PracticeGround: Transforming Training and Delivery of Mental Health EBPs

NCT ID: NCT02314624

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

WILLOW

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

Evidence-based interventions for treating depression and concurrent problems

Treatment-as-Usual

Usual care without access to WILLOW.

Group Type: ACTIVE_COMPARATOR

Care-as-Usual Psychotherapy

Intervention Type: BEHAVIORAL

Usual care psychotherapy for depression and concurrent problems

Interventions

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

Evidence-based interventions for treating depression and concurrent problems

Intervention Type: BEHAVIORAL

Care-as-Usual Psychotherapy

Usual care psychotherapy for depression and concurrent problems

Intervention Type: BEHAVIORAL

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

• 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

• 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

• (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evidence-Based Practice Institute, Seattle, WA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Evidence-Based Practice Institute

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2R44MH093993-02A1

Identifier Type: NIH

Identifier Source: org_study_id

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