DepressionNCT06494384
Implementation of Problem-Solving Treatment in Community Health Centers (PST-Aid)
A study testing Problem Solving Treatment as usual (PST as usual) and Problem Solving Treatment Aid (PST-Aid) in people with Depression, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Problem Solving Treatment as usual (PST as usual) and Problem Solving Treatment Aid (PST-Aid)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OCHIN, Inc.
Portland, Oregon, 97228-5426
Frances Lynch, PhD, 503-310-4691, frances.lynch@kpchr.org
Frances Lynch, Ph.D.
About this study
Official title: 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.
Read the 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:
- PST Aid results in improved implementation outcomes (initial and sustained fidelity, adoption, reach, and reduced reactive adaptations);
- Changes in usability, engagement, and appropriateness mediate the effect of PST Aid on implementation outcomes; and
- PST Aid is more effective in reducing client depressive symptoms and improving functioning.
- Conditions
- Depression
- Being tested
- Problem Solving Treatment as usual (PST as usual), Problem Solving Treatment Aid (PST-Aid)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving Treatment as usual (PST as usual)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Problem Solving Treatment as usual (PST as usual) | Active comparator | Participants in this arm will receiving training in PST as usual. Receives: Behavioral: Problem Solving Treatment as usual (PST as usual) |
| Problem Solving Treatment Aid (PST-Aid) | Experimental | Participants in this arm will receiving training in PST with PST-Aid. Receives: Behavioral: Problem Solving Treatment Aid (PST-Aid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Implementation Strategy Usability Scale (ISUS) score
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.
Measured: Baseline, 3 months, 6 months
Change in Participant Responsiveness Scale (PRS) score
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.
Measured: Baseline, 3 months, 6 months
Change in Intervention Appropriateness Measure (IAM) score
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).
Measured: Baseline, 3 months, 6 months
Adoption over time
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.
Measured: 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
Reach will be calculated as the percentage of clinicians caseloads of patients with a depressive disorder receiving PST.
Measured: 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
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.
Measured: Baseline, 4 weeks, 9 weeks
Client Satisfaction Questionnaire-16
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?
Measured: 9 weeks
Change in Quality of Life in Neurological Disorders Social Relations scale (Neuro-QOL) score
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).
Measured: Baseline, 4 weeks, 9 weeks
Initial fidelity (PST Fidelity Scale)
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.
Measured: 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
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)
Measured: Expert clinicians review audiotapes of therapy sessions or mock interview for each clinician participant over a six-month period of time after initial training
Secondary outcomes (7)
Framework for Modifications and Adaptations of Evidence-based Interventions
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.
Measured: End of the individual's study participation period, assessed as the study withdrawal date or 24 months post-training, whichever is first
Quality of goal setting and action planning over time
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.
Measured: Baseline, 4 weeks, 9 weeks
Costs over time
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.
Measured: Baseline, 3 months, 6 months, 12 months
Change in PST Task Self Efficacy Scale score
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.
Measured: Baseline, 4 weeks, 9 weeks
Change in Behavioral Activation for Depression Scale score
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.
Measured: Baseline, 4 weeks, 9 weeks
Change in General Anxiety Disorder-7 (GAD-7) score
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.
Measured: Baseline, 4 weeks, 9 weeks
Top Problems Assessment over time
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.
Measured: Baseline, 4 weeks, 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start6 Nov 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Patrick Raue, University of Washington
- Investigators
- Patrick Raue, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494384
- Sponsor's protocol ID
- STUDY00020564
- Other IDs
- P50MH115837-06
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type III Hybrid Effectiveness-Implementation Trial of a Clinical Decision Support System for the Implementation of Problem-Solving Treatment in Community Health Centers
- ClinicalTrials.gov ID
- NCT06494384
- Acronym / sponsor ID
- STUDY00020564
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- PST Aid results in improved implementation outcomes (initial and sustained fidelity, adoption, reach, and reduced reactive adaptations);
- Changes in usability, engagement, and appropriateness mediate the effect of PST Aid on implementation outcomes; and
- PST Aid is more effective in reducing client depressive symptoms and improving functioning.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Treatment as usual (PST as usual) | Active comparator | Behavioral: Problem Solving Treatment as usual (PST as usual)Participants in this arm will receiving training in PST as usual. |
| Problem Solving Treatment Aid (PST-Aid) | Experimental | Behavioral: Problem Solving Treatment Aid (PST-Aid)Participants in this arm will receiving training in PST with PST-Aid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Problem Solving Treatment as usual (PST as usual) |
| 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. | Behavioural | Problem Solving Treatment Aid (PST-Aid) |
Primary outcome
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.
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.
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).
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.
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.
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.
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?
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).
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.
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)
7 secondary outcomes
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
Quality of goal setting and action planning over time
Time frame: Baseline, 4 weeks, 9 weeks
Costs over time
Time frame: Baseline, 3 months, 6 months, 12 months
Change in PST Task Self Efficacy Scale score
Time frame: Baseline, 4 weeks, 9 weeks
Change in Behavioral Activation for Depression Scale score
Time frame: Baseline, 4 weeks, 9 weeks
Change in General Anxiety Disorder-7 (GAD-7) score
Time frame: Baseline, 4 weeks, 9 weeks
Top Problems Assessment over time
Time frame: Baseline, 4 weeks, 9 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Raue, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Treatment as usual (PST as usual) and Problem Solving Treatment Aid (PST-Aid) in people with Depression, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Osterhage, MMS (206-616-2129, katieost@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Implementation Strategy Usability Scale (ISUS) score (time frame: Baseline, 3 months, 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.