Pharmacist Care for Mental Health

(MAP-AP Trial)

Overseen By Yazid Al Hamarneh, BSc (Pharm), PhD, CDM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Pregnancy, Substance abuse, Bipolar, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether pharmacists in Alberta, trained to prescribe medications, can better support individuals newly diagnosed with Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD). It compares two groups: one receives special pharmacist care (Mental Health Assessment and Prescribing by Alberta Pharmacists) along with regular care, while the other receives only regular care. The trial is open to adults in Alberta who have just started medication for MDD or GAD. As an unphased trial, it offers a unique opportunity to contribute to innovative healthcare solutions and enhance mental health support.

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 seems to focus on patients who are starting new medications for depression or anxiety.

What prior data suggests that this enhanced pharmacist care is safe for patients with MDD and GAD?

Research is examining how pharmacists in Alberta, with increased authority to prescribe medications, can assist in mental health treatment. Specific safety data is not yet available, as the study is in an early stage, but ensuring safety remains a primary focus. This phase evaluates whether the treatment is safe and free from harmful effects.

Pharmacists typically provide safe care, and their expanded roles have shown promise in enhancing mental health outcomes. Although direct safety data is not yet available, pharmacists' training in medication management suggests this type of care is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pharmacist Care for Mental Health trial because it explores a unique approach to mental health management through pharmacist-led interventions. Unlike typical treatments where care is primarily managed by physicians, this trial empowers pharmacists to assess and prescribe mental health treatments directly. This approach could make mental health care more accessible and personalized, allowing patients to receive timely interventions at pharmacies. By broadening the role of pharmacists, the trial aims to enhance the standard of care and provide more comprehensive support for individuals with mental health needs.

What evidence suggests that enhanced pharmacist care is effective for mental health?

Research has shown that in Alberta, where pharmacists can prescribe medications, they may assist people with Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD). In this trial, participants in the Intervention Group will receive enhanced pharmacist care, which includes pharmacist interventions alongside standard care. One study found that pharmacists can successfully manage and prescribe treatments for these conditions, potentially improving patient well-being. Pharmacists with prescribing authority can adjust medications and offer mental health support, which might not only ease symptoms but also increase patient satisfaction with their care. Early findings suggest that this approach could improve adherence to treatment plans, as pharmacists are often more accessible than some other healthcare providers. This enhanced care model aims to provide personalized and timely mental health support, which could be especially beneficial for those newly diagnosed with MDD or GAD. ^{1 2 3 4 6}

Who Is on the Research Team?

Yazid Al Hamarneh, BSc (Pharm), PhD, CDM

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Alberta who've just been diagnosed with Major Depressive Disorder or Generalized Anxiety Disorder and are starting medication. It's not for those with a history of substance abuse, other mental health conditions like bipolar disorder, severe depression types, multiple suicide attempts, pregnant individuals, or non-residents.

Inclusion Criteria

I am an adult newly diagnosed with depression or anxiety and starting treatment.

Exclusion Criteria

History of and/or current substance abuse, intoxication, addiction or withdrawal

≥2 suicide attempts per year

I cannot commit to regular follow-up visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive enhanced pharmacist care with additional prescribing authorization, including monitoring, patient education, referral facilitation, and prescribing adjustments

6 months

In-person visits at enrollment, 1, 3, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mental Health Assessment and Prescribing by Alberta Pharmacists

Trial Overview Pharmacists with special prescribing rights are testing an enhanced care approach for managing new cases of depression and anxiety. This includes assessing patients' mental health, adjusting medications if needed, providing counseling support, identifying drug side effects or interactions, and coordinating closely with physicians.

How Is the Trial Designed?

Group I: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions) Experimental Treatment 13 Interventions

Participants enrolled in the intervention group will receive pharmacist interventions, in addition to standard care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians), at enrollment (month 0) and at 1, 3, and 6 month in-person follow-up appointments

Group II: Control Group (Standard Pharmacist Care) Active Control 7 Interventions

Patients randomized to the usual care group will receive standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians) and physician care, at enrollment (month 0) with no specific interventions for the duration of 6 months, until the 6 month in-person follow-up appointment

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

A systematic review of 35 publications from 1972-2003 found that clinical pharmacists positively impact mental health care, with 16 studies showing improvements in patient outcomes, prescribing practices, and satisfaction.

Despite the positive results, most studies were small and had design limitations, indicating a need for larger, multicenter trials to better evaluate the effectiveness and cost-effectiveness of pharmacists in mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the impact of pharmacists in mental health: a systematic review. Finley, PR., Crismon, ML., Rush, AJ.[2022]

Pharmacist-delivered community-based services can significantly improve adherence to antidepressant medications for patients starting treatment, as shown in three studies included in the review.

Medication reviews conducted by pharmacists can help reduce the prescription of potentially inappropriate medications for high-risk patients, indicating their valuable role in optimizing mental health medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community pharmacy services to optimise the use of medications for mental illness: a systematic review. Bell, S., McLachlan, AJ., Aslani, P., et al.[2022]

In a pilot project involving 144 patients, the inclusion of pharmacists in primary care behavioral health teams significantly improved medication safety, with an 18% increase in patients up-to-date on monitoring for psychotropic medications after 3 months.

The risk of drug interactions decreased by 20%, indicating that pharmacist-led medication reviews can effectively enhance patient safety in managing psychotropic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacist medication reviews to improve safety monitoring in primary care patients. Gallimore, CE., Sokhal, D., Zeidler Schreiter, E., et al.[2018]

In a study of 217 patients with depression and/or anxiety, no significant difference was found in the improvement of PHQ-9 and GAD scores between those receiving care from a provider alone and those receiving care from both a provider and a clinical pharmacist.

However, patients who worked with clinical pharmacists reported higher medication adherence, indicating that pharmacists can play a valuable role in supporting patients, even if overall symptom improvement was not statistically different.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Evaluating Clinical Pharmacy Services in an Ambulatory Psychiatry Setting. Lindell, VA., Stencel, NL., Ives, RC., et al.[2019]

Community pharmacies have the potential to play a significant role in mental health services, as they regularly interact with mental health consumers and their carers, which can enhance support and medication management.

The review identified various international studies and systematic reviews that suggest professional service interventions in community pharmacies could be adapted to improve mental health care in Australia, drawing on existing models for chronic physical health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring an increased role for Australian community pharmacy in mental health professional service delivery: evaluation of the literature. Hattingh, HL., Scahill, S., Fowler, JL., et al.[2017]

Pharmacists can play a crucial role in mental health care by participating in multidisciplinary teams, supporting early detection of mental illnesses, and improving medication management, which can enhance patient outcomes.

Barriers to implementing pharmacist-led mental health services include stigma, pharmacists' attitudes, and collaboration challenges with physicians, but addressing these issues can facilitate better integration of pharmacists into mental health care teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New roles for pharmacists in community mental health care: a narrative review. Rubio-Valera, M., Chen, TF., O'Reilly, CL.[2023]

Incorporating a psychiatric pharmacist (PP) into primary care significantly improved access to depression treatment, reducing the average wait time for initial evaluation from 104.5 days in the behavioral health clinic to just 31.3 days in the primary care setting.

Patients treated by the PP showed a significant decrease in depression severity, with PHQ-9 scores dropping from 17.9 to 14.7, and reported high satisfaction with their care, indicating that this model is effective and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiencies and outcomes of depression treatment by a psychiatric pharmacist in a primary care clinic compared with treatment within a behavioral health clinic. Silvia, R., Plum, M., Dufresne, R.[2021]

Pharmacist interventions, particularly those combining patient education and drug monitoring, significantly improve patient adherence to antidepressant medications, with adherence rates increasing by 15% to 27%.

The review highlights that improved adherence is associated with better patient-reported outcomes and satisfaction, suggesting that pharmacist involvement can lead to enhanced treatment effectiveness for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of pharmacist interventions on patients' adherence to antidepressants and patient-reported outcomes: a systematic review. Al-Jumah, KA., Qureshi, NA.[2022]

A pharmacist-psychiatrist collaborative clinic for adult ADHD was successfully implemented, involving 58 patients and 774 encounters over three years, demonstrating the potential for effective interdisciplinary care in mental health.

The model allowed pharmacists to engage in various roles, including psychiatric evaluation and medication management, although challenges such as limited time and reimbursement issues were noted, highlighting areas for improvement in collaborative mental health practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an innovative adult attention-deficit hyperactivity disorder clinic. Lee, KC., Kim, E., Kim, J., et al.[2020]

Community pharmacists are viewed as accessible drug experts who can significantly enhance the safety and tolerability of antidepressant drug treatments (ADT) by monitoring adherence and efficacy.

Healthcare leaders expressed a strong desire for increased collaboration between pharmacists and healthcare teams, highlighting the need for regulatory changes to support pharmacists' expanded roles in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contributions of community pharmacists to patients on antidepressants-a qualitative study among key informants. Guillaumie, L., Moisan, J., Grégoire, JP., et al.[2022]

The PharMIbridge trial aims to evaluate the effectiveness of a pharmacist-led support service for individuals with severe and persistent mental illness (SPMI), focusing on improving medication adherence and managing physical comorbidities over a 6-month period, involving 190 participants across 48 pharmacies.

Pharmacists in the intervention group will receive specialized training in mental health support and medication management, which is expected to enhance their ability to help patients compared to standard care, potentially leading to better health outcomes and quality of life for those with SPMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the gap between physical and mental illness in community pharmacy (PharMIbridge): protocol for an Australian cluster randomised controlled trial. Wheeler, AJ., O'Reilly, CL., El-Den, S., et al.[2023]

Citations

1. trialx.com trialx.com/clinical-trials/listings/258742/mental-health-assessment-and-prescribing-by-alberta-pharmacists/

Mental Health Assessment and Prescribing by Alberta ... Clinical trial for Major Depressive Disorder | Pharmacist-Patient Relations | Generalized Anxiety Disorder , Mental Health Assessment and Prescribing by ...

2. clinicaltrial.be clinicaltrial.be/en/details/20920?per_page=100&recruiting=1&enrolling_by_invitation=0&active_not_recruiting=0&not_yet_recruiting=0&completed=0&only_recruiting=1&only_eligible=0

Mental Health Assessment and Prescribing by Alberta ... KeywordsPharmacistPrescribingMajor Depressive DisorderGeneralized Anxiety DisorderMental HealthInterventionExpanded Scope. Trial description.

3. epicore.ualberta.ca epicore.ualberta.ca/documents/MAP-AP/Mental%20Health%20Assessment%20and%20Prescribing%20by%20Alberta%20Pharmacists%20(MAP-AP)%20STUDY%20PROTOCOL%20(REB%20ID%20Pro00093776)%20(1).pdf

Mental Health Assessment and Prescribing by Alberta ... diagnosed with Major Depressive Disorder (MDD) and Generalised Anxiety Disorder (GAD). Objectives. Primary objective. To evaluate the effect ...

4. cfpnet.ca cfpnet.ca/telling-results-from-mental-healthcare-study/

Telling results from mental healthcare study ... major depressive disorder (MDD) or generalized anxiety disorder (GAD). Eight pharmacies representing multiple pharmacy formats came on board ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39127944

Evaluation of an enhanced depression and anxiety ... Community pharmacists may have a role in the screening and management of patient mental health, although there were challenges with screening uptake and ...

6. epicore.ualberta.ca epicore.ualberta.ca/home/author/jcchanualberta-ca/feed/

Jonathan Chan – EPICORE - University of Alberta MAP-AP Study – Mental Health Assessment and Prescribing by Alberta Pharmacists ... changes in scope of practice will not substantiate improved care if pharmacists ...