Trial Outcomes & Findings for Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment (NCT NCT04587661)
NCT ID: NCT04587661
Last Updated: 2024-04-30
Results Overview
A measure of participant engagement. {Number of times the app has been open per week}
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-04-30
Participant Flow
Participant milestones
| Measure |
Off-the-shelf Digital CBT
standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety
|
Adapted Digital CBT
has content or references to SCD, chronic pain, and the unique challenges facing minority groups
adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Designing an Implementation Strategy for Delivering Routine Mental Health Screening and Treatment
Baseline characteristics by cohort
| Measure |
Off-the-shelf Digital CBT
n=11 Participants
standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety
|
Adapted Digital CBT
n=10 Participants
has content or references to SCD, chronic pain, and the unique challenges facing minority groups
adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
22.73 years
STANDARD_DEVIATION 6.00 • n=5 Participants
|
20.7 years
STANDARD_DEVIATION 6.43 • n=7 Participants
|
21.76 years
STANDARD_DEVIATION 6.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
PHQ score
|
11.18 units on a scale
STANDARD_DEVIATION 6.57 • n=5 Participants
|
13.1 units on a scale
STANDARD_DEVIATION 5.86 • n=7 Participants
|
12.1 units on a scale
STANDARD_DEVIATION 6.16 • n=5 Participants
|
|
Pain
|
5.27 units on a scale
STANDARD_DEVIATION 3.17 • n=5 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 1.34 • n=7 Participants
|
5.95 units on a scale
STANDARD_DEVIATION 2.52 • n=5 Participants
|
|
SCD Efficacy
|
30.27 units on a scale
STANDARD_DEVIATION 6.07 • n=5 Participants
|
28 units on a scale
STANDARD_DEVIATION 5.48 • n=7 Participants
|
29.19 units on a scale
STANDARD_DEVIATION 5.77 • n=5 Participants
|
|
GAD score
|
9.27 units
STANDARD_DEVIATION 4.71 • n=5 Participants
|
9.6 units
STANDARD_DEVIATION 6.83 • n=7 Participants
|
9.43 units
STANDARD_DEVIATION 5.67 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksA measure of participant engagement. {Number of times the app has been open per week}
Outcome measures
| Measure |
Off-the-shelf Digital CBT
n=11 Participants
standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety
|
Adapted Digital CBT
n=10 Participants
has content or references to SCD, chronic pain, and the unique challenges facing minority groups
adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
|
|---|---|---|
|
Frequency of App Use
|
5.64 App opening per week
Standard Deviation 5.37
|
8.50 App opening per week
Standard Deviation 8.98
|
PRIMARY outcome
Timeframe: 4 weeksA measure of participant engagement. {Total number of lesson completed over the 4 week period}
Outcome measures
| Measure |
Off-the-shelf Digital CBT
n=11 Participants
standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety
|
Adapted Digital CBT
n=10 Participants
has content or references to SCD, chronic pain, and the unique challenges facing minority groups
adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
|
|---|---|---|
|
Number of Lessons Completed
|
1.27 Lesson completed
Standard Deviation 1.62
|
7.1 Lesson completed
Standard Deviation 13.94
|
PRIMARY outcome
Timeframe: 4 weeksA measure of participant engagement. {Average number of texts messages sent to their health coach over the treatment period}
Outcome measures
| Measure |
Off-the-shelf Digital CBT
n=11 Participants
standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety
|
Adapted Digital CBT
n=10 Participants
has content or references to SCD, chronic pain, and the unique challenges facing minority groups
adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
|
|---|---|---|
|
Number of Interactions (Text/Phone) With Health Coaches
|
2.09 Average text sent per week
Standard Deviation 2.98
|
6.1 Average text sent per week
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: Baseline vs 4 weeksThe Pain scale asks participants to rank their average pain over the previous 7 days. The minimum score is 0. Maximum score is 10. The higher the score, the more severe the pain. (Value at Baseline -Value at 4 weeks = total change of average pain from baseline)
Outcome measures
| Measure |
Off-the-shelf Digital CBT
n=10 Participants
standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety
|
Adapted Digital CBT
n=7 Participants
has content or references to SCD, chronic pain, and the unique challenges facing minority groups
adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
|
|---|---|---|
|
Change in Baseline Pain Scale at 4 Weeks
|
4.2 score on a scale
Standard Deviation 1.93
|
3.86 score on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: Baseline vs 4 weeksA 9-item measure of depressive symptoms. The minimum score is 0. The maximum score is 27. The higher the total score, the more severe the depressive symptoms. (Value at Baseline- Value at 4 weeks - = total change of depressive symptoms from baseline)
Outcome measures
| Measure |
Off-the-shelf Digital CBT
n=11 Participants
standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety
|
Adapted Digital CBT
n=8 Participants
has content or references to SCD, chronic pain, and the unique challenges facing minority groups
adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
|
|---|---|---|
|
Change in Baseline Patient Health Questionnaire (PHQ-9) at 4 Weeks
|
10.09 units on a scale
Standard Deviation 4.89
|
6.57 units on a scale
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Baseline vs 4 weeksA 7-item measure of anxiety. The minimum score is 0. The maximum score is 21. The higher the total score, the more severe the symptoms of anxiety. ( Value at Baseline - Value at 4 weeks ) = total change of average anxiety symptoms from baseline)
Outcome measures
| Measure |
Off-the-shelf Digital CBT
n=11 Participants
standard implementation strategy that has no content or references to SCD, chronic pain, or the unique challenges facing minority groups
off-the-shelf digital CBT: Cognitive behavioral therapy for depression and anxiety
|
Adapted Digital CBT
n=7 Participants
has content or references to SCD, chronic pain, and the unique challenges facing minority groups
adapted digital CBT: Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
|
|---|---|---|
|
Change in Baseline Generalized Anxiety Disorder Scale (GAD-7) at 4 Weeks
|
8.91 score on a scale
Standard Deviation 4.81
|
3.14 score on a scale
Standard Deviation 4.49
|
Adverse Events
Off-the-shelf Digital CBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adapted Digital CBT
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