Trial Outcomes & Findings for A Computer-Assisted CBT Tool to Enhance Fidelity in CBOCs (NCT NCT02488551)
NCT ID: NCT02488551
Last Updated: 2022-09-08
Results Overview
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).
COMPLETED
NA
167 participants
6 months
2022-09-08
Participant Flow
Participant milestones
| Measure |
CALM Tools for Living - Computer
Computer-delivered CALM: This intervention includes the delivery of CALM by computer
|
CALM Tools for Living - Manual
Manual-delivered CALM: This active comparison condition includes the delivery of CALM by manual
|
Mental Health Providers; CALM Tools for Living-Computer
Mental health providers randomized to deliver CALM by computer
|
Mental Health Providers: CALM Tools for Living-Manual
Mental health providers randomized to delivery CALM by manual
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
86
|
49
|
17
|
15
|
|
Overall Study
COMPLETED
|
81
|
41
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
0
|
0
|
Reasons for withdrawal
| Measure |
CALM Tools for Living - Computer
Computer-delivered CALM: This intervention includes the delivery of CALM by computer
|
CALM Tools for Living - Manual
Manual-delivered CALM: This active comparison condition includes the delivery of CALM by manual
|
Mental Health Providers; CALM Tools for Living-Computer
Mental health providers randomized to deliver CALM by computer
|
Mental Health Providers: CALM Tools for Living-Manual
Mental health providers randomized to delivery CALM by manual
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
7
|
0
|
0
|
|
Overall Study
Military Deployment
|
1
|
1
|
0
|
0
|
Baseline Characteristics
Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
Baseline characteristics by cohort
| Measure |
CALM Tools for Living - Computer
n=86 Participants
Computer-delivered CALM: This intervention includes the delivery of the CALM intervention by computer
|
CALM Tools for Living - Manual
n=49 Participants
Manual-delivered CALM: This active comparison condition includes the delivery of the CALM intervention by manual
|
Mental Health Providers: CALM Tools for Living-computer
n=17 Participants
Mental health providers randomized to deliver CALM by manual (baseline characteristics on these participants were not collected and thus are not reported)
|
Mental Health Providers: CALM Tools for Living-Manual
n=15 Participants
Mental health providers randomized to deliver CALM by computer (baseline characteristics on these participants were not collected and thus are not reported)
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.20 years
STANDARD_DEVIATION 12.35 • n=86 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
44.63 years
STANDARD_DEVIATION 14.56 • n=49 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
—
|
—
|
43.72 years
STANDARD_DEVIATION 13.16 • n=135 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
|
Sex/Gender, Customized
Sex : Male
|
60 participants
n=86 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
39 participants
n=49 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
—
|
—
|
99 participants
n=135 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
|
Sex/Gender, Customized
Sex : Female
|
26 participants
n=86 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
10 participants
n=49 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
—
|
—
|
36 participants
n=135 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
|
Race/Ethnicity, Customized
Hispanic
|
15 participants
n=86 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
21 participants
n=49 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
—
|
—
|
36 participants
n=135 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=86 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
6 participants
n=49 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
—
|
—
|
12 participants
n=135 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
|
Race/Ethnicity, Customized
Black
|
14 participants
n=86 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
5 participants
n=49 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
—
|
—
|
19 participants
n=135 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
|
Race/Ethnicity, Customized
White
|
51 participants
n=86 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
17 participants
n=49 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
—
|
—
|
68 participants
n=135 Participants • Data were not collected for the "Mental Health Providers: CALM Tools for Living-computer" and "Mental Health Providers: CALM Tools for Living-Manual" Arms/Groups.
|
|
Region of Enrollment
United States
|
86 Participants
n=86 Participants
|
49 Participants
n=49 Participants
|
17 Participants
n=17 Participants
|
15 Participants
n=15 Participants
|
167 Participants
n=167 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants for this outcome were 32 mental health providers (17 randomized to the computer condition and 15 randomized to the manual condition).We used stratified sampling to randomly select 19% (68/368; 32 and 36 audiotaped treatment sessions in the manual and computer conditions, respectively) of the audiotaped VA CALM sessions across sessions. We pre-specified to report only partial data for this outcome due to resource constraints.
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).
Outcome measures
| Measure |
CALM Tools for Living - Computer
n=36 therapy (audio) tapes
This intervention includes the delivery of CALM via computer
Computer-delivered CALM: This intervention includes the delivery of CALM via computer
|
CALM Tools for Living - Manual
n=32 therapy (audio) tapes
This intervention includes the delivery of CALM delivered manual
Manual-delivered CALM: This active comparison condition includes the delivery of CALM via manual
|
|---|---|---|
|
CBT Treatment Fidelity (a Rating Indicating Provider Overall Competence in Delivering the Intervention)
|
3.99 scores on a scale
Standard Deviation .86
|
3.23 scores on a scale
Standard Deviation .88
|
SECONDARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
CALM Tools for Living - Computer
n=81 Participants
This intervention includes the delivery of CALM via computer
Computer-delivered CALM: This intervention includes the delivery of CALM via computer
|
CALM Tools for Living - Manual
n=41 Participants
This intervention includes the delivery of CALM delivered manual
Manual-delivered CALM: This active comparison condition includes the delivery of CALM via manual
|
|---|---|---|
|
General Mental Health Symptoms (Brief Symptoms Inventory)
|
19.30 scores on a scale
Standard Deviation 12.62
|
22.10 scores on a scale
Standard Deviation 15.53
|
SECONDARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
CALM Tools for Living - Computer
n=81 Participants
This intervention includes the delivery of CALM via computer
Computer-delivered CALM: This intervention includes the delivery of CALM via computer
|
CALM Tools for Living - Manual
n=41 Participants
This intervention includes the delivery of CALM delivered manual
Manual-delivered CALM: This active comparison condition includes the delivery of CALM via manual
|
|---|---|---|
|
General Mental Health Symptoms (Short-Form-12 Mental Health Composite)
|
35.53 scores on a scale
Standard Deviation 6.28
|
35.73 scores on a scale
Standard Deviation 6.94
|
SECONDARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
CALM Tools for Living - Computer
n=81 Participants
This intervention includes the delivery of CALM via computer
Computer-delivered CALM: This intervention includes the delivery of CALM via computer
|
CALM Tools for Living - Manual
n=41 Participants
This intervention includes the delivery of CALM delivered manual
Manual-delivered CALM: This active comparison condition includes the delivery of CALM via manual
|
|---|---|---|
|
Generalized Anxiety Disorder Symptoms
|
9.88 scores on a scale
Standard Deviation 5.81
|
12.00 scores on a scale
Standard Deviation 5.51
|
SECONDARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
CALM Tools for Living - Computer
n=81 Participants
This intervention includes the delivery of CALM via computer
Computer-delivered CALM: This intervention includes the delivery of CALM via computer
|
CALM Tools for Living - Manual
n=41 Participants
This intervention includes the delivery of CALM delivered manual
Manual-delivered CALM: This active comparison condition includes the delivery of CALM via manual
|
|---|---|---|
|
PTSD Symptoms
|
42.57 scores on a scale
Standard Deviation 17.09
|
46.00 scores on a scale
Standard Deviation 17.34
|
SECONDARY outcome
Timeframe: 6-monthsThe 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.
Outcome measures
| Measure |
CALM Tools for Living - Computer
n=81 Participants
This intervention includes the delivery of CALM via computer
Computer-delivered CALM: This intervention includes the delivery of CALM via computer
|
CALM Tools for Living - Manual
n=41 Participants
This intervention includes the delivery of CALM delivered manual
Manual-delivered CALM: This active comparison condition includes the delivery of CALM via manual
|
|---|---|---|
|
Depression Symptoms
|
13.32 scores on a scale
Standard Deviation 6.99
|
12.33 scores on a scale
Standard Deviation 5.85
|
Adverse Events
CALM Tools for Living - Computer
CALM Tools for Living - Manual
Mental Health Providers; CALM Tools for Living-Computer
Mental Health Providers; CALM Tools for Living-Manual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Cucciare
Central Arkansas Veterans Health Care System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place