Clinical trial NCT02314624: PracticeGround: Transforming Training and Delivery of Mental Health EBPs
Official title: PracticeGround: Transforming Training and Delivery of Mental Health EBPs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Insomnia
Suicide
Lead sponsor: Evidence-Based Practice Institute, Seattle, WA
Sponsor class: INDUSTRY
First posted: 2014-12-11
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Depression, Anxiety, and Stress Scale (DASS)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Beck Depression Inventory (BDI-II)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Behavioral Activation for Depression Scale Short Form (BADS-SF)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Mental Health Services Satisfaction Survey (MHSSS)
timeFrame: After first study therapy session, 4 weeks, 8 weeks, 12 weeks
measure: Working Alliance Inventory (WAI)
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Therapy Task Checklist (TTC) - Patient Version
timeFrame: 4 weeks, 8 weeks, 12 weeks
measure: Modified Practice Attitudes Scale (MPAS)
timeFrame: Baseline, 12 weeks
measure: Perceptions of Computer-Assisted Therapy Questionnaire (PCAT)
timeFrame: Baseline, 12 weeks
measure: ASA-Monitoring and Feedback Version (ASA-MF)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Monitoring and Feedback Attitudes Scale (MFA)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Routine Monitoring (RM)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Current Assessment Practice Evaluation-Revised (CAPER)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Therapy Task Checklist (TTC) - Provider Version
timeFrame: 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Evidence-Based Practice Institute
state: Washington
Study officials:
References: