Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for CPT-Text for PTSD (CPT-TEXT)

Stanford University

Status: Enrolling

Conditions: Posttraumatic Stress Disorder

Treatments: Behavioral: Reminder as Usual; Behavioral: Culturally Informed Trauma Treatment (CITT); Behavioral: CPT-Text; Behavioral: Retention Incentive

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05037175

RF1MH128785 (U.S. NIH Grant/Contract)

62509

Details and patient eligibility

About

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 13 different states.

Full 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 a pilot study of a texting-based format of an EBT for PTSD, Cognitive Processing Therapy (CPT-Text), 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. This is 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. Participants will be enrolled in the study once they have consented, and competed the initial assessment, and determined to meet eligibility requirements. The study team 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 Culturally Informed Trauma Treatment as usual (CITT). After approximately a week of onboarding with their therapist (e.g., introduction, establishing treatment goals, etc), the active texting intervention will begin and assessments will occur at established timepoints through 24 weeks after the active intervention begins. Active interventions will occur over the course of 12 weeks. Participants will also be randomized into one of two engagement strategies: therapist reminder as usual (RAU) or RAU + incentive (RI). The study will examine an innovative incentive structure in which the study will "pay it forward by offering free or discounted therapy to other individuals with PTSD when participants remain engaged. The study will compare the impact of an engagement strategy on treatment response and engagement, and will examine motivation as a potential mechanism. The study will also 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Over the age of 18 residing in the United States
• Criterion A event measured by the Life Events Checklist for DSM-5 (LEC-5)
• Significant symptoms of PTSD as evidenced by a score of 33 or above on the PCL-5
• PTSD symptoms that began or increased during the COVID pandemic (per self-report)
• Registered/registering on Talkspace for messaging-based therapy
• Ownership of a personal device for texting
• Residence in a state with therapist capacity on the Talkspace platform

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 4 patient groups

CPT-Text + Incentive

Experimental group

Description:

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.

Treatment:

Behavioral: Retention Incentive

Behavioral: CPT-Text

CPT-Text + Reminder As Usual

Experimental group

Description:

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.

Treatment:

Behavioral: CPT-Text

Behavioral: Reminder as Usual

Culturally Informed Trauma Treatment (CITT) + Incentive

Active Comparator group

Description:

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.

Treatment:

Behavioral: Retention Incentive

Behavioral: Culturally Informed Trauma Treatment (CITT)

CITT+ Reminder as Usual

Active Comparator group

Description:

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.

Treatment:

Behavioral: Reminder as Usual

Behavioral: Culturally Informed Trauma Treatment (CITT)