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Enrolling by Invitation

NCT Number: NCT07375485

Occupational Therapy for Mental Health and Engagement in Neurorehabilitation

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.

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Key information

Conditions

Acquired Brain Injury Anxiety Disorders Anxiety Symptoms Behavior Behavioral Symptoms Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Depression Depressive Symptoms Loneliness Mental Disorders Mental Health Nervous System Diseases Personal Satisfaction Psychological Well-Being Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehab Without Walls Denver, CO, Denver, Colorado, United States

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About this study

This Hybrid Type 3 convergent mixed methods pilot study examines implementation processes, practitioner experiences, and stakeholder perspectives associated with participation in a multifaceted implementation program designed to support OTPs in addressing mental health among adults with ABI in home and community-based care.

Participating OTPs complete a virtual, self-paced, five-module educational training focused on evidence-based mental health screening and intervention strategies relevant to ABI. Additional implementation support activities include periodic check-ins, mentoring and coaching as part of routine clinical practice, fidelity monitoring, and audit and feedback through electronic health record review.

Aim 1. Describe reach, adoption, implementation experiences, and maintenance of mental health-related occupational therapy practices among OTPs participating in a multifaceted implementation training in home and community-based neurorehabilitation.

Aim 2. Explore implementation mechanisms and contextual factors influencing observed implementation experiences, informed by the Practical, Robust Implementation and Sustainability Model (PRISM).

Aim 3. Describe perspectives of key stakeholders, including interdisciplinary team members, administrators, and people with ABI, regarding their experiences of OT addressing mental health.

The primary outcomes of the study are changes in OT practitioners' knowledge, self-efficacy, and mental health practice skills (defined according to the Reach Effectiveness Adoption Implementation and Maintenance [RE-AIM] Model). These outcomes will be assessed through electronic health record review, fidelity monitoring, surveys, and focus groups.

Interdisciplinary stakeholders, including social work, neuropsychology, administrative leadership, patients with ABI and caregivers will participate in focus groups and interviews to provide perspectives on feasibility, acceptability, and perceived impact of the training within the clinical setting.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

are at the level of the therapist:

  • 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)

Exclusion criteria

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

Treatment and study plan

Multifaceted implementation program

Behavioral

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.

Primary outcomes

  1. Implementation outcomes

    Time frame: 24 months

    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.

Secondary outcomes

  1. Identify implementation mechanisms and factors influencing implementation outcomes

    Time frame: 24 months

    The secondary outcome of this study is to understand factors that influenced the adoption of evidence-based mental health screening and intervention practices among occupational therapy practitioners after participation in a multifaceted implementation program.

    Factors influencing the adoption of mental health screening and intervention practices will be measured qualitatively through the identification of themes that influence whether practitioners adopt the mental health screening tools and interventions. We will thematically analyze focus group and interview transcripts with inductive and deductive (from the Practical, Robust Implementation and Sustainability Model [PRISM] and use of a codebook) codes to identify the themes.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • American Occupational Therapy Foundation
  • Rehab Without Walls Neurorehabilitation

Registry information

Official study title

Multifaceted Implementation Program for Occupational Therapy Practitioners Addressing Anxiety and Depressive Symptoms in Home and Community Care

Acronym: OT for ME

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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