Cardiorespiratory FailureBlueprintNCT04329702
Mobile Coping Skills Training to Improve Cardiorespiratory Failure Survivors' Psychological Distress
A study testing Coping skills training mobile app with call from CST therapist and Coping skills training mobile app only in people with Cardiorespiratory Failure, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiorespiratory Failure
- What is being tested?
- Coping skills training mobile app with call from CST therapist and Coping skills training mobile app only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- mechanical ventilation via endotracheal tube for ≥4 hours
- non-invasive ventilation (CPAP, BiPAP) for ≥4 hours in a 24-hour period provided for acute respiratory failure
- new use of supplemental oxygen ≥2 liters per minute (or increase in baseline continuous oxygen)
Show all 21Show fewer
- use of vasopressors for shock of any etiology
- use of inotropes for shock of any etiology
- use of pulmonary vasodilators
- use of aortic balloon pump or cardiac assist device for cardiogenic shock
- use of diuretic intravenous drip
- Cognitive status intact
- No history of pre-existing significant cognitive impairment (e.g., dementia) as per medical chart
- Absence of current significant cognitive impairment (impairment defined as ≥3 errors on the Callahan cognitive status screen)
- Decisional capacity present
- Absence of severe and/or persistent mental illness
- Treatment for severe and/or persistent mental illness (e.g., psychosis, bipolar affective disorder, schizoaffective disorder, schizoid personality disorder, schizophrenia [as per medical record], hospitalization for any psychiatric disorder) within the 6 months preceding the current hospital admission
- No endorsement of active suicidality at time of admission or informed consent
- No active substance abuse at a severity that impairs ability to participate
- Functional English fluency
- 1. Elevated baseline (T1) psychological distress symptoms, defined as HADS total score of ≥8
Who cannot join
- Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for follow up care, disruptive chemotherapy/radiation regimen)
- Unable to complete study procedures as determined by staff
- Lack of access to either reliable smartphone with cellular data plan or wifi
- Failure to randomize within 2 months post-discharge.
- Failure to access app within 1 month after randomization in the absence of other explanation (e.g., hospitalization).
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Optimizing a Self-directed Mobile Coping Skills Training Intervention to Improve Cardiorespiratory Failure Survivors' Psychological Distress
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.
Read the detailed description
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.
- Conditions
- Cardiorespiratory Failure
- Being tested
- Coping skills training mobile app with call from CST therapist, Coping skills training mobile app only
- Keywords
- cardiorespiratory failure, critical illness, psychological distress, depression, intensive care units, adults, mechanical ventilation, post-traumatic stress disorder, anxiety
- Medical subject headings
- Critical Illness, Depression, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping skills training mobile app with call from CST therapistBehavioural
Also called Blueprint; mobile coping skills training (mCST) plus 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.
Coping skills training mobile app onlyBehavioural
Also called Blueprint; mobile coping skills training (mCST)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Coping skills training mobile app with call from CST therapist |
| 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. Receives: Behavioral: Coping skills training mobile app only |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)
Measured: Between baseline and 1 month post-randomization
Secondary outcomes (13)
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)
Measured: Between baseline and 3 months post-randomization
Change in Post-Traumatic Stress Symptom Inventory (PTSS)
Post-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).
Measured: 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).
Measured: Between baseline and 3 months post-randomization
Client Satisfaction Questionnaire (CSQ)
A measure of acceptability. Scores can range from 5 (worst) to 35 (best)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Between baseline and 3 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start3 Dec 2020
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiorespiratory FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christopher E Cox, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329702
- Sponsor's protocol ID
- Pro00101848
- Other IDs
- 1R34HL145387
- Acronym
- Blueprint
- Status last verified
- Dec 2022
- First submitted
- 30 Mar 2020
- Last updated
- 3 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will follow all NIH guidelines and regulations.
Publications
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.
PubMed 28872898Cox 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.
PubMed 22527082Cox 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.
PubMed 36603136
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Self-directed Mobile Coping Skills Training Intervention to Improve Cardiorespiratory Failure Survivors' Psychological Distress
- ClinicalTrials.gov ID
- NCT04329702
- Acronym / sponsor ID
- Blueprint / Pro00101848
- Conditions
- Cardiorespiratory Failure
- Keywords
- cardiorespiratory failure, critical illness, psychological distress, depression, intensive care units, adults, mechanical ventilation, post-traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 1 Apr 2020 (actual)
- Results
- Posted 3 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized control clinical trial
| Arm | Type | Receives |
|---|---|---|
| coping skills training plus therapist input | Experimental | Behavioral: Coping skills training mobile app with call from CST therapistParticipants 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 without therapist input | Experimental | Behavioral: Coping skills training mobile app onlyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (5 listed)
- Complex medical care expected soon after discharge (e.g., planned surgeries, transplantation evaluation, extensive travel needs for follow up care, disruptive chemotherapy/radiation regimen)
- Unable to complete study procedures as determined by staff
- Lack of access to either reliable smartphone with cellular data plan or wifi
- Failure to randomize within 2 months post-discharge.
- Failure to access app within 1 month after randomization in the absence of other explanation (e.g., hospitalization).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping skills training mobile app with call from CST therapistAlso: Blueprint; mobile coping skills training (mCST) plus therapistThe 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. | Behavioural | coping skills training plus therapist input |
| Coping skills training mobile app onlyAlso: Blueprint; mobile coping skills training (mCST)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. | Behavioural | coping skills training without therapist input |
Primary outcome
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
Time frame: Between baseline and 1 month post-randomization
Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)
13 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
Time frame: Between baseline and 3 months post-randomization
Change in Post-Traumatic Stress Symptom Inventory (PTSS)
Time frame: Between baseline and 1 month post-randomization
Change in Post-Traumatic Stress Symptom Inventory (PTSS)
Time frame: Between baseline and 3 months post-randomization
Client Satisfaction Questionnaire (CSQ)
Time frame: 1 month post-randomization
Intervention Adherence
Time frame: 1 month post-randomization
Change in Quality of Life Visual Analog Scale
Time frame: Between baseline and 1 month post-randomization
Change in Quality of Life Visual Analog Scale
Time frame: Between baseline and 3 month post-randomization
Patient Health Questionnaire 10-item Scale (PHQ-10)
Time frame: 1 month post-randomization
Patient Health Questionnaire 10-item Scale (PHQ-10)
Time frame: 3 months post-randomization
Distress Associated With Depression and Anxiety Symptom Frequency
Time frame: Between baseline and 1 month post-randomization
Distress Associated With Depression and Anxiety Symptom Frequency
Time frame: Between baseline and 3 months post-randomization
Distress Associated With PTSD Symptom Frequency
Time frame: Between baseline and 1 month post-randomization
Distress Associated With PTSD Symptom Frequency
Time frame: Between baseline and 3 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28872898Cox 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.
- Background: PubMed 22527082Cox 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.
- Derived from this study: PubMed 36603136Cox 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.
- Individual participant dataSharing planned: Yes. We will follow all NIH guidelines and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher E Cox, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping skills training mobile app with call from CST therapist and Coping skills training mobile app only in people with Cardiorespiratory Failure, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire (time frame: Between baseline and 1 month post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04329702, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.