A Computer-Assisted CBT Tool to Enhance Fidelity in CBOCs

NCT02488551 | Completed Results

• 1 other identifier: CRE 12-314
• Study Type: interventional
• Target: 167
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background and Significance: Mental health (MH) providers in VA Community-Based-Outpatient-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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• CBT Treatment Fidelity (a Rating Indicating Provider Overall Competence in Delivering the Intervention)

  Fidelity was defined as providers' overall competence in delivering the VA CALM protocol, for each rated session (i.e., How skilled was the mental health provider in delivering the information in this section?), rated on a Likert scale of 0 to 6 (higher scores indicate greater fidelity).

  6 months

Secondary Outcomes (5)

• General Mental Health Symptoms (Brief Symptoms Inventory)

  6-months

• General Mental Health Symptoms (Short-Form-12 Mental Health Composite)

  6-months

• Generalized Anxiety Disorder Symptoms

  6-months

• PTSD Symptoms

  6-months

• Depression Symptoms

  6-months

Study Arms (2)

CALM Tools for Living - computer

EXPERIMENTAL

This intervention includes the delivery of CALM via computer

Device: Computer-delivered CALM

CALM Tools for Living - manual

ACTIVE COMPARATOR

This intervention includes the delivery of CALM delivered manual

Other: Manual-delivered CALM

Interventions

Computer-delivered CALM DEVICE

This intervention includes the delivery of CALM via computer

CALM Tools for Living - computer

Manual-delivered CALM OTHER

This active comparison condition includes the delivery of CALM via manual

CALM Tools for Living - manual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients will be considered ineligible if they
• have significant cognitive impairment, are in crisis (e.g., suicidal)
• are dependent on alcohol or drugs (substance abuse is allowed)
• 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.

Sponsors & Collaborators

• Central Arkansas Veterans Healthcare System: lead

Related Publications (1)

• Cucciare MA, Curran GM, Craske MG, Abraham T, McCarthur MB, Marchant-Miros K, Lindsay JA, Kauth MR, Landes SJ, Sullivan G. Assessing fidelity of cognitive behavioral therapy in rural VA clinics: design of a randomized implementation effectiveness (hybrid type III) trial. Implement Sci. 2016 May 10;11:65. doi: 10.1186/s13012-016-0432-4.

  PMID: 27164866 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Michael Cucciare
• Organization: Central Arkansas Veterans Health Care System

michael.cucciare@va.gov

501-526-8179

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Scientist

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 2, 2015
• Study Start: January 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 8, 2022
• Results First Posted: September 8, 2022

Record last verified: 2022-09