Collaborative Care for Anxiety and Depression in Epilepsy

Overseen By Lauren P Richmond

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Psychotropic medications

Disqualifiers: Cognitive limitations, Life expectancy < 6 months, Unstable drug or alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new collaborative care approach, known as the Collaborative Care Model, can assist people with epilepsy who also face anxiety or depression. The study compares this approach, involving a care team with a social worker and psychiatrist, to the usual care from a neurologist. Individuals with epilepsy and symptoms of anxiety or depression, already seeing a neurologist at Atrium Health, might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative care strategies that could enhance their overall well-being.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are currently prescribed 2 or more psychotropic medications for psychiatric reasons and are not considered a good candidate for collaborative care, you may be excluded from the trial.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Collaborative Care Model is safe for adults with epilepsy?

Research has shown that collaborative care is generally safe and well-tolerated. It enhances mental health support by assembling a team to manage conditions like anxiety and depression. This team typically includes a care manager and a psychiatrist, who collaborate with patients and their neurologists.

The collaborative care model is already widely used to address mental health issues. It has effectively managed depression and anxiety, suggesting it may also be safe for people with epilepsy.

Although specific safety data for this treatment in people with epilepsy is lacking, collaborative care has proven safe in other groups. This history of safe use indicates a positive outlook for its safety in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the collaborative care model for anxiety and depression in epilepsy because it offers a team-based approach that integrates mental health directly into neurology care. Unlike standard neurology care, which typically addresses only the physical aspects of epilepsy, this model includes a care manager and psychiatrist who work together with the neurologist to provide comprehensive support for both mental health and epilepsy. This innovative approach could lead to more holistic and effective treatment outcomes, addressing the often-overlooked mental health challenges faced by epilepsy patients.

What evidence suggests that this trial's treatments could be effective for anxiety and depression in epilepsy?

Research has shown that the Collaborative Care Model, which participants in this trial may receive, can significantly improve mental health, particularly for depression and anxiety. Studies have found that when implemented in regular doctor's offices, this model often enhances patient access to mental health services and improves treatment outcomes. The model employs a team approach, with care managers and psychiatrists collaborating closely with patients and their neurologists. Although Collaborative Care has succeeded in general healthcare settings, its effectiveness in neurology, such as for patients with epilepsy, is still under investigation in this trial. Early findings suggest it could enhance the quality of life for those experiencing anxiety and depression. Meanwhile, other participants in this trial will receive usual neurology care, serving as the standard care and control condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Heidi M. Munger Clary, MD, MPH

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 with epilepsy who also experience anxiety or depression. They must be getting care at Atrium Health Wake Forest Baptist and willing to follow the study's procedures. People with a life expectancy under 6 months, those in another study, or with cognitive issues that prevent them from reporting their mental health status are excluded.

Inclusion Criteria

Stated willingness to comply with all study procedures

I experience symptoms of anxiety or depression.

Receiving clinical neurological care at Atrium Health Wake Forest Baptist

Exclusion Criteria

Current participation in another treatment or intervention study

Cognitive limitations precluding completion of Anxiety and Depression self-report instruments

Not a good candidate for collaborative care due to: Active ongoing treatment by a psychiatrist; Active suicidal ideation; Unstable drug or alcohol abuse; history of past suicide attempt and: currently prescribed 2 or more psychotropic medications for psychiatric indication OR receiving ongoing psychotherapy OR has seen a psychiatrist in the past year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 24-week neurology-based collaborative care intervention

24 weeks

Regular visits with care manager/social worker and psychiatrist

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Collaborative Care
• Usual Neurology Care

Trial Overview The trial compares a collaborative care approach versus usual neurology care for managing anxiety and depression in people with epilepsy. It lasts for 24 weeks and involves randomly placing participants into one of these two groups.

How Is the Trial Designed?

Group I: collaborative care Experimental Treatment 1 Intervention

The collaborative care team roles include the care manager/social worker and psychiatrist who interact with the patient participant and the patient's neurologist/neurology provider.

Group II: usual neurology care Active Control 1 Intervention

Ongoing usual neurology care, without the addition of the collaborative care program - current standard care and is thus an ethically appropriate control condition for effectiveness and implementation trials.

Collaborative Care is already approved in United States, European Union for the following indications:

Approved in United States as Collaborative Care for:

• Anxiety in epilepsy
• Depression in epilepsy

Approved in European Union as Integrated Care for:

• Mental health conditions in chronic diseases
• Epilepsy care

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The ADAPT program is a new collaborative care model aimed at improving outcomes for patients with mild to moderate-severe depression and anxiety, utilizing evidence-based practices like measurement-based care and accurate diagnosis.

This study will compare the effectiveness of the ADAPT program against traditional outpatient psychiatric care, potentially providing valuable insights into the implementation and outcomes of collaborative care in a large health system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Implementation and Outcomes of the Achieving Depression and Anxiety Patient-Centered Treatment Collaborative Care Program in a Large, Integrated Health Care System: A Mixed Methods Observational Study Protocol. Ridout, KK., Ridout, SJ., Alavi, M., et al.[2023]

A study involving 80 primary care patients referred to a Collaborative Care Model (CoCM) for anxiety and depression revealed that many declined participation due to uncertainty about insurance coverage, lack of understanding of the program, and feelings that the services were unnecessary.

Qualitative interviews identified 23 barriers to enrollment, including mental health stigma, prioritization of physical health, and concerns about the use of mental health information, highlighting the need for improved communication and relationship-building between patients and their primary care clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation Barriers and Experiences of Eligible Patients Who Failed to Enroll in Collaborative Care for Depression and Anxiety. Fu, E., Carroll, AJ., Rosenthal, LJ., et al.[2023]

The 12-month Collaborative Care (CC) intervention showed that patients with poorly controlled Type 2 Diabetes (T2D) and depression were more likely to maintain significant improvements in depressive symptoms and glucose levels at 36 months compared to those receiving usual care.

While there were no overall differences in health outcomes between the CC and usual care groups at 36 months, patients in the CC group who had improved outcomes at 12 months were more likely to sustain those improvements, indicating the long-term benefits of the CC approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. Suvada, K., Ali, MK., Chwastiak, L., et al.[2023]

Collaborative care models significantly improve depression management, showing a standardized mean difference of 0.34 in depression symptoms and enhancing treatment adherence and response rates in various populations.

The systematic review of 69 studies indicates that these models not only improve clinical outcomes like remission and recovery from symptoms but also enhance patient satisfaction and quality of life, demonstrating their effectiveness across different healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care to improve the management of depressive disorders: a community guide systematic review and meta-analysis. Thota, AB., Sipe, TA., Byard, GJ., et al.[2022]

The integrated collaborative care model, which included low-intensity psychological therapy and support from practice nurses, led to a modest reduction in depression symptoms among 387 patients with chronic physical conditions, achieving a mean score reduction of 0.23 on the SCL-D13 scale.

Patients receiving collaborative care reported better self-management of their conditions and higher satisfaction with their care, although there were no significant differences in overall quality of life or disability compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated primary care for patients with mental and physical multimorbidity: cluster randomised controlled trial of collaborative care for patients with depression comorbid with diabetes or cardiovascular disease. Coventry, P., Lovell, K., Dickens, C., et al.[2022]

Collaborative care is effective for treating depression, regardless of the presence, type, or number of chronic physical conditions, based on an analysis of data from 31 randomized clinical trials involving 10,962 participants.

The study suggests that existing guidelines recommending collaborative care only for those with both depression and chronic physical conditions are not supported, indicating that this care model can benefit all individuals with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Chronic Physical Conditions and the Effectiveness of Collaborative Care for Depression: An Individual Participant Data Meta-analysis. Panagioti, M., Bower, P., Kontopantelis, E., et al.[2022]

The implementation of an app-augmented collaborative care model (CoCM) in a diverse patient population led to significantly more healthcare team contacts and quicker follow-up times compared to standard CoCM, indicating improved patient engagement in treatment.

Patients using the app showed similar clinical outcomes in depression improvement as those in standard CoCM, but with higher appointment compliance and fewer missed appointments, suggesting that technology can enhance the effectiveness and sustainability of behavioral health care in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the scalability of the collaborative care model for depression using mobile technology. Carleton, KE., Patel, UB., Stein, D., et al.[2021]

A low-intensity collaborative care (CC) intervention significantly improved mental health-related quality of life in cardiac patients with depression and anxiety, showing a mean improvement of 11.21 points compared to 5.53 points in the control group over 24 weeks.

The CC intervention also led to notable reductions in depressive symptoms and better overall functioning, indicating its effectiveness in managing mental health alongside cardiac care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care for depression and anxiety disorders in patients with recent cardiac events: the Management of Sadness and Anxiety in Cardiology (MOSAIC) randomized clinical trial. Huffman, JC., Mastromauro, CA., Beach, SR., et al.[2022]

A study involving 15 patients with drug-resistant epilepsy revealed that the psychological impact of epilepsy and seizures often leads to significant depression and anxiety, highlighting the need for integrated psychological care in epilepsy treatment.

The research suggests that viewing epilepsy as an existential challenge can enhance understanding of the psychological issues faced by patients, which may help in developing more effective psychological interventions tailored to their needs, especially for those considering surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizures as a Struggle between Life and Death: An Existential Approach to the Psychosocial Impact of Seizures in Candidates for Epilepsy Surgery. Bauer, PR., Bronnec, MLA., Schulze-Bonhage, A., et al.[2023]

A study involving 480 patients with epilepsy used six machine learning models to effectively predict anxiety and depression, highlighting the importance of these comorbidities in managing epilepsy.

The random forest and multilayer perceptron models showed the best performance in predicting anxiety and depression, suggesting that these methods could be valuable tools for clinicians in identifying patients at high risk for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using machine learning approach to predict depression and anxiety among patients with epilepsy in China: A cross-sectional study. Wei, Z., Wang, X., Ren, L., et al.[2023]

A survey of 146 epilepsy health professionals in Zhejiang Province revealed that while 87.7% recognized the importance of screening for depression and anxiety in patients with epilepsy, actual screening rates were low, with 41.1% screening less than 10% of their patients.

Barriers to effective screening and management included time constraints during clinic visits and a lack of trained mental health specialists, highlighting the need for improved resources and procedures to address psychiatric comorbidities in epilepsy care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing depression and anxiety in patients with epilepsy in eastern China: A survey of epilepsy health professionals in Zhejiang Province. Xu, ZY., Shen, CH., Cai, MT., et al.[2022]

Depression and anxiety are frequently found together in people with epilepsy, significantly impacting their quality of life and the healthcare system, yet many cases go undetected and untreated.

While there are established screening tools for depression in epilepsy, no definitive scale has been validated for anxiety, highlighting a gap in research and the need for effective anxiety assessment tools in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for Depression and Anxiety in Epilepsy. Fiest, KM., Patten, SB., Jetté, N.[2017]

Patients with epilepsy often face psychiatric comorbidities that can negatively impact their quality of life, seizure control, and overall mortality, highlighting the need for comprehensive care.

Multi-professional teams involving various specialists (neurology, psychiatry, psychology, occupational therapy, and social work) can provide tailored care for patients with complex needs, improving care quality and efficiency while reducing individual workloads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Multi-professional epilepsy teams including psychiatric expertise]. Bendix, M., Lindbom, U.[2019]

Collaborative care can significantly improve mental health treatment for anxiety and depression, but its successful implementation depends on securing support from primary care providers and addressing barriers like reimbursement issues.

Key enablers for effective collaborative care include having physician champions, providing feedback on care effectiveness, and ensuring care managers are located within clinics to facilitate regular communication with physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enablers and barriers to implementing collaborative care for anxiety and depression: a systematic qualitative review. Overbeck, G., Davidsen, AS., Kousgaard, MB.[2022]

Collaborative care models, which involve teamwork between primary care and psychiatric providers, can enhance both mental health and overall medical outcomes for patients with bipolar disorder.

Key areas for focus in collaborative care for bipolar disorder include suicide risk assessment, substance use monitoring, tracking side effects like extrapyramidal symptoms, metabolic health monitoring, and providing education specific to bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative mental health and primary care for bipolar disorder. Williams, JW., Manning, JS.[2022]

Citations

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2. aims.uw.edu aims.uw.edu/evidence-base-for-cocm/

Evidence Base for Collaborative Care (CoCM) - AIMS Center Articles and systematic reviews supporting improved depression, PTSD, and/or anxiety outcomes when CoCM is implemented in primary care settings, including ...

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Collaborative Care to Improve Quality of Life for Anxiety ... Collaborative care is an integrated care model with a strong evidence base in primary care and medical settings, but it has not been evaluated in neurology ...

4. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.pn.2025.09.9.29

The Proven Success of the Collaborative Care Model This comprehensive framework represents a paradigm shift in psychiatric care by fostering integration, improving access, and focusing on patient ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05930-w

Multilevel perspectives on the implementation of the ... The Collaborative Care Model (CoCM) is an integrated, evidence-based approach to treating mental health conditions such as depression and ...

6. concerthealth.com concerthealth.com/resources/research

Collaborative Care Research Research on collaborative care has largely focused on improving depressive and anxiety symptoms among adults in primary care settings. The applicability of ...