Acquired Brain InjuryOT for MENCT07375485
Occupational Therapy for Mental Health and Engagement in Neurorehabilitation
A study testing Multifaceted implementation program in people with Acquired Brain Injury and Mental Health, run by Colorado State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury, Mental Health, Depressive Symptoms
- What is being tested?
- Multifaceted implementation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- OTs or OTAs without a state license to practice OT
- OTs or OTAs who do not work in home or community neurorehabilitation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Rehab Without Walls Denver, CO
Denver, Colorado, 80222
Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: 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.
Read the 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.
- Being tested
- Multifaceted implementation program
- Keywords
- Occupational therapy, Mental health, Acquired brain injury, Implementation
- Medical subject headings
- Brain Injuries, Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted implementation programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multifaceted implementation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (1)
Identify implementation mechanisms and factors influencing implementation outcomes
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- Rehab Without Walls Neurorehabilitation, American Occupational Therapy Foundation
- Responsible party
- Principal investigator, Janell Pisegna, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375485
- Sponsor's protocol ID
- IRB #: 6989
- Acronym
- OT for ME
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifaceted Implementation Program for Occupational Therapy Practitioners Addressing Anxiety and Depressive Symptoms in Home and Community Care
- ClinicalTrials.gov ID
- NCT07375485
- Acronym / sponsor ID
- OT for ME / IRB #: 6989
- Keywords
- Occupational therapy, Mental health, Acquired brain injury, Implementation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- Rehab Without Walls Neurorehabilitation, American Occupational Therapy Foundation
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy practitioners | Experimental | Behavioral: Multifaceted implementation programOTPs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- OTs or OTAs without a state license to practice OT
- OTs or OTAs who do not work in home or community neurorehabilitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted implementation programOTPs 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. | Behavioural | Occupational therapy practitioners |
Primary outcome
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.
1 secondary outcome
Identify implementation mechanisms and factors influencing implementation outcomes
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Acquired Brain Injury
Active, not recruitingObservational study
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Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
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Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted implementation program in people with Acquired Brain Injury and Mental Health, run by Colorado State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation outcomes (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.