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Behavioral Intervention

CPT-Text for Post-Traumatic Stress Disorder (CPT-TEXT Trial)

N/A

Recruiting

Led By Shannon Wiltsey-Stirman, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Significant symptoms of PTSD as evidenced by a score of 33 or above on the PCL-5

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 24 weeks at 3 timepoints

Awards & highlights

CPT-TEXT Trial Summary

This trial will compare a texting-based therapy for PTSD against a similar therapy that is tailored to be more culturally sensitive. It will also compare an incentive strategy against reminders to prevent people from discontinuing therapy early.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

As this trial involves psychological interventions through texting rather than medication, side effects may include emotional discomfort due to discussing traumatic events but are unlikely to involve physical side effects.

CPT-TEXT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

CPT-TEXT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 24 weeks, at 3 timepoints

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 24 weeks, at 3 timepoints

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 24 weeks, at 3 timepoints for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PTSD Checklist for DSM-5 (PCL-5)

Secondary outcome measures

Behavioral Intention

Cultural Humility Scale (CHS)

Cultural Missed Opportunities (CMO)

+7 more

CPT-TEXT Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: CPT-Text + Reminder As UsualExperimental Treatment2 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 + IncentiveExperimental Treatment2 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) + IncentiveActive Control2 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 UsualActive Control2 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,394 Previous Clinical Trials

17,341,210 Total Patients Enrolled

The University of Texas Health Science Center at San AntonioOTHER

452 Previous Clinical Trials

91,010 Total Patients Enrolled

TalkspaceIndustry Sponsor

4 Previous Clinical Trials

24,036 Total Patients Enrolled

Media Library

CPT-Text (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05037175 — N/A

Post-Traumatic Stress Disorder Research Study Groups: CPT-Text + Incentive, Culturally Informed Trauma Treatment (CITT) + Incentive, CITT+ Reminder as Usual, CPT-Text + Reminder As Usual

Post-Traumatic Stress Disorder Clinical Trial 2023: CPT-Text Highlights & Side Effects. Trial Name: NCT05037175 — N/A

CPT-Text (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05037175 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research involve participants aged 35 or older?

"The eligibility requirements for this trial indicate that patients must be aged 18-75 to participate."

Answered by AI

How many participants are being accepted for this medical experiment?

"Affirmative. Per the information hosted on clinicaltrials.gov, recruitment for this medical trial is currently ongoing; it was initially posted on March 22nd 2022 and has had its last update November 7th 2022. A total of 400 volunteers are being sought out from a single location."

Answered by AI

Who has the eligibility to take part in this experiment?

"Eligibility for this trial requires that the patient has moral injury and is between 18-75 years old. Currently, up to 400 members of the public can take part in this experiment."

Answered by AI

Are there still opportunities for individuals to partake in this trial?

"Information hosted on clinicaltrials.gov stipulates that recruitment for this medical trial is still in progress, having been originally listed on March 22nd 2022 and updated most recently on November 7th 2022."

Answered by AI

Who else is applying?

What state do they live in?

California

How old are they?

18 - 65

What site did they apply to?

University of Texas Health Sciences Center at San Antonio

Stanford University

Talkspace LLC

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have been on so many different medications to try to help me sleep so that I don’t dream, anxiety about everything especially leaving my home, and for depression. If I can function again and maybe make a little money I’m willing to try anything to help me get back to who I was before or maybe a better version.

PatientReceived 2+ prior treatments