Challenges Related to the Implementation of Measurement-Based Care for the Treatment of Major Depressive Disorder: A Feasibility Study

• Abstract
• Introduction
• Methods
• Study Type and Setting
• Participants
• Measures
• Intervention
• Suicide Risk Management Protocol
• Data Analysis
• Results
• Feasibility and Process of Care
• Change in Depressive Symptoms and Remission
• Suicidality
• Adverse Effects
• Discussion
• Data Access Statement
• Authors Contributions
• Funding Statement
• References

Abstract

Objectives

Measurement-based care (MBC) involves systematically assessing patientsʼ symptoms and adverse events using standardized scales to guide treatment. While MBC has been shown to enhance the quality of care and outcomes in the pharmacotherapy of major depressive disorder (MDD), it is still rarely used in clinical practice. In this study, the feasibility of implementing MBC was assessed for patients with MDD seen in a large outpatient psychiatry clinic.

Methods

Adults diagnosed with MDD were assessed at baseline and during a 12-week follow-up by phone or via emailed links with: the 9-item Patient Health Questionnaire (PHQ-9), an adverse effect rating scale, and a published suicide risk management protocol (SRMP). Antidepressants were recommended based on preferences expressed by the participant and treating psychiatrist; dosages were adjusted by the treating psychiatrist based on symptomatic improvement and adverse events.

Results

Over 2 years, 52 (21.2%) of 246 patients referred to the study were enrolled, 28 (53.8%) completed all assessments at all follow-up visits, 45 (87.0%) participants were prescribed one of the recommended antidepressants, and 22 (42.3%) remitted. Of the 27 participants presenting with suicidal ideation, 18 (66.6%) experienced a full resolution of these ideations.

Conclusion

These findings highlight the challenges in implementing MBC for the pharmacotherapy of MDD and confirm some barriers to its broad adoption in clinical practice. The study also highlights its benefits in the selected group of patients who engage in MBC. Future studies need to continue to explore innovative ways to facilitate its broader implementation.

Introduction

Over the past 30 years, despite a significant increase in the recognition and treatment of major depressive disorder (MDD), its prevalence has not decreased [1] [2]. This lack of impact of treatments, referred to as “the treatment-prevalence paradox” [3], has been attributed in part to the poor quality of usual care provided by family physicians or psychiatrists [1] [4] [5]. Measurement-based care (MBC) is a simple approach involving systematic and regular monitoring of symptoms or adverse events using standardized scales to facilitate timely treatment adjustments [6] [7] [8] [9] [10]. MBC has been shown to more than double the response or remission rates of pharmacotherapy for MDD provided by family physicians [9] or by psychiatrists [11].

Despite evidence supporting the effectiveness of MBC, it has been implemented by less than 20% of clinicians (including psychiatrists) [12]. Barriers to the adoption of MBC include a lack of awareness of MBC, resistance to changing traditional clinical approaches, and concerns about required time and effort [12] [16]. Another barrier to using MBC relates to concerns about how to manage suicidality, which is expected to be reported by one in three patients with MDD [17]. Some strategies have been proposed to overcome these barriers, including using self-report measures, employing electronic monitoring tools, and involving non-clinician (“lay”) providers [13] [18] [19] [20] [21] [22]. In addition, integrating a suicide risk management protocol (SRMP) in MBC could facilitate the management of suicidality, as has been the case in clinical trials [16] [23] [24].

In this context, the Personalized PARTNERS study assessed the feasibility and effectiveness of MBC in a large urban outpatient psychiatry clinic. The study aimed to: (a) determine the potential participant flow and (b) obtain an estimate of the remission rate. Other outcomes included the participantʼs adherence to study assessments, the psychiatrist’s adherence to treatment recommendations, and the occurrence of adverse effects. The study also assessed the feasibility and usefulness of using an SRMP implemented by non-clinicians to detect suicidality and assess its risk.

Methods

Study Type and Setting

The Personalized PARTNERS study was a non-randomized open trial designed to assess the feasibility of implementing MBC for the pharmacotherapy of MDD. It was conducted in the Mood Disorder Outpatient Service at the Centre for Addiction and Mental Health (CAMH), Toronto, Ontario, between November 2021 and November 2023.

Participants

Potentially eligible patients with a primary diagnosis of MDD referred to CAMH for an outpatient consultation were asked to participate and to provide informed e-consent by phone using an informed consent form approved by the Research Ethics Board of CAMH.

Participants completed a baseline assessment during which their eligibility was confirmed (Table S-1). The inclusion criteria comprised: being 18 years or older with a primary diagnosis of MDD and a current single or recurrent major depressive episode without psychotic features according to their consulting psychiatrist based on the criteria of the Diagnostic and Statistical Manual, 5^th edition (DSM -5) [25]; having a corrected auditory and visual acuity enabling them to converse and read in English; having access to the internet and a computer, smartphone, or a similar device; being deemed capable of providing informed consent by their consulting psychiatrist. Exclusion criteria comprised: having a DSM-5 lifetime diagnosis of bipolar disorder, or schizophrenia-spectrum disorder, current post-traumatic stress disorder (PTSD), obsessive-compulsive disorder, or substance use disorder, according to their consulting psychiatrist; cognitive impairment as indicated by a score of 16 or above on the Blessed Orientation Memory Concentration Test (BOMC) [26] if aged 50 years or older; requiring urgent mental health care or admission (e. g., suicidality with intent to attempt imminently).

Measures

The baseline phone assessment done by a trained research associate (RA) included: sociodemographic information; depressive symptoms using the Patient Health Questionnaire-9 items (PHQ-9) scale [6] and five specific items (early morning awakening; anxiety somatic symptoms; general somatic symptoms; suicidality; insight) from the Hamilton Rating Scale for Depression (HamD) [27]; assessment of suicide risk using a published SRMP [24]; dosage and duration of antidepressants taken during the current episode [28]; list of all currently prescribed and over-the-counter medications; and elicitation of adverse events of current antidepressant using an open question (“Have you had any side effects in the past week from your antidepressant”), which were then scored using the Udvalg for Kliniske Undersøgelser (UKU) scale [29]. Both participants and treating psychiatrists were also asked to provide their preferences regarding 11 selected antidepressants (see below).

Follow-up assessments took place at weeks 2, 4, 6, and 8, at which time the participants received a link to an online PHQ-9 questionnaire and answered the open question about adverse events with follow-up questions when warranted. When a participant scored 1 or above on the PHQ-9 suicidality item 9, the RA was automatically informed, and they called the participant to complete the SRMP (see below). Also, when the participant did not complete the online assessment within 48 hours of receiving the link, the RA contacted them and completed the assessment by phone. If participants did not respond to the call, the RA attempted to contact them for at least two weeks before the assessment was documented as incomplete. The week-12 assessment was completed over the phone and comprised the PHQ-9, the five items of the HamD, the assessment of adverse events, and the SRMP (Table S-1).

Intervention

After completing the baseline questionnaires, participants were asked: (a) to select any of 22 antidepressant adverse events they would be concerned about and to rank them based on their degree of concern; and (b) to indicate which antidepressant (if any) they would not be willing to try from this alphabetized list: bupropion, desipramine, duloxetine, escitalopram, fluoxetine, mirtazapine, moclobemide, nortriptyline, paroxetine, sertraline, venlafaxine. Treating psychiatrists were asked which of the same 11 antidepressants they would consider prescribing or not for this participant (or whether they were unsure about it).

Then, considering the preferences of both the participant and the psychiatrist, the RA generated a list of five recommended antidepressants ranked on their desirability (estimated a priori by the investigators) and their effectiveness (based on whether the participant had been treated unsuccessfully with any antidepressant during the current episode). The RA emailed this list to the treating psychiatrists who were encouraged, but not mandated, to prescribe one of the five recommended antidepressants. Participants and their treating psychiatrists collaborated to determine the frequencies of follow-up appointments and to make treatment decisions.

A weekly tracking log including cumulative information on treatment progress of each participant was provided to all treating psychiatrists. Based on PHQ-9 total scores, the scores of completed SRMPs, and adverse events reported by participants. Treating psychiatrists were encouraged to contribute pertinent information to the log. They were free to manage medications as deemed necessary (e. g., reduce dosage or switch medications due to adverse effects; switch or augment medications due to lack of efficacy). At week 12, they could either continue following the participant or transfer them back to their referring family physician.

Suicide Risk Management Protocol

The SRMP is designed to objectively and consistently rate suicide-related ideation and behavior, to assess risk for self-harm on a probability spectrum (low, moderate, high, or imminent), and to recommend actions ranging from documentation to activating emergency medical services) [24]. It includes an adaptive questionnaire with five obligatory questions, the response to which can generate seven to 18 additional questions [24]. Depending on the questions asked, it takes 5 to 40 minutes.

After completing the SRMP, regardless of the estimated suicide risk, the RA shared the phone number of the Canadian Suicide Crisis Line and reminded the participant to call 911 or visit their local Emergency Department (ED) if their suicidal thoughts intensified. If the suicide risk was rated as high, the RA called the treating psychiatrist within two hours of the assessment. Otherwise, the RA implemented the action prescribed by the SRMP and emailed the results of the SRMP to the treating psychiatrist; the treating psychiatrist then decided what to do next (e. g., continuing monitoring, calling the participant to adjust medications, or scheduling an emergency appointment). When the RA could not reach the treating psychiatrist, an on-call psychiatrist was available 24/7.

Data Analysis

For this pilot feasibility study, the data analyses were mostly descriptive. Categorical outcomes (e. g., completion of follow-ups) were described using frequencies and proportions. The PHQ-9 scores were summarised using means and standard deviations (SD) at baseline and follow-ups. A paired t-test compared baseline and week-12 PHQ-9 scores in both the completer sample and in the whole sample (using a Last Observation Carried Forward (LOCF) approach); we also calculated an effect size using Cohen’s d. The rate of remission (defined as a PHQ-9 last score of 7 or lower) was calculated and the association between remission and prior antidepressant treatment was assessed with a Chi-square test. Finally, the change in the proportion of participants reporting suicidality was assessed using a McNemar test. The characteristics of completers and non-completers were compared using a binary logistic regression analysis.

All tests were two-sided and statistical significance was set at p<0.05 for all tests. For this pilot study, the target sample size was based on a ‘rule of thumb’ suggesting that a sample of 35 patients is adequate for a one-arm study using continuous outcomes [30]. Data were analysed using IBM SPSS Statistics (version 27.0.1) [31].

Results

Feasibility and Process of Care

Over a two-year period, 246 patients were referred to the study, with a mean (SD) of 10.2 (1.0) referrals per month. Of these referrals, 216 (87.8%) were pre-screened as potentially eligible, 65 (26.5%) provided written informed consent and 52 (21.1%) completed the baseline assessment and the selection of their antidepressant ([Fig. 1]). [Table 1] presents the characteristics of these 52 participants, of whom 5 (9.7%) withdrew consent, 39 (75.0%) completed the week-12 visit, 30 (57.6%) completed all five follow-up visits, and 28 (53.8%) completed all assessments at all visits ([Table 2]). The differences between the characteristics of these 28 participants and the 24 others were not significant (χ² (8)=6.258, p=0.618) (Table S-2).

Of the 52 participants, 45 (86.5%) received one of the five antidepressants recommended for them ([Table 3]), two (3.8%) continued an antidepressant previously prescribed by their family physician, and five (9.6%) did not receive an antidepressant. Treating psychiatrists augmented the initial antidepressant in two participants and switched the initial antidepressant in five due to: the lack of efficacy and adverse effects (n=3), occurrence of hypomania (n=1), or other adverse effects (n=1); all these switches occurred after 4 weeks or longer. In addition, at week 12, two participants reported that their family physicians had switched their antidepressants – one due to adverse effects and one for an unknown reason.

Change in Depressive Symptoms and Remission

The mean (SD) PHQ-9 score was 16.2 (5.1) at baseline (n=52). In the 39 week-12 completers, the mean (SD) week-12 PHQ-9 score was 8.1 (5.9) and the mean (SD) decrease was 7.6 (5.6) (t (37)=8.27, p<0.001) with a Cohenʼs d=1.3 (95% CI: [0.89–1.77]). In the whole sample, the mean (SD) last PHQ-9 score was 10 (6.6) and the mean (SD) decrease was 6.2 (6.6) (t(51)=7.78, p<0.001), with a Cohenʼs d=1.02 (95% CI=[0.58–1.46]) (Table S-2). Of the 52 participants, 22 (42.3%) met the criteria for remission ([Fig. 2]): 19 (51.3%) of 37 who were treatment naïve or had not received an adequate antidepressant and 3 (20.0%) of 15 who had received one adequate antidepressant trial before participating in the study (χ²=9.3, df=1, p=0.002).

Suicidality

Of the 52 participants, 27 (51.9%) activated the SRMP at least once and they completed a total of 83 suicide assessments (range: 1–6 per participant over 12 weeks) ([Table 2]). The suicide risk was estimated to be: low in 78 (93.9%) instances, moderate (requiring notification of the treating psychiatrist) in two (2.4%), and high in three (3.6%), including one instance at week 12 (which required a change in medication dosage by the treating psychiatrist) and two instances in the same participant once at baseline (of which the treating psychiatrist was already aware) and once at week-2 (for which the treating psychiatrist had to schedule an emergency appointment). Among the 27 participants who presented with suicidal ideation, 18 (66.6%) experienced a full resolution of these ideations ([Fig. 2]) (McNemar test: χ²(1)=15, p<0.001). During the study, there were no deaths, psychiatric hospitalizations, or ED visits due to suicidality or self-harm.

Adverse Effects

Of the 47 participants who received medication during the study, 38 (80.8%) spontaneously reported an adverse effect at least once with a median of 4 (range: 0–16), and an overall total of 240 reported adverse events. Participants rated these 240 adverse effects as mild (96; 40.0%); moderate (113; 47.0%); and severe (31; 12.9%). A single serious adverse event occurred during the study: a participant developed an allergic reaction to acetaminophen; they went to their local ED, received two epinephrine injections, and were discharged within a few hours.

Discussion

This study aimed to assess the feasibility of implementing MBC in the management of non-treatment-resistant depression, including a protocol to assess and manage suicide risk. Only one of the five patients referred to the study were eligible and accepted to participate. The most common reason for declining to participate in the study was a refusal to make any changes to or switch one’s antidepressant. Half the number of participants completed all assessments at all visits. In this small sample, we did not identify any demographic or clinical characteristics associated with completing the treatment and assessment protocol. Psychiatrists prescribed one of the recommended antidepressants in almost nine of 10 participants. As expected, about 40% of participants experienced a remission of their depression. In both the LOCF and completers analyses, there was a significant improvement in mean PHQ-9 scores. More than half of the participants reported suicidality at some point during the 12-week study, with more than two-thirds of them experiencing a full resolution of their suicidality; in only two participants, the protocolized assessment of suicidality required the involvement of the treating psychiatrist.

Approximately four of five patients referred to our study did not participate. The main reason for declining to participate was a reluctance to modify one’s current antidepressant or to start a new one. The absence of demographic or clinical characteristics associated with declining to participate is congruent with the results of a systematic review and meta-analysis of more than 2.7 M patients that failed to identify any demographic or clinical characteristics associated with non-adherence to initiating a prescribed antidepressant [32] In previous studies, many patients being offered or treated with antidepressants mentioned stigma associated with taking antidepressants, concerns about potential adverse effects, or previous negative experiences with antidepressants [33]. Addressing these concerns may help to mitigate them and improve participation rates in antidepressant treatment, with or without MBC.

Overall, our findings in the referred patients who were eligible and consented to participate were congruent with the evidence supporting the impact of MBC in the pharmacotherapy of MDD [8]. For instance, in a randomized clinical trial, the remission rate was 74% when pharmacotherapy was provided by psychiatrists using MBC vs. 29% when it was provided by the same psychiatrists using usual care [11]. Moreover, the treating psychiatrists appeared to be willing to prescribe the antidepressants recommended by the study for most participants.

Our study also contributes to the scant literature on the feasibility and impact of using an SRMP in a clinical study or clinical practice to manage research participants or patients at risk for suicide [23] [ 34] [35] [36]. In our study, an RA was able to implement an SRMP to assess and manage the suicidality reported by more than half of the participants with minimal involvement from the treating psychiatrists. Again, future studies will need to explore whether this approach can be generalized or further automated.

Despite these positive outcomes, our study highlights that MBC remains difficult to implement in actual practice (even in the facilitating context of a research study). Congruent with the literature [20] [32], only a subgroup of our participants was willing and able to complete all scheduled assessments needed for MBC: some were completed by about 80% of participants, but only half the number of participants completed all assessments despite the use of email reminders or follow-up calls by an RA. These completion rates are similar to those in other clinical trials [37] [38]. Several strategies have been suggested to improve completion rates of measurements needed for MBC: providing reimbursement to care providers for incorporating MBC into treatment plans, discussing assessment results with patients during each follow-up visit and emphasizing the direct benefits of MBC, and providing small rewards or recognition to patients who complete assessments [39] [40]. Using MBC as part of a more comprehensive collaborative care framework provided by an interdisciplinary team may improve its uptake [21], but this requires considerably more resources. Future studies will need to explore whether increased automation (i. e., chatbot) may improve the completion of assessments as is being done for other interventions [41] [44]. Alternatively, passive sensing could also be used to monitor outcomes and adjust antidepressant medications [45] [47].

Our study has several limitations. First, as discussed above, a low participation rate resulted in a small sample. Second, the use of a LOCF analysis to impute data in participants who dropped out; this method assumes stability of symptoms among dropouts, potentially leading to an underestimation of improvement in depression scores. Third, the study was conducted in an academic psychiatric hospital, limiting the generalizability of its findings to other healthcare settings. Finally, the study was conducted solely in English-speaking patients who were predominantly of European or Asian descent with a relatively high level of education. Future studies need to assess the feasibility of MBC in other populations.

Data Access Statement

The database of this study can be shared upon request and completion of a data transfer agreement.

Authors Contributions

DMB: investigation, writing-review, editing, and supervision; MIH: conceptualization, methodology, investigation, writing-review, editing, and supervision; SK: investigation, writing-review, editing, and supervision; BHM: conceptualization, methodology, investigation, writing-review, editing, supervision, and funding acquisition; DJM: investigation, writing-review, editing, and supervision; AO: writing-review, editing, and supervision; AP: project administration, writing-review, editing, and funding acquisition; ET: investigation, writing-original draft, writing-review, editing, visualization, and formal analysis; AX: investigation, writing-review, editing, and formal analysis.

Funding Statement

This study was supported by a grant from the CAMH Foundation using funds donated by Bell Canada and the Medical Psychiatry Alliance; the Medical Psychiatry Alliance is a Canadian collaborative partnership between the Centre for Addiction and Mental Health, the Hospital for Sick Children, Trillium Health Partners, and the University of Toronto (all in Ontario, Canada) dedicated to transforming the delivery of mental health services for patients who suffer from physical and psychiatric illness or medically unexplained symptoms.

Conflict of Interest

DMB receives research support from CIHR, NIMH (R01MH112815;R21MH128815; R01MH1192850), Brain Canada and the Temerty Family through the CAMH Foundation and the Campbell Family Research Institute. He received research support and in-kind equipment support for an investigator-initiated study from Brainsway Ltd. He was the site principal investigator for three sponsor-initiated studies for Brainsway Ltd. He also received in-kind equipment support from Magventure for two investigator-initiated studies. He received medication supplies for an investigator-initiated trial from Indivior. He is a scientific advisor for Sooma Medical. He is the Co-Chair of the Clinical Standards Committee of the Clinical TMS Society (unpaid). SK received honorarium for consultation from EmpowerPharm. SK reports grants from the Labatt Family Innovation Fund in Brain Health (Department of Psychiatry, University of Toronto), the Max Bell Foundation, the CAMH Discovery Fund, the Canadian Centre on Substance Use and Addiction, the Centre for Addiction and Mental Health Discovery Fund, the Ontario Ministry of Health and Long-Term Care (MOHLTC), the Canadian Institutes of Health Research (CIHR), and the International OCF Foundation (IOCDF). MIH been a scientific advisor to MindSet Pharma, Wake Network and Psyched Therapeutics. He has led contracted research for COMPASS Pathfinder Ltd. BHM holds and receives support from the Labatt Family Chair in Biology of Depression in Late-Life Adults at the University of Toronto. He currently receives or has received within the past three years research support from Brain Canada, the Canadian Institutes of Health Research, the CAMH Foundation, the US National Institute of Health (NIH), Capital Solution Design LLC (software used in a study founded by CAMH Foundation), and HAPPYneuron (software used in a study founded by Brain Canada). DJM has received grant funding from the Canadian Institutes of Health Research, Ontario Brain Institute, the CAMH AFP Innovation Funds, the CAMH Foundation and Nubiyota. He received a speaking honoraria from Novagenic and TEMPUS. AO receives research support from CIHR, NIMH, AFSP and the University of Toronto. ET, AP and AX do did not disclose any potential conflict of interest related to this research. Declaration of Generative AI and AI-Assisted: Technologies in the Writing Process During the preparation of this work, the authors used scite.ai in order to identify and format relevant citations.

Acknowledgement

We are grateful to the following treating psychiatrists who provided care to study participants: Nick Ainsworth, Leonor Almendraburgos, Yazeed Alsanad, Ofer Finkelstein, Brett Jones, and Daniela Morera-Gonzalez.

^# These authors contributed equally: Abigail Ortiz , Athina Perivolaris, Daniel J. Mueller, Daniel M. Blumberger, Stefan Kloiber

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• 42 Cevasco KE, Morrison Brown RE, Woldeselassie R. et al. Kaplan S. Patient engagement with conversational agents in health applications 2016-2022: A systematic review and meta-analysis. J Med Syst 2024; 48: 40
  CrossrefPubMedSuche in Google Scholar
• 43 Schick A, Feine J, Morana S. et al. Validity of chatbot use for mental health assessment: Experimental study. JMIR mHealth uHealth 2022; 10: e28082
  CrossrefPubMedSuche in Google Scholar
• 44 Yasukawa S, Tanaka T, Yamane K. et al. A chatbot to improve adherence to internet-based cognitive-behavioural therapy among workers with subthreshold depression: A randomised controlled trial. BMJ Ment Health 2024; 27: e300881
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• 45 Halabi R, Mulsant BH, Alda M. et al. Not missing at random: Missing data are associated with clinical status and trajectories in an electronic monitoring longitudinal study of bipolar disorder. J Psychiatr Res 2024; 174: 326-331
  CrossrefPubMedSuche in Google Scholar
• 46 Ortiz A, Hintze A, Burnett R. et al. Identifying patient-specific behaviors to understand illness trajectories and predict relapses in bipolar disorder using passive sensing and deep anomaly detection: protocol for a contactless cohort study. BMC Psychiatry 2022; 22: 288
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• 47 Ortiz A, Park Y, Gonzalez-Torres C. et al. Predictors of adherence to electronic self-monitoring in patients with bipolar disorder: A contactless study using Growth Mixture Models. Int J Bipolar Disord 2023; 11: 18
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Corresponding

Publikationsverlauf

Eingereicht: 15. Juli 2024

Angenommen nach Revision: 29. November 2024

Artikel online veröffentlicht:
25. Februar 2025

© 2025. Thieme. All rights reserved.

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  CrossrefPubMedSuche in Google Scholar
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  CrossrefPubMedSuche in Google Scholar
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