CPT-Text for Post-Traumatic Stress Disorder

(CPT-TEXT Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Shannon Wiltsey-Stirman, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Disqualifiers: Suicidal risk, Psychosis, Substance abuse

No Placebo Group

Trial Summary

What is the purpose of this trial?

There is a pressing need to increase capacity to treat PTSD related to or exacerbated by the COVID-19 pandemic. Texting-based therapy holds promise to increase capacity and reduce barriers to delivering evidence-based treatments (EBTs), but ongoing engagement in digital mental health interventions is low. This study will compare a texting-based EBT for PTSD to culturally-informed texting-based treatment for PTSD as usual, and it will also compare a unique incentive strategy to typical platform reminders aimed to prevent early discontinuation in therapy. This online study is open to individuals who live in 13 different states.

Do I need to stop my current medications for this PTSD trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on texting-based therapy, so you might not need to change your medication routine, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the treatment CPT-Text for Post-Traumatic Stress Disorder?

Cognitive Processing Therapy (CPT) has been shown to significantly reduce PTSD symptoms in various populations, including sexual assault survivors and combat veterans, with improvements maintained over time. Studies indicate that CPT is effective in diverse settings and cultural adaptations, suggesting its potential effectiveness when delivered via text.

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Is CPT-Text safe for humans?

Cognitive Processing Therapy (CPT) is generally considered safe for treating post-traumatic stress disorder (PTSD) in various settings, including telehealth and culturally adapted formats. While specific safety data for CPT-Text is not available, CPT itself is widely regarded as a safe treatment.

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How is the CPT-Text treatment for PTSD different from other treatments?

CPT-Text is unique because it delivers Cognitive Processing Therapy (CPT) through text messages, making it more accessible and convenient for patients who may not be able to attend in-person sessions. This approach allows for culturally informed trauma treatment, which can be tailored to the individual's cultural background and needs.

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Eligibility Criteria

This trial is for adults in the US with significant PTSD symptoms that started or worsened during COVID-19. Participants must score 33+ on the PCL-5, have experienced a Criterion A event, be registered on Talkspace for therapy, and own a texting device. It's not open to those with acute psychosis, substance abuse needing higher care level, or high suicide risk.

Inclusion Criteria

Registered/registering on Talkspace for messaging-based therapy

I live in a state where Talkspace offers therapy services.

I have severe PTSD symptoms, scoring 33 or higher on a specific test.

Exclusion Criteria

Acute risk for suicidal thoughts and/or behaviors measured by the Columbia Suicide Severity Rating Scale Lifetime-Recent Screen

Psychosis or substance abuse that requires prioritization of treatment and/or higher level of care

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Onboarding

Participants undergo onboarding with their therapist, including introduction and establishing treatment goals

1 week

Treatment

Participants receive active texting intervention for PTSD using CPT-Text or CITT over a secure platform

12 weeks

Asynchronous text-based communication

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Participant Groups

The study tests two PTSD treatments delivered via text: Culturally Informed Trauma Treatment (CITT) and CPT-Text against usual reminders. It also examines if incentives help patients stick with therapy longer compared to standard platform reminders.

Group I: CPT-Text + Reminder As Usual Experimental Treatment 2 Interventions

CPT-Text. CPT is a 12-session, trauma-focused, cognitive therapy that teaches clients to examine and change problematic beliefs about themselves and the world that were altered as a result of trauma. Reminder as Usual (RAU). As per Talkspace guidelines, therapists are available to client participants twice per day, five days per week. In the event a client participant has not engaged or messaged in 48 hours, therapists send a personalized message to the client participant to encourage them to re-engage.

Group II: CPT-Text + Incentive Experimental Treatment 2 Interventions

CPT-Text. CPT is a 12-session, trauma-focused, cognitive therapy that teaches clients to examine and change problematic beliefs about themselves and the world that were altered as a result of trauma. Retention Incentive (RI). Participants will be told at baseline that they can earn discounts for other users with PTSD if they message with their therapist regularly.

Group III: Culturally Informed Trauma Treatment (CITT) + Incentive Active Control 2 Interventions

CITT will be conducted by Talkspace therapists with a specialty in PTSD culturally informed PTSD treatment. Retention Incentivefor other users with PTSD in subsequent months if they message with their therapist regularly.

Group IV: CITT+ Reminder as Usual Active Control 2 Interventions

CITT will be conducted by Talkspace therapists with a specialty in culturally informed PTSD treatment. Reminder as Usual (RAU). As per Talkspace guidelines, therapists are available to client participants twice per day, five days per week. In the event a client participant has not engaged or messaged in 48 hours, therapists send a personalized message to the client participant to encourage them to re-engage.

CPT-Text is already approved in United States for the following indications:

🇺🇸 Approved in United States as CPT-Text for:

• Posttraumatic Stress Disorder (PTSD)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Talkspace LLC New York, NY

University of Texas Health Sciences Center at San Antonio San Antonio, TX

Stanford University Palo Alto, CA

Who Is Running the Clinical Trial?

Stanford University Lead Sponsor

The University of Texas Health Science Center at San Antonio Collaborator

Talkspace Industry Sponsor

National Institute of Mental Health (NIMH) Collaborator

University of Pennsylvania Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study. [2019] Cognitive processing therapy (CPT) is widely regarded as a safe and effective first-line treatment for individuals with post-traumatic stress disorder (PTSD); however, no comparative studies have been conducted to examine the treatment outcomes in an Asian population. The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients.

2. United States pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. [2022] Clinical practice guidelines suggest that cognitive behavioral therapies are recommended for the treatment of posttraumatic stress disorder (PTSD). One of these treatments, cognitive processing therapy (CPT), is an evidence-based treatment that has been shown to be effective at treating combat, assault, and interpersonal violence trauma in randomized controlled trials. The Department of Veterans Affairs (VA) Office of Mental Health Services has implemented an initiative to disseminate CPT as part of a broad effort to make evidence-based psychotherapies widely available throughout the VA healthcare system. This article provides an overview of CPT and reviews the efficacy and program evaluation data supporting its use in a variety of settings. In addition, we report on survey data from individuals who have participated in the VA initiative and on outcome data from patients treated by rollout-trained therapists. Our data suggest that many clinicians trained in the rollout show good adoption of the CPT model and demonstrate solid improvements in their patients' PTSD and depressive symptomotology. Finally, we offer recommendations for using CPT in clinical settings.

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. [2019] Cognitive processing therapy (CPT) is an exposure-based protocol designed to reduce posttraumatic stress disorder (PTSD) symptoms and challenge faulty beliefs and interpretations that prevent trauma survivors from coming to terms with their traumatic experiences. This article provides a brief summary of this treatment and the related literature and describes how the CPT protocol was modified to implement this treatment in this study's setting. Also provided is a discussion of various institutional and intrapatient barriers that existed before the introduction of CPT and how these difficulties were ultimately resolved. Patients' responses to treatment, as indicated by both qualitative and quantitative data, are also reviewed. A total of 18 patients participated and completed treatment with CPT (50% Caucasian, 22.2% African American, 16.7% biracial, 5.6% Native American, and 5.6% Hispanic). Overall, the women participating in the protocol benefited greatly, and 15 of the 18 women had a statistically significant reduction in scores measuring PTSD symptoms. The article concludes with recommendations to other programs and providers interested in providing CPT to similar treatment populations. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for sexual assault victims. [2022] Cognitive processing therapy (CPT) was developed to treat the symptoms of posttraumatic stress disorder (PTSD) in rape victims. CPT is based on an information processing theory of PTSD and includes education, exposure, and cognitive components. Nineteen sexual assault survivors received CPT, which consists of 12 weekly sessions in a group format. They were assessed at pretreatment, posttreatment, and 3- and 6-month follow-up. CPT subjects were compared with a 20-subject comparison sample, drawn from the same pool who waited for group therapy for at least 12 weeks. CPT subjects improved significantly from pre- to posttreatment on both PTSD and depression measures and maintained their improvement for 6 months. The comparison sample did not change from the pre- to the posttreatment assessment sessions.

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive Processing Therapy for Spanish-speaking Latinos: A Formative Study of a Model-Driven Cultural Adaptation of the Manual to Enhance Implementation in a Usual Care Setting. [2022] As part of a larger implementation trial for cognitive processing therapy (CPT) for posttraumatic stress disorder (PTSD) in a community health center, we used formative evaluation to assess relations between iterative cultural adaption (for Spanish-speaking clients) and implementation outcomes (appropriateness and acceptability) for CPT.

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. [2022] Cognitive processing therapy (CPT), an evidence-based treatment for posttraumatic stress disorder (PTSD), has not been tested as an individual treatment among active-duty military. Group CPT may be an efficient way to deliver treatment.

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive Processing Therapy for Posttraumatic Stress Disorder via Telehealth: Practical Considerations During the COVID-19 Pandemic. [2022] The global outbreak of COVID-19 has required mental health providers to rapidly rethink and adapt how they provide care. Cognitive processing therapy (CPT) is a trauma-focused, evidence-based treatment for posttraumatic stress disorder that is effective when delivered in-person or via telehealth. Given current limitations on the provision of in-person mental health treatment during the COVID-19 pandemic, this article presents guidelines and treatment considerations when implementing CPT via telehealth. Based on lessons learned from prior studies and clinical delivery of CPT via telehealth, recommendations are made with regard to overall strategies for adapting CPT to a telehealth format, including how to conduct routine assessments and ensure treatment fidelity.