Clinical trial NCT05384171: Develop and Validation of Measurement-Based Transition Assistance
Official title: Measurement-Based Transition Assistance (MBTA): Evaluating the Promise of a Web-Based Approach to Promote Veterans' Support Seeking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Keywords: well-being
mental health
help-seeking
veteran
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-05-20
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to an assessment only condition or to the full MBTA intervention (assessment, feedback and resource recommendations)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 randomized controlled trial (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. Only quantitative results from this pilot study are presented in clinicaltrials.gov.

Next Steps/Implementation: This pilot study will inform a subsequent proposal for a fully powered RCT to confirm the effectiveness of MBTA and to evaluate strategies to promote its dissemination and implementation.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Assessed for the Feasibility of Study Procedures
timeFrame: baseline (T1) and three-month follow-up (T2)
measure: Satisfaction With MBTA Tool
timeFrame: baseline assessment (T1 only for intervention group)
measure: Satisfaction With MBTA Tool
timeFrame: three-month follow-up (T2 only for active control group)
Secondary outcomes:
measure: University of Rhode Island Change Assessment Scale (URICA) - Readiness to Change
timeFrame: 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
measure: Stages Algorithm
timeFrame: 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
measure: Theory of Planned Behavior Constructs
timeFrame: 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
measure: Attitudes Toward Seeking Professional Psychological Help-Short Form
timeFrame: 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
measure: Support-Seeking Actions to Improve Well-Being
timeFrame: Measured at T2 (three-month follow-up) for intervention group only
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Dawne S Vogt, PhD BA
role: PRINCIPAL_INVESTIGATOR
References: