Reducing Dropout and Improving Outcomes From PTSD Therapy: When to Switch Therapies or Stay the Course
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 8
- 主要终点
- PTSD severity (via structured clinical interview)
研究概览
简要总结
Investigators' overall objective is to compare methods of identifying individuals who may be experiencing challenges in Cognitive Processing Therapy (CPT) and compare methods of intervening to optimize treatment retention and outcomes. Investigators' specific aims are:
- to determine whether the use of CPT skills versus collaboratively considering switching to Present Centered Therapy (PCT) is more effective in improving outcomes for individuals experiencing challenges with CPT. Outcomes include post-traumatic stress disorder (PTSD) severity [primary], depression, functioning, and treatment retention;
- to compare two approaches to identifying individuals in CPT in need of additional support during treatment;
- to study the barriers and facilitators of implementing these intervention strategies.
Finally, exploratory aims will examine the stability of differences between treatment conditions, compare combinations of interventions tested, and examine moderators of intervention effects.
详细描述
Background: Trauma-focused treatments (TFTs) for PTSD, including Cognitive Processing Therapy (CPT), result in clinically significant symptom relief for many. However, they are not equally effective for everyone, and an important subgroup will discontinue before fully completing therapy. Identifying this subgroup is an important, but elusive, first step. In their prior work, investigators found Veterans were often unlikely to tell providers about the nature and extent of the challenges they experienced while trying to effectively participate in TFTs. Use of behavioral and attitudinal indices that do not rely on individuals' willingness to speak up in session may help providers identify with whom to intervene. Using weekly measures, investigators will compare two approaches to cut scores to classify individuals as "in need of intervention." One will liberally classify many individuals (Catchall); the other will take a more targeted approach (Targeted). For the present study, investigators will focus on CPT, as it is the most widely disseminated TFT in VA and DoD.
Once investigators have used the above approaches to identify individuals who may need additional support and help with CPT, an important next question is what is the most effective way to intervene with these individuals. TFTs have built in strategies for flexing the treatments to help patients who are experiencing challenges in treatment. These strategies are of unknown efficacy. Alternatively, patients and their therapists could consider switching to a different form of therapy besides TFTs. Present Centered Therapy (PCT) may be a well-suited alternative. While PCT is somewhat less effective than TFTs, it has solid evidence of efficacy. There is no reflection on past trauma, homework demands are modest, and it has superior completion rates to TFTs. Starting with CPT and then considering switching to PCT, is a potentially promising pathway to ensure individuals who are challenged by CPT complete an effective treatment. Given the efficacy differences between CPT and PCT, switching should be done collaboratively between patients and providers (versus forcing all participants to PCT). This ensures the choice to switch is patient-centered, relevant to real-world care, and consistent with Veteran end-users' recommendations.
Objectives/Aims: Investigators overall objective is to compare methods of identifying individuals who may be experiencing difficulties with CPT and compare methods of intervening to optimize treatment retention and outcomes. Investigators will use weekly measures developed with Veteran end-users to identify individuals who could benefit from intervention. When identified, providers will either use CPT skills to address participants' treatment challenges or collaboratively consider switching to PCT.
Investigators' specific aims are:
- to determine whether the use of CPT skills versus collaboratively considering switching to PCT is more effective in improving outcomes for individuals experiencing challenges with CPT. Outcomes include PTSD severity [primary], depression, functioning, and treatment retention;
- to compare two approaches (Catchall versus Targeted) to identifying individuals in CPT in need of additional support;
- to study the barriers/facilitators of implementing these intervention strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 interested in outpatient VA psychotherapy for PTSD
- •Meets DSM-5 criteria for PTSD
- •Be able to provide informed consent
- •Be willing to be randomized
- •Agree to not receive non-study psychotherapy for PTSD during study treatment (case management, supportive therapy/group, and concurrent substance use treatment are allowable)
排除标准
- •Severe cognitive impairment
- •Current suicidal or homicidal intent with a specific plan
- •Uncontrolled psychotic or manic symptoms
- •A psychiatric medication change in the past month
- •A severe SUD as diagnosed by the DSM-5
研究组 & 干预措施
Catchall
The Catchall approach to identifying individuals in need of intervention is intended to provide a generous, all-inclusive approach to identifying anyone who might have some concerns about their experiences with Cognitive Processing Therapy (CPT) and may benefit from discussing these concerns. The goal of this approach is to err on the side of intervening within anyone who may be experiencing challenges with the therapy. This approach assumes that spending a session talking about any concerns or struggles patients are having will help with patient-provider communication, improve attitudes about treatment, and improve treatment retention and outcomes.
干预措施: Cognitive Processing Therapy (Behavioral)
Catchall
The Catchall approach to identifying individuals in need of intervention is intended to provide a generous, all-inclusive approach to identifying anyone who might have some concerns about their experiences with Cognitive Processing Therapy (CPT) and may benefit from discussing these concerns. The goal of this approach is to err on the side of intervening within anyone who may be experiencing challenges with the therapy. This approach assumes that spending a session talking about any concerns or struggles patients are having will help with patient-provider communication, improve attitudes about treatment, and improve treatment retention and outcomes.
干预措施: Measurement Based Care (Behavioral)
Targeted
The Targeted approach to identifying individuals is intended to capture a narrower band of participants with clearer concerns about Cognitive Processing Therapy (e.g., at least one of their self-report scale scores is similar to or worse than patients who ultimately dropped out of CPT treatment in investigators' pilot data). Providers are more likely to miss some participants who may benefit from intervention through this approach but are less likely to unintentionally undermine CPT for participants who did not need intervention.
干预措施: Cognitive Processing Therapy (Behavioral)
Targeted
The Targeted approach to identifying individuals is intended to capture a narrower band of participants with clearer concerns about Cognitive Processing Therapy (e.g., at least one of their self-report scale scores is similar to or worse than patients who ultimately dropped out of CPT treatment in investigators' pilot data). Providers are more likely to miss some participants who may benefit from intervention through this approach but are less likely to unintentionally undermine CPT for participants who did not need intervention.
干预措施: Measurement Based Care (Behavioral)
CPT Skills
Cognitive Processing Therapy is a 12-session, cognitive-behavioral treatment for PTSD that focuses on challenging and modifying maladaptive beliefs related to prior trauma. The goal is to build a new understanding of prior trauma in order to limit the negative influence trauma and it's reminders have on individuals' daily lives. CPT has built in strategies to address any challenges patients participating in the therapy. The degree to which these strategies are more effective than other approaches to addressing treatment challenges (e.g., switching to another therapy) are unknown.
干预措施: CPT Skills (Behavioral)
CPT Skills
Cognitive Processing Therapy is a 12-session, cognitive-behavioral treatment for PTSD that focuses on challenging and modifying maladaptive beliefs related to prior trauma. The goal is to build a new understanding of prior trauma in order to limit the negative influence trauma and it's reminders have on individuals' daily lives. CPT has built in strategies to address any challenges patients participating in the therapy. The degree to which these strategies are more effective than other approaches to addressing treatment challenges (e.g., switching to another therapy) are unknown.
干预措施: Cognitive Processing Therapy (Behavioral)
Consider Switching
When patients are experiencing challenges with PTSD therapy, providers and their patients will consider switching from CPT to Present Centered Therapy. While PCT is somewhat less effective than CPT, it has solid evidence that it improves symptoms of PTSD. There is also no reflection on past trauma, homework demands are modest, and it has superior completion rates to CPT. Starting with a CPT and then considering switching to PCT, is a promising pathway to ensure individuals struggling in CPT complete an effective treatment. Given the efficacy differences between CPT and PCT, switching will be done collaboratively between patients and providers using shared decision making (versus requiring all patients to switch to PCT). This ensures the choice to switch is patient-centered and relevant to how these decisions would be made in real-world care.
干预措施: Cognitive Processing Therapy (Behavioral)
Consider Switching
When patients are experiencing challenges with PTSD therapy, providers and their patients will consider switching from CPT to Present Centered Therapy. While PCT is somewhat less effective than CPT, it has solid evidence that it improves symptoms of PTSD. There is also no reflection on past trauma, homework demands are modest, and it has superior completion rates to CPT. Starting with a CPT and then considering switching to PCT, is a promising pathway to ensure individuals struggling in CPT complete an effective treatment. Given the efficacy differences between CPT and PCT, switching will be done collaboratively between patients and providers using shared decision making (versus requiring all patients to switch to PCT). This ensures the choice to switch is patient-centered and relevant to how these decisions would be made in real-world care.
干预措施: Present Centered Therapy (Behavioral)
Consider Switching
When patients are experiencing challenges with PTSD therapy, providers and their patients will consider switching from CPT to Present Centered Therapy. While PCT is somewhat less effective than CPT, it has solid evidence that it improves symptoms of PTSD. There is also no reflection on past trauma, homework demands are modest, and it has superior completion rates to CPT. Starting with a CPT and then considering switching to PCT, is a promising pathway to ensure individuals struggling in CPT complete an effective treatment. Given the efficacy differences between CPT and PCT, switching will be done collaboratively between patients and providers using shared decision making (versus requiring all patients to switch to PCT). This ensures the choice to switch is patient-centered and relevant to how these decisions would be made in real-world care.
干预措施: Shared Decision Making (Behavioral)
结局指标
主要结局
PTSD severity (via structured clinical interview)
时间窗: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.
Measured using the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (CAPS-5). This standardized interview is conducted by an evaluator blinded to study condition, via telehealth.
次要结局
- Depression severity(Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.)
- PTSD severity (via self report)(Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.)
- Psychosocial functioning (IPF scores)(Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.)
- Treatment completion(At the end of treatment. Treatment takes an average of 4 months.)
研究者
Laura A. Meis
Principal Investigator
University of Minnesota
