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

NCT05037175 | Active Not Recruiting DMC

• 2 other identifiers: 62509RF1MH128785
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Digital Mental Health; COVID-19

Outcome Measures

Primary Outcomes (2)

• PTSD Checklist for DSM-5 (PCL-5)

  The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that evaluates the degree to which individuals have been bothered by PTSD symptoms tied to their most currently distressing event \[114\] . The monthly version will be administered at baseline and the weekly version thereafter.

  Baseline through 24 weeks

• Engagement-Completion

  Completion of the intervention, defined as 13 weeks of CPT or CITT, or completion of all CPT modules, whichever comes first OR early completer (achievement of a PCL score below 20, which indicates good end-state functioning)

  13 Weeks

Secondary Outcomes (12)

• Patient Health Questionnaire (PHQ-9)

  Baseline through 24 weeks

• The Brief Inventory of Psychosocial Functioning (B-IPF)

  Baseline through 24 weeks

• The Client Satisfaction Questionnaire (CSQ)

  Baseline through 24 weeks

• Working Alliance Inventory, Short Form (WAI-SF)

  Week 1 through Week 12

• Behavioral Intention

  Baseline through week 8

Study Arms (4)

CPT-Text + Incentive

EXPERIMENTAL

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.

Behavioral: CPT-Text; Behavioral: Retention Incentive

CPT-Text + Reminder As Usual

EXPERIMENTAL

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.

Behavioral: CPT-Text; Behavioral: Reminder as Usual

Culturally Informed Trauma Treatment (CITT) + Incentive

ACTIVE COMPARATOR

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.

Behavioral: Culturally Informed Trauma Treatment (CITT); Behavioral: Retention Incentive

CITT+ Reminder as Usual

ACTIVE COMPARATOR

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.

Behavioral: Culturally Informed Trauma Treatment (CITT); Behavioral: Reminder as Usual

Interventions

CPT-Text 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

CPT-Text + Incentive; CPT-Text + Reminder As Usual

Culturally Informed Trauma Treatment (CITT) 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.

CITT+ Reminder as Usual; Culturally Informed Trauma Treatment (CITT) + Incentive

Retention Incentive 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 + Incentive; Culturally Informed Trauma Treatment (CITT) + Incentive

Reminder as Usual 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.

CITT+ Reminder as Usual; CPT-Text + Reminder As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• The University of Texas Health Science Center at San Antonio: collaborator
• Talkspace: collaborator
• National Institute of Mental Health (NIMH): collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

Stanford University

Palo Alto, California, 94025, United States

Location

Talkspace LLC

New York, New York, 10025, United States

Location

University of Texas Health Sciences Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 32347814 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; COVID-19

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shannon Wiltsey-Stirman, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Katy Dondanville, PsyD

  University of Texas Health Sciences Center for San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 8, 2021
• Study Start: March 22, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 29, 2026
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After publication of main outcome papers for each aim
• Access Criteria: Investigators and institutions seeking data from NDA will be expected to meet data security measures, will be asked to submit a Data Use Certification co-signed by the investigator and the designated Institutional Official(s) at the NIH-recognized sponsoring institution with a current Federal Wide Assurance (FWA), and will be require to follow the procedures associated with data access described at https://ndar.nih.gov/ndarpublicweb/policies.go#sop4). Any data directly (e.g., qualitative data, outcome data) shared with other investigators would entail a data use agreement, signed by the research team and institutional authorities, and the individual(s) requesting data.

Locations

US (3)