Abstract
Background Suicidal ideation is associated with chronic pain. The need for empathy is a common theme reported by survivors of suicide attempts.
Aim To measure the association of clinical empathy with suicidal ideation among patients with chronic low back pain (CLBP).
Design & setting A target trial emulation was performed using adult patients selected from a national pain research registry in the US from May 2018 to December 2023.
Method Patients who had a designated physician who provided primary health care for their pain were followed for 12 months. Clinical empathy was assessed using the Consultation and Relational Empathy (CARE) measure. Propensity-score matching of 936 registry patients without suicidal ideation at baseline yielded 185 patients each in the greater clinical empathy (GCE) group and the lesser clinical empathy (LCE) group. Suicidal ideation and helplessness were measured with the Pain Catastrophizing Scale.
Results The median age of patients was 55 years (interquartile range [IQR] 42–64 years) and 281 (75.9%) were female. Twenty-seven (14.6%) patients in the GCE group and 45 (24.3%) patients in the LCE group expressed suicidal ideation (relative risk [RR] 0.60, 95% confidence interval [CI] = 0.39 to 0.92; P = 0.02). Correspondingly, 140 (75.7%) patients in the GCE group and 164 (88.6%) patients in the LCE group expressed helplessness (RR 0.85, 95% CI = 0.78 to 0.94; P = 0.001).
Conclusion The decreased risk of suicidal ideation in the GCE group has potentially important implications for the delivery of primary health care for chronic pain. Research is needed to replicate these findings and to determine the effects of clinical empathy on suicide attempts and completed suicides.
How this fits in
Chronic pain is often associated with depression and feelings of helplessness that may lead to suicidal ideation and suicide attempts. Survivors of suicide attempts often cite a need for empathy but there is little research on the association of empathy with suicidal ideation among patients with chronic pain. A target trial emulation of clinical empathy among the primary healthcare providers for patients with chronic pain was performed to avoid the logistical and ethical issues in conducting a randomised controlled trial. The decreased risk of suicidal ideation over 12 months reported by patients having more empathic physicians has potentially important implications for the delivery of primary health care for chronic pain.
Introduction
Suicidal ideation, suicide attempts, and deaths by suicide are associated with chronic pain.1 More than 10% of suicide decedents in the US have chronic pain, according to the National Violent Death Reporting System.2 Data from the Veterans Affairs National Patient Care Database and Centers for Disease Control and Prevention’s (CDC’s) National Death Index reveal increased suicide deaths among patients with pain conditions.3 Although depression is a risk factor for suicide among patients with chronic pain,4,5 enhanced interpersonal communication manifested by clinical empathy reduces suicidal ideation among patients with bipolar disorder.6,7 The need for empathy is a common theme reported by suicide attempt survivors.8
A biological perspective of empathy emerged in the psychological literature in the early 20th century.9 However, the concept of therapeutic empathy as a theoretical model to deal with suicide did not appear until the end of the century.10 This involves a multiphasic plan by psychotherapists to enhance their interpersonal relationships with patients experiencing suicidality through empathic encounters to explore their states of mind. This is important in countering feelings of helplessness, defined as anticipation of negative experiences, which contribute to suicide.11 An association between helplessness and suicidality has been observed in adolescence,12 and remains among adult patients with chronic pain.13
The need for clinical empathy was widely recognised in the early 21st century. In contrast to detached concern for patients, clinical empathy involves an emotional attunement with patients that facilitates trust and disclosure.14 This is important in creating a therapeutic alliance with patients having chronic pain,15 especially if they feel isolated, misunderstood, or stigmatised.16 Clinical empathy has been associated with patient satisfaction in pain populations,17,18 and with better longitudinal outcomes pertaining to pain, function, and health-related quality of life.19
There is little research on the association of clinical empathy with suicidal ideation among patients with chronic pain. This may be attributed to methodological concerns in conducting such research, including randomising patients to clinicians lacking in empathy. Target trial emulation represents an alternative to conducting a randomised controlled trial under these circumstances.20–22 This framework involves a two-step approach to improve causal inference from observational data by specifying the protocol of a hypothetical trial that would answer the causal question of interest and using available data to attempt to emulate that trial.23 Properly performed, target trial emulation overcomes common biases associated with observational data such as confounding and immortal time bias.24 The latter occurs when time zero of follow-up is not aligned with the time when eligibility criteria are met and a treatment strategy is assigned.
This study aimed to perform a target trial emulation using observational data from a national pain research registry to measure the association of clinical empathy with suicidal ideation among patients with chronic low back pain (CLBP) over 12 months.
Method
Study design and target trial protocol
Study patients were selected from the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION) and followed for 12 months during the period from May 2018 through December 2023. Study data were acquired from the registry using measures collected within its case report forms.25 A unique aspect of the registry involves research on the patient–physician relationship, including clinical empathy. This study emulated the target trial with respect to major design elements (Table 1). Study inclusion criteria were being aged 21–79 years (a registry-specific requirement); having low back pain for at least 3 months; and having a personal physician designated as the primary healthcare provider for CLBP management. Exclusion criteria were reporting suicidal ideation at baseline and registry-specific exclusion criteria (being pregnant, residing at an institutional facility, or being unable to complete case report forms in English). Patients self-reported data using a digital research platform with telephonic reporting available as needed. Registry research was approved by the North Texas Regional Institutional Review Board and all participants provided written informed consent. The PRECISION study plan is available at ClinicalTrials.gov (NCT04853732).25 Patients were not involved in the design or conduct of this study because of logistical difficulties in acquiring a nationally representative sample of willing participants, explaining their roles, and fostering engagement during the limited time period in which registry data were acquired and analysed.
Treatment strategies
Treatment strategies were emulated by classifying patient–physician dyads as those in which the patient had a highly empathic physician (greater clinical empathy [GCE] group) or a less empathic physician (lesser clinical empathy [LCE] group) based on patient-reported scores at baseline on the Consultation and Relational Empathy (CARE) measure.26 The CARE measure was developed and validated for use in general medical settings.27 It has face and content validity and is highly reliable (Cronbach’s alpha, 0.93). The CARE measure ranges from 10–50 when responses to its 10 items are aggregated. The GCE group consisted of patient–physician dyads in which patients rated physicians above the median (≥43), whereas the LCE group consisted of the remaining patient–physician dyads.
Propensity-score matching
To emulate randomisation, patients in each clinical empathy group were matched on baseline sociodemographic and clinical characteristics using propensity scores. These were computed with a logistic regression model that included age category, sex, race (White or non-White), depression, number of comorbid medical conditions, bothersomeness of widespread pain, pain self-efficacy, low back pain intensity, and back-related disability. Bothersomeness of widespread pain was defined as being ‘bothered a lot’ by widespread pain in the past 4 weeks and measured with the minimum dataset item.28 Pain self-efficacy scores ranged from 0–60 on the Pain Self-Efficacy Questionnaire, with higher scores representing greater pain self-efficacy.29 Low back pain intensity ranged from 0–10 on a numerical rating scale for typical pain in the past 7 days. Back-related disability scores ranged from 0–24 on the Roland–Morris Disability Questionnaire, with higher scores representing greater disability.30 The clinical empathy groups were matched within a caliper width of 0.001 on propensity scores.
Double-blinding
Double-blinding was emulated by registry procedures. Because the registry collects data on approximately 250 items at enrolment and 200 items at 12 months, patients were effectively blinded to study hypotheses. Also, the registry does not collect names or characteristics of personal physicians designated by patients as primary healthcare providers for CLBP management. Consequently, physicians were generally unaware that their patients participated in the study and were blinded to research measures and hypotheses. Finally, registry staff were also unaware of study hypotheses.
Outcome measures
Suicidal ideation was measured at enrolment with item 2 of the Pain Catastrophizing Scale, which is one of six items comprising the helplessness subscale. This item queried patients about the frequency of thoughts and feelings they have when they are in pain, specifically in response to the statement: ‘I feel I can’t go on.’31 Response options and their scores were: ‘not at all’ (0); ‘to a slight degree’ (1); ‘to a moderate degree’ (2); ‘to a great degree’ (3); and ‘all the time’ (4). Contextual analysis of this item reveals that it may be informed by suicidal ideation and renders clinicians vulnerable to documented evidence of possibly undiagnosed suicidality.32 Patients reporting any frequency of suicidal ideation at enrolment were excluded. Helplessness subscale scores involving the six items range from 0 (no helplessness) to 24 (greatest level of helplessness). The subscale has good internal consistency (Cronbach’s alpha, 0.78).31
Statistical analysis
Clinical empathy groups were compared on propensity-score matched variables and another set of baseline characteristics on theoretical grounds as potential confounders. The latter included ethnic group, education, cigarette smoking status, body mass index, low back pain frequency, fibromyalgia, lawsuits or legal claims for low back pain, pain extension into the lower extremity, bothersomeness of pain in the arms, legs, or joints other than in the back, headache, stomach pain, and opioid therapy for low back pain. Race was dichotomised as White or non-White because of the small number of patients identifying as non-White racial groups other than Black. Standardised differences between clinical empathy groups were measured using Cohen’s d-statistic to determine the adequacy of matching. d-statistics ≤0.1 were considered to represent negligible differences between groups.33,34
Suicidal ideation at 12 months was the primary outcome. This was treated as a dichotomous variable with suicidal ideation considered present if patients reported any frequency of suicidal ideation. The relative risk (RR) (95% confidence interval [CI]) for suicidal ideation was computed for the GCE group compared with the LCE group. A sensitivity analysis compared clinical empathy groups on their ordinal-scale responses for frequency of suicidal ideation using the Mann–Whitney test. Helplessness was measured as the secondary outcome and similarly analysed. The CARE measure score, rather than the clinical empathy group, was used to predict suicidal ideation and helplessness at 12 months using the Mann–Whitney test to emulate assessment of dose response.
Intention-to-treat analysis was used to conform to accepted clinical trial methods.35 Although the prevalence of suicidal ideation among patients with chronic pain ranges from 18–50%,36 a study using data collection methods similar to PRECISION found that almost 40% of patients met criteria for suicide risk.5 Using OpenEpi,37 and a suicidal ideation prevalence of 40% among community-dwelling patients with chronic pain, our sample size exceeded 80% statistical power in detecting a clinically important reduction in suicidal ideation (RR ≤0.65) in the GCE group.38 Data were analysed with the SPSS Statistics software (version 29) using two-tailed tests at the alpha level of 0.05. This study is reported using the TARGET statement for transparent reporting of observational studies emulating a target trial.39
Results
Patient characteristics and flow through the study
A total of 936 registry patients met eligibility criteria. Of these, 75 (8.0%) were lost to follow-up; 129 (13.8%) completed 12 months of follow-up before the registry began measuring suicidal ideation at that encounter; and 101 (10.8%) had not yet accrued 12 months of follow-up at the time of analysis. The remaining 631 patients included 319 in the GCE group and 312 in the LCE group (Figure 1). There were 185 patients in each clinical empathy group following propensity-score matching. Overall, the median (interquartile range [IQR]) age of these patients was 55 years (42–64 years) and 281 (75.9%) were female. The median (IQR) CARE measure scores were 50 (47–50) and 32 (25–38), respectively, in the GCE and LCE groups (P<0.001) (Figure 2). There were no other significant differences between clinical empathy groups in any of 21 baseline patient characteristics (Supplementary Table 1). Standardised differences between clinical empathy groups were <0.1 for all variables, suggesting negligible between-group differences.
Flowchart showing the recruitment and data-handling pathway for participants: the workflow begins with identification of potentially eligible registry participants with chronic low back pain. Eligibility is assessed using pre-specified inclusion and exclusion criteria derived from the study protocol and available registry data. Patient inclusion flow begins with 1726 registry participants with chronic low back pain; 21 participants excluded due to their registry enrolment before the requirement of having a personal physician came into effect; 1705 progress; 50 patients excluded due to their registry enrolment before administration of the CARE measure; 1665 patients therefore have a personal physician with a reported empathy level; 729 patients excluded for some frequency of suicidal ideation at baseline; 936 patients progress; 75 patients lost to follow-up, 129 excluded due to completion of 12-month encounter prior to registry administration of Pain Catastrophizing Scale (PCS), 101 excluded due to not yet having progressed to 12-month follow-up. 312 patients were in the Lesser Clinical Empathy Group; 127 patients were unmatched, leaving 185 matched patients. 319 patients were in the Greater Clinical Empathy Group; 134 patients were unmatched, leaving 185 matched patients.
Diverging horizontal bar chart comparing CARE Measure Score distributions by Clinical Empathy Group. The chart has two mirrored panels: Lesser Greater Clinical Empathy on the left and Greater Clinical Empathy on the right. The vertical axis is labelled CARE Measure Score, with tick marks from 10 to 50. The horizontal axis is labelled No. of Patients, with counts increasing outward from the centre line from 0 to 150 on both sides.The left panel uses horizontal bars for the Lesser Clinical Empathy group. Bars are distributed across a wider range of CARE Measure scores, from approximately 10 to 42. The longest bar in this panel is around a CARE Measure Score of 40, with a smaller bar around 42 and progressively fewer patients at lower scores.The right panel uses horizontal bars for the Greater r Clinical Empathy group. Bars are concentrated at higher CARE Measure scores, approximately 44 to 50. The longest bar is at the highest visible score, around 50, and extends past the 100-patient mark, while the bars at approximately 44, 46, and 48 are shorter.Overall, the figure presents the number of patients at each CARE Measure Score level for the two clinical empathy groups, using mirrored bars to compare the distributions side by side.
Suicidal ideation
Overall, 72 (19.5%) of the 370 patients reported some frequency of suicidal ideation at 12 months (Figure 3A). There were 27 (14.6%) patients in the GCE group and 45 (24.3%) patients in the LCE group who reported suicidal ideation (RR 0.60, 95% CI = 0.39 to 0.92; P = 0.02). Similar results were observed when the frequency of suicidal ideation was measured on an ordinal scale (mean rank, 176 versus 195 in the GCE and LCE groups, respectively, P = 0.02).
Two-panel figure comparing outcomes between Lesser Clinical Empathy and Greater Clinical Empathy groups. In both panels, blue bars represent the Lesser Clinical Empathy group and magenta bars represent the Greater Clinical Empathy group.Panel A is a grouped bar chart showing Frequency of Suicidal Ideation on the horizontal axis and Percentage of Patients on the vertical axis, ranging from 0% to 100%. The frequency categories are Not at All, Slight Degree, Moderate Degree, Great Degree, and All the Time.In Panel A, most patients in both clinical empathy groups reported suicidal ideation “Not at All”. The percentage is higher in the Greater Clinical Empathy group, at about 86%, than in the Lesser Clinical Empathy group, at about 76%. The Slight Degree category is higher in the Lesser Clinical Empathy group, at about 21%, compared with about 13% in the Greater Clinical Empathy group. The remaining categories — Moderate Degree, Great Degree, and All the Time — each account for only small percentages of patients in both groups. The panel reports RR, 0.60 (0.39–0.92); P=0.02.Panel B is a grouped bar chart showing Helplessness Score on the horizontal axis and Percentage of Patients on the vertical axis, ranging from 0% to 25%. The visible helplessness scores are 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 20, 23, and 24.In Panel B, the Greater Clinical Empathy group has the highest percentage at a helplessness score of 0, at just under 25%, compared with about 11% for the Lesser Clinical Empathy group. For many higher helplessness scores, the Lesser Clinical Empathy group has similar or higher percentages than the Greater Clinical Empathy group, especially at scores around 1, 3, 6, 7, 10, 11, 12, 13, 14, 16, 20, and 23. Percentages generally decrease as helplessness scores increase, with only small percentages of patients at the highest scores. The panel reports RR, 0.85 (0.78–0.94); P=0.001.Overall, the figure shows that the Greater Clinical Empathy group had a higher proportion of patients reporting no suicidal ideation and a higher proportion with a helplessness score of zero, while the Lesser Clinical Empathy group tended to have higher percentages in several non-zero helplessness score categories.
Frequency of suicidal ideation and degree of helplessness were measured 12 months post-baseline with the helplessness subscale of the Pain Catastrophizing Scale. (A) Suicidal ideation was considered present in the main analysis if patients reported any frequency of suicidal ideation ranging from a ‘slight degree’ to ‘all the time’ and measured by the RR (95% CI) for the greater clinical empathy group compared with the lesser clinical empathy group. A sensitivity analysis was performed using the Mann–Whitney test by assigning scores ranging from 0–4 for each incremental response option for the frequency of suicidal ideation. (B) Helplessness was considered present in the main analysis if patients reported any degree of helplessness (scores ≥1) and measured by the RR (95% CI) for the greater clinical empathy group compared with the lesser clinical empathy group. A sensitivity analysis was performed using the Mann–Whitney test and the actual helplessness subscale scores
Helplessness
The overall median (IQR) helplessness subscale score was 3 (1–6) (Figure 3B). There were 140 (75.7%) patients in the GCE group and 164 (88.6%) patients in the LCE group who expressed helplessness at 12 months (RR 0.85, 95% CI = 0.78 to 0.94; P = 0.001). Similar results were observed when helplessness subscale scores were analysed (mean rank, 174 versus 198 in the GCE and LCE groups, respectively, P = 0.001).
Dose response
Patients who reported suicidal ideation were treated by physicians having less empathy (mean rank, 162 versus 191 among patients reporting and not reporting suicidal ideation, respectively, P = 0.03). Correspondingly, patients who reported helplessness were also treated by physicians having less empathy (mean rank, 177 versus 226 among patients reporting and not reporting helplessness, respectively, P<0.001).
Discussion
Summary
This target trial emulation found that clinical empathy was associated with decreased risk of suicidal ideation over 12 months among patients with chronic pain. Causal inference was enhanced by propensity-score matching of clinical empathy groups, double-blinding of patient–physician dyads, an inverse dose-response relationship, and consistency with helplessness outcomes measured with a validated research instrument.
Comparison with existing literature
Our findings are congruent with the theoretical benefits of clinical empathy,10,16 and extend understanding of the impact of clinical empathy beyond prior cross-sectional studies that focused on suicidal ideation among patients with bipolar disorder.6,7 A short-term study of patients with cancer found that the empathy of social workers was inversely associated with suicidal ideation, and that this relationship was mediated by the impact of empathy in decreasing patient depression while increasing self-efficacy.40 A study of patients with fibromyalgia simultaneously recorded their brain activity and that of their treating clinicians using functional magnetic resonance imaging (MRI) hyperscanning;41 patients receiving empathic interactions reported an enhanced therapeutic alliance and lower pain intensity following a painful stimulus than patients not receiving the interactions. Empathic interactions were associated with stronger activation of prefrontal cortex and somatosensory areas of the brain, with concordant findings observed in patients and clinicians. Research is needed to determine whether such findings extend to patients experiencing suicidal ideation.
Strengths and limitations
There were several strengths of this study. First, patients were recruited from a national pain research registry and mirrored patients with CLBP in the US on characteristics such as age, sex, education, cigarette smoking, and medical comorbidities.42 Second, the CARE measure is validated and widely accepted. It differs from physician self-assessments of empathy that are used in less rigorous studies,43 and may reflect physician attitudes about empathy rather than empathic ability.44 Third, propensity-score matching yielded clinical empathy groups with negligible differences on matched variables and an additional set of potential confounders.33,34 Fourth, double-blinding of patient–physician dyads and investigators was maintained because of registry procedures. Fifth, analysis was performed using intention-to-treat. Sixth, an inverse dose-response between CARE measure scores and outcomes strengthened causal inference.
There were also study limitations. First, because the registry is not population-based and non-English speakers were excluded, the results may not be generalisable. The registry uses a comprehensive battery of validated research instruments,25 and it is not possible to include non-English speakers unless all instruments are translated into another common language. Second, the registry does not collect ‘big data’ of the magnitude seen in commercial or government databases commonly used for target trial emulation.45 Our propensity-score matching model used a parsimonious set of nine predictor variables to identify sufficient numbers of matched patients to ensure adequate statistical power. Nevertheless, the treatment groups were also adequately matched on 12 other potential confounders. Third, because usual care for CLBP comprises many non-pharmacological treatments and medications, it was not feasible to match patients on all of them. Fourth, because data on physician characteristics and intensity of medical care were not collected by the registry, we were unable to assess the impact of these factors on outcomes. Fifth, the primary outcome was assessed with a single item that has not been validated as a measure of suicidal ideation. Although single items have been used in previous studies,6,46,47 our findings should be replicated with more robust measures of suicidal ideation. The helplessness subscale was used as a secondary outcome to enhance causal inference because it is validated and helplessness can represent a step along the path to suicidal ideation.
Prevalent user bias48 may also be considered a potential limitation because patients assigned to the treatment strategies had pre-existing relationships with their physicians. This bias occurs in clinical trials if patients initiate drug therapy before baseline and then continue therapy. A selection bias favours drug therapy because the treatment group is enriched with prevalent users who have survived early adverse outcomes. Although our study was not a drug trial, the GCE group may have been enriched with patients less susceptible to suicidal ideation or helplessness owing to prior treatment by their physicians. It is unlikely that prevalent user bias materially affected our results because patients in both clinical empathy groups were closely matched on all 21 baseline variables, including those often related to suicide risk (that is, depression, pain self-efficacy, medical comorbidities, and opioid therapy).
Implications for practice and research
The implications of cultivating clinical empathy in a general medical setting are underscored by a population-based study in Denmark, which found that patients with a painful condition, but without a mental disorder, were more likely to die by suicide than those having a pre-existing mental condition.49 The patient–physician relationship is crucial in treating patients with chronic pain, particularly those who feel isolated, misunderstood, or stigmatised16 or who may be dealing with an opioid use disorder.36 A collaborative therapeutic relationship is an important factor in mitigating suicide risk,6 which could be helpful for such patients. Future research should seek to replicate our findings by using more robust measures of suicidal ideation among diverse chronic pain populations and should determine the downstream effects of clinical empathy on suicide attempts and deaths by suicide.
Notes
Funding
No funding was provided for this study.
Ethical approval
North Texas Regional Institutional Review Board, protocol 2015-169.
Provenance
Freely submitted; externally peer reviewed.
Data
These data belong to an existing registry that continues to use them to conduct ongoing research. Updates regarding the registry’s future plans to share individual participant data may be posted to ClinicalTrials.gov.
Competing interests
The authors declare that no competing interests exist.
- Received July 15, 2025.
- Revision received October 17, 2025.
- Accepted November 24, 2025.
- Copyright © 2026, The Authors
This article is Open Access: CC BY license (https://creativecommons.org/licenses/by/4.0/)









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