Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial.

BACKGROUND: Depression and anxiety impact up to 1 in 5 pregnant and postpartum women worldwide. Yet, as few as 20% of these women are treated with frontline interventions such as evidence-based psychological treatments. Major barriers to uptake are the limited number of specialized mental health treatment providers in most settings, and problems with accessing in-person care, such as childcare or transportation. Task sharing of treatment to non-specialist providers with delivery on telemedicine platforms could address such barriers. However, the equivalence of these strategies to specialist and in-person models remains unproven. METHODS: This study protocol outlines the Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) randomized trial. SUMMIT is a pragmatic, non-inferiority test of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a brief, behavioral activation (BA) treatment for perinatal depressive and anxiety symptoms. Specialists (psychologists, psychiatrists, and social workers with ≥ 5 years of therapy experience) and non-specialists (nurses and midwives with no formal training in mental health care) were trained in the BA protocol, with the latter supervised by a BA expert during treatment delivery. Consenting pregnant and postpartum women with Edinburgh Postnatal Depression Scale (EPDS) score of ≥ 10 (N = 1368) will be randomized to one of four arms (telemedicine specialist, telemedicine non-specialist, in-person specialist, in-person non-specialist), stratified by pregnancy status (antenatal/postnatal) and study site. The primary outcome is participant-reported depressive symptoms (EPDS) at 3 months post-randomization. Secondary outcomes are maternal symptoms of anxiety and trauma symptoms, perceived social support, activation levels and quality of life at 3-, 6-, and 12-month post-randomization, and depressive symptoms at 6- and 12-month post-randomization. Primary analyses are per-protocol and intent-to-treat. The study has successfully continued despite the COVID-19 pandemic, with needed adaptations, including temporary suspension of the in-person arms and ongoing randomization to telemedicine arms. DISCUSSION: The SUMMIT trial is expected to generate evidence on the non-inferiority of BA delivered by a non-specialist provider compared to specialist and telemedicine compared to in-person. If confirmed, results could pave the way to a dramatic increase in access to treatment for perinatal depression and anxiety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04153864 . Registered on November 6, 2019.

Attachment and psychosomatic medicine: developmental contributions to stress and disease.

OBJECTIVE: The object of this study was to evaluate the evidence linking attachment insecurity to illness. Attachment theory describes lifelong patterns of response to threat that are learned in the interaction between an infant and his or her primary caregiver. Despite its biopsychosocial domain, attachment theory has only recently been applied to psychosomatic medicine. METHOD: MEDLINE and PsychInfo databases were searched from 1966 to 2000 for English language papers with key words "attachment" and "object relations." Papers and their cited references were reviewed if they were directly related to physical illness, symptoms, or physiology. A hypothetical causal model was developed. RESULTS: Direct and indirect evidence from survey studies supports an association between attachment insecurity and disease. Animal studies and human experiments suggest that attachment contributes to individual differences in physiological stress response. There is also less robust support for insecure attachment leading to symptom reporting and to more frequent health risk behaviors, especially substance use and treatment nonadherence. Evidence supports the prediction from attachment theory that the benefits of social support derive more from attachment relationships than nonattachment relationships. CONCLUSIONS: Although the available data are suggestive rather than conclusive, the data can be organized into a model that describe attachment insecurity leading to disease risk through three mechanisms. These are increased susceptibility to stress, increased use of external regulators of affect, and altered help-seeking behavior. This model warrants further prospective investigation.

Use of community resources before inflammatory bowel disease surgery is associated with postsurgical quality of life.

BACKGROUND: Research in chronic illness shows that community resources can have a lasting influence on the course of the illness; however, little research has been done to evaluate the community agencies that specifically address the needs of inflammatory bowel disease (IBD) patients. OBJECTIVES: To survey awareness of community agency resources among patients who have surgery for IBD, and to analyze the association between using these resources and qualitative postsurgical outcomes. SUBJECTS AND METHODS: Ninety-two subjects who had surgery over a 12-month period completed, in full, the Inflammatory Bowel Disease Questionnaire (IBDQ), and a self-report instrument used to probe awareness and use of local community resources. Community resources were divided into two groups: those involving primarily social and educational participation ('social/ educational') and those involving some individualized attention, usually from a professional or trained lay facilitator ('professional/individual'). The contribution of presurgical participation in each type of resource to postsurgical quality of life was tested using ANOVA, with IBDQ score as the dependent variable. The ANOVA was repeated with postsurgical disease activity as a covariable. IBDQ subscale scores were compared between groups that were found to differ in the ANOVA. RESULTS: Almost all subjects were aware of at least one available resource. Participation in resources before surgery was variable, but 50% of the sample participated in at least one social/educational resource, and 46.9% participated in at least one professional/individual support. For the 92 subjects who completed both the IBDQ and the survey of resources, ANOVA revealed a main effect of professional/individual resource use on postsurgical quality of life but no main effect of social/educational resources and no interaction. DISCUSSION: The association between presurgical participation in professional or individualized community resources and better subjective outcome of IBD surgery may be explained by a positive contribution of participation to coping with surgery for IBD. The data do not support the alternative explanation that subjects with less severe disease (and thus better outcome) have greater ability to participate, although further research is required.

A controlled comparison of light box and head-mounted units in the treatment of seasonal depression.

BACKGROUND: Patterns of response to the light box and head-mounted unit (HMUs) in seasonal affective disorder (SAD) appear to differ. The current study employed a "no light" condition to compare the response rates with the light box and HMU against a plausible placebo. METHOD: Forty-three subjects with DSM-III-R nonpsychotic, unipolar major depression, seasonal subtype, were randomly assigned, in a double-blind manner, to receive 2 weeks of active treatment with a light box (N=9) or HMU (N=12) that emitted no visible light, or 2 weeks of placebo treatment with a light box (N=12) or HMU (N=10) that emitted no visible light. Response was defined as a 50% or greater reduction in both the 17-item "typical" score and 8-item "atypical" score on the Structured Interview Guide for the Hamilton Rating Scale for Depression-SAD version (SIGH-SAD). RESULTS: Using ANOVA for repeated measures, with change in total SIGH-SAD score as the dependent measure, we found no significant main effect of light (F=0.20, p=N.S.) or unit (F=0.50, p=N.S.), and no interaction (F=0.21, p=N.S.). Using log-linear analysis, we found no significant difference in response rate between the four cells (likelihood ratio chi-square = 2.1, p=N.S.). Using chi-square analysis, we found no significant difference in response rates between patients who received light (48%) versus patients who received no light (41%; chi-square = 0.2, p=N.S.) or between patients who received the light box (38%) versus HMU (50%; chi-square = 0.62, p=N.S.). CONCLUSION: The failure to detect any significant difference in efficacy between active and placebo treatments calls into question the specificity of light in light therapy for SAD. Methodological limitations, particularly small sample size, are discussed.