Implementation of Problem-Solving Treatment in Community Health Centers (PST-Aid)

NCT ID: NCT06494384

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-06

Study Completion Date

2028-03-31

Brief Summary

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Although evidence-based clinical interventions (CI) are a preferred treatment option for patients with depression, CIs are rarely available in community primary care settings. When available, CIs are often delivered with poor fidelity and abandoned by practitioners during the initial months post-training. Identifying effective implementation strategies to support the adoption, reach, and sustained use with fidelity of these CIs could enhance the effectiveness of primary care-based treatment of depression, as primary care is where most treatment for this disorder is delivered. Current models of primacy care practitioner training and supervision follow standard formal didactic procedures that might not be sufficient for successful adoption, high-fidelity delivery, and sustainment of CIs. Automated decision support tools and feedback systems embedded in health informatics technology have been found to be effective in supporting the use of best practices and hence might be useful for the transition from training to sustained CI use. In practice, however, these tools are ignored by practitioners, have mixed success on outcomes, and can hinder clinical care owing to poor design. Problem Solving Treatment Aid (PST-Aid), an educate and reorganize implementation strategy, is a web-based app that promotes practitioner-client collaboration in the use of PST for goal setting and action planning. A pilot randomized trial comparing Problem Solving Treatment (PST) training-as-usual to training plus PST-Aid found PST-Aid was deemed to be appropriate and usable to both practitioner and client users with preliminary support for benefits in depression outcomes.

Detailed Description

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This study is a hybrid type III effectiveness-implementation randomized clinical trial comparing standard PST implementation with PST augmented by the PST-Aid implementation strategy. The study will test whether:

1. PST Aid results in improved implementation outcomes (initial and sustained fidelity, adoption, reach, and reduced reactive adaptations);
2. Changes in usability, engagement, and appropriateness mediate the effect of PST Aid on implementation outcomes; and
3. PST Aid is more effective in reducing client depressive symptoms and improving functioning.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Problem Solving Treatment as usual (PST as usual)

Participants in this arm will receiving training in PST as usual.

Group Type ACTIVE_COMPARATOR

Problem Solving Treatment as usual (PST as usual)

Intervention Type BEHAVIORAL

PST is a skills-based intervention that teaches clients a 7-step approach in which they 1) select a specific problem and define it in concrete terms,2) select a goal that is feasible to reach before next session, 3) brainstorm various ways to accomplish the goal, 4) evaluate pros and cons of each solution, including the likelihood they can actually implement it, 5) select the best solution, 6) create a plan to implement the solution, and 7) evaluate the plan afterward to ascertain the effectiveness of the solution. Practitioners teach and illustrate the PST process to clients at each session and encourage clients to implement action plans developed using the PST process. Clients are also encouraged to practice the PST process with additional problems between sessions, in order to gain mastery over the PST skills, enhance behavioral activation and as a result improve their belief in their ability to solve problems on their own (self efficacy).

Problem Solving Treatment Aid (PST-Aid)

Participants in this arm will receiving training in PST with PST-Aid.

Group Type EXPERIMENTAL

Problem Solving Treatment Aid (PST-Aid)

Intervention Type BEHAVIORAL

PST-Aid is an internet-based tool to support the delivery of PST. PST-Aid incorporates decision support for the practitioner as well as client and provides PST treatment support functions (i.e., scaffolding), including patient problem lists and session worksheets. PST-Aid was designed to be used during remote sessions, such that practitioners and clients can interact throughout the session while collaboratively viewing and editing worksheets on their own browsers.This system was developed into a prototype that was piloted and found to be acceptable and with adequate usability.

Interventions

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Problem Solving Treatment as usual (PST as usual)

PST is a skills-based intervention that teaches clients a 7-step approach in which they 1) select a specific problem and define it in concrete terms,2) select a goal that is feasible to reach before next session, 3) brainstorm various ways to accomplish the goal, 4) evaluate pros and cons of each solution, including the likelihood they can actually implement it, 5) select the best solution, 6) create a plan to implement the solution, and 7) evaluate the plan afterward to ascertain the effectiveness of the solution. Practitioners teach and illustrate the PST process to clients at each session and encourage clients to implement action plans developed using the PST process. Clients are also encouraged to practice the PST process with additional problems between sessions, in order to gain mastery over the PST skills, enhance behavioral activation and as a result improve their belief in their ability to solve problems on their own (self efficacy).

Intervention Type BEHAVIORAL

Problem Solving Treatment Aid (PST-Aid)

PST-Aid is an internet-based tool to support the delivery of PST. PST-Aid incorporates decision support for the practitioner as well as client and provides PST treatment support functions (i.e., scaffolding), including patient problem lists and session worksheets. PST-Aid was designed to be used during remote sessions, such that practitioners and clients can interact throughout the session while collaboratively viewing and editing worksheets on their own browsers.This system was developed into a prototype that was piloted and found to be acceptable and with adequate usability.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Practitioner Participants. (a) are employed by a clinic that is an OCHIN clinical network member;
* Practitioner Participants. (b) hold a master's degree in social work, psychology, counseling, or a related field;
* Practitioner Participants. (c) provide psychotherapeutic care in the OCHIN network;
* Practitioner Participants. (d) have not previously received formal training in PST as defined by University of Washington Advancing Integrated Mental Health Solutions Center (AIMS) criteria;
* Practitioner Participants. (e) are not currently receiving specialized training outside of standard clinic support to implement a depression-specific psychosocial intervention; and
* Practitioner Participants. (f) are English-speaking.
* Client Participants. a) 18+,
* Client Participants. b) English-speaking,
* Client Participants. c) have a diagnosis of unipolar depression per provider report, and
* Client Participants. d) have a PHQ-9 score ≥ 10, which is above the clinical cutoff for depression symptoms.

Exclusion Criteria

* Client Participants. (a) history or presence of psychiatric diagnoses other than unipolar, nonpsychotic depression or anxiety disorders,
* Client Participants. (b) active suicidal ideation,
* Client Participants. (c) current alcohol or substance abuse disorders, or
* Client Participants. (d) have dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Patrick Raue

Professor, Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Raue, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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OCHIN, Inc.

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katie Osterhage, MMS

Role: CONTACT

206-616-2129

Patrick Raue, PhD

Role: CONTACT

206-543-3807

Facility Contacts

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Frances Lynch, PhD

Role: primary

503-310-4691

Other Identifiers

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P50MH115837-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00020564

Identifier Type: -

Identifier Source: org_study_id

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