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Clinical Trial Summary

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 texting-based treatment as usual, and it will also compare a unique incentive strategy to typical platform reminders aimed to prevent early discontinuation in therapy.

Clinical Trial Description

The COVID-19 pandemic has exacerbated mental health challenges for trauma-exposed individuals due to increased isolation, insufficient capacity in the mental health workforce, and a predicted fourth wave of mental health impacts of the pandemic itself. There is a pressing need to increase treatment capacity. Digital mental health (DMH) interventions for posttraumatic stress disorder (PTSD) address well-documented barriers to traditional in-person psychotherapy or telehealth delivery of evidence-based treatments (EBTs) for PTSD, but many consumers do not remain engaged. Thus, acceptable, efficient, and engaging forms of EBTs are sorely needed, particularly for those who are less likely to access traditional psychotherapy or use online programs. Asynchronous texting therapy platforms may facilitate treatment engagement among those who seek discrete, convenient, and affordable support. In our pilot of a texting-based format of an EBT for PTSD, Cognitive Processing Therapy (CPT-Text), we found CPT-Text was feasible to deliver, and clients showed substantially greater PTSD symptom improvement over a shorter time compared to text therapy as usual (TAU). A larger scale, more rigorous test is necessary. We propose a randomized, Hybrid Type 1, effectiveness-implementation trial with a factorial design to compare text-based therapies for PTSD utilizing the HIPAA-compliant secure texting platform of our DMH partner, Talkspace. We will randomize participants (N= 400) who have PTSD that is related to or has been exacerbated by the COVID-19 pandemic into CPT-Text or text-based TAU. Participants will also be randomized into one of two engagement strategies: therapist reminder as usual (RAU) or RAU + incentive (RI). We will examine an innovative incentive structure in which participants who remain engaged in the intervention will have the option of retaining their introductory discount or donating it to individuals in need of financial support. We will compare the impact of engagement strategy on treatment response and engagement, and we will examine motivation as a potential mechanism. We also will evaluate a novel Natural Language Processing (NLP) approach to assessing CPT-Text fidelity. This study will (1) provide critical information about how to promote sustained DMH engagement using unique incentive strategies and moderators of engagement and outcomes and (2) offer first guidance on supporting quality and fidelity of messaging-based EBTs using NLP. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05037175
Study type Interventional
Source Stanford University
Contact Shannon L Wiltsey-Stirman, PhD
Phone 650-493-5000
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 30, 2021
Completion date September 29, 2024

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