PracticeGround: Transforming Training and Delivery of Mental Health EBPs

NCT02314624 | Completed Results DMC

• 1 other identifier: 2R44MH093993-02A1
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Insomnia; Suicide

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• Mental Health Services Satisfaction Survey (MHSSS)

  We created a ten-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 5(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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

WILLOW

EXPERIMENTAL

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

Behavioral: Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality

Treatment-as-Usual

ACTIVE COMPARATOR

Usual care without access to WILLOW.

Behavioral: Care-as-Usual Psychotherapy

Interventions

Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality BEHAVIORAL

Evidence-based interventions for treating depression and concurrent problems

WILLOW

Care-as-Usual Psychotherapy BEHAVIORAL

Usual care psychotherapy for depression and concurrent problems

Treatment-as-Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• English speaker
• 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
• (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

Sponsors & Collaborators

• Evidence-Based Practice Institute, Seattle, WA: lead

Study Sites (1)

Evidence-Based Practice Institute

Seattle, Washington, 98121, United States

Location

MeSH Terms

Conditions

Depression; Sleep Initiation and Maintenance Disorders; Suicide

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Self-Injurious Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

Overall study recruitment was lower than anticipated (target n=110). To address this, data from both pilot and full RCTs were included to maximize sample size and the Generalized Linear Model was used as it yields more power with missing data.

Results Point of Contact

• Title: Linda Dimeff, PhD
• Organization: Evidence Based Practice Institute

linda.dimeff@jasprhealth.com

206-384-7371

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 11, 2014
• Study Start: December 1, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 30, 2024
• Results First Posted: June 15, 2023

Record last verified: 2024-08

Locations

US (1)