PST-NA: DDBT Adapted Problem Solving Treatment for Primary Care

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT03514394
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 44
• Location: 1
• Arms: 2
• Actual Duration (Months): 30
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; PTSD	Behavioral: Usual Care; Behavioral: Modified Behavioral Activation (Task Sharing)	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 trialPhase 1 will consist of observation and qualitative interviews; Phase two will consist of iterative design methods; phase three is a pilot randomized clinical trial
• 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.
• Primary Purpose: Health Services Research
• Official Title: DDBT Adapted Problem Solving Treatment for Primary Care
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Jun 25, 2021
• Actual Study Completion Date: Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual Care Usual care administered for depression at clinic.	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).
Experimental: Modified Behavioral Activation (Task Sharing) This intervention will be a modification 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. Specifically, we will introduce a Task Sharing modification, which will allow clinicians and care managers to more efficiently share the tasks involved in BA. These modifications will be based on clinician and care manager feedback from Phases 1 and 2 of this study.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Patient Health Questionnaire-9 (PHQ-9) [Patient participants will complete the PHQ-9 at baseline and weekly for 6 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.

2. Generalized Anxiety Disorder (7-item) Scale (GAD-7) [Patient participants will complete the GAD-7 at baseline and weekly for 6 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 Outcome Measures

1. 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.

2. User Burden Scale [Clinician 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.

3. Time to Certification [Hours 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.

4. Skill Drift Using the PST Adherence Checklist [We 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

5. System Usability Scale [Clinician participants will complete the SUS at baseline and 3-month follow-up]

   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.

6. Intervention Appropriateness Measure (IAM) [Clinician participants will complete the IAM at baseline and 3-month follow-up]

   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.

7. Feasibility of Intervention Measure (FIM) [Clinician participants will complete the FIM at baseline and 3-month follow-up]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Big Horn Valley Health Center	Hardin	Montana	United States	59034

Sponsors and Collaborators

• University of Washington
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Patricia Arean, PhD, UWMC Psychiatry

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 21, 2020
• Informed Consent Form - Dec 21, 2020

More Information

Publications

None provided.

• Responsible Party: Pat Arean, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT03514394
• Other Study ID Numbers: STUDY00004236; 1P50MH115837-01
• First Posted: May 2, 2018
• Last Update Posted: Aug 23, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

Participant Flow

Arm/Group Title	Usual Care	Task Sharing - Patients	Task Sharing - Clinicians
Arm/Group Description	Usual care administered for depression at clinic.	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 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.
Period Title: Overall Study
STARTED	17	16	11
COMPLETED	17	16	10
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Usual Care	Task Sharing - Patients	Task Sharing - Clinicians	Total
Arm/Group Description	Usual care administered for depression at clinic.	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 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 of all reporting groups
Overall Participants	17	16	11	44
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.9 (15.0)	39.5 (13.9)	39.3 (9.6)	38.8 (13.1)
Sex: Female, Male (Count of Participants)
Female	14 82.4%	14 87.5%	9 81.8%	37 84.1%
Male	3 17.6%	2 12.5%	1 9.1%	6 13.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	14 82.4%	16 100%	10 90.9%	40 90.9%
Unknown or Not Reported	3 17.6%	0 0%	1 9.1%	4 9.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 23.5%	6 37.5%	2 18.2%	12 27.3%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	13 76.5%	10 62.5%	8 72.7%	31 70.5%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 9.1%	1 2.3%

Outcome Measures

1. Primary Outcome

Title	Patient Health Questionnaire-9 (PHQ-9)
Description	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 6 weeks, single value calculated averaging across all available observations.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	Task Sharing - Patient
Arm/Group Description	Usual care administered for depression at clinic.	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.
Measure Participants	17	16
Mean (Standard Deviation) [score on a scale]	13.3 (6.6)	10.7 (6.8)

2. Primary Outcome

Title	Generalized Anxiety Disorder (7-item) Scale (GAD-7)
Description	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 6 weeks, single value calculated averaging across all available observations.

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Care	Task Sharing - Patient
Arm/Group Description	Usual care administered for depression at clinic.	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.
Measure Participants	17	16
Mean (Standard Deviation) [score on a scale]	10.2 (6.7)	8.1 (5.3)

3. Secondary Outcome

Title	Acceptability Intervention Measure (AIM)
Description	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.

Outcome Measure Data

Analysis Population Description

Clinicians in the task sharing arm.

Arm/Group Title	Usual Care	Task Sharing
Arm/Group Description	Usual care administered for depression at clinic.	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.
Measure Participants	0	10
Baseline	4.6 (0.5)
3-month Follow Up	4.5 (0.5)

4. Secondary Outcome

Title	User Burden Scale
Description	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.

Outcome Measure Data

Analysis Population Description

Clinicians in the task sharing arm.

Arm/Group Title	Usual Care	Task Sharing
Arm/Group Description	Usual care administered for depression at clinic.	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.
Measure Participants	0	10
Baseline	5.0 (5.2)
3-month Follow Up	5.0 (6.0)

5. Secondary Outcome

Title	Time to Certification
Description	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.

Outcome Measure Data

Analysis Population Description

No data displayed because outcome measure data was not collected therefore zero total participants analyzed.

Arm/Group Title	Usual Care	Task Sharing
Arm/Group Description	Usual care administered for depression at clinic.	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.
Measure Participants	0	0

6. Secondary Outcome

Title	Skill Drift Using the PST Adherence Checklist
Description	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.

Outcome Measure Data

Analysis Population Description

No data displayed because outcome measure data was not collected therefore zero total participants analyzed.

Arm/Group Title	Usual Care	Task Sharing
Arm/Group Description	Usual care administered for depression at clinic.	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.
Measure Participants	0	0

7. Secondary Outcome

Title	System Usability Scale
Description	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

Outcome Measure Data

Analysis Population Description

Clinicians in the task sharing arm.

Arm/Group Title	Usual Care	Task Sharing
Arm/Group Description	Usual care administered for depression at clinic.	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.
Measure Participants	0	10
Baseline	73.4 (9.3)
3-month Follow-Up	73.0 (8.5)

8. Secondary Outcome

Title	Intervention Appropriateness Measure (IAM)
Description	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

Outcome Measure Data

Analysis Population Description

Clinicians in the task sharing arm.

Arm/Group Title	Usual Care	Task Sharing
Arm/Group Description	Usual care administered for depression at clinic.	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.
Measure Participants	0	9
Baseline	4.7 (0.5)
3-month Follow-Up	4.3 (0.5)

9. Secondary Outcome

Title	Feasibility of Intervention Measure (FIM)
Description	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

Outcome Measure Data

Analysis Population Description

Clinicians in the task sharing arm.

Arm/Group Title	Usual Care	Task Sharing
Arm/Group Description	Usual care administered for depression at clinic.	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.
Measure Participants	0	10
Baseline	4.6 (0.4)
3-month Follow-Up	4.4 (0.5)

Adverse Events

Time Frame	Adverse events were collected over the 6 week time period.
Arm/Group Title	Usual Care		Task Sharing - Patients		Task Sharing - Clinicians
Arm/Group Description	Usual care administered for depression at clinic.		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 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.
All Cause Mortality
	Usual Care		Task Sharing - Patients		Task Sharing - Clinicians
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)		0/11 (0%)
Serious Adverse Events
	Usual Care		Task Sharing - Patients		Task Sharing - Clinicians
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		Task Sharing - Patients		Task Sharing - Clinicians
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/16 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.