Integrated Care for Mental Health Disorders

(PARTNERs Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Psychotic illness, Bipolar, OCD, PTSD, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with mental health issues such as depression and anxiety, using a phone-based support system with a Mental Health Technician. The goal is to determine if this approach improves symptoms and quality of life more effectively than standard care alone. Individuals dealing with depression, anxiety, or alcohol-related issues who receive care from a participating doctor might be suitable candidates. Participants need phone access and should be able to communicate in English over the phone. As an unphased trial, this study provides a unique opportunity to explore innovative support methods that could enhance the mental health care experience.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this integrated care model is safe for mental health treatment?

Research has shown that digital mental health programs, such as those involving a Mental Health Technician, are generally safe. In one study, only about 4.8% of participants reported worsening depression due to the program, indicating that most handle it well. Harmful side effects were rare. Another study found these programs can significantly reduce stress and anxiety, suggesting they provide mental health benefits without major safety concerns. Overall, while some risks exist, most people tolerate the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this approach because it integrates Mental Health Technicians into the care process, offering a unique layer of support that focuses on monitoring symptoms and promoting treatment adherence through brief, telephone-based interventions. Unlike standard treatments that may rely heavily on in-person therapy sessions or medication, this method provides continuous, personalized care remotely, which can be more accessible and convenient for patients. By providing psychoeducation and regular assessments, this approach aims to enhance the overall quality of care and improve mental health outcomes, making it a potentially transformative addition to existing treatment options for mental health disorders.

What evidence suggests that this trial's treatments could be effective for mental health disorders?

Research has shown that having a Mental Health Technician, one of the interventions in this trial, can aid mental health care. These technicians often use digital tools to manage conditions like depression and anxiety. Studies have found that digital mental health programs can reduce symptoms in individuals with mood and anxiety disorders. These programs have also successfully reduced stress and burnout. The approach typically includes regular check-ins and support, helping individuals adhere to their treatment plans and improve over time. Meanwhile, another group in this trial will receive Enhanced Usual Care, where the Primary Care Provider receives assessment results to inform treatment planning. ^{2 4 6 7 8}

Who Is on the Research Team?

Benoit H Mulsant, MD

Principal Investigator

Centre for Addition and Mental Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are suspected of having depression, anxiety, or alcohol-related issues and are under the care of a primary care provider at participating organizations. They must be able to communicate in English by phone and give informed consent. People with certain mental health conditions, substance abuse (excluding alcohol), cognitive impairment, high suicide risk, physical instability requiring hospitalization, or expected to die within 6 months cannot join.

Inclusion Criteria

Receiving care from a Primary Care Provider at one of the participating health care organizations

Having access to a telephone

Corrected auditory acuity that enables to converse in English by telephone

Exclusion Criteria

Clinically significant cognitive impairment as indicated by a score of 16 or above on the Blessed Orientation Memory Concentration Test

High risk for suicide as indicated by the 5-item Paykel Scale

I am currently hospitalized due to my physical condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment of symptoms, quality of life, and function conducted by telephone

1 week

1 visit (telephone)

Treatment

Participants receive either enhanced usual care or an intervention with telephone-based psychoeducation and monitoring by a Mental Health Technician

12 months

Monthly contacts (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 4, 8, and 12 months

12 months

3 visits (telephone)

Chart Audit

Review of participants' charts to abstract interventions and health services received during the study

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Mental Health Technician

Trial Overview The study tests an integrated care model where Mental Health Technicians use specialized software to help primary care providers manage mental health via telephone. It's compared against enhanced usual care to see if it better starts treatment, reduces symptom severity, and improves life quality/functioning.

How Is the Trial Designed?

Group I: Intervention: Mental Health Technician Experimental Treatment 1 Intervention

The subject's Primary Care Provider will receive results of baseline, four, eight, and twelve month assessments examining the subject's symptoms of depression, anxiety, and other mental health problems, use of alcohol and illicit substances, physical pain, and quality of life and recommendations for treatment. Over a 3-12 months period, the Intervention group will receive a brief, telephone-based intervention by a Mental Health Technician that will focus on monitoring symptoms, treatment adherence, and providing psychoeducation.

Group II: Enhanced Usual Care Experimental Treatment 1 Intervention

This group will receive Enhanced Usual Care. The subject's Primary Care Provider will receive results of baseline, four, eight, and twelve month assessments examining the subject's symptoms of depression, anxiety, and other mental health problems, use of alcohol and illicit substances, physical pain, and quality of life . If the subjects primary care provider chooses, they can use this information to construct the subject's treatment plan.

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

CAMH Foundation

Collaborator

Trials

3

Recruited

910+

Capital Solution Design LLC

Collaborator

Trials

1

Recruited

640+

Published Research Related to This Trial

Adverse events in mental health care are common and can lead to significant distress and even death, highlighting the need for improved practices in treatment and discharge processes.

The study identifies critical areas for improvement, including assessment processes, communication, documentation, and training, to reduce the frequency of these adverse events based on coronial recommendations in three Australian States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, risk and mental health: decision-making processes prescribed by Australian mental health legislation. Smith-Merry, J., Caple, A.[2014]

The Health Technology Program (HTP) was well-accepted by patients with schizophrenia spectrum disorders, with 96% rating it as satisfying, indicating a positive response to the integration of digital tools and human support.

Out of 200 patients, 87% utilized at least one digital tool, and they had an average of 28 contacts with a mental health technology coach, suggesting that the program effectively engaged patients in their relapse prevention plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Technology Intervention After Hospitalization for Schizophrenia: Service Utilization and User Satisfaction. Baumel, A., Correll, CU., Hauser, M., et al.[2018]

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

A comprehensive analysis of adverse events in Veterans Health Administration mental health units revealed 87 root cause analysis reports and 9780 safety reports, highlighting a significant risk of various incidents, including 31 suicide attempts and 16 elopements.

Falls were the most frequently reported safety event, followed by medication errors and assaults, indicating that a broad approach to patient safety is essential in mental health settings, similar to medical units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events occurring on mental health units. Mills, PD., Watts, BV., Shiner, B., et al.[2018]

A significant 73% of psychiatrists and nurses in six Flemish psychiatric hospitals reported being involved in at least one adverse event during their careers, with suicide-related incidents being the most impactful for nearly 64% of them.

The study highlights the critical need for timely support for healthcare professionals after adverse events, as those affected are at a higher risk of experiencing further incidents within the first 4-24 hours following the event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious reportable events within the inpatient mental health care: Impact on physicians and nurses. Martens, J., Van Gerven, E., Lannoy, K., et al.[2017]

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11138032/

The effectiveness of e-mental health interventions on stress ... Many healthcare professionals are experiencing psychological distress. Electronic mental health (e-mental health) interventions are ...

3. jmir.org jmir.org/2019/7/e12869/

Digital Mental Health Interventions for Depression, Anxiety ... Background: College students are increasingly reporting common mental health problems, such as depression and anxiety, and they frequently ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9109782/

Digital Health Interventions for Delivery of Mental Health Care A majority (52%) of research involved the treatment of substance use disorders, 29% focused on mood, anxiety, and traumatic stress disorders, and >5% for each ...

5. ajph.aphapublications.org ajph.aphapublications.org/doi/full/10.2105/AJPH.2023.307556

Addressing Health Care Workers' Mental Health: A Systematic ... Several interventions were successful in improving symptoms of stress, burnout, anxiety, and depression among health care workers. Since 2020, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10594135/

The Safety of Digital Mental Health Interventions At follow-up, 14.8% of the participants showed worse depression. Subjective deterioration attributed to the program was at 4.8%. A total of 4 AEs ( ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001259

Fostering Psychological Safety and Supporting Mental ... Other data show a higher risk of suicide among registered nurses, health technicians, and health care support workers in the United States ...

8. formative.jmir.org formative.jmir.org/2024/1/e54816

Using a Digital Mental Health Intervention for Crisis Support ... This study demonstrates that participation in a collaborative care DMHI is associated with improved mental health outcomes in children and adolescents ...