Telehealth 2.0: Evaluating Effectiveness and Engagement Strategies for Asynchronous Texting Based Trauma Focused Therapy for PTSD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CPT-Text + Incentive
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.
干预措施: CPT-Text (Behavioral)
CPT-Text + Incentive
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.
干预措施: Retention Incentive (Behavioral)
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.
干预措施: CPT-Text (Behavioral)
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.
干预措施: Reminder as Usual (Behavioral)
Culturally Informed Trauma Treatment (CITT) + Incentive
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.
干预措施: Culturally Informed Trauma Treatment (CITT) (Behavioral)
Culturally Informed Trauma Treatment (CITT) + Incentive
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.
干预措施: Retention Incentive (Behavioral)
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.
干预措施: Culturally Informed Trauma Treatment (CITT) (Behavioral)
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.
干预措施: Reminder as Usual (Behavioral)
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5)
时间窗: 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.
PTSD Checklist for DSM-5 (PCL-5)
时间窗: 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
时间窗: 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)
次要结局
- 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)
- Oppression-based traumatic stress inventory(Baseline through 24 weeks at 3 timepoints)
- Post-traumatic Cognitions Inventory(baseline through 24 weeks, at 3 timepoints)
- Self-Report Altruism Scale (SRA)(Baseline)
- Cultural Humility Scale (CHS)(Week 1 through week 13, at 4 timepoints)
- Cultural Missed Opportunities (CMO)(Week 1 through week 13, at 4 timepoints)
- 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)
- Oppression-based traumatic stress inventory(Baseline through 24 weeks at 3 timepoints)
- Post-traumatic Cognitions Inventory(baseline through 24 weeks, at 3 timepoints)
- Self-Report Altruism Scale (SRA)(Baseline)
- Cultural Humility Scale (CHS)(Week 1 through week 13, at 4 timepoints)
- Cultural Missed Opportunities (CMO)(Week 1 through week 13, at 4 timepoints)
- Engagement(13 weeks)
- Adequate Dose of CPT(13 weeks)
研究者
Shannon Wiltsey Stirman, PhD
Associate Professor of Psychiatry and Behavioral Sciences
Stanford University