Trial Outcomes & Findings for Mobile Coping Skills Training to Improve Cardiorespiratory Failure Survivors' Psychological Distress (NCT NCT04329702)
NCT ID: NCT04329702
Last Updated: 2023-02-03
Results Overview
Depression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Between baseline and 1 month post-randomization
Results posted on
2023-02-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
15
|
|
Overall Study
COMPLETED
|
13
|
8
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
illness
|
3
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
|
Overall Study
Death
|
0
|
2
|
0
|
Baseline Characteristics
Mobile Coping Skills Training to Improve Cardiorespiratory Failure Survivors' Psychological Distress
Baseline characteristics by cohort
| Measure |
Coping Skills Training Plus Therapist Input
n=16 Participants
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.
|
Coping Skills Training Without Therapist Input
n=14 Participants
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.
|
Usual Care Control
n=15 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.7 years
STANDARD_DEVIATION 12.5 • n=93 Participants
|
52.7 years
STANDARD_DEVIATION 15.0 • n=4 Participants
|
46.5 years
STANDARD_DEVIATION 14.1 • n=27 Participants
|
49.4 years
STANDARD_DEVIATION 12.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
45 Participants
n=483 Participants
|
|
Financial distress
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Between baseline and 1 month post-randomizationDepression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=16 Participants
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.
|
Coping Skills Training Without Therapist Input
n=14 Participants
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.
|
Usual Care Control
n=15 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
|---|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
|
11.7 units on a scale
Interval 8.5 to 14.8
|
11.3 units on a scale
Interval 7.7 to 14.8
|
12.1 units on a scale
Interval 8.7 to 15.6
|
SECONDARY outcome
Timeframe: Between baseline and 3 months post-randomizationDepression and anxiety symptoms. Scores range from 0 (better) to 42 (worse)
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=16 Participants
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.
|
Coping Skills Training Without Therapist Input
n=14 Participants
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.
|
Usual Care Control
n=15 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
|---|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS) Questionnaire
|
11.0 units on a scale
Interval 7.2 to 14.8
|
11.4 units on a scale
Interval 6.8 to 16.1
|
13.5 units on a scale
Interval 9.5 to 17.5
|
SECONDARY outcome
Timeframe: Between baseline and 1 month post-randomizationPost-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=16 Participants
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.
|
Coping Skills Training Without Therapist Input
n=14 Participants
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.
|
Usual Care Control
n=15 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
|---|---|---|---|
|
Change in Post-Traumatic Stress Symptom Inventory (PTSS)
|
28.8 units on a scale
Interval 23.7 to 33.9
|
26.4 units on a scale
Interval 20.6 to 32.1
|
30.5 units on a scale
Interval 25.0 to 36.1
|
SECONDARY outcome
Timeframe: Between baseline and 3 months post-randomizationPost-traumatic stress disorder symptoms. Scores can range from 10 (best) to 70 (worst).
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=16 Participants
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.
|
Coping Skills Training Without Therapist Input
n=14 Participants
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.
|
Usual Care Control
n=15 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
|---|---|---|---|
|
Change in Post-Traumatic Stress Symptom Inventory (PTSS)
|
28.9 units on a scale
Interval 22.0 to 35.9
|
29.4 units on a scale
Interval 21.0 to 37.8
|
31.3 units on a scale
Interval 24.2 to 38.4
|
SECONDARY outcome
Timeframe: 1 month post-randomizationA measure of acceptability. Scores can range from 5 (worst) to 35 (best)
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=16 Participants
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.
|
Coping Skills Training Without Therapist Input
n=14 Participants
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.
|
Usual Care Control
n=15 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
|---|---|---|---|
|
Client Satisfaction Questionnaire (CSQ)
|
29 units on a scale
Interval 27.0 to 30.0
|
29.5 units on a scale
Interval 24.0 to 32.5
|
25 units on a scale
Interval 23.0 to 30.0
|
SECONDARY outcome
Timeframe: 1 month post-randomizationPopulation: Participants who received intervention.
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.
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=14 Participants
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.
|
Coping Skills Training Without Therapist Input
n=13 Participants
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.
|
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.
|
|---|---|---|---|
|
Intervention Adherence
|
36.5 tasks
Standard Deviation 11.8
|
34.1 tasks
Standard Deviation 10.9
|
—
|
SECONDARY outcome
Timeframe: Between baseline and 1 month post-randomizationA measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=16 Participants
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.
|
Coping Skills Training Without Therapist Input
n=14 Participants
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.
|
Usual Care Control
n=15 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
|---|---|---|---|
|
Change in Quality of Life Visual Analog Scale
|
54.0 units on a scale
Interval 44.6 to 63.4
|
66.7 units on a scale
Interval 56.0 to 77.4
|
61.8 units on a scale
Interval 51.5 to 72.1
|
SECONDARY outcome
Timeframe: Between baseline and 3 month post-randomizationA measure of quality of life. Scores can range from 0 (worst) to 100 (best)
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=16 Participants
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.
|
Coping Skills Training Without Therapist Input
n=14 Participants
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.
|
Usual Care Control
n=15 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
|---|---|---|---|
|
Change in Quality of Life Visual Analog Scale
|
61.4 units on a scale
Interval 50.6 to 72.3
|
72.5 units on a scale
Interval 58.3 to 86.7
|
67.1 units on a scale
Interval 55.9 to 78.3
|
SECONDARY outcome
Timeframe: 1 month post-randomizationAn adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst).
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=16 Participants
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.
|
Coping Skills Training Without Therapist Input
n=14 Participants
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.
|
Usual Care Control
n=15 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
|---|---|---|---|
|
Patient Health Questionnaire 10-item Scale (PHQ-10)
|
11.3 units on a scale
Standard Deviation 2.7
|
10.1 units on a scale
Standard Deviation 2.7
|
8.3 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 3 months post-randomizationPopulation: Participants with a PHQ-10 score available at 3 months.
An adapted version of the PHQ-15; a measure of physical symptoms. Scores can range from 0 (best) to 30 (worst).
Outcome measures
| Measure |
Coping Skills Training Plus Therapist Input
n=13 Participants
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.
|
Coping Skills Training Without Therapist Input
n=8 Participants
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.
|
Usual Care Control
n=13 Participants
Control participants will receive the same safety oversight as intervention participants and will be provided with phone and email contacts for study staff.
|
|---|---|---|---|
|
Patient Health Questionnaire 10-item Scale (PHQ-10)
|
7.9 units on a scale
Standard Deviation 2.8
|
6.5 units on a scale
Standard Deviation 3.8
|
5.7 units on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Between baseline and 1 month post-randomizationPopulation: Data not collected.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between baseline and 3 months post-randomizationPopulation: Data not collected.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between baseline and 1 month post-randomizationPopulation: Data not collected.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Between baseline and 3 months post-randomizationPopulation: Data not collected.
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)
Outcome measures
Outcome data not reported
Adverse Events
Coping Skills Training Plus Therapist Input
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Coping Skills Training Without Therapist Input
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Usual Care Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place