PracticeGround: Transforming Training and Delivery of Mental Health EBPs

Depression Clinical Trial

Official title:

PracticeGround: Transforming Training and Delivery of Mental Health EBPs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314624
• Other study ID #: 2R44MH093993-02A1
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2023
• Source: Evidence-Based Practice Institute, Seattle, WA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Insomnia
• Suicide

Intervention

Behavioral:
• Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality
Evidence-based interventions for treating depression and concurrent problems
• Care-as-Usual Psychotherapy
Usual care psychotherapy for depression and concurrent problems

Locations

Country	Name	City	State
United States	Evidence-Based Practice Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Evidence-Based Practice Institute, Seattle, WA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 4 weeks, 8 weeks, 12 weeks
Primary	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).	baseline, 4 weeks, 8 weeks, 12 weeks
Primary	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.	baseline, 4 weeks, 8 weeks, 12 weeks
Primary	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.	baseline, 4 weeks, 8 weeks, 12 weeks
Primary	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.	After first study therapy session, 4 weeks, 8 weeks, 12 weeks
Primary	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.	4 weeks, 8 weeks, 12 weeks
Primary	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.	4 weeks, 8 weeks, 12 weeks
Primary	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.	Baseline, 12 weeks
Primary	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.	Baseline, 12 weeks
Primary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks
Primary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks
Primary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks
Primary	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.	Baseline, 4 weeks, 8 weeks, 12 weeks
Primary	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.	4 weeks, 8 weeks, 12 weeks