Depression
Conditions
Brief summary
Problem Solving Therapy for Primary Care (PST-PC) is an evidence based psychosocial intervention (EBPI) for use in primary care settings, with more than 100 clinical trials. Despite its proven efficacy we have found that implementation of PST-PC is complicated, resulting in rapid program drift (deviation from protocol with associated loss of efficacy), among practitioners following completion of training. Many studied have shown that program drift is not uncommon in the implementation of EBPIs and can be mitigated through on-going decision support and supervision. Unfortunately, decision support and supervisors of EBPIs are not widely available in low-resourced primary care clinics. We will address this problem by creating decision support tools to be integrated into electronic health records. Because these tools are deemed by many practitioners in other fields to be burdensome, we will explicitly involve active input on the content, design and function of these support tools. Outcomes may include electronic dashboards for panel management, automated suggestions for application of PST-PC elements based on patient reported outcomes or integration of automated patient tracking, and support of patient engagement. We hypothesize that enhanced decision support (target mechanism) will sustain quality delivery of PST-PC, which in turn will improve patient reported outcomes.
Detailed description
Specific aims. Although evidence-based psychosocial interventions (EBPIs) are a preferred treatment option by vulnerable populations, they are rarely available in community primary care settings and when available, are often delivered with poor fidelity. High quality delivery of evidence-based psychosocial interventions (EBPIs) in primary care medicine is a function of many variables, including clinician training and usability of the intervention. Several studies find that for EBPIs to be delivered with sustained quality, on-going supervision and guidance is critical (this study's focus). While the availability of clinicians trained in EBPIs is scarce, the availability to supervisors trained in EBPIs is even more limited. Given the ubiquity of electronic health records, automated decision support tools and feedback systems have been found to be effective in supporting sustained quality EBPIs, but in practice have had mixed success on outcomes such that they may actually hinder clinical care and are often ignored by clinicians. In a report by the Agency for Healthcare Research and Quality, a significant barrier to the use of decision support tools is that these tools have not been developed with input from the clinician or in consideration of their work environment. Using the Center's Discover, Design, Build, Test (DDBT) framework, we will work with clinicians from 13 Behavioral Health Integration Program (BHIP) sites to create a clinical decision tool that addresses the common decisional dilemmas clinicians face when implementing EBPIs. We hypothesize that creating tools to support EBPIs will result in improved clinician competency and sustained skill (target) to EBPIs, compared to clinicians without these supports, resulting in better patient outcomes . The specific aims of this study are: Aim 1: Discover Phase (6 months). Using Participant Action research (PAR) informed user-centered design methods we will interview clinicians in primary care about challenges they face in the delivery of two EBPIs, Behavioral Activation and Problem Solving Treatment, observe them delivering these EBPIs, and receiving feedback on cases from experts in these EBPIs. This process will help us to identify the common decisional dilemma's clinician's face in delivering EBPIs, their preferences for expert guidance strategies, and how decision support tools could be embedded into clinic workflow to reduce obstacles and enhance the delivery of EBPIs. Aim 2: Design/Build Phase (6 months). Based on information obtained in the discover phase, we will engage in a rapid cycle iterative prototype development and testing of decision support tools to support PST-PC, to be carried out using user-centered design (UCD). The build of these tools will include the development of prototypes for user testing and refinement with input from care managers across the 13 BHIP sites. Data from this phase will be used to inform the Matrix of EBPI Modifications. Aim 3: Test Phase (18 months) In the second to third year of the proposed project we will test the decision support tools in a small pilot trial with six providers and thirty patients randomized to the use of the decision support tools. H1: Clinicians with access to decision tools will report better acceptability, usability, and less burden when using PST-PC than clinicians without the tools. H2: Clinicians randomized to decision support tools will more competently deliver EBPI elements than clinicians randomized to unsupported EBPI. H3: Patients treated by clinicians with access to decision tools will have better patient-reported outcomes than patients treated by clinicians without access to these tools as assessed with functional disability and change in depression symptoms over time .
Interventions
BEHAVIORALProblem Solving Therapy as Usual
Treatment as usual to deliver 6 weekly sessions to teach patients how to use the seven step process to solve problems.
BEHAVIORALAssisted Problem Solving Therapy
Smart note assisted delivery of 6 weekly session to teach patients how to use the seven step process to solve problems
Sponsors
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Research Assistants and expert raters will not be informed of condition therapists are assigned to.
Intervention model description
Phase 1 will consist of qualitative interviews; Phase 2 will consist of rapid iterative design that includes qualitative interviews; Phase 3 will be an interventional pilot randomized trial. Data reported on ClinicalTrials.gov are for Phase 3.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinicians: 18 years of age, able to read and speak English, provides psychotherapy as part of the University of Washington Medicine network, and willing to video-record PST sessions with patient participants Clients: 18+ years of age, able to read and speak English, willing to receive psychotherapy from a clinician who is also participating in the study, willing to have therapy sessions video-recorded, Patient Health Questionnaire-9 score of 10 or higher
Exclusion criteria
Client: History or presence of psychiatric diagnoses other than unipolar, non-psychotic depression or generalized anxiety disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention Measure | Clinicians: Six months after certification in the intervention. Clients: Six week follow-up | The Acceptability of Intervention Measure 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. Total scores depicted here are mean item scores and therefore the minimum and maximum values are 1 and 5. Higher scores mean more acceptable. |
| User Burden Scale | Clinicians: Six months follow-up after they have been certified in PST. Clients: six week follow-up timepoint | The User Burden Scale is a 20-item scale that assesses user burden when working with a system or technology. Each item is rated on a 0-4 scale, with a maximum score of 80 (high burden) and minimum score of 0 (low burden). |
| System Usability Scale | Clinicians: 6 month follow-up after certification in PST. Clients: Six week follow-up | The System Usability Scale is a 10-item scale with each item ranked on a five point system of low to high usability. Items are ranked from 1=strongly disagree to 5=strongly agree. The scale score is calculated by adding the item scores and multiplying the total by 2.5, with 0 being the least and 100 being the maximum. A score of 68 or better is considered to be above average usability. As score less than 68 is considered to be poor usability. In this study, a score of 80 or more is considered our cut off for high usability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire | Baseline, 6 week follow-up | The Patient Health Questionnaire is a 9 item self report measure of depression, where each item is rated on a scale of 0-3, for a total possible score of 0-27. Higher scores are indicative of more depressed mood, with scores over 10 considered to be clinically depressed. |
| Sheehan Disability Assessment Scale | Baseline, 6 week follow up | The Sheehan Disability Assessment Scale is 3-item self report measure of functioning, where each item is ranked on a scale of 1-10, with 1 = no disability and 10 =high disability, for a total scale score ranging from 0 to 30. Higher scores reflect greater disability. |
| Problem Solving Therapy Clinician Certification | Expert clinicians reviewed audiotapes of therapy sessions for each clinician participant over a six month period of time after initial training. | Problem Solving Therapy Clinician Certification was determined using the Problem Solving Therapy Adherence Scale, an observer-rated, 11 item scale, with each scale raking therapist competency in delivering the seen steps of PST using a 0 (not competent) to 5 (expert level) scale. Coders then use these item scores to rate a global fidelity rating on the same 0 to 5 scale. Receiving a 3 or higher on two sessions resulted in certification to practice PST. Therefore the outcome of importance is a dichotomous certified/not certified. We report here on the number of clinicians in each group who certified. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Problem Solving Therapy as Usual Clinicians Clinicians in this arm of care had access to the Case Management Tracking System which is already in use.
Intervention: unguided Problem Solving Therapy
Problem Solving Therapy as Usual: Treatment as usual to deliver 6 weekly sessions to teach patients how to use the seven step process to solve problems. | 4 |
| Assisted Problem Solving Therapy Clinicians Clinicians in this arm of care had access to a Case Management and Problem Solving Therapy digitally assisted system
Intervention: guided Problem Solving Therapy
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to teach patients how to use the seven step process to solve problems | 7 |
| Problem Solving Therapy as Usual Clients Clients in this arm were served by clinicians in the Problem Solving Therapy as usual arm.
Problem Solving Therapy as Usual: Treatment as usual to receive 6 weekly sessions to learn how to use the seven step process to solve problems. | 4 |
| Assisted Problem Solving Therapy Clients Clients in this arm were served by clinicians in the Problem Solving Therapy as usual arm.
Assisted Problem Solving Therapy: Smart note assisted delivery of 6 weekly session to learn how to use the seven step process to solve problems | 9 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Assisted Problem Solving Therapy Clinicians | Problem Solving Therapy as Usual Clients | Assisted Problem Solving Therapy Clients | Problem Solving Therapy as Usual Clinicians | Total |
|---|---|---|---|---|---|
| Age, Continuous | 47.0 years STANDARD_DEVIATION 15.1 | 56.5 years STANDARD_DEVIATION 22.4 | 34.4 years STANDARD_DEVIATION 10.6 | 35.5 years STANDARD_DEVIATION 6.81 | 41.9 years STANDARD_DEVIATION 15.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 9 Participants | 4 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire | — | 17.25 score on a scale STANDARD_DEVIATION 5.5 | 15.78 score on a scale STANDARD_DEVIATION 4.68 | — | 16.23 score on a scale STANDARD_DEVIATION 4.76 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 3 Participants | 2 Participants | 14 Participants |
| Region of Enrollment United States | 7 participants | 4 participants | 9 participants | 4 participants | 24 participants |
| Sex/Gender, Customized Gender Agender | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Gender Man | 3 Participants | 2 Participants | 2 Participants | 0 Participants | 7 Participants |
| Sex/Gender, Customized Gender Woman | 4 Participants | 2 Participants | 6 Participants | 4 Participants | 16 Participants |
| Sheehan Disability Assessment Scale | — | 17.25 score on a scale STANDARD_DEVIATION 5.12 | 20.33 score on a scale STANDARD_DEVIATION 5.12 | — | 19.38 score on a scale STANDARD_DEVIATION 5.12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 7 | 0 / 4 | 0 / 9 |
| other Total, other adverse events | 0 / 4 | 0 / 7 | 0 / 4 | 0 / 9 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 | 0 / 4 | 0 / 9 |
Outcome results
Primary
Acceptability of Intervention Measure
The Acceptability of Intervention Measure 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. Total scores depicted here are mean item scores and therefore the minimum and maximum values are 1 and 5. Higher scores mean more acceptable.
Time frame: Clinicians: Six months after certification in the intervention. Clients: Six week follow-up
Population: All participants with baseline data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Solving Therapy as Usual Clinicians | Acceptability of Intervention Measure | 4.13 score on a scale | Standard Deviation 0.53 |
| Assisted Problem Solving Therapy Clinicians | Acceptability of Intervention Measure | 4.25 score on a scale | Standard Deviation 1.3 |
| Problem Solving Therapy as Usual Clients | Acceptability of Intervention Measure | 3.69 score on a scale | Standard Deviation 1.03 |
| Assisted Problem Solving Therapy Clients | Acceptability of Intervention Measure | 4.31 score on a scale | Standard Deviation 0.43 |
p-value: 0.905t-test, 2 sided
p-value: 0.32t-test, 2 sided
Primary
System Usability Scale
The System Usability Scale is a 10-item scale with each item ranked on a five point system of low to high usability. Items are ranked from 1=strongly disagree to 5=strongly agree. The scale score is calculated by adding the item scores and multiplying the total by 2.5, with 0 being the least and 100 being the maximum. A score of 68 or better is considered to be above average usability. As score less than 68 is considered to be poor usability. In this study, a score of 80 or more is considered our cut off for high usability.
Time frame: Clinicians: 6 month follow-up after certification in PST. Clients: Six week follow-up
Population: All participants with follow-up data, and only those who experienced PST-Aid (therefore, as usual participants were not administered the measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Assisted Problem Solving Therapy Clinicians | System Usability Scale | 75.5 score on a scale | Standard Deviation 72.5 |
| Assisted Problem Solving Therapy Clients | System Usability Scale | 66.25 score on a scale | Standard Deviation 68.8 |
Primary
User Burden Scale
The User Burden Scale is a 20-item scale that assesses user burden when working with a system or technology. Each item is rated on a 0-4 scale, with a maximum score of 80 (high burden) and minimum score of 0 (low burden).
Time frame: Clinicians: Six months follow-up after they have been certified in PST. Clients: six week follow-up timepoint
Population: All participants with follow-up timepoints
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Solving Therapy as Usual Clinicians | User Burden Scale | 13.5 score on a scale | Standard Deviation 0.71 |
| Assisted Problem Solving Therapy Clinicians | User Burden Scale | 5.8 score on a scale | Standard Deviation 6.14 |
| Problem Solving Therapy as Usual Clients | User Burden Scale | 8.68 score on a scale | Standard Deviation 8.94 |
| Assisted Problem Solving Therapy Clients | User Burden Scale | 8.53 score on a scale | Standard Deviation 6.32 |
p-value: 0.155t-test, 2 sided
p-value: 0.974t-test, 2 sided
Secondary
Patient Health Questionnaire
The Patient Health Questionnaire is a 9 item self report measure of depression, where each item is rated on a scale of 0-3, for a total possible score of 0-27. Higher scores are indicative of more depressed mood, with scores over 10 considered to be clinically depressed.
Time frame: Baseline, 6 week follow-up
Population: Participants included all clients who reported data at follow-up. Clinicians did not complete this measure and therefore were not analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Solving Therapy as Usual Clients | Patient Health Questionnaire | 13.75 score on a scale | Standard Deviation 2.99 |
| Assisted Problem Solving Therapy Clients | Patient Health Questionnaire | 10.33 score on a scale | Standard Deviation 4.69 |
p-value: 0.212t-test, 2 sided
Secondary
Problem Solving Therapy Clinician Certification
Problem Solving Therapy Clinician Certification was determined using the Problem Solving Therapy Adherence Scale, an observer-rated, 11 item scale, with each scale raking therapist competency in delivering the seen steps of PST using a 0 (not competent) to 5 (expert level) scale. Coders then use these item scores to rate a global fidelity rating on the same 0 to 5 scale. Receiving a 3 or higher on two sessions resulted in certification to practice PST. Therefore the outcome of importance is a dichotomous certified/not certified. We report here on the number of clinicians in each group who certified.
Time frame: Expert clinicians reviewed audiotapes of therapy sessions for each clinician participant over a six month period of time after initial training.
Population: Therapists who submitted audiotapes for review by expert coders. PST adherence was not conducted for clients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Problem Solving Therapy as Usual Clinicians | Problem Solving Therapy Clinician Certification | 1 Participants |
| Assisted Problem Solving Therapy Clinicians | Problem Solving Therapy Clinician Certification | 5 Participants |
p-value: 0.091t-test, 2 sided
Secondary
Sheehan Disability Assessment Scale
The Sheehan Disability Assessment Scale is 3-item self report measure of functioning, where each item is ranked on a scale of 1-10, with 1 = no disability and 10 =high disability, for a total scale score ranging from 0 to 30. Higher scores reflect greater disability.
Time frame: Baseline, 6 week follow up
Population: Analysis on all clients who completed measures at 6 week follow-up. Clinicians did not complete this measure and are not analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Solving Therapy as Usual Clients | Sheehan Disability Assessment Scale | 15.25 score on a scale | Standard Deviation 4.86 |
| Assisted Problem Solving Therapy Clients | Sheehan Disability Assessment Scale | 17.89 score on a scale | Standard Deviation 6.9 |
p-value: 0.507t-test, 2 sided