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PracticeGround: Transforming Training and Delivery of Mental Health EBPs

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ClinicalTrials.gov Identifier: NCT02314624
Recruitment Status : Enrolling by invitation
First Posted : December 11, 2014
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Evidence-Based Practice Institute, Seattle, WA

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.

Condition or disease Intervention/treatment Phase
Depression Insomnia Suicide Behavioral: Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality Behavioral: Care-as-Usual Psychotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: PracticeGround: Transforming Training and Delivery of Mental Health EBPs
Study Start Date : December 2014
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: PracticeGround
Clinicians have access to PracticeGround'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
Evidence-based interventions for treating depression and concurrent problems

Active Comparator: Care-as-Usual
Usual care without access to PracticeGround.
Behavioral: Care-as-Usual Psychotherapy
Usual care psychotherapy for depression and concurrent problems




Primary Outcome Measures :
  1. Change in Depression over 18 weeks of treatment [ Time Frame: baseline, 6, 12, and 18 weeks ]
    Scores on a battery of standardized depression scales

  2. Change in Psychological Distress over 18 weeks of treatment [ Time Frame: baseline, 6, 12, and 18 weeks ]
    Scores on a battery of standardized measures of distress

  3. Change in Treatment Satisfaction over 18 weeks of treatment [ Time Frame: 6, 12, and 18 weeks ]
    Scores on a standardized treatment satisfaction scale

  4. Treatment Dropout [ Time Frame: 18 weeks ]
    Rates of drop-out from treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314624


Locations
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United States, Washington
Evidence-Based Practice Institute
Seattle, Washington, United States, 98144
Sponsors and Collaborators
Evidence-Based Practice Institute, Seattle, WA

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Responsible Party: Evidence-Based Practice Institute, Seattle, WA
ClinicalTrials.gov Identifier: NCT02314624     History of Changes
Other Study ID Numbers: 2R44MH093993-02A1 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms