PracticeGround: Transforming Training and Delivery of Mental Health EBPs
Primary Purpose
Depression, Insomnia, Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality
Care-as-Usual Psychotherapy
Sponsored by
About this trial
This is an interventional health services research trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Meets DSM-IV criteria for MDD and/or DD
- Obtains a score of 11 or greater on the PHQ-9
- Currently receiving psychosocial treatment for depression by a study-participant clinician
- Payment-eligible to receive at least 12 weeks of additional psychosocial treatment
Exclusion Criteria:
- Current diagnosis of bipolar disorder or another psychotic disorder
- Active mania
- Current diagnosis of alcohol and/or drug dependence
- At imminent risk of suicide (as deemed by their clinician).
Sites / Locations
- Evidence-Based Practice Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
WILLOW
Treatment-as-Usual
Arm Description
Clinicians have access to WILLOW's dynamic progress monitoring, clinical decision support, rich visual displays of client outcomes, online training modules in ESTs, just-in-time training for guided real-time assistance in delivering ESTs, educational videos, and a client portal
Usual care without access to WILLOW.
Outcomes
Primary Outcome Measures
Depression, Anxiety, and Stress Scale (DASS)
Higher scores on subscales from this 23-item measure reflected higher depression, anxiety, stress, and suicidality. Other researchers added two suicidality items to the original 21-item measure with permission from the original authors. Each subscale score is computed by summing the subscale items, then multiplying by 2. Total possible scores for the depression, anxiety, and stress subscales range from 0-42. We categorized DASS depression, anxiety, and stress scores into severity levels coded as 0, 1, and 2: Normal (0 through 9), Mild/moderate (10 through 20), and Severe/extremely severe (21 through 42) (Psychology Foundation of Australia, 2018). The DASS suicide subscale ranged from 0-12 and not recategorized.
Beck Depression Inventory (BDI-II)
Higher scores on this 21-item reflect greater depressive symptoms in the past two weeks. All items are summed to a total score (possible range 0-63). We categorized BDI scores into severity levels coded as 0, 1, and 2: Minimal (raw scores 0 through 13), Mild/moderate (14 through 28), and Severe (29 through 63).
Patient Health Questionnaire-9 (PHQ-9)
Higher scores on this ten-item measure reflects more severe depression. The total score (possible range 0-27) is created by summing the first nine items. We categorized PHQ severity levels coded as 0, 1, and 2 based on authors' research as minimal (0 through 4), mild/moderate (5 through 14), and moderately severe/severe (15 through 27). The recategorized scores are reported here.
Behavioral Activation for Depression Scale Short Form (BADS-SF)
The Behavioral Activation for depression Scale Short Form has 9 questions each having a scale from 0 (Not at All) to 6 (Completely) with a total range of 0-54. Higher scores on this nine-item scale reflect lower engagement in avoidance and higher engagement in activation behaviors over the course of BA for depression.
Mental Health Services Satisfaction Survey (MHSSS)
We created a nine-item measure in which higher scores reflected greater satisfaction with services they received. The measure had 10 questions each having a scale of 1(Strongly Disagree) to 4(Strongly Agree) with a total range of 10-50. Higher scores indicated a better outcome.
Working Alliance Inventory (WAI)
We modified this measure to include items from the BHS from Group Health. The resulting 12-item scale measures the therapeutic relationship with higher scores indicating stronger alliance. With 12 questions and each having a scale of 1(Never) to 7(Always) the total range was 12-84.
Therapy Task Checklist (TTC) - Patient Version
We developed the TTC. The Therapy Task Checklist-Patient Version with 25 questions and each having a scale of 0 (Never/Very Rarely) to 7 (All of the Time) has a total range of 0-100. Higher scores reflected more frequent use of evidence-based therapy tasks, positive outcomes.
Modified Practice Attitudes Scale (MPAS)
The Modified Practice Attitudes Scale with eight questions, each having a scale of 0 (Not at all) to 4(To a very great extent), has a total range of 0-32. Higher scores on this eight-item scale reflect more positive attitudes towards evidence-based practices.
Perceptions of Computer-Assisted Therapy Questionnaire (PCAT)
The Perceptions of Computer-Assisted Therapy Questionnaire has 34 questions each having a scale of 1(Strongly Disagree) to 7 Strongly Agree). Thus, the total range was 34-238. Higher scores on this 34-item scale indicate stronger agreement with the benefits of computer-assisted therapy, or a better outcome.
ASA-Monitoring and Feedback Version (ASA-MF)
The ASA-Monitoring and Feedback Version (ASA-MF) measure has 18 questions each having a scale of 1(Strongly Disagree) to 5(Strongly Agree) with a total range of 18-90. Higher scores on this 18-item scale reflect positive attitudes about standardized and routine progress monitoring, or positive outcomes.
Monitoring and Feedback Attitudes Scale (MFA)
The Monitoring and Feedback Attitudes Scale has 14 questions and each has a scale of 1(Strongly Disagree) to 5(Strongly Agree), thus the total range was 14-70. Higher scores on this 14-item measure indicate more positive attitudes about routine progress monitoring and providing feedback to patients about treatment progress, or positive outcomes.
Routine Monitoring (RM)
We created a three-item measure where the total score is found by summing the items. The first two items are yes(scored 1)/no(scored 0) questions. The last item is a count measure that can be any number greater than or equal to 0. Thus, the total score can have any integer value greater than or equal to 0, with higher scores reflecting greater use of routine progress monitoring.
Current Assessment Practice Evaluation-Revised (CAPER)
We modified the original measure into nine items. The Current Assessment Practice Evaluation-Revised has 9 questions with each having a scale of 1(None, 0%) to 5 (Nearly All, 81-100%). Thus, the total range was 9-45 and higher scores reflect greater provider use of measurement-based care or positive outcomes.
Therapy Task Checklist (TTC) - Provider Version
The Therapy Task Checklist -Provider Version has 22 questions and each have a scale of 0(Never/Very Rarely) to 4 (All of the time) with a total range of 0-88. Higher scores reflected more frequent use of evidence-based therapy tasks, or positive outcomes.
Secondary Outcome Measures
Full Information
NCT ID
NCT02314624
First Posted
December 5, 2014
Last Updated
May 22, 2023
Sponsor
Evidence-Based Practice Institute, Seattle, WA
1. Study Identification
Unique Protocol Identification Number
NCT02314624
Brief Title
PracticeGround: Transforming Training and Delivery of Mental Health EBPs
Official Title
PracticeGround: Transforming Training and Delivery of Mental Health EBPs
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evidence-Based Practice Institute, Seattle, WA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The ultimate goal is to facilitate the delivery of empirically supported treatments (ESTs) for mental disorders and to improve client mental health outcomes. Toward this end, this Phase II SBIR proposal seeks to complete the development and testing of PracticeGround, a comprehensive software system designed to integrate with electronic health records, and that contains multiple methods of training clinicians in ESTs and delivering ESTs to clients, continuous progress monitoring of client outcomes, and clinical support tools to guide clinicians and clients through delivery of the necessary EST. The investigators will conduct an 18-week randomized controlled trial (N=80) comparing PracticeGround (n=40) to care-as-usual (n=40) in depressed outpatient clients. PracticeGround clinicians will have full access to the software. Study clinicians and clients will be assessed once every six weeks (baseline, 6, 12, and 18 weeks). To ensure generalizability of findings, the investigators will not control for natural therapy variations (e.g.,session frequency, medication use, etc.). Primary outcomes include: depression, psychological distress, treatment satisfaction (clients and clinicians), and treatment drop out. Secondary clinician outcomes include: extent of PracticeGround use with clients across clinicians' caseload.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Insomnia, Suicide
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WILLOW
Arm Type
Experimental
Arm Description
Clinicians have access to WILLOW's dynamic progress monitoring, clinical decision support, rich visual displays of client outcomes, online training modules in ESTs, just-in-time training for guided real-time assistance in delivering ESTs, educational videos, and a client portal
Arm Title
Treatment-as-Usual
Arm Type
Active Comparator
Arm Description
Usual care without access to WILLOW.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality
Intervention Description
Evidence-based interventions for treating depression and concurrent problems
Intervention Type
Behavioral
Intervention Name(s)
Care-as-Usual Psychotherapy
Intervention Description
Usual care psychotherapy for depression and concurrent problems
Primary Outcome Measure Information:
Title
Depression, Anxiety, and Stress Scale (DASS)
Description
Higher scores on subscales from this 23-item measure reflected higher depression, anxiety, stress, and suicidality. Other researchers added two suicidality items to the original 21-item measure with permission from the original authors. Each subscale score is computed by summing the subscale items, then multiplying by 2. Total possible scores for the depression, anxiety, and stress subscales range from 0-42. We categorized DASS depression, anxiety, and stress scores into severity levels coded as 0, 1, and 2: Normal (0 through 9), Mild/moderate (10 through 20), and Severe/extremely severe (21 through 42) (Psychology Foundation of Australia, 2018). The DASS suicide subscale ranged from 0-12 and not recategorized.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Beck Depression Inventory (BDI-II)
Description
Higher scores on this 21-item reflect greater depressive symptoms in the past two weeks. All items are summed to a total score (possible range 0-63). We categorized BDI scores into severity levels coded as 0, 1, and 2: Minimal (raw scores 0 through 13), Mild/moderate (14 through 28), and Severe (29 through 63).
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
Higher scores on this ten-item measure reflects more severe depression. The total score (possible range 0-27) is created by summing the first nine items. We categorized PHQ severity levels coded as 0, 1, and 2 based on authors' research as minimal (0 through 4), mild/moderate (5 through 14), and moderately severe/severe (15 through 27). The recategorized scores are reported here.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Behavioral Activation for Depression Scale Short Form (BADS-SF)
Description
The Behavioral Activation for depression Scale Short Form has 9 questions each having a scale from 0 (Not at All) to 6 (Completely) with a total range of 0-54. Higher scores on this nine-item scale reflect lower engagement in avoidance and higher engagement in activation behaviors over the course of BA for depression.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
Mental Health Services Satisfaction Survey (MHSSS)
Description
We created a nine-item measure in which higher scores reflected greater satisfaction with services they received. The measure had 10 questions each having a scale of 1(Strongly Disagree) to 4(Strongly Agree) with a total range of 10-50. Higher scores indicated a better outcome.
Time Frame
After first study therapy session, 4 weeks, 8 weeks, 12 weeks
Title
Working Alliance Inventory (WAI)
Description
We modified this measure to include items from the BHS from Group Health. The resulting 12-item scale measures the therapeutic relationship with higher scores indicating stronger alliance. With 12 questions and each having a scale of 1(Never) to 7(Always) the total range was 12-84.
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Therapy Task Checklist (TTC) - Patient Version
Description
We developed the TTC. The Therapy Task Checklist-Patient Version with 25 questions and each having a scale of 0 (Never/Very Rarely) to 7 (All of the Time) has a total range of 0-100. Higher scores reflected more frequent use of evidence-based therapy tasks, positive outcomes.
Time Frame
4 weeks, 8 weeks, 12 weeks
Title
Modified Practice Attitudes Scale (MPAS)
Description
The Modified Practice Attitudes Scale with eight questions, each having a scale of 0 (Not at all) to 4(To a very great extent), has a total range of 0-32. Higher scores on this eight-item scale reflect more positive attitudes towards evidence-based practices.
Time Frame
Baseline, 12 weeks
Title
Perceptions of Computer-Assisted Therapy Questionnaire (PCAT)
Description
The Perceptions of Computer-Assisted Therapy Questionnaire has 34 questions each having a scale of 1(Strongly Disagree) to 7 Strongly Agree). Thus, the total range was 34-238. Higher scores on this 34-item scale indicate stronger agreement with the benefits of computer-assisted therapy, or a better outcome.
Time Frame
Baseline, 12 weeks
Title
ASA-Monitoring and Feedback Version (ASA-MF)
Description
The ASA-Monitoring and Feedback Version (ASA-MF) measure has 18 questions each having a scale of 1(Strongly Disagree) to 5(Strongly Agree) with a total range of 18-90. Higher scores on this 18-item scale reflect positive attitudes about standardized and routine progress monitoring, or positive outcomes.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Monitoring and Feedback Attitudes Scale (MFA)
Description
The Monitoring and Feedback Attitudes Scale has 14 questions and each has a scale of 1(Strongly Disagree) to 5(Strongly Agree), thus the total range was 14-70. Higher scores on this 14-item measure indicate more positive attitudes about routine progress monitoring and providing feedback to patients about treatment progress, or positive outcomes.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Routine Monitoring (RM)
Description
We created a three-item measure where the total score is found by summing the items. The first two items are yes(scored 1)/no(scored 0) questions. The last item is a count measure that can be any number greater than or equal to 0. Thus, the total score can have any integer value greater than or equal to 0, with higher scores reflecting greater use of routine progress monitoring.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Current Assessment Practice Evaluation-Revised (CAPER)
Description
We modified the original measure into nine items. The Current Assessment Practice Evaluation-Revised has 9 questions with each having a scale of 1(None, 0%) to 5 (Nearly All, 81-100%). Thus, the total range was 9-45 and higher scores reflect greater provider use of measurement-based care or positive outcomes.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Therapy Task Checklist (TTC) - Provider Version
Description
The Therapy Task Checklist -Provider Version has 22 questions and each have a scale of 0(Never/Very Rarely) to 4 (All of the time) with a total range of 0-88. Higher scores reflected more frequent use of evidence-based therapy tasks, or positive outcomes.
Time Frame
4 weeks, 8 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PATIENTS
Inclusion Criteria:
Meets DSM-IV criteria for MDD and/or DD
Obtains a score of 11 or greater on the PHQ-9
Currently receiving psychosocial treatment for depression by a study-participant clinician
Payment-eligible to receive at least 12 weeks of additional psychosocial treatment
Exclusion Criteria:
Current diagnosis of bipolar disorder or another psychotic disorder
Active mania
Current diagnosis of alcohol and/or drug dependence
At imminent risk of suicide (as deemed by their clinician).
PROVIDERS
Inclusion Criteria:
English speaker
18 years or older
Currently licensed mental health treatment provider (or a therapist working towards licensure under direct supervision of licensed mental health treatment provider)
Have an office with access to internet
Have access to computer with sound card and/or tablet and printer
Capacity to accept new patients seeking treatment for depressive symptoms
Exclusion Criteria:
(PILOT ONLY) Receiving training for an evidence based treatment for depression, including behavioral activation, interpersonal therapy, cognitive/cognitive-behavioral therapy, mindfulness-based cognitive therapy or cognitive behavioral analysis system of psychotherapy
Participated in the Field Test for WILLOW
Is not comfortable/savvy with technology (by answering "I get easily frustrated and usually walk away from it" to the question "Which response best matches how you typically respond to complicated problems you encounter when using a new app, computer, or technology for the first time?"; answering "I am not comfortable and/or do not enjoy technology, particularly new forms of technology. I avoid the use of technology as much as is realistically possible." to the question "How technologically savvy/skilled are you?")
Does not have a feasible office set up for using a computer in therapy
Facility Information:
Facility Name
Evidence-Based Practice Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98121
Country
United States
12. IPD Sharing Statement
Learn more about this trial
PracticeGround: Transforming Training and Delivery of Mental Health EBPs
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