Reducing Dropout and Improving Outcomes From PTSD Therapy: When to Switch Therapies or Stay the Course

Conditions

• Post Traumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CPT Skills — BEHAVIORAL
  CPT trainings recommend that if an individual is experiencing challenges with the CPT protocol (e.g., ambivalence about continuing treatment or struggling with completing homework), the provider can apply the skills of CPT to that particular problem. Those skills include problem solving and cognitive restructuring to identify and alter maladaptive underlying beliefs. The purpose of this work is to address the individual's underlying problem or problematic beliefs to improve the individual's attitudes about CPT and/or improve the individual's compliance with treatment activities. The therapist's end-goal is to keep the individual moving forward in the CPT protocol.
• Cognitive Processing Therapy — BEHAVIORAL
  CPT 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. The treatment involves education about PTSD and skill building to identify and challenge maladaptive, trauma-related thinking through Socratic questioning and worksheets that teach individuals to challenge this thinking themselves. Later sessions focus on specific themes that are difficult for individuals with PTSD and can keep individuals "stuck" in their symptoms. Themes include safety, trust, control, self-esteem, and intimacy. Although the skills utilized in CPT may be used to respond to challenges individuals have with participating in CPT, the effectiveness of these strategies has not been explicitly tested.
• Present Centered Therapy — BEHAVIORAL
  PCT was developed as a comparator for "active" TFT, so protocol length typically matches the comparator. PCT focuses on "current life problems as manifestations of PTSD" in weekly 60-minute sessions. It includes psychoeducation and normalization of responses to trauma, problem solving related to life difficulties and stress, and emotional support and validation. Its hypothesized mechanisms are increased interpersonal connection and mastery in managing life stressors. Therapist skills include validation, support, and reflective listening. The first 2 sessions provide an overview and rationale for PCT. Subsequent sessions focus on topics participants choose and are less structured. Participants use a daily diary to record any concerning problems or issues they experience during the week. These diaries are used to select session topics.
• Shared Decision Making — BEHAVIORAL
  Shared decision making (SDM) is widely considered the best model for achieving patient-provider agreement on treatment plans and an ethical imperative for decision making. SDM is a communicative process in which patients and their provider personalize treatment approaches to the individual, their situation, and the problems that they are experiencing. Providers and patients engage in a shared deliberation of meaningful treatment alternatives, including pros and cons, how choices align or misalign with values, and patients' abilities to complete the plans under consideration.
• Measurement Based Care — BEHAVIORAL
  Investigators will compare methods of identifying individuals experiencing challenges in CPT. Investigators will use self-report measures administered each week during treatment to identify individuals who may be struggling in during CPT and compare two approaches to cut scores on these measures to classify individuals as "in need of intervention." Investigators will also use behavioral indices to determine if veterans are in need of intervention, including homework compliance and session attendance. One approach will liberally classify many individuals as "in need of intervention" (Catchall), while the other will take a more targeted approach (Targeted).

Study Details

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: 1. 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; 2. to compare two approaches to identifying individuals in CPT in need of additional support during treatment; 3. 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.

Key Dates

Start date

Mar 17, 2025

Status verified

Apr 2025

Primary completion

May 31, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

280 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: 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.
• Active Comparator: 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.
• Active Comparator: 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.
• Active Comparator: 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.

Primary Outcome Measure

PTSD severity (via structured clinical interview) [ Time Frame: Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months. ]

Central Contacts

• Emily M Hudson, PhD
  612-629-7262
  [email protected]
• Donald Lemon
  (612) 467-1957
  [email protected]

Locations (4)

Find similar trials in Phoenix, AZ

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