NCT05384171: MBTA

Develop and Validation of Measurement-Based Transition Assistance

Completed NA Results posted Last updated 9 October 2024

What this trial tests

NA trial testing Measurement-Based Transition Assistance (MBTA) in Well-being in 46 participants. Completed in 26 June 2023.

Timeline

3 November 2022

Primary endpoint
30 April 2023

26 June 2023

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	46
Start date	3 November 2022
Primary completion	30 April 2023
Estimated completion	26 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Measurement-Based Transition Assistance (MBTA)

Conditions studied

• Well-being — all drugs for Well-being →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Well-being. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Assessed for the Feasibility of Study Procedures Primary · baseline (T1) and three-month follow-up (T2)

Participation in the study will be evaluated to assess feasibility of the study procedures. To determine feasibility, at the end of data collection the investigators will calculate the following: 1. Percentage of veterans who enroll in the study out of those invited (baseline; T1) 2. Percentage of veterans who complete both T1 and T2 surveys (baseline \[T1\] and three-month follow-up \[T2\] data) 3. Percentage of veterans who access the MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 4. Percentage of veterans who complete the MBT

Percent of veterans who enroll in the study out of those invited (T1; baseline)

Group	Value	95% CI
Intervention Group	27
Active Control Group	19

Percent of veterans who complete both baseline and three-month follow-up surveys (T1 and T2 data)

Group	Value	95% CI
Intervention Group	15
Active Control Group	10

Percent who access MBTA assessment (Intervention: baseline; Active Control: three-month follow-up)

Group	Value	95% CI
Intervention Group	22
Active Control Group	10

Percent who complete MBTA assessment (Intervention: baseline; Active Control: three-month follow-up)

Group	Value	95% CI
Intervention Group	21
Active Control Group	10

Percent who review the personal report (Intervention:baseline; Active Control:three-month follow-up)

Group	Value	95% CI
Intervention Group	21
Active Control Group	10

Satisfaction With MBTA Tool Primary · baseline assessment (T1 only for intervention group)

For the intervention group at the baseline assessment (T1), the investigators assessed satisfaction with the MBTA tool with items developed specifically for this pilot study. T1 (baseline) was the only timeframe these questions were administered for this group). The investigators asked open-ended questions such as: What did you like about the tool? What did you not like about the tool? Is there anything you would change about the tool?

Provided positive feedback about MBTA prototype

Group	Value	95% CI
Intervention Group	14

Provided a critique about MBTA prototype

Group	Value	95% CI
Intervention Group	5

Provided constructive feedback about MBTA prototype

Group	Value	95% CI
Intervention Group	4

Satisfaction With MBTA Tool Primary · three-month follow-up (T2 only for active control group)

For the active control group, they were asked at the three-month follow-up (T2) their satisfaction with the MBTA tool with items developed specifically for this pilot study. T2 (three-month follow-up) was the only timeframe these questions were administered for this group). The investigators asked open-ended questions such as: What did you like about the tool? What did you not like about the tool? Is there anything you would change about the tool?

Provided positive feedback about MBTA prototype

Group	Value	95% CI
Active Control Group	7

Provided a critique about MBTA prototype

Group	Value	95% CI
Active Control Group	3

Provided constructive feedback about MBTA prototype

Group	Value	95% CI
Active Control Group	2

University of Rhode Island Change Assessment Scale (URICA) - Readiness to Change Secondary · measured at T1(baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scores

The investigators administered the University of Rhode Island Change Assessment Scale (URICA; DiClemente et al., 2004) to measure movement in the stages of change. Questions in the URICA were slightly modified to focus on well-being. To score the URICA, the investigators will calculate a readiness to change score based on the four stages of change (precontemplation, contemplation, action, and maintenance). The investigators will calculate means for precontemplation responses, contemplation responses, action responses and maintenance responses and subtract the mean from the precontemplation sco

Group	Value	95% CI
Intervention Group	11.20	± 0.72
Active Control Group	10.69	± 0.68

Stages Algorithm Secondary · measured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; challenges reported are from baseline (T1) and if they were were taking action to address these challenges are data from three-month follow-up

The investigators administered the Stages Algorithm (DiClemente et al., 1991) to measure movement in the stages of change from baseline to the three-month follow-up. Questions were modified slightly to assess for willingness to work on resolving problems or challenges related to areas of well-being (i.e., mental health/emotional well-being, physical health, vocation, social life, and finances). This measure is designed as a decision tree based on reported challenges, and is scored based on where participants fall within the decision tree. It classifies participants according to the following s

Vocation (reported challenges at T1; baseline)

Group	Value	95% CI
Intervention Group	7
Active Control Group	5

Vocation(of those reporting challenges at T1, # that were taking action to work on challenges at T2)

Group	Value	95% CI
Intervention Group	7
Active Control Group	5

Finances (reported challenges at T1; baseline)

Group	Value	95% CI
Intervention Group	5
Active Control Group	3

Finances(of those reporting challenges at T1, # that were taking action to work on challenges at T2)

Group	Value	95% CI
Intervention Group	5
Active Control Group	2

Social (reported challenges at T1; baseline)

Group	Value	95% CI
Intervention Group	11
Active Control Group	5

Social (of those reporting challenges at T1, # that were taking action to work on challenges at T2)

Group	Value	95% CI
Intervention Group	10
Active Control Group	4

Mental Health (reported challenges at T1; baseline)

Group	Value	95% CI
Intervention Group	9
Active Control Group	7

Mental Health(of those with challenges at T1, # that were taking action to work on challenges at T2)

Group	Value	95% CI
Intervention Group	7
Active Control Group	6

Theory of Planned Behavior Constructs Secondary · measured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scores

The investigators used Theory of Planned Behavior Questionnaire (Ajzen, 1991) to assess movement from baseline to the three-month follow-up in the constructs from the theory of planned behavior (intention, attitude toward the behavior, subjective norm, perceived behavioral control). Questions were slightly modified to focus on well-being. The investigators scored each of the aforementioned constructs/subscales separately. For each subscale, the investigators calculated the the mean of the items. Scores could range from 1 to 7 with higher scores indicating a more positive response.

Intentions

Group	Value	95% CI
Intervention Group	4.95	± 0.35
Active Control Group	5.61	± 0.36

Attitudes

Group	Value	95% CI
Intervention Group	5.97	± 0.31
Active Control Group	6.03	± 0.31

Social norms

Group	Value	95% CI
Intervention Group	5.14	± 0.33
Active Control Group	4.68	± 0.36

Perceived behavioral control

Group	Value	95% CI
Intervention Group	5.53	± 0.32
Active Control Group	5.05	± 0.34

Attitudes Toward Seeking Professional Psychological Help-Short Form Secondary · measured at T1 (baseline) and T2 (three-month follow-up) for the intervention group and active control group; estimates reported below are three-month follow-up adjusted mean scores

The investigators assessed movement in support seeking perceptions from baseline (T1) to the three-month follow-up (T2) with the Attitudes Toward Seeking Professional Psychological Help - Short Form scale (Picco et al., 2016). Questions were slightly modified to focus on seeking support to address well-being challenges and problems. To calculate a total score, items 2, 4, 8, 9, and 10 were reverse scored. Scores were then summed together, with higher scores indicating more positive attitudes toward seeking professional help. Scores could range range for 0-30.

Group	Value	95% CI
Intervention Group	19.24	± 0.95
Active Control Group	19.04	± 1.00

Support-Seeking Actions to Improve Well-Being Secondary · Measured at T2 (three-month follow-up) for intervention group only

For the intervention group, the investigators assessed support seeking behavior with items developed specifically for this pilot study at T2 (three-month follow-up). Questions asked about the extent to which the tool has helped increase awareness about well-being related challenges or problems, the extent to which the tool has helped encourage improving well-being related problems or challenges, and which types of resources the participant has used since using the tool. Items were examined separately. A response of moderately or higher on the two Likert scale items was considered a positive re

Reported MBTA prototype increased awareness about their well-being related challenges or problems

Group	Value	95% CI
Intervention Group	6

Reported MBTA prototype helped encourage them to improve well-being related problems or challenges

Group	Value	95% CI
Intervention Group	7

Reported using a resource/service (not previously using before study) as a result the MBTA prototype

Group	Value	95% CI
Intervention Group	10

Used a mental health resource/service

Group	Value	95% CI
Intervention Group	5

Used a financial resource/service

Group	Value	95% CI
Intervention Group	2

Used a health behavior resource/service

Group	Value	95% CI
Intervention Group	1

Used other general health resource/service

Group	Value	95% CI
Intervention Group	1

Used a resource/service related to their social life

Group	Value	95% CI
Intervention Group	1

Sponsor's own description

Although some Veterans seek help when they experience post-military readjustment challenges, many do not. One factor that stands in the way of Veterans' willingness to seek help for these challenges is their lack of knowledge, both with regard to how severe challenges must be to warrant help-seeking and what resources are available to address these challenges. Measurement-Based Transition Assistance (MBTA) aims to address these barriers to help-seeking by providing Veterans with individualized feedback on areas in which they would benefit from additional support with regard to their health, vocational, financial, and social circumstances, along with personalized recommendations for relevant programs, services, and supports. If effective, this scalable, population-based intervention strategy could be used independently or in conjunction with other approaches to enhancing Veterans' help-seeking to interrupt high-risk trajectories before they lead to chronic maladjustment and increased risk for suicide.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.