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

September 8, 2025 updated by: Patrick Raue, University of Washington

Type III Hybrid Effectiveness-Implementation Trial of a Clinical Decision Support System for the Implementation of Problem-Solving Treatment in Community Health Centers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Katie Osterhage, MMS
  • Phone Number: 206-616-2129
  • Email: katieost@uw.edu

Study Contact Backup

  • Name: Patrick Raue, PhD
  • Phone Number: 206-543-3807
  • Email: praue@uw.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97228-5426
        • Recruiting
        • OCHIN, Inc.
        • Contact:
        • Principal Investigator:
          • Frances Lynch, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Client Participants. (e) all exclusion criteria cannot be confirmed via provider report.
  • Practitioner Participants. Exclusion criteria are those that do not meet the inclusion criteria listed above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Problem Solving Treatment as usual (PST as usual)
Participants in this arm will receiving training in PST as usual.
Behavioral: 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).
Experimental: Problem Solving Treatment Aid (PST-Aid)
Participants in this arm will receiving training in PST with PST-Aid.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Implementation Strategy Usability Scale (ISUS) score
Time Frame: Baseline, 3 months, 6 months
Usability will be evaluated with clinician report on the 10-item Implementation Strategy Usability Scale (ISUS), which is based closely on the well-validated System Usability Scale. Ratings are on a 1 to 5 scale and yield a total score from 0 to 100. Half the items are reverse scored; higher total scores reflect greater usability. The ISUS has good inter-item consistency (a = .83) and sensitivity. Research has also demonstrated that the original version of the ISUS (the SUS) functions similarly-and yields similar scores-for adults and youth as young as 11 years.
Baseline, 3 months, 6 months
Change in Participant Responsiveness Scale (PRS) score
Time Frame: Baseline, 3 months, 6 months
Clinicians will complete the Participant Responsiveness Scale (PRS), an adapted version of the 12-item Patient Responsiveness Scale tailored to be developmentally appropriate for children aged 8 and above as well as adults. The PRS measures two factors, Participation and Enthusiasm. The original Patient Responsiveness Scale has demonstrated strong reliability (a = .86) and construct validity.
Baseline, 3 months, 6 months
Change in Intervention Appropriateness Measure (IAM) score
Time Frame: Baseline, 3 months, 6 months
Clinicians will complete the Intervention Appropriateness Measure (IAM) is a rigorously developed, pragmatic instrument with strong good internal consistency (a = .87) and test-retest reliability (a = .87).
Baseline, 3 months, 6 months
Adoption over time
Time Frame: Baseline, 7 months post-initial training in the intervention, and end of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first
Adoption is operationalized as whether or not the clinician completes at least 1 PST session with 3 or more cases at any point during study participation.
Baseline, 7 months post-initial training in the intervention, and end of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first
Reach over time
Time Frame: Baseline, 7 months post-initial training in the intervention, and end of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first
Reach will be calculated as the percentage of clinicians caseloads of patients with a depressive disorder receiving PST.
Baseline, 7 months post-initial training in the intervention, and end of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first
Change in Patient Health Questionnaire (PHQ-9) score
Time Frame: Baseline, 4 weeks, 9 weeks
The Patient Health Questionnaire is one of the most used short depression measures. The PHQ features 9 items on a four-point scale (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day), with cutpoints for 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe levels of depressive symptoms. Four original validation studies were conducted on nearly 10,000 patients, and there have been multiple meta-analyses. Scores have been found valid, with sensitivity of 88% and specificity of 88% for a cut point of 10 has been found for Major Depressive Disorders.
Baseline, 4 weeks, 9 weeks
Change in Quality of Life in Neurological Disorders Social Relations scale (Neuro-QOL) score
Time Frame: Baseline, 4 weeks, 9 weeks
The Quality of Life in Neurological Disorders Satisfaction with Social Roles scale (Neuro-QOL) is a widely used 8-item measure of functioning in usual social roles, activities, and responsibilities. Factor analyses and Item Response Theory analyses have ensured broad information parameters without differential item functioning by demographics. Scale scores have been validated and normed on thousands of participants in the US general and clinical inpatient and outpatient settings, presenting with a variety of problem areas. Scores provide a T score with a mean of 50 and standard deviation of 10, aligned with a variety of norming samples. An example item stem is: In the past 7 days I am able to do all of my regular family activities. Response options are on a scale of 1 to 5 (1=never, 2-rarely, 3=sometimes, 4=often, 5=always).
Baseline, 4 weeks, 9 weeks
Initial fidelity (PST Fidelity Scale)
Time Frame: Expert clinicians review audiotapes of therapy sessions or mock interview for each clinician participant over a six-month period of time prior to certification in the intervention
Fidelity will be measured using the PST Adherence and Competency Scale (PST Fidelity Scale). The PST Fidelity Scale includes seven items assessing the seven key problem-solving steps rated on a 5 point scale (0=very poor, 5=very good), an average score of 3 or greater indicates a satisfactory performance.Internal consistency is good, with Cronbach alpha ranging from .83 to .89. A Principal Components Analysis found all factors loaded on a common factor accounting for 76.6% of the variance.Interrater reliability has been found to be high (r=.822-.918), with 86% of two-rater comparisons within one point of each other. Initial fidelity will be defined as the hours of training until fidelity-based certification is reached, measured by trainer PST Fidelity Scale ratings of session recordings or mock interviews.
Expert clinicians review audiotapes of therapy sessions or mock interview for each clinician participant over a six-month period of time prior to certification in the intervention
Sustained fidelity
Time Frame: Expert clinicians review audiotapes of therapy sessions or mock interview for each clinician participant over a six-month period of time after initial training
Sustained fidelity will be rated via observer coding of recordings of one randomly selected session (or mock interview) per client using the PST Fidelity Scale (i.e., fidelity tool)
Expert clinicians review audiotapes of therapy sessions or mock interview for each clinician participant over a six-month period of time after initial training
Client Satisfaction Questionnaire-16
Time Frame: 9 weeks
This measure will ask 3 items from the Client Satisfaction Questionnaire-16: Did treatment meet your needs? Are you satisfied with treatment services? Would you use the same treatment again if needed?
9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of goal setting and action planning over time
Time Frame: Baseline, 4 weeks, 9 weeks
Using observations of audio recorded sessions, coders will complete the PST Adherence Scale, a seven-item measure scored on a 0 to 5 scale (0=very poor, 5=very good). Six items assess fidelity to technical skills and completing the six specific problem-solving stages. Cronbach alpha coefficients range from .83 to .89. Average item-level interrater agreement is 86%. A seventh item provides a global rating of overall clinician performance, accounting for patient and problem complexity.
Baseline, 4 weeks, 9 weeks
Costs over time
Time Frame: Baseline, 3 months, 6 months, 12 months
A cost checklist will be built for (1) trainers, (2) trainees, and (3) clinics. Participants will estimate the amount of time they spend on conducting PST-related training, meetings, treatment, and providing materials and other costs.
Baseline, 3 months, 6 months, 12 months
Change in PST Task Self Efficacy Scale score
Time Frame: Baseline, 4 weeks, 9 weeks
Clients will complete the PST Task Self Efficacy scale, which is based on guidelines for task-specific reliable and valid measures of Task Self Efficacy. Items are on a scale from 0-100 with the stem: Rate your degree of confidence in your ability to do the following. Items are keyed to the specific actions in PST such as defining a problem in their lives connected to depression, establishing realistic goals, and generating solutions. This approach to generating action-specific (task) self-efficacy measures has been successfully used by hundreds of research projects, and is theoretically more internally valid for a study than standardized general measures of self-efficacy.
Baseline, 4 weeks, 9 weeks
Change in Behavioral Activation for Depression Scale score
Time Frame: Baseline, 4 weeks, 9 weeks
Clients will complete the Behavioral Activation for Depression Scale, a 25-item measure on a scale from 0 (not at all) to 6 (completely), which tracks changes in behaviors that underlie depression in the following areas: activation, avoidance/rumination, work/school impairment, and social impairment.Total score and subscale internal consistencies range from .78 to .87. Construct validity has been established with correlations in expected directions with the Beck Depression Inventory, Beck Anxiety Inventory, and Interpersonal Events Schedule.
Baseline, 4 weeks, 9 weeks
Change in General Anxiety Disorder-7 (GAD-7) score
Time Frame: Baseline, 4 weeks, 9 weeks
The General Anxiety Disorder-7 is a seven-item measure on a four-point scale (0=not at all, 1=several days, 2=more than half the days,3=nearly every day), with cutpoints for 5, 10, and15 representing mild, moderate, and severe levels of anxiety symptoms. Scores have been found valid, at the cutpoint of 10 sensitivity and specificity exceeds .80 for Generalized Anxiety Disorder diagnoses. Concurrent validity has been found with positive associations with the Beck Anxiety Inventory and other anxiety scales. Factor analyses have confirmed anxiety items from the GAD as a separate dimension from depression items on the PHQ.
Baseline, 4 weeks, 9 weeks
Top Problems Assessment over time
Time Frame: Baseline, 4 weeks, 9 weeks
The Top Problems Assessment (TPA) is an assessment in which clients are asked to list the problems they are most concerned about. Upon completion of the list, respondents are asked to assign a severity rating for each problem by answering the questions: how big of a problem is this for you? (0 = not at all to 10 =very, very much). Respondents are then asked to identify which of the problems listed is the biggest problem right now? Which one is the most important to work on? Then the second and third most important until 3 top problems are identified.The TPA is an unchanged version of the Youth Top Problems Assessment (YTPA), which shows excellent concurrence with standardized assessments (Kappa ranging from .78 to .91), while also adding specificity for treatment targets. While the TPA has not yet been validated using an adult sample, the wording is applicable to all age ranges and there is all rationale supports the appropriateness of its usage.
Baseline, 4 weeks, 9 weeks
Framework for Modifications and Adaptations of Evidence-based Interventions
Time Frame: End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first
This measure will document reactive adaptations to the use of the PST-Aid implementation strategy and the unadapted PST implementation strategy. Based on randomization, clinicians will be provided the set of implementation strategies (e.g., Aid vs. the unadapted PST implementation strategy), and this measure will document what they will be able to do with the goal of understanding some of the natural refinements and adaptations to the implementation strategy. The Framework for Modifications and Adaptations of Evidence-based interventions (FRAME), the leading method for evaluating the nature of intervention adaptations will be used.
End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Raue, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00020564
  • P50MH115837-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings