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

NCT06957067 | Recruiting DMC

• 2 other identifiers: 1806524-49HT94252410639
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 4

Brief Summary

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. 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. 2.to compare two approaches to identifying individuals in CPT in need of additional support during treatment;
3. 3.to study the barriers and facilitators of implementing these intervention strategies.

Conditions

Post Traumatic Stress Disorder

Keywords

Cognitive Processing Therapy; Post Traumatic Stress Disorder; Trauma-focused treatments; Veterans

Outcome Measures

Primary Outcomes (1)

• PTSD severity (via structured clinical interview)

  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.

  Baseline, through six-months after treatment completion. Treatment completion takes an average of 4 months.

Secondary Outcomes (4)

• 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.

Study Arms (4)

Catchall

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Processing Therapy; Behavioral: Measurement Based Care

Targeted

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Processing Therapy; Behavioral: Measurement Based Care

CPT Skills

ACTIVE COMPARATOR

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.

Behavioral: CPT Skills; Behavioral: Cognitive Processing Therapy

Consider Switching

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Processing Therapy; Behavioral: Present Centered Therapy; Behavioral: Shared Decision Making

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.

CPT Skills

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.

CPT Skills; Catchall; Consider Switching; Targeted

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.

Consider Switching

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.

Consider Switching

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).

Catchall; Targeted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Department of Defense: lead
• University of Minnesota: collaborator
• Lowcountry Center for Veterans Research: collaborator
• Baylor College of Medicine: collaborator
• Louisiana Veterans Research and Education Corporation: collaborator
• Mayo Clinic: collaborator
• Veterans Education and Research Association of Michigan: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator
• Center for Veterans Research and Education: collaborator
• New Orleans VA Medical Center: collaborator
• Boston VA Research Institute, Inc.: collaborator
• Arizona Veterans Research and Education Foundation: collaborator
• Ocean State Research Institute, Inc.: collaborator
• Veterans Education and Research Association of Northern New England, Inc: collaborator
• Michael E. DeBakey VA Medical Center: collaborator
• Phoenix VA Health Care System: collaborator
• Charleston VA Medical Center: collaborator

Study Sites (4)

VA Phoenix Health Care System

Phoenix, Arizona, 85012, United States

RECRUITING

New Orleans VA Medical Center

New Orleans, Louisiana, 70119, United States

RECRUITING

Ralph H. Johnson VA Health Care System (Charleston VA)

Charleston, South Carolina, 29401, United States

RECRUITING

VA Houston Healthcare System

Houston, Texas, 77030, United States

RECRUITING

Related Publications (12)

• Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214.

  PMID: 15677582 BACKGROUND

• Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.

  PMID: 26241600 BACKGROUND

• Maguen S, Li Y, Madden E, Seal KH, Neylan TC, Patterson OV, DuVall SL, Lujan C, Shiner B. Factors associated with completing evidence-based psychotherapy for PTSD among veterans in a national healthcare system. Psychiatry Res. 2019 Apr;274:112-128. doi: 10.1016/j.psychres.2019.02.027. Epub 2019 Feb 11.

  PMID: 30784780 BACKGROUND

• Nahum-Shani I, Almirall D, Yap JRT, McKay JR, Lynch KG, Freiheit EA, Dziak JJ. SMART longitudinal analysis: A tutorial for using repeated outcome measures from SMART studies to compare adaptive interventions. Psychol Methods. 2020 Feb;25(1):1-29. doi: 10.1037/met0000219. Epub 2019 Jul 18.

  PMID: 31318231 BACKGROUND

• Meis LA, Polusny MA, Kehle-Forbes SM, Erbes CR, O'Dougherty M, Erickson EPG, Orazem RJ, Burmeister LB, Spoont MR. Making sense of poor adherence in PTSD treatment from the perspectives of veterans and their therapists. Psychol Trauma. 2023 May;15(4):715-725. doi: 10.1037/tra0001199. Epub 2022 Mar 24.

  PMID: 35324228 BACKGROUND

• Lei H, Nahum-Shani I, Lynch K, Oslin D, Murphy SA. A "SMART" design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012;8:21-48. doi: 10.1146/annurev-clinpsy-032511-143152. Epub 2011 Dec 12.

  PMID: 22224838 BACKGROUND

• Maguen S, Holder N, Madden E, Li Y, Seal KH, Neylan TC, Lujan C, Patterson OV, DuVall SL, Shiner B. Evidence-based psychotherapy trends among posttraumatic stress disorder patients in a national healthcare system, 2001-2014. Depress Anxiety. 2020 Apr;37(4):356-364. doi: 10.1002/da.22983. Epub 2019 Dec 18.

  PMID: 31850650 BACKGROUND

• Kehle-Forbes SM, Ackland PE, Spoont MR, Meis LA, Orazem RJ, Lyon A, Valenstein-Mah HR, Schnurr PP, Zickmund SL, Foa EB, Chard KM, Alpert E, Polusny MA. Divergent experiences of U.S. veterans who did and did not complete trauma-focused therapies for PTSD: A national qualitative study of treatment dropout. Behav Res Ther. 2022 Jul;154:104123. doi: 10.1016/j.brat.2022.104123. Epub 2022 May 21.

  PMID: 35644083 BACKGROUND

• Meis LA, Noorbaloochi S, Hagel Campbell EM, Erbes CR, Polusny MA, Velasquez TL, Bangerter A, Cutting A, Eftekhari A, Rosen CS, Tuerk PW, Burmeister LB, Spoont MR. Sticking it out in trauma-focused treatment for PTSD: It takes a village. J Consult Clin Psychol. 2019 Mar;87(3):246-256. doi: 10.1037/ccp0000386.

  PMID: 30777776 BACKGROUND

• Howard KP, Spoont MR, Polusny MA, Eftekhari A, Rosen CS, Meis LA. The role of symptom accommodation in trauma-focused treatment engagement and response. J Trauma Stress. 2023 Jun;36(3):524-536. doi: 10.1002/jts.22912. Epub 2023 Feb 13.

  PMID: 36782380 BACKGROUND

• Belsher BE, Beech E, Evatt D, Smolenski DJ, Shea MT, Otto JL, Rosen CS, Schnurr PP. Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2019 Nov 18;2019(11):CD012898. doi: 10.1002/14651858.CD012898.pub2.

  PMID: 31742672 BACKGROUND

• Holliday R, Holder N, Monteith LL, Suris A. Decreases in Suicide Cognitions After Cognitive Processing Therapy Among Veterans With Posttraumatic Stress Disorder Due to Military Sexual Trauma: A Preliminary Examination. J Nerv Ment Dis. 2018 Jul;206(7):575-578. doi: 10.1097/NMD.0000000000000840.

  PMID: 29905663 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Laura Meis, PhD

  Women's Health Sciences Division of the National Center for PTSD; University of Minnesota

  PRINCIPAL INVESTIGATOR

• Princess Ackland, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily M Hudson, PhD

CONTACT

612-629-7262; emily.hudson@va.gov

Donald Lemon

CONTACT

(612) 467-1957; donald.lemon2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Investigators will use a two-stage sequential, multiple assignment, randomized trial design (SMART) in which all participants beginning CPT are randomized to a first-stage intervention. In this first-stage, providers use one of two approaches to decision rules to identify patients who may be experiencing challenges in CPT (Catchall vs Targeted). The tailoring variables used in these decision rules will include weekly self-report measures and behavioral indicators. Investigators will evaluate if a participant meets criteria for their assigned decision rules every week during treatment. If individuals meet their decision rule criteria, participants will be randomized again to a second-stage intervention. For the second stage, providers will meet with their patients to either collaboratively consider switching to Present Centered Therapy or to discuss any problems they may be having with treatment using existing CPT skills, per randomization.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: May 4, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (4)