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N/A Completed N=44 Randomized Single-blind Health Services Research

DDBT Adapted Problem Solving Treatment for Primary Care

Source: ClinicalTrials.gov NCT03514394 ↗
Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Patient Health Questionnaire-9 (PHQ-9) — 13.3; 10.7 score on a scale

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Health Questionnaire-9 (PHQ-9)
13.3; 10.7
PRIMARY
Generalized Anxiety Disorder (7-item) Scale (GAD-7)
10.2; 8.1
SECONDARY
Acceptability Intervention Measure (AIM)
4.6; 4.5
SECONDARY
User Burden Scale
5.0; 5.0
SECONDARY
Time to Certification
SECONDARY
Skill Drift Using the PST Adherence Checklist
SECONDARY
System Usability Scale
73.4; 73.0
SECONDARY
Intervention Appropriateness Measure (IAM)
4.7; 4.3
SECONDARY
Feasibility of Intervention Measure (FIM)
4.6; 4.4

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • none
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03514394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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