Occupational Therapy for Mental Health and Engagement in Neurorehabilitation (OT for ME)

January 21, 2026 updated by: Janell Pisegna, Colorado State University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80222
        • Rehab Without Walls Denver, CO
      • Fort Collins, Colorado, United States, 80523
        • Colorado State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Occupational therapy practitioners
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Colorado State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Occupational Therapy Foundation
Rehab Without Walls Neurorehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB #: 6989

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depressive Symptoms

Clinical Trials on Multifaceted implementation program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings