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

Posttraumatic Stress Disorder Clinical Trial

— CPT-TEXT  

Official title:

Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for Asynchronous Texting Based Trauma Focused Therapy for PTSD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05037175
• Other study ID #: 62509
• Secondary ID: RF1MH128785
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2022
• Est. completion date: September 29, 2025

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Shannon L Wiltsey-Stirman, PhD
• Phone: 650-493-5000
• Email: texting_study[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 29, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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. 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 [5,6]. Clients work at their own pace, with therapists sending the skill or module after the client has practiced the previous one.
• 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 [5].
• Retention Incentive
Participants will be told at baseline that they can earn discounts 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 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.

Locations

Country	Name	City	State
United States	Talkspace LLC	New York	New York
United States	Stanford University	Palo Alto	California
United States	University of Texas Health Sciences Center at San Antonio	San Antonio	Texas

Sponsors (5)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH), Talkspace, The University of Texas Health Science Center at San Antonio, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (5)

Arango C, Wykes T, Moreno C. Mental health care and COVID-19. Lancet Psychiatry. 2020 Dec;7(12):1013. doi: 10.1016/S2215-0366(20)30480-6. No abstract available. — View Citation

Czeisler ME, Lane RI, Petrosky E, Wiley JF, Christensen A, Njai R, Weaver MD, Robbins R, Facer-Childs ER, Barger LK, Czeisler CA, Howard ME, Rajaratnam SMW. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic - United States, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1. — View Citation

Hull TD, Malgaroli M, Connolly PS, Feuerstein S, Simon NM. Two-way messaging therapy for depression and anxiety: longitudinal response trajectories. BMC Psychiatry. 2020 Jun 12;20(1):297. doi: 10.1186/s12888-020-02721-x. — View Citation

Kaseda ET, Levine AJ. Post-traumatic stress disorder: A differential diagnostic consideration for COVID-19 survivors. Clin Neuropsychol. 2020 Oct-Nov;34(7-8):1498-1514. doi: 10.1080/13854046.2020.1811894. Epub 2020 Aug 26. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Baseline through 24 weeks
Secondary	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.	Baseline through 24 weeks
Secondary	The Client Satisfaction Questionnaire (CSQ)	The Client Satisfaction Questionnaire (CSQ; [118] ) is an 8-item measure of participant satisfaction with treatment.	Baseline through 24 weeks
Secondary	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.	Week 1 through Week 12
Secondary	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.	Baseline through week 8
Secondary	Oppression-based traumatic stress inventory	An assessment of trauma-related symptoms related to oppression or race/ethnicity-based trauma.	Baseline through 24 weeks at 3 timepoints
Secondary	Post-traumatic Cognitions Inventory	Assessment of common beliefs after trauma	baseline through 24 weeks, at 3 timepoints
Secondary	Self-Report Altruism Scale (SRA)	Assessment of altruism via self-report	Baseline
Secondary	Cultural Humility Scale (CHS)	Assessment of important and central aspects of one's identity Assessment of customer perceptions of staff's cultural humility	Week 1 through week 13, at 4 timepoints
Secondary	Cultural Missed Opportunities (CMO)	Assessment of degree to which clients perceived that their therapist missed opportunities to discuss their cultural identity.	Week 1 through week 13, at 4 timepoints