Develop and Validation of Measurement-Based Transition Assistance

Well-being Clinical Trial

— MBTA  

Official title:

Measurement-Based Transition Assistance (MBTA): Evaluating the Promise of a Web-Based Approach to Promote Veterans' Support Seeking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05384171
• Other study ID #: SDR 21-075
• Status: Completed
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: June 26, 2023

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 26, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Well-being

Intervention

Behavioral:
• Measurement-Based Transition Assistance
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.
• Assessment Only
Veterans randomized to this condition will complete a well-being assessment only

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants assessed for the feasibility of study procedures	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: Percentage of veterans who enroll in the study out of those invited; Percentage of veterans who complete both T1 and T2 evaluations; Percentage of veterans in both conditions who access the MBTA assessment; Percentage of veterans in both conditions who complete the MBTA assessment; Percentage of veterans in both conditions who review the personalized well-being report	baseline and three-month follow-up
Primary	Satisfaction with MBTA tool	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
Primary	Satisfaction with MBTA Tool	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
Secondary	Change from Baseline in modified University of Rhode Island Change Assessment Scale (URICA) at three months	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
Secondary	Changes in Stages Algorithm from 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
Secondary	Changes in Theory of Planned Behavior Questionnaire from 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
Secondary	Changes in Attitudes Toward Seeking Professional Psychological Help-Short Form from 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
Secondary	Support-Seeking Actions to Improve Well-Being	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