DDBT Adapted Problem Solving Treatment for Primary Care

Depression Clinical Trial

— PST-NA  

Official title:

DDBT Adapted Problem Solving Treatment for Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514394
• Other study ID #: STUDY00004236
• Secondary ID: 1P50MH115837-01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 30, 2021
• Est. primary completion date: June 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Depression
• PTSD

Intervention

Behavioral:
• Usual 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).
• Modified 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.

Locations

Country	Name	City	State
United States	Big Horn Valley Health Center	Hardin	Montana

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Patient participants will complete the PHQ-9 at baseline and weekly for 10 weeks, single value calculated averaging across all available observations.
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.	Patient participants will complete the GAD-7 at baseline and weekly for 10 weeks, single value calculated averaging across all available observations.
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.	Clinician participants will complete the AIM at baseline and 3-month follow-up.
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.	Clinician participants will complete the UBS at baseline and 3-month follow-up.
Secondary	Time to Certification	We will record the number of hours needed for clinicians in each group to be trained in their assigned intervention.	Hours toward certification will be collected over a three month period.
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	We will rate nine therapy sessions per clinician over a six month period.
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.	Clinician participants will complete the SUS at baseline and 3-month follow-up
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.	Clinician participants will complete the IAM at baseline and 3-month follow-up
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.	Clinician participants will complete the FIM at baseline and 3-month follow-up