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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

167 participants

Primary outcome timeframe

6 months

Results posted on

2022-09-08

Participant Flow

Participant milestones

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

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

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 months

Population: 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

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-months

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.

Outcome measures

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-months

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.

Outcome measures

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-months

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.

Outcome measures

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-months

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.

Outcome measures

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-months

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.

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

CALM Tools for Living - Manual

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Mental Health Providers; CALM Tools for Living-Computer

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Mental Health Providers; CALM Tools for Living-Manual

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 501-526-8179

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place