CPT-Text for Post-Traumatic Stress Disorder

(CPT-TEXT Trial)

Not currently recruiting at 2 trial locations

Overseen By Katy Dondanville, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Suicidal risk, Psychosis, Substance abuse

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores texting-based therapy to treat PTSD (Post-Traumatic Stress Disorder) symptoms that began or worsened during the COVID-19 pandemic. It compares two texting treatments: CPT-Text (Cognitive Processing Therapy via Text), which focuses on changing negative beliefs from trauma, and culturally-informed therapy. The study also examines whether incentives or regular reminders improve therapy adherence. It suits individuals with significant PTSD symptoms who started using Talkspace, own a texting device, and reside in a state where therapists are available on the platform. As an unphased trial, this study provides a unique opportunity to explore innovative therapy methods for PTSD.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that Cognitive Processing Therapy (CPT) is a safe treatment for PTSD. As one of the most researched therapies, studies have found no major safety concerns. People tend to continue with CPT, whether in person or online, indicating they handle it well.

Research also shows that culturally informed trauma treatment (CITT) is safe. Although less data exists specifically on CITT, therapies that consider cultural backgrounds have generally been effective in treating PTSD without major safety issues. Focusing on cultural understanding might make treatment more comfortable for people from different backgrounds.

Both therapies involve talking and help individuals work through their trauma. They are non-invasive, meaning they don't involve medication or medical procedures, which usually makes them safer options for treating PTSD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CPT-Text for PTSD because it offers a unique, text-based approach to cognitive therapy, allowing participants to engage with the treatment at their own pace, unlike traditional face-to-face therapy sessions. This method can provide greater flexibility and accessibility, particularly for those who may struggle with attending in-person sessions regularly. Additionally, the incorporation of retention incentives, which rewards consistent engagement, is designed to improve therapy adherence and outcomes. These features could make CPT-Text a convenient and effective alternative to current PTSD treatments.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Cognitive Processing Therapy (CPT), which participants in this trial may receive as CPT-Text, effectively treats PTSD. Many studies have found that CPT significantly reduces symptoms of PTSD, depression, and anxiety. It also improves quality of life and increases the likelihood of symptoms disappearing completely, making CPT one of the most studied and reliable treatments for PTSD.

Culturally Informed Trauma Treatment (CITT) is another treatment option in this trial. It adapts therapy to fit individuals' cultural backgrounds and has shown positive results in helping people from various cultures manage PTSD. This approach considers unique cultural symptoms and reactions to trauma, providing a treatment tailored to each person. ^{1 2 4 6 7}

Who Is on the Research Team?

Shannon Wiltsey-Stirman, PhD

Principal Investigator

Stanford University

Katy Dondanville, PsyD

Principal Investigator

University of Texas Health Sciences Center for San Antonio

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CPT-Text
• Culturally Informed Trauma Treatment (CITT)
• Reminder as Usual
• Retention Incentive
• Texting as Usual

Trial Overview 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.

How Is the Trial Designed?

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 (13 text-based modules), 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. Clients can work at their own pace. 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 Incentive for 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)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

The University of Texas Health Science Center at San Antonio

Collaborator

Trials

486

Recruited

92,500+

Talkspace

Industry Sponsor

Trials

5

Recruited

15,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Cognitive Processing Therapy (CPT) effectively reduced PTSD symptoms in a study of 18 patients, with 15 participants showing statistically significant improvements in their symptom scores.

The study highlights the successful adaptation of the CPT protocol to address specific barriers faced by trauma survivors, demonstrating its potential for broader implementation in similar treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. Zappert, LN., Westrup, D.[2019]

Cognitive Processing Therapy (CPT) significantly improved PTSD and depression symptoms in 19 sexual assault survivors after 12 weekly group sessions, with benefits maintained for 6 months post-treatment.

In contrast, a comparison group of 20 individuals who waited for therapy showed no improvement, highlighting the efficacy of CPT in treating PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for sexual assault victims. Resick, PA., Schnicke, MK.[2022]

Cognitive Processing Therapy (CPT) was culturally adapted for Spanish-speaking clients, leading to improved appropriateness and acceptability of the treatment, as assessed through qualitative data from 22 clients and 6 providers.

The study highlights the importance of integrating cultural adaptation with implementation science to effectively meet the PTSD treatment needs of diverse populations.

NCBI (Pubmed)

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. Valentine, SE., Borba, CP., Dixon, L., et al.[2022]

Cognitive processing therapy (CPT) is an effective treatment for posttraumatic stress disorder (PTSD) that can be successfully delivered through telehealth, making it adaptable during the COVID-19 pandemic.

The article provides guidelines for implementing CPT via telehealth, focusing on maintaining treatment quality and conducting assessments, which are crucial for effective mental health care in challenging circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Processing Therapy for Posttraumatic Stress Disorder via Telehealth: Practical Considerations During the COVID-19 Pandemic. Moring, JC., Dondanville, KA., Fina, BA., et al.[2022]

This study aims to evaluate the efficacy of Cognitive Processing Therapy (CPT) for treating PTSD in Japanese patients through a 16-week trial involving 58 participants, comparing CPT combined with usual treatment against usual treatment alone.

The primary outcome will be measured using the Clinician-Administered PTSD Scale, with an expected effect size of 1.4, indicating that CPT may significantly improve PTSD symptoms in this population.

NCBI (Pubmed)

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. Ito, M., Horikoshi, M., Resick, PA., et al.[2019]

In a study of 268 active-duty servicemembers, individual cognitive processing therapy (CPT) was found to be more effective than group CPT in reducing PTSD severity, with significant improvements noted immediately after treatment.

Both individual and group formats of CPT led to reductions in depression and suicidal ideation, but about 50% of participants still experienced PTSD symptoms after treatment, highlighting the need for improved or new therapeutic options in this population.

NCBI (Pubmed)

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. Resick, PA., Wachen, JS., Dondanville, KA., et al.[2022]

Cognitive Processing Therapy (CPT) is an effective evidence-based treatment for PTSD, particularly for individuals who have experienced combat, assault, or interpersonal violence, as supported by randomized controlled trials.

The Department of Veterans Affairs has successfully implemented CPT across its healthcare system, with trained clinicians showing good adoption of the therapy and significant improvements in patients' PTSD and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. Chard, KM., Ricksecker, EG., Healy, ET., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ... In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in ...

2. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD It is one of the most researched treatments for PTSD. A large number of studies show it is effective, including in patients with complicated presentations, such ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ... This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK362339/

Executive Summary - Cognitive Processing Therapy for ... - NCBI Most studies found that CPT was better than WL/UC for improving PTSD symptoms, depression, anxiety, quality of life (QoL), and remission rates. The proportion ...

5. journals.lww.com journals.lww.com/invn/fulltext/2022/20020/cognitive_processing_therapy_for_the_treatment_of.6.aspx

Cognitive Processing Therapy for the Treatment of PTSD,... The purpose of this study is to examine the efficacy of cognitive processing therapy (CPT) in treating posttraumatic stress disorder (PTSD), depression and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7272815/

Cognitive Processing Therapy for Posttraumatic Stress ... In‐home CPT had the lowest drop‐out rates (21%), followed by telehealth (33%) and in‐office treatment (44%). However, there were no significant differences in ...

7. ptsd.va.gov ptsd.va.gov/understand_tx/cognitive_processing.asp

Cognitive Processing Therapy (CPT) for PTSD The treatments that work best for PTSD are trauma-focused talk therapies. Trauma-focused therapy helps you work through the trauma and what it means to you.