CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 167 enrolled / 167 target
Drug / intervention
Computer-delivered CALM +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02488551
NCT02488551N/ACompletedMonitor (1.3/mo)Completion was 84mo ago

A Computer-Assisted Cognitive Behavioral Therapy Tool to Enhance Fidelity in CBO

VA Office of Research and Development·interventional·Posted Jul 2, 2015·Updated Jun 12, 2026

In Brief

A clinical study evaluating Computer-delivered CALM and Manual-delivered CALM for Depression. Completed, enrolled 167 participants.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
Countries--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2, 2015
Enrollment StartJan 1, 2016
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11 years ago

Arms & Interventions

CALM Tools for Living - computerexperimental

This intervention includes the delivery of CALM via computer

Device: Computer-delivered CALM
CALM Tools for Living - manualactive_comparator

This intervention includes the delivery of CALM delivered manual

Other: Manual-delivered CALM

Interventions

Computer-delivered CALMdevice

This intervention includes the delivery of CALM via computer

Manual-delivered CALMother

This active comparison condition includes the delivery of CALM via manual