Personalizing Cognitive Processing Therapy With a Case Formulation Approach to Intentionally Target Impairment in Psychosocial Functioning Associated With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 15
- 主要终点
- Inventory of Psychosocial Functioning (assessing change over time)
研究概览
简要总结
Recent estimates suggest that over 610,000 US Veterans treated by the Veterans Health Administration (VHA) suffer from PTSD, a disorder that can be chronic and debilitating. The heterogeneity of the 20 symptoms of PTSD; comorbidity with disorders such as depression, panic, and substance use; high rates of lingering effects of physical injury; and suicidality all contribute to complex clinical presentations and can exact a significant toll on functioning, quality of life, and well-being even decades after exposure to the traumatic event. Perhaps spurred by the President's New Freedom Commission on Mental Health, psychosocial rehabilitation has shifted from the periphery in mental health recovery models to a more primary focus in clinical settings, including recommendations for use of psychosocial rehabilitation techniques in trauma-focused mental health care. Support for the efficacy of psychosocial rehabilitation techniques in PTSD recovery programs has burgeoned in recent years and data supporting psychological treatments for PTSD has increased exponentially, yet the two approaches to recovery have largely remained independent.
Cognitive Processing Therapy (CPT), the evidence-based psychotherapy (EBP) for PTSD most frequently delivered within VHA, yields large magnitude reductions in primary PTSD outcomes. Corresponding gains in occupational, social, leisure, and sexual functioning, and in health-related concerns have also been demonstrated. Despite CPT's effectiveness, there is room for improvement in overall outcomes and patient engagement. Further, improvements in functioning and quality of life are more modest than those observed in PTSD and associated mental health symptoms. Prior work suggests that unaddressed difficulties in functioning contribute to premature dropout from EBPs for PTSD among Veterans. Directly targeting impairments associated with psychosocial functioning has the potential to substantially increase the scope of recovery beyond the core symptoms of PTSD and facilitate greater patient engagement, resulting in more Veterans benefitting from CPT. Modifying the CPT protocol to personalize the intervention for the individual patient has resulted in better overall response rates for a wider variety of patient populations suffering from complicated clinical presentations.
Case formulation (CF) is a well-established approach to cognitive-behavioral treatment that facilitates a collaborative process between providers and patients to guide the tailoring of treatment to meet idiosyncratic patient needs. Integrating CF strategies into the existing CPT protocol will enable providers to personalize CPT to directly address impairment in functioning as well as provide the latitude to directly intervene with the complex challenges that threaten optimal outcomes within the context of trauma-focused therapy. CF-integrated CPT (CF-CPT) expands and enhances the CPT protocol to facilitate a personalized and flexible approach to treating PTSD that prioritizes the administration of the full dose of CPT while expanding the protocol to directly target important domains of functioning and result in more holistic outcomes.
This controlled treatment outcome trial will randomize a national sample of CPT providers (Veteran n = 200; provider n = 50) to either deliver CF-CPT or CPT to compare the relative effectiveness of CF-CPT to CPT in improving primary outcomes, including Veterans' psychosocial functioning, quality of life and well-being over the course of treatment and 3-month follow-up as compared to Veterans who receive standard CPT. Further, Veterans who receive CF-CPT will demonstrate greater reductions in PTSD and depression over the course of treatment and 3-month follow-up than those who receive CPT.
This study also seeks to determine the effectiveness of CF-CPT as compared to CPT in improving Veterans' treatment engagement (CF-CPT will demonstrate higher rates of Veteran treatment completion than CPT).
This study will valuate CF-CPT's indirect impact on Veterans' psychosocial functioning and PTSD/depression symptomology Change in functioning, quality of life, and well-being & PTSD and depression will be associated with improvement in the idiosyncratic clinical challenges targeted by the CF.
This study will also examine between-group differences across secondary outcomes (e.g. anger, anxiety, health concerns, sleep, numbing/reactivity) and describe the frequency and type of the clinical and rehabilitative needs of the Veterans and the type and duration of divergences (e.g. rehabilitative techniques) made by providers.
详细描述
Posttraumatic stress disorder (PTSD) is common and complicated. Recent estimates suggest that over 610,000 US Veterans treated by the Veterans Health Administration (VHA) suffer from posttraumatic stress disorder (PTSD), a disorder that can be chronic and debilitating. The heterogeneity of the 20 symptoms of PTSD; comorbidity with disorders such as depression, panic, and substance use; high rates of concurrent and lingering effects of physical injury, and suicidality all contribute to complex clinical presentations and can exact a significant toll on functioning, quality of life, and well-being decades after exposure to the trauma. The complex and enduring challenges inherent in PTSD and their effect on patients' functioning pose significant hurdles for patients and clinicians.
Impairments in psychosocial functioning are an important, but less well-attended, facet of PTSD. While significant impairment in functioning is clearly a requirement for the diagnosis of PTSD as indicated by Criterion G of the diagnostic criteria for PTSD, resolution of functional impairment is not considered to be a primary therapeutic target in evidence-based PTSD treatment protocols. Improvements in domains of functioning and, more broadly, quality of life and well-being, are most typically considered secondary outcomes in RCTs, if they are reported at all. This seeming lack of attention to impairments in functioning stands in stark contrast to patients' reports of the meaningfulness of these impairments in their lives. In fact, it is often precisely these types of impairments that drive patients suffering from PTSD to seek treatment, arguably more so than the 20 core symptoms of the disorder.
Researchers and providers alike recognize the importance of well-being and seek to maximize functional recovery. It has theoretically been difficult to directly target impairment in functioning (PTSD Criterion G) in manualized therapies, perhaps because "functional impairment" is quite variable across patients in breadth and scope. Including explicit and manualized instruction on "treating functional impairment" is impossible and is likely the reason that no single PTSD psychotherapy exists that is specifically designed to "treat" functional recovery. Trauma-focused EBPs instead are specifically designed to directly target the core symptoms of PTSD. Functional impairment is targeted indirectly through relief in the core symptoms. For example, improvement in occupational functioning may be achieved through decreases in avoidance, mood or anger symptoms that might be interfering with job performance. Gains in functioning (e.g. improving marital relations or workplace functioning) and large effects in well-being and quality of life have historically been difficult to operationalize and are often considered more longterm therapeutic goals, perhaps beyond the scope of brief therapies. However, given the importance of functioning to patients with PTSD, intentionally and thoughtfully building on the success of the skills acquired in evidence-based psychotherapies (EBPs) and expanding those skills to specifically target functional outcomes warrants further exploration.
Cognitive Processing Therapy (CPT) is effective at reducing PTSD symptoms and is widely used. CPT is one of the therapies with the most accumulated empirical support to date. Recent meta-analyses indicate that CPT has the largest effect size of existing evidence-based treatments for PTSD in soldiers and Veterans and across trauma populations (mean ES = 1.69). The effectiveness of CPT extends across patient populations suffering from a range of comorbid conditions including TBI, chronic child abuse histories, comorbid psychiatric and substance use disorders, and ongoing peritraumatic situations. CPT has been designated a first-line treatment in a number of clinical guidelines, including the VHA / Department of Defense (DoD) PTSD Clinical Practice Guidelines. Since 2007, VHA has dedicated substantial resources and effort to the historic, large-scale dissemination of CPT via the Mental Health Dissemination Initiative. To date, over 4,150 VHA providers have been trained in CPT and at least 20,774 Veterans have begun CPT in the last year. Yet the impact of CPT on both PTSD symptoms and psychosocial functioning can be improved.
Veterans with PTSD present to treatment with challenges in psychosocial functioning and other clinical complexities; the failure of manualized treatments for PTSD to provide guidance on how to address these concerns is negatively impacting outcomes. Nearly all (87%) Veterans with PTSD presenting to VHA primary care have at least one comorbid psychiatric condition and, on average, Veterans with PTSD had 2.95 comorbid mental health diagnoses and over 50% reported suicidal ideation. Across trauma populations, PTSD is associated with severe impairments in social and occupational functioning, exerting a more deleterious effect than most mental health diagnoses. Clinical presentations in Veterans suffering from PTSD are further complicated by a host of psychosocial stressors, impairments in major domains of functioning, and comorbid physical conditions. Veterans are more likely to be homeless, be under- or unemployed, and have poor physical health status as compared to non-Veterans. Prior work suggests that unaddressed difficulties in these domains contributes to suboptimal outcomes and premature dropout from CPT among Veterans. The investigators posit that frontline treatments for PTSD must be expanded to directly and intentionally target functional impairments and improve holistic outcomes.
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
- Single (Outcomes Assessor)
盲法说明
Independent evaluators will be blind to treatment condition.
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
- •Veterans with posttraumatic stress disorder (PTSD)
排除标准
- •Study exclusion criteria include active suicidal ideation with intent, homicidality, current mania, psychosis, or serious drug or alcohol abuse that requires immediate medical attention (e.g. inpatient care)
- •Patients should not be participating in another trauma-focused therapy at the time of enrollment but can continue any psychiatric medications (dose must be stable for one month prior to enrollment)
研究组 & 干预措施
Case Formulation plus Cognitive Processing Therapy
The CF approach alters the CPT protocol in two ways: expanding the protocol to intentionally and systematically address impairment in functioning, and enhancing the providers' latitude to navigate challenges to optimal therapy outcomes (COTOS). CF-CPT begins with a formal CF assessment session; elements of CF are then integrated throughout CPT. CF modifications to the original CPT protocol occur in each session by intentionally attending to cognitions that are impeding the patient's functional recovery. The second modification includes enhancing the provider's latitude to diverge from the protocol when clinically wise. CF-CPT provides guidance around the identification, monitoring and management of COTOs, and, importantly, the expedient return to the CPT protocol with continued attention to COTOs.
干预措施: Case Formulation plus Cognitive Processing Therapy (Behavioral)
Cognitive Processing Therapy
CPT is a brief therapy for PTSD predominantly based on cognitive theory. Traditionally delivered over 12 one-hour sessions weekly or twice weekly, CPT is now variable length depending on patient's recovery from PTSD. CPT is delivered in three phases: education, processing, and challenging and focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Changing dysfunctional beliefs alters negative emotions emanating from those beliefs.
干预措施: Cognitive Processing Therapy (Behavioral)
结局指标
主要结局
Inventory of Psychosocial Functioning (assessing change over time)
时间窗: Assesses functioning over the 30 days prior to baseline assessment, change between baseline and session 6, change over following treatment (post-treatment), and at the 3-month follow-up interval.
This standardized self-report instrument assesses PTSD-related psychosocial functioning. The IPF is an 80-item self-report questionnaire of functional impairment across several domains including relationships, work, parenting, education, and general daily functioning over the past 30 days. Domain scores can range from 0 to 100 with higher values corresponding to higher functioning. Overall functioning score was calculated as the mean of all completed IPF domain scores. As participants may skip certain domains that do not apply to them (thus leading to different sample sizes for analyses predicting different domains of functioning), overall score was calculated as total sum of all completed IPF domain scores divided by the actual number of domains completed by the participant.
Clinician-Administered PTSD Scale-5 (CAPS) (assessing change over time)
时间窗: Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.
The CAPS is a 30-item structured interview that corresponds to the DSM-5 criteria for PTSD. The CAPS will be used to make a current (past month) and lifetime diagnosis of PTSD. In addition to assessing the 20 PTSD symptoms, questions target the impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and frequency and intensity of five associated symptoms. For each item, standardized questions and probes are provided. CAPS-5 diagnosis demonstrated strong interrater reliability, and test-retest reliability, as well as strong correspondence with a diagnosis based on the CAPS for DSM-IV. CAPS-5 total severity score demonstrated high internal consistency, and interrater reliability, and good test-retest reliability, and good discriminant validity with measures of anxiety, depression, somatization, functional impairment, psychopathy, and alcohol abuse.
次要结局
- WHO - Disability Assessment Schedule 2.0 (WHODAS-II) (assessing change over time)(Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.)
- WHO - Quality of Life - Brief (assessing change over time)(Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.)
- Well-Being Inventory (WBI) (assessing change over time)(Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.)
- PTSD Checklist-DSM-5 (PCL-5) (assessing change over time)(Administered at baseline, weekly (during treatment) mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.)
- Patient Health Questionnaire - 9 (assessing change over time)(Administered at baseline, weekly (during treatment), mid-treatment (after session 6), two weeks following treatment (post-treatment), and at the 3-month follow-up interval.)
- session progress notes (assessing change over time)(Session progress notes will be written by clinician following each weekly treatment session through study completion (an average of three months). This will reflect participant change and progress over the course of the week as well as current status.)
- DSM-5 Cross-cutting symptom measure (CCSM) (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- Weekly stress inventory (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- Veterans Rand Short Form (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- Pittsburgh Sleep Quality Index (PSQI) (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- PEG measure (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- State-Trait Anxiety Inventory (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- Emotional Reactivity and Numbing Scale (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- Dimensions of Anger Reactions (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- Beck Suicidal Ideation Scale (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- Brief Addiction Monitor (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- University of Rhode Island Change Assessment (assessing change over time)(Administered at baseline, mid-treatment (after session 6), and two weeks following treatment (post-treatment).)
- Daily monitoring diary (assessing change over time)(Administered at baseline, daily throughout therapy, and two weeks following treatment (post-treatment).)
- PhenX Demographic Questionaire(Administered at baseline.)
- Life Events Checklist 5 (assessing change over time)(Administered at baseline, mid-treatment (after session 6), two weeks following treatment (post-treatment), and three months following treatment. .)
- Trauma Interview(Administered at baseline)
