Task-sharing and telemedicine delivery of psychotherapy to treat perinatal depression: a pragmatic, noninferiority randomized trial

Abstract

Task-sharing and telemedicine can increase access to effective psychotherapies. Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) is pragmatic, multisite, noninferiority, four-arm trial that tested the non-inferiority of provider (non-specialist vs. specialist providers) and modality (telemedicine vs. in-person) in delivering psychotherapy for perinatal depressive symptoms. Across three university-affiliated networks in the United States and Canada, pregnant and postpartum adult participants were randomized 1:1:1:1 to each arm (472 nonspecialist telemedicine, 145 nonspecialist in-person, 469 specialist telemedicine and 144 specialist in-person) and offered weekly behavioral activation treatment sessions. The primary outcome was depressive symptoms (Edinburgh Postnatal Depression Scale (EPDS)) and the secondary outcome was anxiety (Generalized Anxiety Disorder (GAD-7)) symptoms at 3 months post-randomization. Between 8 January 2020 and 4 October 2023, 1,230 participants were recruited. Noninferiority was met for the primary outcome comparing provider (EPDS: nonspecialist 9.27 (95% CI 8.85-9.70) versus specialist 8.91 (95% CI 8.49-9.33)) and modality (EPDS: telemedicine 9.15 (95% CI 8.79-9.50) versus in-person 8.92 (95% CI 8.39-9.45)) for both intention-to-treat and per protocol analyses. Noninferiority was also met for anxiety symptoms in both comparisons. There were no serious or adverse events related to the trial. This trial suggests compelling evidence for task-sharing and telemedicine to improve access to psychotherapies for perinatal depressive and anxiety symptoms. ClinicalTrials.gov NCT04153864.

Fig. 1. Enrollment, randomization and follow-up of the participants by arm (N = 1,230).

Participants (N = 1,230) were randomly assigned to one of four arms, and all were offered BA. LTF, lost to follow-up; NSP, nonspecialist provider; SP, specialist provider; TM, telemedicine; IP, in-person. *Includes one participant who was a screen fail. **Due to the COVID-19 pandemic, recruitment to in-person (NSP–IP and SP–IP) occurred during the following time periods: January 2020 to March 2020, April 2022 to April 2023 and July 2021 to January 2022 (Extended Data Fig. 1). ***Reflects participants who completed the primary outcome (EPDS). ^±Per protocol analyses were only conducted for modality (TM versus IP) comparisons because protocol deviations were defined as instances where participants were switched from IP to TM due to the COVID-19 pandemic. ^¥Imputed analyses including the full sample (N = 1,230) were also conducted for all ITT and PP analyses (see Extended Data Fig. 2 for a flow chart by condition).

Fig. 2. Comparing depressive (EPDS) symptom scores by provider and modality.

a,b, The primary outcome was depressive symptom scores, as assessed by the EPDS at 3 months post-randomization, by provider (a) and modality (b). The t statistics and P values correspond to two-sample t-tests conducted to evaluate the difference in depressive symptom scores at baseline that presented no significant differences between conditions. We tested for a modality by provider interaction (P = 0.93) for our primary (EPDS) outcome and we found it to be nonsignificant in all cases.

Fig. 3. Comparing anxiety (GAD-7) symptom scores by provider and modality.

a,b, The secondary outcome was anxiety symptom scores, as assessed by the GAD-7 at 3 months post-randomization by provider (a) and modality (b). The t statistics and P values correspond to two-sample t-tests conducted to evaluate differences in anxiety symptom scores at baseline that presented no significant differences between conditions. We tested for a modality by provider interaction (P = 0.71) for our secondary (GAD-7) outcome and we found it to be nonsignificant in all cases.

Fig. 4. Comparing baseline clinical severity depressive (EPDS) scores by provider and modality.

a,b, Clinical severity EPDS scores were assessed at baseline and the change over time within each severity group between conditions by provider (a) and modality (b) were not significant. Severity groups based on baseline EPDS score: mild (10–11), moderate (12–19) and severe (20–30). The F statistics and P values correspond to the time by condition interaction term from a linear mixed model.

Extended Data Fig. 1. Randomisation strategy.

Note. In-Person (IP). Randomisation shifted to the two telemedicine (TM) arms based on site specific, COVID-related institutional restrictions, and once enrollment to in-person arms was complete.

Extended Data Fig. 2. Enrollment, randomisation and follow-up of the participants by condition.

1A. Participants (N=1230) were randomly assigned to the provider condition: Non-specialist provider (NSP) or Specialist provider (SP) and all were offered Behavioral Activation. 1B. Participants (N=1230) were randomly assigned to the modality condition: Telemedicine (TM) or In-person (IP) and all were offered Behavioral Activation. Note. Lost to follow-up (LTF). *Includes one participant who was a screen fail. **Reflects participants who completed the primary outcome (EPDS). ^±Per protocol analyses were only conducted for modality (TM vs. IP) comparisons because protocol deviations were defined as instances where participants were switched from in-person to telemedicine due to the COVID-19 pandemic. ^¥Imputed analyses including the full sample (N=1230) were also conducted for all ITT and PP analysis.

Extended Data Fig. 3. Comparing baseline clinical severity anxiety (GAD-7) scores by provider (Supplementary Fig. 3a) and modality (Supplementary Fig. 3b).

Note. Generalized Anxiety Disorder (GAD-7). Clinical severity GAD-7 scores were assessed at baseline. Change over time within each severity group between conditions by provider (a) and modality (b) were not significant. Severity groups based on baseline GAD-7 score: Mild (5-9), Moderate (10-14), Severe (15-21). F-statistic and p-value corresponds to the time by condition interaction term from a linear mixed-model.

Extended Data Fig. 4. Comparing non-imputed depressive (EPDS) and anxiety (GAD-7) symptom scores among participants who did and did not complete BA sessions.

Note. Edinburgh Postnatal Depression Scale (EPDS), General Anxiety Disorder-7 (GAD-7); *p<0.05; **p<0.01. The figures depict non-imputed data. (a) Primary outcome was depressive symptom scores, as assessed by the EPDS at 3-months post-randomisation. (b) Secondary outcome was anxiety symptom scores, as assessed by the GAD-7 at 3-months post-randomisation. Participants who did not complete any sessions had significantly higher (a) depressive and (b) anxiety scores at 3-months post-randomisation. p-value asterisks correspond to the two-sample t-test conducted to examine the difference in EPDS symptom scores between individuals who did and did not complete BA sessions, at 3-months.

Extended Data Fig. 5. Comparing imputed depressive (EPDS) and anxiety (GAD-7) symptom scores among participants who did and did not complete BA sessions.

Note. Edinburgh Postnatal Depression Scale (EPDS), General Anxiety Disorder-7 (GAD-7); *p<0.05; **p<0.01. The figures depict imputed data. (a) Primary outcome was depressive symptom scores, as assessed by the EPDS at 3-months post-randomisation. (b) Secondary outcome was anxiety symptom scores, as assessed by the GAD-7 at 3-months post-randomisation. Participants who did not complete any sessions had significantly higher (a) depressive and (b) anxiety scores at 3-months post-randomisation. p-value asterisks correspond to the two-sample t-test conducted to examine the difference in EPDS symptom scores between individuals who did and did not complete BA sessions, at 3-months on imputed data.