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DDBT Adapted Problem Solving Treatment for Primary Care (PST-NA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03514394
Recruitment Status : Not yet recruiting
First Posted : May 2, 2018
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Pat Arean, University of Washington

Brief Summary:
Evidence-based psychosocial interventions (EBPI) 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. The investigators 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. The investigators will modify Problem-Solving Therapy for Primary Care (PSTPC) because it is the EBPI used in Collaborative Care (CC). Our aims are to (1) identify usability problems clinicians encounter with PST-PC (2) create a clinician driven modification of PST-PC and (3) compare the modified version of PST-PC to traditional PST-PC on usability, clinician competence and patient reported outcomes.

Condition or disease Intervention/treatment Phase
Depression PTSD Behavioral: Problem Solving Therapy Behavioral: Modified PST Not Applicable

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. The investigators 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. The investigators will modify Problem-Solving Therapy for Primary Care (PST-PC) because it is the EBPI used in Collaborative Care (CC). To prepare for a larger trial to test hypotheses regarding the impact of EBPI usability on uptake, fidelity and competence, the aims of this R34 are: Aim 1: Discover Phase (3 months). Using iterative and participatory methods, the investigators will interview 10 clinicians from FHQCs affiliated with the Washington, Wyoming, Alaska, Montana and Idaho (WWAMI) region Practice Research Network (WPRN, a collaborative group of primary care practices to facilitate innovative community-based research), and observe the clinicians using PST-PC to identify usability challenges.

Aim 2: Design/Build Phase (6 months) After identification of potential targets, the research team will work with the original 10 clinicians to engage in a rapid cycle of iterative prototype development and testing of PST-PC modifications. The build of these modifications will include the development of intervention prototypes for user testing and refinement with input from these care managers.

Aim 3: Test Phase (15 months). The research team will test and compare the PST-PC modification (mPST-PC) to unmodified PST-PC in a small randomized clinical trial (RCT). Six newly identified clinicians will be randomized to the two conditions; each will see five patients for a total of 30 patients (15 in each arm) in the trial. H1: Modifications developed in the Design/Build phase for targets identified in the Discover Phase will result in better usability compared to traditional PST-PC. H2: Clinicians randomized to mPST-PC will certify faster, and will deliver PST elements more competently than clinicians randomized to PST-PC. H3: mPST-PC will be more effective than PST-PC on improving clinical outcomes of functional disability and change in depression symptoms over time.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 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
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Problem Solving Therapy (PST)
6 weekly sessions to teach patients seven steps of problem solving (problem orientation, problem definition, goal setting, brain storming, decision making, action planning, solution evaluation).
Behavioral: Problem Solving Therapy
six weekly sessions to train patients in seven step problem solving method.
Other Name: Problem Solving Treatment, PST

Experimental: Modified PST
This intervention will be a modification of PST, based on clinician feedback. It will be developed in phase 1 and 2 of this study. It will include elements of cognitive processing therapy, behavioral activation and distress tolerance. Anticipated number of sessions is 6.
Behavioral: Modified PST
This intervention will contain elements of problem solving therapy, cognitive process therapy, and other interventions clinicians determine are important in their patient population




Primary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Patient participants will complete the PHQ-9 at baseline and weekly for 6 weeks. We will compare changes in depression over 6 weeks between the two groups.. ]
    9 item patient self report measure of mood, where each item as rated on a 0 (no problem) to 3 (every day) scale. Higher scores indicate increased depression, a score of 10 or greater is considered to be clinical depression.


Secondary Outcome Measures :
  1. Acceptability Intervention Measure (AIM) [ Time Frame: We will compare clinician acceptability of PST and the new intervention 6 months after they certify in their intervention ]
    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. each group will be compared on the degree they find the training they participated in acceptable after they complete training.

  2. User Burden Scale [ Time Frame: We will compare clinician ratings of intervention burden of PST and the new intervention 6 months after they certify in their intervention ]
    The User Burden Scale is a 20-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 80 (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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: We will compare clinician ratings of intervention usabilty of PST and the new intervention 6 months after they certify in their intervention ]
    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. A score of 68 or better is considered to be above average usablilty. As score less than 68 s considered to be poor usability. In this study, a score of 80 or more is considered our cut off for high usability. We will compare the two training programs on usability with this scale.

  6. Sheehan Disability Asssesment Scale [ Time Frame: Patient participants will complete this scale at baseline and at 6 weeks. We will compare patient changes in disability over the six week period. ]
    Patient 4 item self report measure of daily functioning, where each item is rated on a scale of 0 (not disabled) to 3 (disabled). Higher scores reflect greater disability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514394


Contacts
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Contact: Patricia Arean, PhD 2062218692 patji@me.com
Contact: Brenna Renn, PhD bnrenn@uw.edu

Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Patricia Arean, PhD UWMC Psychiatry

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pat Arean, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03514394    
Other Study ID Numbers: STUDY00004236
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available through the UW ALACRITY Center once it is collected and analyzed.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be made available January 2022
Access Criteria: All interested parties may contact Dr. Renn for access to data. Dr. Renn will review all requests and facilitate data use agreements and data access.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms