Clinical trial NCT05037175: Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for CPT-Text for PTSD
Official title: Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for Asynchronous Texting Based Trauma Focused Therapy for PTSD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Digital Mental Health
COVID-19
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: Talkspace
name: National Institute of Mental Health (NIMH)
name: University of Pennsylvania
First posted: 2021-09-08
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Baseline through 24 weeks
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline through 24 weeks
measure: The Brief Inventory of Psychosocial Functioning (B-IPF)
timeFrame: Baseline through 24 weeks
measure: The Client Satisfaction Questionnaire (CSQ)
timeFrame: Baseline through 24 weeks
measure: Working Alliance Inventory, Short Form (WAI-SF)
timeFrame: Week 1 through Week 12
measure: Behavioral Intention
timeFrame: Baseline through week 8
measure: Oppression-based traumatic stress inventory
timeFrame: Baseline through 24 weeks at 3 timepoints
measure: Post-traumatic Cognitions Inventory
timeFrame: baseline through 24 weeks, at 3 timepoints
measure: Self-Report Altruism Scale (SRA)
timeFrame: Baseline
measure: Cultural Humility Scale (CHS)
timeFrame: Week 1 through week 13, at 4 timepoints
measure: Cultural Missed Opportunities (CMO)
timeFrame: Week 1 through week 13, at 4 timepoints
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New York
country: United States
facility: Talkspace LLC
state: New York
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center at San Antonio
state: Texas
Study officials:
affiliation: Stanford University
name: Shannon Wiltsey-Stirman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Health Sciences Center for San Antonio
name: Katy Dondanville, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
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.