Trial Outcomes & Findings for DDBT Adapted Problem Solving Treatment for Primary Care (NCT NCT03514394)
NCT ID: NCT03514394
Last Updated: 2023-07-27
Results Overview
9 item patient self report measure of mood, where each item as rated on a 0 (no problem) to 3 (every day) scale. Total scores range from 0 - 27. Higher scores indicate increased depression, a score of 10 or greater is considered to be clinical depression. Data points were collected from each individual multiple times across the course of the study. For comparisons we conducted a multiple case study design examining each person's individual trajectory. The means and standard deviations reported are for all available observations stratified by condition.
COMPLETED
NA
44 participants
Patient participants will complete the PHQ-9 at baseline and weekly for 10 weeks, single value calculated averaging across all available observations.
2023-07-27
Participant Flow
Participant milestones
| Measure |
Usual Care
Usual care administered for depression at clinic.
|
Task Sharing - Patients
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
Task Sharing - Clinicians
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
11
|
|
Overall Study
COMPLETED
|
17
|
16
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One clinician in the Task Sharing arm did not contribute age data.
Baseline characteristics by cohort
| Measure |
Usual Care
n=17 Participants
Usual care administered for depression at clinic.
|
Task Sharing - Patients
n=16 Participants
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
Task Sharing - Clinicians
n=11 Participants
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 15.0 • n=17 Participants • One clinician in the Task Sharing arm did not contribute age data.
|
39.5 years
STANDARD_DEVIATION 13.9 • n=16 Participants • One clinician in the Task Sharing arm did not contribute age data.
|
39.3 years
STANDARD_DEVIATION 9.6 • n=10 Participants • One clinician in the Task Sharing arm did not contribute age data.
|
38.8 years
STANDARD_DEVIATION 13.1 • n=43 Participants • One clinician in the Task Sharing arm did not contribute age data.
|
|
Sex: Female, Male
Female
|
14 Participants
n=17 Participants • One clinician participant in the task sharing arm did not contribute demographic data.
|
14 Participants
n=16 Participants • One clinician participant in the task sharing arm did not contribute demographic data.
|
9 Participants
n=10 Participants • One clinician participant in the task sharing arm did not contribute demographic data.
|
37 Participants
n=43 Participants • One clinician participant in the task sharing arm did not contribute demographic data.
|
|
Sex: Female, Male
Male
|
3 Participants
n=17 Participants • One clinician participant in the task sharing arm did not contribute demographic data.
|
2 Participants
n=16 Participants • One clinician participant in the task sharing arm did not contribute demographic data.
|
1 Participants
n=10 Participants • One clinician participant in the task sharing arm did not contribute demographic data.
|
6 Participants
n=43 Participants • One clinician participant in the task sharing arm did not contribute demographic data.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=17 Participants
|
16 Participants
n=16 Participants
|
10 Participants
n=11 Participants
|
40 Participants
n=44 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=44 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=17 Participants
|
6 Participants
n=16 Participants
|
2 Participants
n=11 Participants
|
12 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=17 Participants
|
10 Participants
n=16 Participants
|
8 Participants
n=11 Participants
|
31 Participants
n=44 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=44 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=17 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=44 Participants
|
|
Patient Health Questionnaire-9
|
18.4 units on a scale
STANDARD_DEVIATION 7.5 • n=17 Participants • Clinicians were not administered the PHQ, so they are left blank here. Only 13 of the participants in the intervention condition responded to enough items on the PHQ at baseline to compute their score.
|
11.0 units on a scale
STANDARD_DEVIATION 6.9 • n=13 Participants • Clinicians were not administered the PHQ, so they are left blank here. Only 13 of the participants in the intervention condition responded to enough items on the PHQ at baseline to compute their score.
|
—
|
15.2 units on a scale
STANDARD_DEVIATION 8.0 • n=30 Participants • Clinicians were not administered the PHQ, so they are left blank here. Only 13 of the participants in the intervention condition responded to enough items on the PHQ at baseline to compute their score.
|
|
Generalized Anxiety Disorder (7-item) Scale (GAD-7)
|
14.6 units on a scale
STANDARD_DEVIATION 6.2 • n=17 Participants • Clinicians did not respond to this measure, so they are not included here. Only 13 participants in the intervention condition responded to this measure.
|
8.1 units on a scale
STANDARD_DEVIATION 6.7 • n=13 Participants • Clinicians did not respond to this measure, so they are not included here. Only 13 participants in the intervention condition responded to this measure.
|
—
|
11.8 units on a scale
STANDARD_DEVIATION 7.1 • n=30 Participants • Clinicians did not respond to this measure, so they are not included here. Only 13 participants in the intervention condition responded to this measure.
|
PRIMARY outcome
Timeframe: Patient participants will complete the PHQ-9 at baseline and weekly for 10 weeks, single value calculated averaging across all available observations.Population: Sample sizes were too small to appropriately run any tests of statistical significance. Data points were collected from each individual multiple times across the course of the study. For comparisons we conducted a multiple case study design examining each person's individual trajectory. The means and standard deviations above are for all available observations stratified by condition.
9 item patient self report measure of mood, where each item as rated on a 0 (no problem) to 3 (every day) scale. Total scores range from 0 - 27. Higher scores indicate increased depression, a score of 10 or greater is considered to be clinical depression. Data points were collected from each individual multiple times across the course of the study. For comparisons we conducted a multiple case study design examining each person's individual trajectory. The means and standard deviations reported are for all available observations stratified by condition.
Outcome measures
| Measure |
Usual Care
n=17 Participants
Usual care administered for depression at clinic.
|
Task Sharing - Patient
n=16 Participants
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
|
13.3 score on a scale
Standard Deviation 6.6
|
10.7 score on a scale
Standard Deviation 6.8
|
PRIMARY outcome
Timeframe: Patient participants will complete the GAD-7 at baseline and weekly for 10 weeks, single value calculated averaging across all available observations.Population: Sample sizes were too small to appropriately run any tests of statistical significance. Data points were collected from each individual multiple times across the course of the study. For comparisons we conducted a multiple case study design examining each person's individual trajectory. The means and standard deviations above are for all available observations stratified by condition.
A 7-item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. Total scores range from 0 - 21. The scale is a valid screener for GAD. High scores indicate higher anxiety symptom severity. Data points were collected from each individual multiple times across the course of the study. For comparisons we conducted a multiple case study design examining each person's individual trajectory. The means and standard deviations reported are for all available observations stratified by condition.
Outcome measures
| Measure |
Usual Care
n=17 Participants
Usual care administered for depression at clinic.
|
Task Sharing - Patient
n=16 Participants
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
|---|---|---|
|
Generalized Anxiety Disorder (7-item) Scale (GAD-7)
|
10.2 score on a scale
Standard Deviation 6.7
|
8.1 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Clinician participants will complete the AIM at baseline and 3-month follow-up.Population: Clinicians in the task sharing arm.
This is a four item measure of intervention acceptability, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Total scores are calculated taking the mean of the four items, reporting a range of 1 - 5.
Outcome measures
| Measure |
Usual Care
Usual care administered for depression at clinic.
|
Task Sharing - Patient
n=10 Participants
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
|---|---|---|
|
Acceptability Intervention Measure (AIM)
Baseline
|
—
|
4.6 score on a scale
Standard Deviation 0.5
|
|
Acceptability Intervention Measure (AIM)
3-month Follow Up
|
—
|
4.5 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Clinician participants will complete the UBS at baseline and 3-month follow-up.Population: Clinicians in the task sharing arm.
The User Burden Scale is a 26-item scale that assesses six domains of user burden: use, physical burden, time/social burdens, mental/emotional burden, privacy concerns and financial burdens. The scale is calculated item measure of perceived burden of use that covers 6 domains: difficulty of use, emotional burden, physical burden, time and social burden, financial burden and privacy. Each item is rated on a 04- scale, with a maximum score of 104 (high burden) and minimum score of 0 (low burden). We will compare the ratings of intervention burden between groups to determine if the new intervention is considered less burdensome than the traditional model.
Outcome measures
| Measure |
Usual Care
Usual care administered for depression at clinic.
|
Task Sharing - Patient
n=10 Participants
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
|---|---|---|
|
User Burden Scale
Baseline
|
—
|
5.0 score on a scale
Standard Deviation 5.2
|
|
User Burden Scale
3-month Follow Up
|
—
|
5.0 score on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Hours toward certification will be collected over a three month period.Population: No data displayed because outcome measure data was not collected therefore zero total participants analyzed.
We will record the number of hours needed for clinicians in each group to be trained in their assigned intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: We will rate nine therapy sessions per clinician over a six month period.Population: No data displayed because outcome measure data was not collected therefore zero total participants analyzed.
This is a 20 item scale, where each item rates clinician competencies in the delivery of PST, using a 0 (not competent) to 5 (expert level) scale. Higher scores indicate greater competence. IN this use case, we will be measuring the time to which clinicians receive their first score below 3 (average) on the PST Adherence Checklist
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Clinician participants will complete the SUS at baseline and 3-month follow-upPopulation: Clinicians in the task sharing arm.
This is a 10-item scale with each item ranked on a five point system of low to high usability. The scale score is calculated by adding the item scores and multiplying by 2.5. This is your total score and can range from 0 - 100. A score of 68 or better is considered to be above average usability. A score less than 68 is considered to be poor usability. In this study, a score of 80 or more is considered our cut off for high usability.
Outcome measures
| Measure |
Usual Care
Usual care administered for depression at clinic.
|
Task Sharing - Patient
n=10 Participants
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
|---|---|---|
|
System Usability Scale
Baseline
|
—
|
73.4 score on a scale
Standard Deviation 9.3
|
|
System Usability Scale
3-month Follow-Up
|
—
|
73.0 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Clinician participants will complete the IAM at baseline and 3-month follow-upPopulation: Clinicians in the task sharing arm.
This is a four item measure of intervention appropriateness, where each item is rated on a 1-5, with 1 = not at all acceptable and 5 = very acceptable. High scores (min: 1, max:5) indicate higher levels of appropriateness. Total scores are calculated taking the mean of the four items, reporting a range of 1 - 5.
Outcome measures
| Measure |
Usual Care
Usual care administered for depression at clinic.
|
Task Sharing - Patient
n=9 Participants
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
|---|---|---|
|
Intervention Appropriateness Measure (IAM)
Baseline
|
—
|
4.7 score on a scale
Standard Deviation 0.5
|
|
Intervention Appropriateness Measure (IAM)
3-month Follow-Up
|
—
|
4.3 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Clinician participants will complete the FIM at baseline and 3-month follow-upPopulation: Clinicians in the task sharing arm.
This is a four-item measure of intervention feasibility, where each item is rated on a 1-5 scale, with 1 = not at all acceptable and 5 = very acceptable. Higher scores indicate higher levels of feasibility. Total scores are calculated taking the mean of the four items, reporting a range of 1 - 5.
Outcome measures
| Measure |
Usual Care
Usual care administered for depression at clinic.
|
Task Sharing - Patient
n=10 Participants
Task sharing is a modified version of a depression treatment called Behavioral Activation, which allows therapists and care managers to more efficiently share the tasks involved in patient care.
|
|---|---|---|
|
Feasibility of Intervention Measure (FIM)
Baseline
|
—
|
4.6 score on a scale
Standard Deviation 0.4
|
|
Feasibility of Intervention Measure (FIM)
3-month Follow-Up
|
—
|
4.4 score on a scale
Standard Deviation 0.5
|
Adverse Events
Usual Care - Patients
Task Sharing - Patients
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