NCT07375485

Brief Summary

Changes in mental health are common after acquired brain injury (ABI), defined as any traumatic or non-traumatic injury to the brain after birth, affecting approximately 1 in 3 adults with ABI. Occupational therapy (OT) practitioners are uniquely qualified to contribute to addressing how mental and physical health influence engagement in activities of daily living, yet many OT practitioners working in neurorehabilitation do not implement recommended evidence-based mental health screening or intervention. This study aims to test a comprehensive implementation program for integrating evidence-based mental healthcare into OT rehabilitation services for people with ABI. The study will be conducted with OT practitioners working in home and community neurorehabilitation settings. The focus of the study is to better understand strategies to help OT practitioners adopt and implement evidence-based mental healthcare into routine practice. By doing so, the study aims to improve neurorehabilitation care delivery and promote positive mental health and community engagement among people with ABI.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Jul 2025Jun 2027

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

January 3, 2026

Last Update Submit

January 21, 2026

Conditions

Keywords

Occupational therapyMental healthAcquired brain injuryImplementation

Outcome Measures

Primary Outcomes (1)

  • Implementation outcomes

    The primary outcome of this study is the adoption of evidence-based mental health screening and intervention practices among occupational therapy practitioners after participating in a multifaceted implementation program. We have defined adoption as a dichotomous outcome (adopted vs. did not adopt), with the a priori established benchmark for adoption as the observed use of evidence-based mental health screening tools and intervention practices with 90% of clients in 10 or more sessions across the client's length of stay. We will measure adoption using directed content analysis of electronic health record data, on-site observations, and self-reported use of screening and intervention practices from qualitative focus groups and interviews.

    24 months

Secondary Outcomes (1)

  • Identify implementation mechanisms and factors influencing implementation outcomes

    24 months

Study Arms (1)

Occupational therapy practitioners

EXPERIMENTAL

OTPs will complete training and coaching sessions on evidence-based OT mental health screening (anxiety and depressive symptoms and loneliness) and intervention practices (cognitive behavioral therapy, problem-solving therapy, motivational interviewing, behavior change, and self-regulation), receive job and decision aid templates, attend monthly check-insas a team and with clinical experts in OT mental healthcare, and fidelity monitoring and observation. Additional strategies may be identified through interviews or focus groups by tailoring implementation strategies further to the local context. Interdisciplinary team members will only undergo the training and share their experiences and perceptions of OT's role in mental health during neurorehabilitation.

Behavioral: Multifaceted implementation program

Interventions

OTPs will complete training and coaching sessions on evidence-based OT mental health screening (anxiety and depressive symptoms and loneliness) and intervention practices (cognitive behavioral therapy, problem-solving therapy, motivational interviewing, behavior change, and self-regulation), receive job and decision aid templates, attend monthly check-insas a team and with clinical experts in OT mental healthcare, and fidelity monitoring and observation. Additional strategies may be identified by the OT practitioners in the study through interviews or focus groups, allowing for further tailoring of implementation strategies to the local context.

Occupational therapy practitioners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • State-licensed occupational therapists (OTs) or occupational therapy assistants (OTAs) in the United States
  • OTs or OTAs who work in home or community neurorehabilitation practice settings and treat adults (18 years of age or older) with acquired brain injury (defined as any traumatic or non-traumatic injury to the brain after birth)

You may not qualify if:

  • OTs or OTAs without a state license to practice OT
  • OTs or OTAs who do not work in home or community neurorehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rehab Without Walls Denver, CO

Denver, Colorado, 80222, United States

Location

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

MeSH Terms

Conditions

Brain InjuriesPsychological Well-BeingDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPersonal SatisfactionBehaviorBehavioral SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 3, 2026

First Posted

January 29, 2026

Study Start

July 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

A small number of sites pose risks to participant privacy and confidentiality, and risk for identification. IPD would only be shared with a data use agreement between all relevant parties.

Locations