Healthy Recovery After Trauma Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
Mental contamination-an internal experience of dirtiness evoked in the absence of physical contact with an external source-has been linked to the development and maintenance of posttraumatic stress disorder (PTSD) following exposure to sexual abuse or assault (Adams et al., 2014; Badour et al., 2013; Brake et al., 2017). Mental contamination has been associated with greater PTSD severity (Rachman et al., 2015) and higher elevations in specific PTSD symptom clusters (particularly those of intrusive reexperiencing, negative cognitions/mood, and arousal/reactivity; Brake et al., 2019; Fergus & Bardeen, 2016). Additionally, trauma-related mental contamination has been linked to a number of negative posttraumatic emotions such as shame, guilt, disgust, and anger (Fairbrother & Rachman, 2004; Radomsky & Elliott, 2009) Despite clear and consistent links between mental contamination and problematic posttraumatic outcomes following sexual trauma, there is a dearth of research investigating how existing or promising new interventions for PTSD impact mental contamination.
Cognitive Processing Therapy (CPT) is an efficacious and effective 12-session manualized cognitive-behavioral intervention for PTSD that is considered a gold-standard empirically-supported treatment for PTSD that is recommended by the American Psychological Association (APA, 2017). In addition to PTSD symptom improvement, CPT has also demonstrated benefit for improving feelings of shame and guilt, which are often seen among individuals with trauma-related mental contamination (Nishith et al., 2005; Resick et al., 2002, 2008). Cognitive reappraisal, a primary technique employed in CPT, involves challenging one's view of an emotionally-eliciting situation to alter its emotional impact (Gross & John, 2003). However, some investigators have suggested that cognitive reappraisal may be less effective in targeting moral emotions such as shame, guilt, and self-disgust that are based on an individual's standards and virtues (Finlay, 2015). Self-compassion (SC; i.e., self-directed care and kindness; forgiveness; and feelings of common humanity; Neff, 2003) has been proposed as an alternative method for addressing trauma-related shame and preliminary evidence suggests a 6-session self-compassion intervention may have benefit for reducing both PTSD symptoms and trauma-related shame (Au et al., 2017). Given the centrality of shame, guilt, and self-disgust to the experience of mental contamination, and the fact that mental contamination often arises in response to experiences involving moral violation or betrayal (Millar et al., 2016; Rachman, 2010), a SC intervention for PTSD may also offer promise as a standalone or adjunctive intervention for reducing trauma-related mental contamination. A test of these interventions for their impact on reducing trauma-related mental contamination is needed.
The current study will use Single Case Experimental Design to isolate and evaluate the effects of CPT and SC in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma.
Aims: 1) explore whether participants demonstrate reductions in mental contamination and PTSD symptoms in response to 12-sessions of CPT or 6-sessions of a SC intervention; 2) evaluate whether presentation of either treatment first yields differences in symptom reduction for PTSD and/or mental contamination symptoms; 3) evaluate whether the addition of the alternative module will enhance reductions in PTSD symptoms and mental contamination; 4) evaluate if such reductions are maintained during follow-up.
Visual inspection analysis and statistical methods will be used to draw conclusions regarding the effects of the interventions on PTSD symptoms and mental contamination.
详细描述
In this multiple baseline single case experimental design with phase shift, up to 100 participants will be screened to identify 12 eligible individuals to participate in all study procedures. After the baseline assessment, participants will be randomized (1:1 ratio) to either a two or four-week baseline phase (assessment-only). Participants will then be randomized (1:1 ratio) to either a 12-session CPT intervention or a 6-session self-compassion intervention. All participants will complete one orientation session at the beginning of the first treatment phase. Following a second three-week baseline phase, all participants will then shift into the alternate intervention. Participants will be invited to complete a post-treatment and one-month follow-up assessment. In total, participants who take part in this research study will be in this research study for up to 34 weeks and will attend up to 20 in-person study visits.
Individuals interested in participating in this study will complete a phone screening to determine if they are likely to be eligible and can be scheduled for an in-person diagnostic intake to take place at the Stress Trauma and Recovery Research Collaborative (STARRC) within the UK Clinic for Emotional Health (i.e., the PI's research lab space located on Waller Avenue in an office park rented by the University of Kentucky) or via HIPAA compliant Zoom. All participants will be provided with details regarding the phone screen questions and will be required to provide implied consent over the phone before proceeding with the phone screen.
During the intake session, the participant will first be given a written and verbal description of the study and informed consent. The consent form will be presented to the participant on a tablet, or remotely, through REDCap in which they will be asked to provide a digital signature. They may request a paper copy if preferred. If consent is provided, they will be given the option to be emailed a copy. The PI or designated staff will discuss the informed consent form with the participant volunteer. The consent process will take place in a quiet and private room or online via HIPAA compliant Zoom. Participants may take as much time as needed to make a decision about their trial participation and may take the document home if desired. The person obtaining consent will thoroughly explain each element of the document and outline the risks and benefits, alternative treatment(s), and follow-up requirements of the study. Participants will be informed that they can withdraw from the research at any time. Procedures and consent forms will comply with the requirements of the UK Institutional Review Board and Office of Research Integrity's Best Practices for Remote Informed Consent. The experimenter will then complete a consent post-test with participants. If a participant screens out of the study due to a consent capacity issue, any data from that participant that may have been previously collected during the phone screening and/or online surveys will not be used.
Participant privacy will be maintained and questions regarding participation will be answered. No coercion or undue influence will be used in the consent process. No research-related procedures will be performed prior to obtaining informed consent. All signatures and dates will be obtained. A copy of the signed consent will be given to the participant. Signed electronic consents will be maintained and stored through REDCap and will be separated from participant data. We do not have reason to expect that participants are likely to have impaired consent capacity in this study. However, in a previous study our lab conducted where we did have this expectation we included a consent capacity evaluation document and found that we liked using it as an extra check that participants were aware of the study details and what they were agreeing to, and could state back to us in their own words what they could do if they became uncomfortable or decided they wished to take a break, skip sections, or discontinue the study. It is now our lab's standard operating procedure to include this measure in all in-person studies.
Any study personnel member who obtains informed consent from a patient will not serve as that participant's assigned therapist.
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
- 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
- •individuals with a history of sexual trauma meeting past-month diagnostic criteria for PTSD (meeting diagnostic status on the DIAMOND and score greater than or equal to 36 on the PCL-5) and
- •reporting current experiences of trauma-related mental contamination (greater than or equal to 10 on the PEMC).
- •18 years of age or older
- •fluent in English
- •Patients on psychotropic medications will be included if they have been maintained on a stable dose for at least 4 weeks prior to beginning the study and are willing to maintain a stable dosage throughout the study period; this procedure allows for a broader range of participants and avoids having outcomes assessment confounded by the initiation of medication during treatment.
- •Finally, patients must be willing to refrain from additional trauma-related treatment for the duration of the study.
排除标准
- •We will exclude individuals diagnosed with psychological conditions that may be better addressed by alternative treatments; these conditions include
- •psychotic disorders
- •dissociative identity disorder
- •unmanaged (i.e., unmedicated or currently experiencing a manic/hypomanic episode) bipolar disorder
- •bulimia nervosa
- •anorexia nervosa
- •imminent risk of suicide (i.e., intent/plan)
- •severe substance use disorders.
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: Change in prior week symptom severity assessed from 3 or 5 weeks prior to beginning treatment (intake + baseline), compared to weekly during treatment, compared to 3 weeks between treatments, and compared to 3 weeks after completing the second treatment
Change in Posttraumatic Stress Disorder Symptom Severity
Posttraumatic Experience of Mental Contamination (PEMC)
时间窗: Change in prior week symptom severity assessed from 3 or 5 weeks prior to beginning treatment (intake + baseline), compared to weekly during treatment, compared to 3 weeks between treatments, and compared to 3 weeks after completing the second treatment
Change in Severity of Mental Contamination Symptoms
次要结局
- Trauma-Related Shame Inventory (TRSI)(Change in prior week symptom severity assessed from 3 or 5 weeks prior to beginning treatment (intake + baseline), compared to weekly during treatment, compared to 3 weeks between treatments, and compared to 3 weeks after completing the second treatment)
- Trauma-Related Guilt Inventory (TRGI)(Change in prior week symptom severity assessed from 3 or 5 weeks prior to beginning treatment (intake + baseline), compared to weekly during treatment, compared to 3 weeks between treatments, and compared to 3 weeks after completing the second treatment)
研究者
Christal L Badour
Assistant Professor of Psychology
University of Kentucky