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DDBT Adapted Problem Solving Treatment for Primary Care

DDBT Adapted Problem Solving Treatment for Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03514394
Acronym
PST-NA
Enrollment
44
Registered
2018-05-02
Start date
2019-07-01
Completion date
2021-12-30
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, PTSD

Brief summary

Evidence-based psychosocial interventions are rarely used in part because of their design complexity. Although many implementation frameworks do address the importance of EBPI characteristics, adapting and modifying EBPIs to enhance usability has not been a focus. User-centered design (UCD) approaches, which have been successful in creating hardware and software tools that are accessible and compelling to use, have the potential to modify EBPIs so that they are accessible and compelling to clinicians. We hypothesize that UCD driven modifications to EBPI usability (target mechanism) will result in enhanced clinician ability to deliver EBPI elements competently, and that better competence results in better patient reported outcomes. We will modify Behavioral Activation (BA), an EBPI often used in primary care, to function as a Task Sharing model between clinicians and care managers. Our specific aims are to (1) identify usability problems clinicians and care managers encounter with BA (2) create a clinician- and care manager-driven modification of BA and (3) compare the modified Task Sharing version of BA to usual care on usability, clinician competence, and patient reported outcomes.

Detailed description

High quality delivery of evidence-based psychosocial interventions (EBPIs) in primary care medicine is a function of many variables, including clinician training and ready access to EBPI decision support. Importantly, quality is also driven by the clinician's ability to implement the therapeutic elements of EBPIs to fidelity and with competence. Even when clinicians undergo rigorous training, and find the intervention components useful in care, clinicians significantly drift from the original protocol because the processes, structure and elements of care frequently clash with clinician productivity and the shifting needs of the patient populations they serve. Clinicians in low resource settings like federally qualified health centers (FQHCs) report that while elements of EBPIs are important, their design is cumbersome, complex, overwhelming, inflexible, and minimize the nonspecific factors clinicians feel are crucial for quality delivery of care. In short, EBPIs demonstrate low usability (i.e., the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use. Although many implementation science (IS) frameworks do address the importance of EBPI characteristics, adapting and modifying EBPIs to enhance usability has not been a focus. User centered design (UCD) approaches, which have been successful in creating hardware and software tools that are accessible and compelling to use, have the potential to modify EBPIs so that they are accessible and compelling to clinicians. We hypothesize that UCD-driven modifications to EBPI usability will result in enhanced clinician ability to deliver EBPI elements competently (target), and that better competence results in better patient-reported outcomes. We will modify Behavioral Activation (BA) because it is the EBPI often used in primary care settings. To prepare for a larger trial to test hypotheses regarding the impact of EBPI usability on uptake, fidelity and competence, the aims of Project 002 R34 are: Aim 1: Discover Phase (3 months). Using iterative and participatory methods, we will interview up to 15 clinicians from FHQCs affiliated with the WWAMI region Practice Research Network (WPRN, a collaborative group of primary care practices through the states of Washington, Wyoming, Alaska, Montana and Idaho to facilitate innovative community-based research), and observe them in routine practice to identify usability challenges. Contribution to the Center: Data from this phase will be used to inform the Typology of EBPI Targets. Aim 2: Design/Build Phase (6 months) After identification of potential targets, the research team will work via Zoom teleconferencing with the original clinicians from the discover phase and 0-5 new clinicians to engage in a rapid cycle of iterative prototype development and testing (e.g., storyboarding, paper prototypes) of BA modifications. The build of these modifications will include the development of intervention prototypes for user testing and refinement with input from these care managers. Contribution to the Center: Data from this phase will be used to inform the Matrix of EBPI Modifications. Aim 3: Test Phase (15 months). We will test and compare the BA modification (Task Sharing) to usual care in a small non-randomized trial. We will assign all provider teams (therapist & care manager(s)) in the clinic to use Task Sharing with their patients. We will then compare patient outcomes for those receiving Task Sharing vs. patients receiving usual clinic care. H1: Modifications developed in the Design/Build phase for targets identified in the Discover Phase will result in better usability (System Usability and User Burden Scales) compared to usual care. H2: Task Sharing will be more effective than usual care on improving clinical outcomes of functional disability (Sheehan Disability Scale \[SDS\]), change in depression symptoms over time (PHQ-9 total score), and change in anxiety symptoms over time (GAD-7 total score).

Interventions

BEHAVIORALUsual Care

The clinic's usual care includes counseling, substance use disorder treatment, peer support services, and some elements of traditional BA (not the modified BA).

BEHAVIORALModified Behavioral Activation (Task Sharing)

This intervention will include all core elements of Behavioral Activation (BA), which is a behavioral intervention that identifies work, social, health, or family activities that patients have stopped engaging in because of their mood. The intervention will also include a Task Sharing modification, which will allow clinicians and care managers to more efficiently share the tasks involved in BA.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Research Assistants and expert reviewers of therapy sessions will not be made aware of which condition the therapist is assigned to.

Intervention model description

Phase 1 will consist of observation and qualitative interviews; Phase two will consist of iterative design methods; phase three is a pilot randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Primary care patient in rural MT and WY; Speaks English; Patient Health Questionnaire - 9 \> 10.

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire-9 (PHQ-9)Patient participants will complete the PHQ-9 at baseline and weekly for 10 weeks, single value calculated averaging across all available observations.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.
Generalized Anxiety Disorder (7-item) Scale (GAD-7)Patient participants will complete the GAD-7 at baseline and weekly for 10 weeks, single value calculated averaging across all available observations.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.

Secondary

MeasureTime frameDescription
Time to CertificationHours toward certification will be collected over a three month period.We will record the number of hours needed for clinicians in each group to be trained in their assigned intervention.
Skill Drift Using the PST Adherence ChecklistWe will rate nine therapy sessions per clinician over a six month period.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
Acceptability Intervention Measure (AIM)Clinician participants will complete the AIM at baseline and 3-month follow-up.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.
Intervention Appropriateness Measure (IAM)Clinician participants will complete the IAM at baseline and 3-month follow-upThis 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.
Feasibility of Intervention Measure (FIM)Clinician participants will complete the FIM at baseline and 3-month follow-upThis 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.
System Usability ScaleClinician participants will complete the SUS at baseline and 3-month follow-upThis 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.
User Burden ScaleClinician participants will complete the UBS at baseline and 3-month follow-up.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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Usual Care
Usual care administered for depression at clinic.
17
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.
16
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.
11
Total44

Baseline characteristics

CharacteristicTask Sharing - PatientsUsual CareTask Sharing - CliniciansTotal
Age, Continuous39.5 years
STANDARD_DEVIATION 13.9
37.9 years
STANDARD_DEVIATION 15
39.3 years
STANDARD_DEVIATION 9.6
38.8 years
STANDARD_DEVIATION 13.1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants14 Participants10 Participants40 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants3 Participants1 Participants4 Participants
Generalized Anxiety Disorder (7-item) Scale (GAD-7)8.1 units on a scale
STANDARD_DEVIATION 6.7
14.6 units on a scale
STANDARD_DEVIATION 6.2
11.8 units on a scale
STANDARD_DEVIATION 7.1
Patient Health Questionnaire-911.0 units on a scale
STANDARD_DEVIATION 6.9
18.4 units on a scale
STANDARD_DEVIATION 7.5
15.2 units on a scale
STANDARD_DEVIATION 8
Race (NIH/OMB)
American Indian or Alaska Native
6 Participants4 Participants2 Participants12 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
10 Participants13 Participants8 Participants31 Participants
Sex: Female, Male
Female
14 Participants14 Participants9 Participants37 Participants
Sex: Female, Male
Male
2 Participants3 Participants1 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 16
other
Total, other adverse events
0 / 170 / 16
serious
Total, serious adverse events
0 / 170 / 16

Outcome results

Primary

Generalized Anxiety Disorder (7-item) Scale (GAD-7)

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Usual CareGeneralized Anxiety Disorder (7-item) Scale (GAD-7)10.2 score on a scaleStandard Deviation 6.7
Task Sharing - PatientGeneralized Anxiety Disorder (7-item) Scale (GAD-7)8.1 score on a scaleStandard Deviation 5.3
Primary

Patient Health Questionnaire-9 (PHQ-9)

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Usual CarePatient Health Questionnaire-9 (PHQ-9)13.3 score on a scaleStandard Deviation 6.6
Task Sharing - PatientPatient Health Questionnaire-9 (PHQ-9)10.7 score on a scaleStandard Deviation 6.8
Secondary

Acceptability Intervention Measure (AIM)

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.

Time frame: Clinician participants will complete the AIM at baseline and 3-month follow-up.

Population: Clinicians in the task sharing arm.

ArmMeasureGroupValue (MEAN)Dispersion
Task Sharing - PatientAcceptability Intervention Measure (AIM)Baseline4.6 score on a scaleStandard Deviation 0.5
Task Sharing - PatientAcceptability Intervention Measure (AIM)3-month Follow Up4.5 score on a scaleStandard Deviation 0.5
Secondary

Feasibility of Intervention Measure (FIM)

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.

Time frame: Clinician participants will complete the FIM at baseline and 3-month follow-up

Population: Clinicians in the task sharing arm.

ArmMeasureGroupValue (MEAN)Dispersion
Task Sharing - PatientFeasibility of Intervention Measure (FIM)Baseline4.6 score on a scaleStandard Deviation 0.4
Task Sharing - PatientFeasibility of Intervention Measure (FIM)3-month Follow-Up4.4 score on a scaleStandard Deviation 0.5
Secondary

Intervention Appropriateness Measure (IAM)

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.

Time frame: Clinician participants will complete the IAM at baseline and 3-month follow-up

Population: Clinicians in the task sharing arm.

ArmMeasureGroupValue (MEAN)Dispersion
Task Sharing - PatientIntervention Appropriateness Measure (IAM)Baseline4.7 score on a scaleStandard Deviation 0.5
Task Sharing - PatientIntervention Appropriateness Measure (IAM)3-month Follow-Up4.3 score on a scaleStandard Deviation 0.5
Secondary

Skill Drift Using the PST Adherence Checklist

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

Time frame: 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.

Secondary

System Usability Scale

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.

Time frame: Clinician participants will complete the SUS at baseline and 3-month follow-up

Population: Clinicians in the task sharing arm.

ArmMeasureGroupValue (MEAN)Dispersion
Task Sharing - PatientSystem Usability ScaleBaseline73.4 score on a scaleStandard Deviation 9.3
Task Sharing - PatientSystem Usability Scale3-month Follow-Up73.0 score on a scaleStandard Deviation 8.5
Secondary

Time to Certification

We will record the number of hours needed for clinicians in each group to be trained in their assigned intervention.

Time frame: 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.

Secondary

User Burden Scale

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.

Time frame: Clinician participants will complete the UBS at baseline and 3-month follow-up.

Population: Clinicians in the task sharing arm.

ArmMeasureGroupValue (MEAN)Dispersion
Task Sharing - PatientUser Burden ScaleBaseline5.0 score on a scaleStandard Deviation 5.2
Task Sharing - PatientUser Burden Scale3-month Follow Up5.0 score on a scaleStandard Deviation 6

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026