- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05384171
Develop and Validation of Measurement-Based Transition Assistance (MBTA)
Measurement-Based Transition Assistance (MBTA): Evaluating the Promise of a Web-Based Approach to Promote Veterans' Support Seeking
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: There is a growing recognition that Veterans' broader vocational, financial, and social circumstances have substantial implications for their health and health care. These circumstances include factors such as whether a Veteran has a job, can pay his or her bills, and has a strong social support network. Although some Veterans seek help when they experience challenges in these life domains, many do not. One factor that stands in the way of Veterans' help-seeking is 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. If not addressed, Veterans' readjustment challenges may become chronic, escalate in severity, and negatively influence more aspects of Veterans' lives over time and thus, become more difficult to intervene on.
Significance: This study will provide a preliminary examination of the potential benefit of Measurement-Based Transition Assistance (MBTA) in promoting Veterans' help-seeking. MBTA involves providing individualized feedback on areas in which Veterans would benefit from additional support, 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 help-seeking promotion approaches to interrupt high-risk trajectories before they lead to chronic maladjustment and risk for suicide.
Innovation and Impact: While there has been substantial attention to the importance of promoting Veterans' use of mental health care, the investigators are not aware of any broad, measurement-based effort to enhance Veterans' willingness to seek help for multiple areas of unmet need. In addition, most intervention strategies are targeted to the needs of Veterans with chronic patterns of functional impairment and poor health rather than Veterans who experience initial readjustment challenges as they adapt to post-military life. The current project is innovative in its evaluation of a self-administered, population-based approach to raise Veterans' awareness of areas in which they may benefit from additional support and to connect them with relevant resources. Given that MBTA may be most beneficial to Veterans who experience initial readjustment challenges as they adapt to post-military life, this intervention will be evaluated among Veterans who have recently left military service.
Specific Aim: Aim 1 is to refine MBTA based on input from VA stakeholders (n=6) and qualitative interviews with Veterans (n=12). A key focus of this aim is to determine the optimal approach for presenting results and recommended resources. Aim 2 is to evaluate the feasibility, acceptability, and preliminary effectiveness of MBTA in promoting Veterans' support-seeking by testing this intervention in a sample of 60 Veterans.
Methodology: The proposed work will be guided by established methods for intervention development and implementation that emphasize user-centered design principles and iterative cycles of refinement and pilot testing to enhance MBTA's effectiveness and scalability. After refining MBTA based on feedback from VA stakeholders and Veterans (Aim 1), a national sample of Veterans will be randomized to MBTA or an assessment-only condition in a pilot RCT (Aim 2). The MBTA assessment will be comprised of validated measures of Veterans' status, functioning, and satisfaction across life domains, along with well-established mental health screeners. Veterans in the MBTA condition will receive a user-friendly web-based report that summarizes areas of unmet need, as well as tailored recommendations for relevant resources. Feasibility and acceptability will be evaluated based on participation and completion rates, as well as satisfaction and usability ratings. The investigators will also examine preliminary evidence for effectiveness by comparing pre-post changes in support-seeking outcomes for Veterans in intervention and control conditions.
Next Steps/Implementation: This pilot study will inform a subsequent IIR proposal for a fully powered RCT to confirm the effectiveness of MBTA and to evaluate strategies to promote its dissemination and implementation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130-4817
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- having separated from active duty military service within the prior three years, but not the past three months (for whom not enough time may have gone by to adequately assess readjustment challenge)
- having a postal address in the U.S
- having access to the internet
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MBTA intervention
assessment, feedback, and resource referrals
|
Measurement-Based Transition Assistance (MBTA) provides 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.
|
Active Comparator: Assessment Only
assessment only
|
Veterans randomized to this condition will complete a well-being assessment only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with MBTA tool
Time Frame: baseline assessment
|
For the intervention group at the baseline assessment the investigators will assess satisfaction with the MBTA tool with items developed specifically for this pilot study.
The investigators will ask 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?
|
baseline assessment
|
Satisfaction with MBTA Tool
Time Frame: three-month follow-up
|
For the control group at the three-month follow-up assessment the investigators will assess satisfaction with the MBTA tool with items developed specifically for this pilot study.
The investigators will ask 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?
|
three-month follow-up
|
Number of participants assessed for the feasibility of study procedures
Time Frame: baseline and three-month follow-up
|
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:
|
baseline and three-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Stages Algorithm from Baseline to Three Months
Time Frame: baseline to three months
|
The investigators will administer the Stages Algorithm (DiClemente et al., 1991) to measure movement in the stages of change from baseline to the three-month follow-up.
Questions have been 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, and is scored based on where participants fall within the decision tree.
It classifies participants according to the following stages of change: precontemplation, contemplation, preparation, action, and maintenance stages.
|
baseline to three months
|
Changes in Theory of Planned Behavior Questionnaire from Baseline to Three Months
Time Frame: baseline to three months
|
The investigators will use the Theory of Planned Behavior Questionnaire (Ajzen, 1991) to assess change 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 have been slightly modified to focus on well-being.
The investigators will score each of the aforementioned constructs/subscales separately.
For each subscale, the investigators will calculate the sum of items and then calculate the mean.
Scores can range from 1 to 7 with higher scores indicating a more positive response.
|
baseline to three months
|
Change from Baseline in modified University of Rhode Island Change Assessment Scale (URICA) at three months
Time Frame: baseline to three-month follow-up
|
The investigators will administer the University of Rhode Island Change Assessment Scale (URICA; DiClemente et al., 2004) to measure movement in the stages of change from baseline to the three-month follow-up.
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 score from the summation of the other three stages.
This sum score represents an individual's readiness to change.
The investigators will use cutoff scores to determine which change stage the readiness score corresponds to: 1) 8 or lower classified as Precontemplation; 2) 8-11 classified as Contemplation; 3) 11-14 classified Preparation or Action.
|
baseline to three-month follow-up
|
Changes in Attitudes Toward Seeking Professional Psychological Help-Short Form from Baseline to Three Months
Time Frame: baseline to three months
|
The investigators will assess change in support seeking perceptions from baseline to the three-month follow-up 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 are first reverse scored.
Scores are then summed together, with higher scores indicating more positive attitudes toward seeking professional help.
Scores can range for 0-30.
|
baseline to three months
|
Support-Seeking Actions to Improve Well-Being
Time Frame: baseline and three-month follow-up
|
For the intervention group, the investigators will assess support seeking behavior with items developed specifically for this pilot study.
Questions ask 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 has the participant used since using the tool.
Items will be examined separately.
A response of moderately or higher on the two Likert scale items will be a considered a positive response.
|
baseline and three-month follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dawne S Vogt, PhD BA, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SDR 21-075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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