A Computer-Assisted CBT Tool to Enhance Fidelity in CBOCs

Overview

Background and Significance: Randomized Controlled Trials (RTCs) have demonstrated that evidence-based psychotherapies (EBPs), particularly Cognitive Behavioral Therapy (CBT), are highly effective in treating anxiety and depression, the most common mental health disorders in primary care settings. Mental health (MH) providers in VA Community-Based-Out-Patient-Clinics (CBOCs) are often located in rural areas and isolated from educational opportunities. Almost half of Veterans now use CBOCs. Studies have shown that the quality of delivery of EBPs (fidelity) impacts clinical outcomes. This study will test a computer-assisted tool (CALM Tools for Living) that increases fidelity to CBT in treating depression and four common anxiety disorders, including PTSD. Although results of a large RCT, the CALM study, suggested that the tool contributed to fidelity to the CBT protocol, this hypothesis has not been tested. This study will test the tool in primarily rural CBOCs in VA VISN16. Objective: To modify a computer-assisted CBT tool to meet the needs of CBOC MH providers and Veterans, to evaluate the impact on providers' fidelity to the CBT model and clinical outcomes, and to assess how best to support future implementation. Specific Aims/Hypothesis: (1) Engage CBOC MH providers in modifying the computer-assisted CBT tool such that its content is relevant and acceptable to Veterans and providers. The investigators hypothesize that the modified tool will be acceptable to both Veterans and providers. (2) Compare MH provider fidelity to CBT and clinical outcomes among providers who used the tool and those who did not. The investigators hypothesize that clinicians who use the tool will have a higher fidelity to CBT and clinical outcomes among patients will be superior. (3) Prepare for future implementation of the tool in the VA. Methodology: This study will use a Type III hybrid effectiveness design. Methods common to the field of Instructional Design and Technology (IDT) will be used to modify the tool. Thirty-four CBOC MH providers will be trained in CBT and randomized to use the tool or not. Both groups will receive external facilitation to encourage the full implementation of CBT into practice on the clinic level. MH providers will treat 10 patients each. Patients will be assessed at baseline, 3, 6, and 12 months. Provider fidelity to the CBT protocol will be measured, and finally, a tool kit for future implementation of the tool will be disseminated. Impact: The investigators expect the intervention to improve the technical quality of MH treatment in CBOCs and improve clinical outcomes among Veterans.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 30, 2019

Interventions

  • Device: Computer-delivered CALM
    • This intervention includes the delivery of CALM via computer
  • Other: Manual-delivered CALM
    • This active comparison condition includes the delivery of CALM via manual

Arms, Groups and Cohorts

  • Experimental: CALM Tools for Living – computer
    • This intervention includes the delivery of CALM via computer
  • Active Comparator: CALM Tools for Living – manual
    • This intervention includes the delivery of CALM delivered manual

Clinical Trial Outcome Measures

Primary Measures

  • CBT treatment fidelity
    • Time Frame: 6 months
    • coding of audiotaped treatment sessions

Secondary Measures

  • General Mental Health Symptoms
    • Time Frame: 6-Months
    • Brief Symptom Inventory (Global Severity Index, GSI) Sum of BSI Items / total number of items responded to
  • Mental Health Functioning
    • Time Frame: 6-Months
    • 12 Item Short Form Health Survey (SF-12) (Mental Health Composite) Lower scores indicate worse functioning
  • Symptoms of Posttraumatic Stress Disorder (PTSD)
    • Time Frame: 6-Months
    • PTSD Checklist for DSM-5
  • Symptoms of Generalized Anxiety Disorder (GAD)
    • Time Frame: 6-Months
    • Generalized Anxiety Disorder-7 (GAD-7; lower score indicates fewer symptoms)
  • Symptoms of Depression
    • Time Frame: 6-Months
    • Patient Health Questionnaire-9 (PHQ-9; lower scores indicate fewer symptoms)

Participating in This Clinical Trial

Inclusion Criteria

  • Patients will be considered eligible if they: 1. plan to continue to receive mental health care at the CBOC 2. have depression, PTSD, or other anxiety disorder (PD, GAD, SAD) 3. want to receive CBT specifically 4. are willing to have their therapy sessions audio-taped 5. are willing and able to participate in clinical assessments (baseline, 3, 6, and 12 months) by phone. Exclusion Criteria:

  • Patients will be considered ineligible if they 1. have significant cognitive impairment, are in crisis (e.g., suicidal) 2. are dependent on alcohol or drugs (substance abuse is allowed) 3. have previously completed a course of CBT or CPT treatment (patients who have previously had only one or two sessions of CBT or CPT will be allowed), or (4) have a comorbid diagnosis of schizophrenia or bipolar disorder.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Central Arkansas Veterans Healthcare System
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael A. Cucciare, PhD, Research Health Scientist – Central Arkansas Veterans Healthcare System

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.