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

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ClinicalTrials.gov Identifier: NCT05037175
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : May 10, 2022
Sponsor:
Collaborators:
The University of Texas Health Science Center at San Antonio
Talkspace
National Institute of Mental Health (NIMH)
University of Pennsylvania
Information provided by (Responsible Party):
Shannon Wiltsey Stirman, PhD, Stanford University

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: CPT-Text Behavioral: Culturally Informed Trauma Treatment (CITT) Behavioral: Retention Incentive Behavioral: Reminder as Usual Not Applicable

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. We 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 engagement strategy on treatment response and engagement, and we 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for Asynchronous Texting Based Trauma Focused Therapy for PTSD
Actual Study Start Date : March 22, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : September 29, 2024

Arm Intervention/treatment
Experimental: CPT-Text + Incentive

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.

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
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.

Behavioral: 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.

Experimental: 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.

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.

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.

Active Comparator: Culturally Informed Trauma Treatment (CITT) + Incentive

CITT will be conducted by Talkspace therapists with a specialty in PTSD culturally informed PTSD treatment.

Retention Incentivefor other users with PTSD in subsequent months if they message with their therapist regularly.

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 [5].

Behavioral: 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.

Active Comparator: 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.

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 [5].

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline through 24 weeks ]
    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.

  2. The Brief Inventory of Psychosocial Functioning (B-IPF) [ Time Frame: Baseline through 24 weeks ]
    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.

  3. The Client Satisfaction Questionnaire (CSQ) [ Time Frame: Baseline through 24 weeks ]
    The Client Satisfaction Questionnaire (CSQ; [118] ) is an 8-item measure of participant satisfaction with treatment.

  4. Working Alliance Inventory, Short Form (WAI-SF) [ Time Frame: Week 1 through Week 12 ]
    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.

  5. Behavioral Intention [ Time Frame: Baseline through week 8 ]
    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.

  6. Oppression-based traumatic stress inventory [ Time Frame: Baseline through 24 weeks at 3 timepoints ]
    An assessment of trauma-related symptoms related to oppression or race/ethnicity-based trauma.

  7. Post-traumatic Cognitions Inventory [ Time Frame: baseline through 24 weeks, at 3 timepoints ]
    assessment of common beliefs after trauma



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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); and 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 and ownership of a personal device for texting. In a state with therapist capacity on the Talkspace platform

Exclusion Criteria:

  • (1) acute risk for suicidal thoughts and/or behaviors measured by the Columbia Suicide Severity Rating Scale Lifetime-Recent Screen, and (2) psychosis or substance abuse that requires prioritization of treatment and/or higher level of care.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037175


Contacts
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Contact: Shannon L Wiltsey-Stirman, PhD 650-493-5000 ext 1-2-20007 sws1@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94025
Contact: Shannon Wiltsey Stirman, PhD    650-493-5000 ext 20007    sws1@stanford.edu   
Sponsors and Collaborators
Stanford University
The University of Texas Health Science Center at San Antonio
Talkspace
National Institute of Mental Health (NIMH)
University of Pennsylvania
Investigators
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Principal Investigator: Shannon Wiltsey-Stirman, PhD Stanford University
Publications:
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Responsible Party: Shannon Wiltsey Stirman, PhD, Associate Professor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT05037175    
Other Study ID Numbers: 62509
RF1MH128785 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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), we will request explicit consent for sharing of these data but allow participants to opt out of sharing beyond the research team and institutions.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shannon Wiltsey Stirman, PhD, Stanford University:
Digital Mental Health
COVID-19
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders