distinct intervention approaches.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

入选标准

  • Identifies as female.
  • Between the age of 18 and
  • Reports a sexual assault in the last 4 weeks to 1 year.
  • Current PTSD severity of 23+ on the PSS-I-
  • Current heavy alcohol use (2+ heavy episodic drinking occasions [4+ drinks on one occasion] in past month).
  • Access to the internet and a device with a webcam.

排除标准

  • Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-
  • Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
  • Unwilling or unable to discontinue current trauma-focused psychotherapy or current substance use psychotherapy.
  • Unstable dose of psychotropic medications in the prior 3 months.
  • Ongoing intimate relationship with the perpetrator of most recent assault.
  • Current diagnosis of a severe substance use disorder according to DSM-5, other than alcohol in the last month.
  • No clear trauma memory.
  • Current higher dose use of benzodiazepines (greater than the equivalent of 4 mg of lorazepam, 2 mg alprazolam, 1.5 mg clonazepam, or 20 mg of diazepam).

研究组 & 干预措施

Imaginal Exposure First, no additional treatment

Experimental

Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. No additional treatment.

干预措施: Imaginal Exposure (Behavioral)

Imaginal Exposure First, then Alcohol Skills

Experimental

Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. After imaginal exposure, alcohol skills targeting alcohol misuse after sexual assault.

干预措施: Imaginal Exposure (Behavioral)

Imaginal Exposure First, then Alcohol Skills

Experimental

Imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault. After imaginal exposure, alcohol skills targeting alcohol misuse after sexual assault.

干预措施: Alcohol Skills Training (Behavioral)

Alcohol Skills First, then Imaginal Exposure

Experimental

Alcohol skills targeting alcohol misuse after sexual assault. After alcohol skills training, imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault.

干预措施: Imaginal Exposure (Behavioral)

Alcohol Skills First, then Imaginal Exposure

Experimental

Alcohol skills targeting alcohol misuse after sexual assault. After alcohol skills training, imaginal exposure to the sexual assault memory targeting PTSD symptoms after sexual assault.

干预措施: Alcohol Skills Training (Behavioral)

Supportive Counseling/Telehealth

Active Comparator

Internet-based intervention focusing on providing support.

干预措施: Supportive Telehealth (Behavioral)

Alcohol Skills First, no additional treatment

Experimental

Alcohol skills targeting alcohol misuse after sexual assault only. No additional treatment.

干预措施: Alcohol Skills Training (Behavioral)

结局指标

主要结局

Alcohol Use Interview

时间窗: Past month

Alcohol use will be measured using the Timeline Followback Interview (TLFB) to measure frequency and quantity of drinking behavior over the past month. The TLFB is a count of total drinks per day over the last month. Higher number of drinks on the TLFB represents higher alcohol use and worse outcomes.

Alcohol Use Self-Report

时间窗: Past month

Alcohol use will be measured using the Daily Drinking Questionnaire (DDQ) to assess for self report of typical weekly drinking (quantity, frequency). The DDQ asks for an estimated number of drinks consumed on each day in a typical week over the last month. Higher estimates for number of typical drinks each day on the DDQ represents higher alcohol use and worse outcomes.

Posttraumatic Stress Disorder Severity (PTSD) Interview

时间窗: Past two weeks

PTSD symptom severity will be measured using the Posttraumatic Stress Symptoms Scale- Interview Version for DSM-5 (PSS-I-5). The PSS-I-5 is a 20 item scale, with a minimum score of 0 and a maximum score of 80; higher values represent increased PTSD symptom severity and worse outcomes.

Posttraumatic Stress Disorder Severity (PTSD) Self-Report

时间窗: Past two weeks

PTSD symptom severity will be measured using the Posttraumatic Stress Symptoms Scale- Self-report Version for DSM-5 (PSS-SR-5). The PSS-SR-5 is a 20 item scale, with a minimum score of 0 and a maximum score of 80; higher values represent increased PTSD symptom severity and worse outcomes.

次要结局

  • Alcohol Cravings(Past week)
  • Alcohol Consequences(Past week)
  • Psychosocial Functioning(Past two weeks)
  • Quality of Life Functioning(Past two weeks)
  • Depression Interview(Past week)
  • Reward(Past week)
  • Fear(Past week)
  • Depression Self-Report(Past week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michele Bedard-Gilligan

Professor, School of Medicine: Psychiatry

University of Washington

研究点 (2)

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