DepressionNCT02488551
A Computer-Assisted CBT Tool to Enhance Fidelity in CBOCs
A study testing Computer-delivered CALM and Manual-delivered CALM in people with Depression, run by VA Office of Research and Development.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Computer-delivered CALM and Manual-delivered CALM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: A Computer-Assisted Cognitive Behavioral Therapy Tool to Enhance Fidelity in CBO
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.
Read more
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.
Read the detailed description
Power analysis for primary outcome We aimed to recruit a total sample of 34 (17 per condition) providers to achieve a statistical power of 0.94 for analysis comparing our primary outcome of CBT fidelity between the two conditions. We used a general linear mixed model to account for patients clustered within the same providers and a type I error rate of .05. This initial sample size was also determined by assuming an effect size of 1.0 (1.3 point difference on a scale of CBT fidelity; 5.3 of 6 for the computer condition versus 4 of 6 for manual condition), a medium intraclass correlation of 0.5, and four patients per provider.
A total of 16 of 32 clinicians self-selected to provide audiotaped sessions that were assessed for fidelity. Assuming an effect size of 1.0 for condition on the fidelity outcome, an intraclass correlation of 0.5, four participants per provider, and a type I error rate of .05, our statistical power for comparing our primary outcome of fidelity between conditions using general linear mixed model is 0.65.
Statistical analysis For the primary outcome of providers' CBT fidelity, descriptive statistics were calculated for the entire sample and by session. The association between condition and the outcome of fidelity was examined using a general linear mixed model to account for Veteran participants clustered within providers. The treatment session and strata variables were also included in the model.
For the patient-level secondary outcomes, bivariate analysis was performed using generalized estimating equations due to the clustered structure of Veterans within the same providers. Associations between condition and potential covariates and between outcomes and potential covariates were examined. Covariates with p-values less than 0.10 were included in the multivariate models for associations between condition and outcomes over time. Generalized linear mixed models were used to account for the correlations for patients within providers as well as the correlations of multiple assessments within patients. Gamma distribution was specified for BSI-18 GSI scores after a small rescale for zero value due to its violation of normality and normal distribution was specified for the remaining outcomes as they were approximately normally distributed. All the models included the condition indicator variable, time (for the three interviews), strata, and covariates identified in the bivariate analysis. The covariates associated with condition (gender and primary diagnosis) were included in all the models with the exception of primary diagnosis not being included in the subgroup specific diagnosis group analysis. The covariates associated with the outcomes were also included in the corresponding outcome models. The interaction between condition and time was included in all of the models as hypothesized. General linear mixed models were also fit for disorder specific outcomes for subgroups of Veterans with the corresponding specific disorders as they were approximately normally distributed.
The LS mean differences (or ratios depending on the outcomes) between the two conditions and their corresponding 95% confidence intervals were calculated for evaluating the effect of condition. Similar differences (or ratios) between each follow-up and baseline by each condition and their corresponding 97.5% confidence intervals were also calculated for evaluating the effect of time. A narrower confidence interval (equivalent to a p-value of 0.025) was used to adjust for multiple comparisons. All the analyses were performed using SAS 9.4.
- Conditions
- Depression
- Being tested
- Computer-delivered CALM, Manual-delivered CALM
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| CALM Tools for Living - computer | Experimental | This intervention includes the delivery of CALM via computer Receives: Device: Computer-delivered CALM |
| CALM Tools for Living - manual | Active comparator | This intervention includes the delivery of CALM delivered manual Receives: Other: Manual-delivered CALM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (5)
General Mental Health Symptoms (Brief Symptoms Inventory)
The BSI-18 is designed to measure general psychological distress and consists of three six-item subscales (somatization, anxiety, and depression). Respondents are asked to indicate, using a 5-point Likert scale, how much they have been bothered by each symptom over the past week. All 18-items can be summed to derive a total score or GSI score which is an indicator of overall level of psychological distress. GSI scores can range from 0-72, with higher scores representing worse outcomes.
Measured: 6-months
General Mental Health Symptoms (Short-Form-12 Mental Health Composite)
The SF-12 was designed to measure physical and mental health of persons in the United States, with all items weighted and summed to construct summary scores representing both aspects of overall health.
Only the mental health composite was used in the present study. Total scores are converted to z-scores and can range from 0-50 with higher scores indicating better mental health functioning.
Measured: 6-months
Generalized Anxiety Disorder Symptoms
The Generalized Anxiety Disorder-7(GAD-7) is a reliable and valid assessment of GAD symptoms. Participants indicate how bothered (0=not at all, 3=nearly every day) they have been by anxiety symptoms (e.g., trouble relaxing) over the past two weeks. A sum of the GAD-7 scores was used as the outcome. Scores can range from 0-21 with higher scores indicating more anxiety.
Measured: 6-months
PTSD Symptoms
The Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual for Mental Disorders (Fifth Edition) was used to assess symptoms of PTSD. Participants are asked to indicate how much they have been bothered (0=not at all, 4=extremely) by each item (e.g., feeling distant or cutoff from other people). A sum of the items on this measure was used for the outcome. Scores can range from 0-80 with higher scores indicating more PTSD symptoms.
Measured: 6-months
Depression Symptoms
The Patient Health Questionnaire (PHQ-9) was used to measure the severity of depression symptoms. The PHQ-9 is a valid measure for assessing how often participants have been bothered (0=not at all, 3=nearly every day), in the past two weeks, by depression symptoms (e.g., feeling tired or having little energy). A sum of the items on this measure was used for the outcome. Scores can range from 0-27 with higher scores indicating more depression symptoms.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start1 Jan 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Central Arkansas Veterans Healthcare System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488551
- Sponsor's protocol ID
- CRE 12-314
- Status last verified
- May 2026
- First submitted
- 29 Jun 2015
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ecker AH, Abraham TH, Martin LA, Marchant-Miros K, Cucciare MA. Factors Affecting Adoption of Coordinated Anxiety Learning and Management (CALM) in Veterans' Affairs Community-Based Outpatient Clinics. J Rural Health. 2021 Mar;37(2):447-455. doi: 10.1111/jrh.12528. Epub 2020 Oct 20.
PubMed 33078451Cucciare MA, Marchant K, Lindsay J, Craske MG, Ecker A, Day S, Hogan J, Henn J, LeBeau RT, Rabalais A, Rose RD, Qualls M, Treanor M, Abraham TH. An Evidence-Based Model for Disseminating-Implementing Coordinated Anxiety Learning and Management in Department of Veterans Affairs' Community-Based Outpatient Clinics. J Rural Health. 2020 Jun;36(3):371-380. doi: 10.1111/jrh.12398. Epub 2019 Sep 11.
PubMed 31508861Abraham TH, Marchant-Miros K, McCarther MB, Craske MG, Curran GM, Kearney LK, Greene C, Lindsay JA, Cucciare MA. Adapting Coordinated Anxiety Learning and Management for Veterans Affairs Community-Based Outpatient Clinics: Iterative Approach. JMIR Ment Health. 2018 Aug 22;5(3):e10277. doi: 10.2196/10277.
PubMed 30135051Cucciare 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.
PubMed 27164866
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computer-Assisted Cognitive Behavioral Therapy Tool to Enhance Fidelity in CBO
- ClinicalTrials.gov ID
- NCT02488551
- Acronym / sponsor ID
- CRE 12-314
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Central Arkansas Veterans Healthcare System
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 8 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Power analysis for primary outcome We aimed to recruit a total sample of 34 (17 per condition) providers to achieve a statistical power of 0.94 for analysis comparing our primary outcome of CBT fidelity between the two conditions. We used a general linear mixed model to account for patients clustered within the same providers and a type I error rate of .05. This initial sample size was also determined by assuming an effect size of 1.0 (1.3 point difference on a scale of CBT fidelity; 5.3 of 6 for the computer condition versus 4 of 6 for manual condition), a medium intraclass correlation of 0.5, and four patients per provider.
A total of 16 of 32 clinicians self-selected to provide audiotaped sessions that were assessed for fidelity. Assuming an effect size of 1.0 for condition on the fidelity outcome, an intraclass correlation of 0.5, four participants per provider, and a type I error rate of .05, our statistical power for comparing our primary outcome of fidelity between conditions using general linear mixed model is 0.65.
Statistical analysis For the primary outcome of providers' CBT fidelity, descriptive statistics were calculated for the entire sample and by session. The association between condition and the outcome of fidelity was examined using a general linear mixed model to account for Veteran participants clustered within providers. The treatment session and strata variables were also included in the model.
For the patient-level secondary outcomes, bivariate analysis was performed using generalized estimating equations due to the clustered structure of Veterans within the same providers. Associations between condition and potential covariates and between outcomes and potential covariates were examined. Covariates with p-values less than 0.10 were included in the multivariate models for associations between condition and outcomes over time. Generalized linear mixed models were used to account for the correlations for patients within providers as well as the correlations of multiple assessments within patients. Gamma distribution was specified for BSI-18 GSI scores after a small rescale for zero value due to its violation of normality and normal distribution was specified for the remaining outcomes as they were approximately normally distributed. All the models included the condition indicator variable, time (for the three interviews), strata, and covariates identified in the bivariate analysis. The covariates associated with condition (gender and primary diagnosis) were included in all the models with the exception of primary diagnosis not being included in the subgroup specific diagnosis group analysis. The covariates associated with the outcomes were also included in the corresponding outcome models. The interaction between condition and time was included in all of the models as hypothesized. General linear mixed models were also fit for disorder specific outcomes for subgroups of Veterans with the corresponding specific disorders as they were approximately normally distributed.
The LS mean differences (or ratios depending on the outcomes) between the two conditions and their corresponding 95% confidence intervals were calculated for evaluating the effect of condition. Similar differences (or ratios) between each follow-up and baseline by each condition and their corresponding 97.5% confidence intervals were also calculated for evaluating the effect of time. A narrower confidence interval (equivalent to a p-value of 0.025) was used to adjust for multiple comparisons. All the analyses were performed using SAS 9.4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CALM Tools for Living - computer | Experimental | Device: Computer-delivered CALMThis intervention includes the delivery of CALM via computer |
| CALM Tools for Living - manual | Active comparator | Other: Manual-delivered CALMThis intervention includes the delivery of CALM delivered manual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients will be considered eligible if they:
Key exclusion criteria (4 listed)
- Patients will be considered ineligible if they
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-delivered CALMThis intervention includes the delivery of CALM via computer | Device | CALM Tools for Living - computer |
| Manual-delivered CALMThis active comparison condition includes the delivery of CALM via manual | Other | CALM Tools for Living - manual |
Primary outcome
CBT Treatment Fidelity (a Rating Indicating Provider Overall Competence in Delivering the Intervention)
Time frame: 6 months
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).
5 secondary outcomes
General Mental Health Symptoms (Brief Symptoms Inventory)
Time frame: 6-months
General Mental Health Symptoms (Short-Form-12 Mental Health Composite)
Time frame: 6-months
Generalized Anxiety Disorder Symptoms
Time frame: 6-months
PTSD Symptoms
Time frame: 6-months
Depression Symptoms
Time frame: 6-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33078451Ecker AH, Abraham TH, Martin LA, Marchant-Miros K, Cucciare MA. Factors Affecting Adoption of Coordinated Anxiety Learning and Management (CALM) in Veterans' Affairs Community-Based Outpatient Clinics. J Rural Health. 2021 Mar;37(2):447-455. doi: 10.1111/jrh.12528. Epub 2020 Oct 20.
- Background: PubMed 31508861Cucciare MA, Marchant K, Lindsay J, Craske MG, Ecker A, Day S, Hogan J, Henn J, LeBeau RT, Rabalais A, Rose RD, Qualls M, Treanor M, Abraham TH. An Evidence-Based Model for Disseminating-Implementing Coordinated Anxiety Learning and Management in Department of Veterans Affairs' Community-Based Outpatient Clinics. J Rural Health. 2020 Jun;36(3):371-380. doi: 10.1111/jrh.12398. Epub 2019 Sep 11.
- Background: PubMed 30135051Abraham TH, Marchant-Miros K, McCarther MB, Craske MG, Curran GM, Kearney LK, Greene C, Lindsay JA, Cucciare MA. Adapting Coordinated Anxiety Learning and Management for Veterans Affairs Community-Based Outpatient Clinics: Iterative Approach. JMIR Ment Health. 2018 Aug 22;5(3):e10277. doi: 10.2196/10277.
- Background: PubMed 27164866Cucciare 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-delivered CALM and Manual-delivered CALM in people with Depression, run by VA Office of Research and Development.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBT Treatment Fidelity (a Rating Indicating Provider Overall Competence in Delivering the Intervention) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488551, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.