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

NCT ID: NCT05037175

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2026-06-29

Brief 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 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.

Detailed 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= 360) who have PTSD that is related to, has been exacerbated, or developed during 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) or Large-Language Model (LLM) based 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 computational methods.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CPT-Text + Incentive

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 Type: EXPERIMENTAL

CPT-Text

Intervention Type: BEHAVIORAL

CPT is a 12-session (13 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. Each session includes psychoeducation and introduction of a new skill or module, which builds on the previous information and skills. Participants will receive psychoeducation video links via Talkspace and an electronic workbook with handouts, written explanations of the concepts and activities, and CPT worksheets, which will be embedded in the platform and sent by the therapist at the appropriate point in the protocol. Therapists encourage the client to complete each module using the provided materials and assist clients in reflecting on their beliefs through Socratic questions and feedback on their worksheets. Clients work at their own pace, with therapists sending the skill or module after the client has practiced the previous one. Brief synchronous messaging sessions can be arranged

Retention Incentive

Intervention Type: BEHAVIORAL

Participants will be told at baseline that they can earn free or discounted therapy for other individuals with PTSD who are in need of financial assistance if they remain consistently engaged in treatment. If client participants do not re-engage after 24 hours from the RAU (3 days without engagement), they will receive an automated text-message reminding them to message their therapist regularly (on average, every other business day) in order to get a discount donated it to a fund that will offer free or discounted therapy to individuals with PTSD who require financial assistance. Throughout treatment, participants will be sent reminders every other week of what the incentive is and how it can be acquired, in addition to feedback about whether they are on or off track to earn the discount.

CPT-Text + Reminder As Usual

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 Type: EXPERIMENTAL

CPT-Text

Intervention Type: BEHAVIORAL

CPT is a 12-session (13 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. Each session includes psychoeducation and introduction of a new skill or module, which builds on the previous information and skills. Participants will receive psychoeducation video links via Talkspace and an electronic workbook with handouts, written explanations of the concepts and activities, and CPT worksheets, which will be embedded in the platform and sent by the therapist at the appropriate point in the protocol. Therapists encourage the client to complete each module using the provided materials and assist clients in reflecting on their beliefs through Socratic questions and feedback on their worksheets. Clients work at their own pace, with therapists sending the skill or module after the client has practiced the previous one. Brief synchronous messaging sessions can be arranged

Reminder as Usual

Intervention Type: BEHAVIORAL

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.

Culturally Informed Trauma Treatment (CITT) + Incentive

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 Type: ACTIVE_COMPARATOR

Culturally Informed Trauma Treatment (CITT)

Intervention Type: BEHAVIORAL

CITT will be conducted by Talkspace therapists with a specialty in PTSD treatment. Based on previous research and Talkspace's analysis of TAU and the therapists' training in culturally informed trauma treatment, it is likely CITT will include culturally informed, supportive and client-centered interventions, problem solving, and elements from EBTs such as cognitive-behavioral therapy. Brief synchronous messaging sessions can be arranged.

Retention Incentive

Intervention Type: BEHAVIORAL

Participants will be told at baseline that they can earn free or discounted therapy for other individuals with PTSD who are in need of financial assistance if they remain consistently engaged in treatment. If client participants do not re-engage after 24 hours from the RAU (3 days without engagement), they will receive an automated text-message reminding them to message their therapist regularly (on average, every other business day) in order to get a discount donated it to a fund that will offer free or discounted therapy to individuals with PTSD who require financial assistance. Throughout treatment, participants will be sent reminders every other week of what the incentive is and how it can be acquired, in addition to feedback about whether they are on or off track to earn the discount.

CITT+ Reminder as Usual

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.

Group Type: ACTIVE_COMPARATOR

Culturally Informed Trauma Treatment (CITT)

Intervention Type: BEHAVIORAL

CITT will be conducted by Talkspace therapists with a specialty in PTSD treatment. Based on previous research and Talkspace's analysis of TAU and the therapists' training in culturally informed trauma treatment, it is likely CITT will include culturally informed, supportive and client-centered interventions, problem solving, and elements from EBTs such as cognitive-behavioral therapy. Brief synchronous messaging sessions can be arranged.

Reminder as Usual

Intervention Type: BEHAVIORAL

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.

Interventions

CPT-Text

CPT is a 12-session (13 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. Each session includes psychoeducation and introduction of a new skill or module, which builds on the previous information and skills. Participants will receive psychoeducation video links via Talkspace and an electronic workbook with handouts, written explanations of the concepts and activities, and CPT worksheets, which will be embedded in the platform and sent by the therapist at the appropriate point in the protocol. Therapists encourage the client to complete each module using the provided materials and assist clients in reflecting on their beliefs through Socratic questions and feedback on their worksheets. Clients work at their own pace, with therapists sending the skill or module after the client has practiced the previous one. Brief synchronous messaging sessions can be arranged

Intervention Type: BEHAVIORAL

Culturally Informed Trauma Treatment (CITT)

CITT will be conducted by Talkspace therapists with a specialty in PTSD treatment. Based on previous research and Talkspace's analysis of TAU and the therapists' training in culturally informed trauma treatment, it is likely CITT will include culturally informed, supportive and client-centered interventions, problem solving, and elements from EBTs such as cognitive-behavioral therapy. Brief synchronous messaging sessions can be arranged.

Intervention Type: BEHAVIORAL

Retention Incentive

Participants will be told at baseline that they can earn free or discounted therapy for other individuals with PTSD who are in need of financial assistance if they remain consistently engaged in treatment. If client participants do not re-engage after 24 hours from the RAU (3 days without engagement), they will receive an automated text-message reminding them to message their therapist regularly (on average, every other business day) in order to get a discount donated it to a fund that will offer free or discounted therapy to individuals with PTSD who require financial assistance. Throughout treatment, participants will be sent reminders every other week of what the incentive is and how it can be acquired, in addition to feedback about whether they are on or off track to earn the discount.

Intervention Type: BEHAVIORAL

Reminder as Usual

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: collaborator

Talkspace

INDUSTRY

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Shannon Wiltsey Stirman, PhD

Associate Professor of Psychiatry and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shannon Wiltsey-Stirman, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Katy Dondanville, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Sciences Center for San Antonio

Locations

Stanford University

Palo Alto, California, United States

Talkspace LLC

New York, New York, United States

University of Texas Health Sciences Center at San Antonio

San Antonio, Texas, United States

Countries

United States

References

Malgaroli M, Hull TD, Wiltsey Stirman S, Resick P. Message Delivery for the Treatment of Posttraumatic Stress Disorder: Longitudinal Observational Study of Symptom Trajectories. J Med Internet Res. 2020 Apr 29;22(4):e15587. doi: 10.2196/15587.

Reference Type: BACKGROUND

PMID: 32347814 (View on PubMed)

Other Identifiers

RF1MH128785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

62509

Identifier Type: -

Identifier Source: org_study_id