Posttraumatic Stress DisorderCPT-TEXTNCT05037175
Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for CPT-Text for PTSD
A study testing CPT-Text, Culturally Informed Trauma Treatment (CITT) and Retention Incentive in people with Posttraumatic Stress Disorder, run by Stanford University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- CPT-Text, Culturally Informed Trauma Treatment (CITT) and Retention Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Mar 2022to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Talkspace LLC
New York, New York, 10025
Stanford University
Palo Alto, California, 94025
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for Asynchronous Texting Based Trauma Focused Therapy for PTSD
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.
Read the 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
- Being tested
- CPT-Text, Culturally Informed Trauma Treatment (CITT), Retention Incentive, Reminder as Usual
- Keywords
- Digital Mental Health, COVID-19
- Medical subject headings
- Stress Disorders, Post-Traumatic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPT-TextBehavioural
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
Culturally Informed Trauma Treatment (CITT)Behavioural
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 IncentiveBehavioural
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.
Reminder as UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Culturally Informed Trauma Treatment (CITT); Behavioral: Reminder as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 13 Weeks
Secondary outcomes (12)
Patient Health Questionnaire (PHQ-9)
The PHQ-9 [115,116] is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders that will be administered on the schedule outlined in the table. The PHQ-9 is the 9-item depression module and is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression.
Measured: Baseline through 24 weeks
The Brief Inventory of Psychosocial Functioning (B-IPF)
The Brief Inventory of Psychosocial Functioning (B-IPF; [117] ) is a 7-item self-report instrument measuring respondents' level of functioning over the past 30 days in seven life domains including: romantic, family, parenting, friendship, work, education, and self-care.
Measured: Baseline through 24 weeks
The Client Satisfaction Questionnaire (CSQ)
The Client Satisfaction Questionnaire (CSQ; [118] ) is an 8-item measure of participant satisfaction with treatment.
Measured: Baseline through 24 weeks
Working Alliance Inventory, Short Form (WAI-SF)
The Working Alliance Inventory, Short Form (WAI-SF, [125] ) is a measure to index the degree of therapeutic cohesion between the client and the therapist.
Measured: Week 1 through Week 12
Behavioral Intention
Behavioral Intention (BI; which captures motivation to engage in a behavior) will be measured to examine patterns of motivation in our treatment conditions and to investigate BI as the hypothesized mechanism of change in engagement. BI measures are created based on recommendations for constructing a very brief BI measure, a frequent approach to measuring this construct, which has demonstrated reliability [119-123] . Participants will be asked, "How likely or unlikely are you to complete (baseline) or continue (mid-treatment) treatment?" on a 7-item Likert scale ranging from "Extremely Unlikely" to "Extremely Likely" at the baseline and both mid-treatment assessments.
Measured: Baseline through week 8
Oppression-based traumatic stress inventory
An assessment of trauma-related symptoms related to oppression or race/ethnicity-based trauma.
Measured: Baseline through 24 weeks at 3 timepoints
Post-traumatic Cognitions Inventory
Assessment of common beliefs after trauma
Measured: baseline through 24 weeks, at 3 timepoints
Self-Report Altruism Scale (SRA)
Assessment of altruism via self-report
Measured: Baseline
Cultural Humility Scale (CHS)
Assessment of important and central aspects of one's identity Assessment of customer perceptions of staff's cultural humility
Measured: Week 1 through week 13, at 4 timepoints
Cultural Missed Opportunities (CMO)
Assessment of degree to which clients perceived that their therapist missed opportunities to discuss their cultural identity.
Measured: Week 1 through week 13, at 4 timepoints
Engagement
THe number of days the client messaged divided by the total intervention days (days of active treatment before early response or 13 weeks, whichever comes first)
Measured: 13 weeks
Adequate Dose of CPT
Completion of at least 8 modules of CPT-Text
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start22 Mar 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, Talkspace, National Institute of Mental Health (NIMH), University of Pennsylvania
- Responsible party
- Principal investigator, Shannon Wiltsey Stirman, PhD, Stanford University
- Investigators
- Shannon Wiltsey-Stirman, PhD, Principal investigator, Stanford UniversityKaty Dondanville, PsyD, Principal investigator, University of Texas Health Sciences Center for San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037175
- Sponsor's protocol ID
- 62509
- Other IDs
- RF1MH128785
- Acronym
- CPT-TEXT
- Status last verified
- Aug 2025
- First submitted
- 31 Aug 2021
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators funded under this FOA will share those data via the National Database for Clinical Trials related to Mental Illness in a timely manner. The final quantitative dataset will be de-identified and individual records will include an NIMH Data Archive (NDA) Global Unique identifier when submitted to NDA. The research team will comply with other data submission and sharing requirements and schedule as provided in NIMH Data Archive Data Sharing Terms and Conditions (effective 7/1/15). Due to the sensitive nature of therapy transcripts (even when de-identified), the investigators will request explicit consent for sharing of these data but allow participants to opt out of sharing beyond the research team and institutions.
Publications
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.
PubMed 32347814
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for Asynchronous Texting Based Trauma Focused Therapy for PTSD
- ClinicalTrials.gov ID
- NCT05037175
- Acronym / sponsor ID
- CPT-TEXT / 62509
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Digital Mental Health, COVID-19
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, Talkspace, National Institute of Mental Health (NIMH), University of Pennsylvania
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CPT-Text + Incentive | Experimental | Behavioral: CPT-Text, Behavioral: Retention IncentiveCPT-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. |
| CPT-Text + Reminder As Usual | Experimental | Behavioral: CPT-Text, Behavioral: Reminder as UsualCPT-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. |
| Culturally Informed Trauma Treatment (CITT) + Incentive | Active comparator | Behavioral: Culturally Informed Trauma Treatment (CITT), Behavioral: Retention IncentiveCITT 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. |
| CITT+ Reminder as Usual | Active comparator | Behavioral: Culturally Informed Trauma Treatment (CITT), Behavioral: Reminder as UsualCITT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPT-TextCPT 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 | Behavioural | CPT-Text + Incentive, CPT-Text + Reminder As Usual |
| 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. | Behavioural | CITT+ Reminder as Usual, Culturally Informed Trauma Treatment (CITT) + Incentive |
| Retention IncentiveParticipants 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. | Behavioural | CPT-Text + Incentive, Culturally Informed Trauma Treatment (CITT) + Incentive |
| Reminder as UsualAs 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. | Behavioural | CITT+ Reminder as Usual, CPT-Text + Reminder As Usual |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline through 24 weeks
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.
Engagement-Completion
Time frame: 13 Weeks
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)
12 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline through 24 weeks
The Brief Inventory of Psychosocial Functioning (B-IPF)
Time frame: Baseline through 24 weeks
The Client Satisfaction Questionnaire (CSQ)
Time frame: Baseline through 24 weeks
Working Alliance Inventory, Short Form (WAI-SF)
Time frame: Week 1 through Week 12
Behavioral Intention
Time frame: Baseline through week 8
Oppression-based traumatic stress inventory
Time frame: Baseline through 24 weeks at 3 timepoints
Post-traumatic Cognitions Inventory
Time frame: baseline through 24 weeks, at 3 timepoints
Self-Report Altruism Scale (SRA)
Time frame: Baseline
Cultural Humility Scale (CHS)
Time frame: Week 1 through week 13, at 4 timepoints
Cultural Missed Opportunities (CMO)
Time frame: Week 1 through week 13, at 4 timepoints
Engagement
Time frame: 13 weeks
Adequate Dose of CPT
Time frame: 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 32347814Malgaroli 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.
- Individual participant dataSharing planned: Yes. Investigators funded under this FOA will share those data via the National Database for Clinical Trials related to Mental Illness in a timely manner. The final quantitative dataset will be de-identified and individual records will include an NIMH Data Archive (NDA) Global Unique identifier when submitted to NDA. The research team will comply with other data submission and sharing requirements and schedule as provided in NIMH Data Archive Data Sharing Terms and Conditions (effective 7/1/15). Due to the sensitive nature of therapy transcripts (even when de-identified), the investigators will request explicit consent for sharing of these data but allow participants to opt out of sharing beyond the research team and institutions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Wiltsey-Stirman, PhD principal investigator
Stanford University
Katy Dondanville, PsyD principal investigator
University of Texas Health Sciences Center for San Antonio
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPT-Text, Culturally Informed Trauma Treatment (CITT) and Retention Incentive in people with Posttraumatic Stress Disorder, run by Stanford University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Baseline through 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05037175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.