CPT-Text for Post-Traumatic Stress Disorder

(CPT-TEXT Trial)

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

360 Participants Needed

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 18 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. ^{1 2 3 4 5}

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. ^{1 3 5 6 7}

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. ^{1 3 4 6 7}

Research Team

Shannon Wiltsey-Stirman, PhD

Principal Investigator

Stanford University

Katy Dondanville, PsyD

Principal Investigator

University of Texas Health Sciences Center for San Antonio

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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

Dissemination and experience with cognitive processing therapy. [2022]

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

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. [2019]

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

Cognitive processing therapy for sexual assault victims. [2022]

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]

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]

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]