NCT05384171

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 20, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 3, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

October 9, 2024

Status Verified

September 1, 2024

Enrollment Period

6 months

First QC Date

March 18, 2022

Results QC Date

December 6, 2023

Last Update Submit

September 25, 2024

Conditions

Keywords

well-beingmental healthhelp-seekingveteran

Outcome Measures

Primary Outcomes (3)

  • 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: 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 MBTA assessment (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group) 5. Percentage of veterans who review the personalized well-being report (baseline \[T1\] for intervention group; three-month follow-up \[T2\] for active control group)

    baseline (T1) and three-month follow-up (T2)

  • Satisfaction With MBTA Tool

    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?

    baseline assessment (T1 only for intervention group)

  • Satisfaction With MBTA Tool

    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?

    three-month follow-up (T2 only for active control group)

Secondary Outcomes (5)

  • University of Rhode Island Change Assessment Scale (URICA) - Readiness to Change

    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

  • Stages Algorithm

    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

  • Theory of Planned Behavior Constructs

    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

  • Attitudes Toward Seeking Professional Psychological Help-Short Form

    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

  • Support-Seeking Actions to Improve Well-Being

    Measured at T2 (three-month follow-up) for intervention group only

Study Arms (2)

Intervention Group

EXPERIMENTAL

MBTA, MBTA satisfaction measures, and other assessment measures at T1 (baseline); MBTA and other assessment measures at T2 (three month follow-up)

Behavioral: Measurement-Based Transition Assistance (MBTA)

Active Control Group

ACTIVE COMPARATOR

assessment measures only at T1 (baseline); MBTA, MBTA satisfaction measures, and other assessment measures at T2 (three month follow-up)

Behavioral: Measurement-Based Transition Assistance (MBTA)

Interventions

Measurement-Based Transition Assistance (MBTA) asks Veterans about their well-being and then 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 Control GroupIntervention Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Limitations and Caveats

The number of veterans that enrolled in this pilot study was lower than expected which resulted in the study being underpowered.

Results Point of Contact

Title
Dr. Dawne Vogt
Organization
VA Boston Healthcare system

Study Officials

  • Dawne S Vogt, PhD BA

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants are randomized to an assessment only condition or to the full MBTA intervention (assessment, feedback and resource recommendations)
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2022

First Posted

May 20, 2022

Study Start

November 3, 2022

Primary Completion

April 30, 2023

Study Completion

June 26, 2023

Last Updated

October 9, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations