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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34HL145387 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a pilot randomized clinical trial involving adult survivors of cardiorespiratory failure treated in intensive care units (ICUs) that is designed to test the acceptability, feasibility, and clinical impact of a coping skills training intervention (Blueprint) delivered via a mobile app. This trial will allow us to determine if new changes to intervention delivery, inclusion criteria, and other factors are successful. It will also inform the development of a next-step efficacy focused trial.
As survival has improved for the 2 million people with cardiorespiratory failure managed annually in US intensive care units (ICUs), research has clarified how these survivors suffer from severe and persistent symptoms of psychological distress-depression, anxiety, and post-traumatic stress disorder (PTSD)-after discharge. However, few interventions exist that are relevant to patients' experiences and that also accommodate their many physical, social, and financial barriers to personalized care. To fill this gap, we developed a telephone- and web-based coping skills training (CST) program.
CST is an empirically-supported psychosocial intervention that targets the use of the adaptive coping skills to decrease psychological distress and improve quality of life. We conducted a multicenter randomized clinical trial (RCT) called CSTEP that compared CST to an education program (EP) among a general sample of ICU survivors who received mechanical ventilation for cardiorespiratory failure. CST reduced depression symptoms and improved quality of life at 6 months in a pre-specified subgroup with elevated baseline distress. This RCT also identified key questions regarding best practices for identifying patients who are highly distressed yet whose physical illness is manageable, as well as delivering the intervention in a more convenient, and scalable manner. In a recent RCT testing a mindfulness intervention (LIFT), we found that a self-directed mobile app approach increased dose, adherence, and retention. However, many patients reported low enthusiasm for a meditation-based intervention.
What is needed before a second multicenter RCT is to apply the promising CST content to a LIFT-inspired mobile app-based delivery system, and then to test it within a targeted patient population with a high likelihood of response (i.e., high baseline psychological distress). Therefore, we propose a 2-year R34 mixed-methods project that includes a pilot RCT in which we will randomize 45 cardiorespiratory failure / insufficiency survivors to one of three arms in equal ratios: intervention plus therapist for non-responders (n ~15), intervention without a therapist (n ~15), and usual care control (n ~15). Randomization will be stratified by ICU service (medical vs. surgical), baseline HADS score (<14 vs. ≥14), and age (<50 vs. ≥50). Our specific aims will: (1) Optimize the usability of a self-directed mobile app (Blueprint) and an automated post-discharge distress screening system; (2) Test two promising iterations of Blueprint vs. usual care in a pilot 3-arm RCT with 3-month follow up, and (3) Explore facilitators and barriers to Blueprint implementation, using these data to inform any necessary final revisions to the Blueprint app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| coping skills training plus therapist input | Experimental | Participants will receive a CST therapist call within 48 hours of randomization to discuss the study rationale, to conduct a relaxation exercise, and to review app and study logistics. Participants will use the Blueprint mobile app for 1 month. |
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| coping skills training without therapist input | Experimental | Participants will receive a call from a research coordinator to get them started with the trial. Participants will use the Blueprint mobile app for 1 month. No therapist calls will be provided. Chat room access in the app will be provided. |
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| usual care control | No Intervention | Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coping skills training mobile app with call from CST therapist | Behavioral | The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. A therapist will call participant to introduce the intervention and perform a brief relaxation exercise. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire | Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse) | Between baseline and 1 month post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire | Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse) | Between baseline and 3 months post-randomization |
| Change in Post-Traumatic Stress Symptom Inventory (PTSS) |
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INCLUSION CRITERIA
Adult (age ≥18)
Managed in a hospital setting for ≥24 hours during the time inclusion criterion #3 is met.
Acute cardiorespiratory failure / insufficiency, defined as ≥1 of the following:
Cognitive status intact
Absence of severe and/or persistent mental illness
Functional English fluency
EXCLUSION CRITERIA (in hospital):
INCLUSION CRITERIA (post-discharge)
1. Elevated baseline (T1) psychological distress symptoms, defined as HADS total score of ≥8
EXCLUSION CRITERIA (post-discharge)
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| Name | Affiliation | Role |
|---|---|---|
| Christopher E Cox, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28872898 | Background | Cox CE, Hough CL, Carson SS, White DB, Kahn JM, Olsen MK, Jones DM, Somers TJ, Kelleher SA, Porter LS. Effects of a Telephone- and Web-based Coping Skills Training Program Compared with an Education Program for Survivors of Critical Illness and Their Family Members. A Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jan 1;197(1):66-78. doi: 10.1164/rccm.201704-0720OC. | |
| 22527082 | Background | Cox CE, Porter LS, Hough CL, White DB, Kahn JM, Carson SS, Tulsky JA, Keefe FJ. Development and preliminary evaluation of a telephone-based coping skills training intervention for survivors of acute lung injury and their informal caregivers. Intensive Care Med. 2012 Aug;38(8):1289-97. doi: 10.1007/s00134-012-2567-3. Epub 2012 Apr 18. |
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We will follow all NIH guidelines and regulations.
We will follow NIH and institutional guidelines.
We will follow NIH and institutional guidelines.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coping Skills Training Plus Therapist Input | Participants will receive a CST therapist call within 48 hours of randomization to discuss the study rationale, to conduct a relaxation exercise, and to review app and study logistics. Participants will use the Blueprint mobile app for 1 month. Coping skills training mobile app with call from CST therapist: The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. A therapist will call participant to introduce the intervention and perform a brief relaxation exercise. |
| FG001 | Coping Skills Training Without Therapist Input | Participants will receive a call from a research coordinator to get them started with the trial. Participants will use the Blueprint mobile app for 1 month. No therapist calls will be provided. Chat room access in the app will be provided. Coping skills training mobile app only: The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. App chat room access will be provided. |
| FG002 | Usual Care Control | Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Coping Skills Training Plus Therapist Input | Participants will receive a CST therapist call within 48 hours of randomization to discuss the study rationale, to conduct a relaxation exercise, and to review app and study logistics. Participants will use the Blueprint mobile app for 1 month. Coping skills training mobile app with call from CST therapist: The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. A therapist will call participant to introduce the intervention and perform a brief relaxation exercise. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire | Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse) | Posted | Mean | 95% Confidence Interval | units on a scale | Between baseline and 1 month post-randomization |
|
16 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coping Skills Training Plus Therapist Input | Participants will receive a CST therapist call within 48 hours of randomization to discuss the study rationale, to conduct a relaxation exercise, and to review app and study logistics. Participants will use the Blueprint mobile app for 1 month. Coping skills training mobile app with call from CST therapist: The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. A therapist will call participant to introduce the intervention and perform a brief relaxation exercise. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Cox | Duke University | 9196817232 | christopher.cox@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2020 | Aug 4, 2022 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2021 | Aug 4, 2022 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 29, 2021 | Oct 13, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
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randomized control clinical trial
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PI and analysts blinded to allocation. Outcomes completed by participants via a mobile app and as such, outcomes assessors are blinded.
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| Coping skills training mobile app only | Behavioral | The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. App chat room access will be provided. |
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Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst). |
| Between baseline and 1 month post-randomization |
| Change in Post-Traumatic Stress Symptom Inventory (PTSS) | Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst). | Between baseline and 3 months post-randomization |
| Client Satisfaction Questionnaire (CSQ) | A measure of acceptability. Scores can range from 5 (worst) to 35 (best) | 1 month post-randomization |
| Intervention Adherence | Measured by how many total tasks of the 33 possible that participants completed within the app during the intervention. Note that a value >33 indicates that participants completed more tasks than required. | 1 month post-randomization |
| Change in Quality of Life Visual Analog Scale | A measure of quality of life. Scores can range from 0 (worst) to 100 (best) | Between baseline and 1 month post-randomization |
| Change in Quality of Life Visual Analog Scale | A measure of quality of life. Scores can range from 0 (worst) to 100 (best) | Between baseline and 3 month post-randomization |
| Patient Health Questionnaire 10-item Scale (PHQ-10) | An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst). | 1 month post-randomization |
| Patient Health Questionnaire 10-item Scale (PHQ-10) | An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst). | 3 months post-randomization |
| Distress Associated With Depression and Anxiety Symptom Frequency | A visual analog scale appended to the HADS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the HADS. Scores range from 0 (best) to 100 (worst) | Between baseline and 1 month post-randomization |
| Distress Associated With Depression and Anxiety Symptom Frequency | A visual analog scale appended to the HADS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the HADS. Scores range from 0 (best) to 100 (worst) | Between baseline and 3 months post-randomization |
| Distress Associated With PTSD Symptom Frequency | A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst) | Between baseline and 1 month post-randomization |
| Distress Associated With PTSD Symptom Frequency | A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst) | Between baseline and 3 months post-randomization |
| 36603136 | Derived | Cox CE, Kelleher SA, Parish A, Olsen MK, Bermejo S, Dempsey K, Jaggers J, Hough CL, Moss M, Porter LS. Feasibility of Mobile App-based Coping Skills Training for Cardiorespiratory Failure Survivors: The Blueprint Pilot Randomized Controlled Trial. Ann Am Thorac Soc. 2023 Jun;20(6):861-871. doi: 10.1513/AnnalsATS.202210-890OC. |
| Death |
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| BG001 | Coping Skills Training Without Therapist Input | Participants will receive a call from a research coordinator to get them started with the trial. Participants will use the Blueprint mobile app for 1 month. No therapist calls will be provided. Chat room access in the app will be provided. Coping skills training mobile app only: The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. App chat room access will be provided. |
| BG002 | Usual Care Control | Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Financial distress | Count of Participants | Participants |
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| OG001 | Coping Skills Training Without Therapist Input | Participants will receive a call from a research coordinator to get them started with the trial. Participants will use the Blueprint mobile app for 1 month. No therapist calls will be provided. Chat room access in the app will be provided. Coping skills training mobile app only: The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. App chat room access will be provided. |
| OG002 | Usual Care Control | Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff. |
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| Secondary | Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire | Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse) | Posted | Mean | 95% Confidence Interval | units on a scale | Between baseline and 3 months post-randomization |
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| Secondary | Change in Post-Traumatic Stress Symptom Inventory (PTSS) | Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst). | Posted | Mean | 95% Confidence Interval | units on a scale | Between baseline and 1 month post-randomization |
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| Secondary | Change in Post-Traumatic Stress Symptom Inventory (PTSS) | Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst). | Posted | Mean | 95% Confidence Interval | units on a scale | Between baseline and 3 months post-randomization |
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| Secondary | Client Satisfaction Questionnaire (CSQ) | A measure of acceptability. Scores can range from 5 (worst) to 35 (best) | Posted | Median | Inter-Quartile Range | units on a scale | 1 month post-randomization |
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| Secondary | Intervention Adherence | Measured by how many total tasks of the 33 possible that participants completed within the app during the intervention. Note that a value >33 indicates that participants completed more tasks than required. | Participants who received intervention. | Posted | Mean | Standard Deviation | tasks | 1 month post-randomization |
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| Secondary | Change in Quality of Life Visual Analog Scale | A measure of quality of life. Scores can range from 0 (worst) to 100 (best) | Posted | Mean | 95% Confidence Interval | units on a scale | Between baseline and 1 month post-randomization |
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| Secondary | Change in Quality of Life Visual Analog Scale | A measure of quality of life. Scores can range from 0 (worst) to 100 (best) | Posted | Mean | 95% Confidence Interval | units on a scale | Between baseline and 3 month post-randomization |
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| Secondary | Patient Health Questionnaire 10-item Scale (PHQ-10) | An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst). | Posted | Mean | Standard Deviation | units on a scale | 1 month post-randomization |
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| Secondary | Patient Health Questionnaire 10-item Scale (PHQ-10) | An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst). | Participants with a PHQ-10 score available at 3 months. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-randomization |
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| Secondary | Distress Associated With Depression and Anxiety Symptom Frequency | A visual analog scale appended to the HADS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the HADS. Scores range from 0 (best) to 100 (worst) | Data not collected. | Posted | Between baseline and 1 month post-randomization |
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| Secondary | Distress Associated With Depression and Anxiety Symptom Frequency | A visual analog scale appended to the HADS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the HADS. Scores range from 0 (best) to 100 (worst) | Data not collected. | Posted | Between baseline and 3 months post-randomization |
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| Secondary | Distress Associated With PTSD Symptom Frequency | A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst) | Data not collected. | Posted | Between baseline and 1 month post-randomization |
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| Secondary | Distress Associated With PTSD Symptom Frequency | A visual analog scale appended to the PTSS which allows participants to report how distressing they perceive the depression and anxiety symptoms to be that they reported in the PTSS. Scores range from 0 (best) to 100 (worst) | Data not collected. | Posted | Between baseline and 3 months post-randomization |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Coping Skills Training Without Therapist Input | Participants will receive a call from a research coordinator to get them started with the trial. Participants will use the Blueprint mobile app for 1 month. No therapist calls will be provided. Chat room access in the app will be provided. Coping skills training mobile app only: The intervention is a mobile app that delivers a 4-week long program of coping skills training. The app contains video, visual, and text content and has a companion PDF workbook. It provides timeline-driven prompts to complete weekly tasks (e.g., viewing videos, completing surveys) and coaching participants to use their current stressors as context for real-life application of adaptive coping skills. App chat room access will be provided. | 2 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Usual Care Control | Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |