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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

No Placebo-Only Group

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTSD Checklist for DSM-5 (PCL-5)

Secondary study objectives

Behavioral Intention

Cultural Humility Scale (CHS)

Cultural Missed Opportunities (CMO)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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