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.

Relationship between social support and autonomic function during a stress protocol in ulcerative colitis patients in remission.

BACKGROUND: The relationship of psychological stress to relapse in ulcerative colitis (UC) is inconsistent. This may be due to a failure to identify patient characteristics, such as social support, which moderate the transduction of stress from the central nervous system to the immune system. In this study we tested the hypothesis that social support enhances parasympathetic modulation of heart rate in UC. METHODS: An indirect measure of autonomic function (heart rate variability; HRV) was measured in 108 patients with UC in remission during a standard protocol involving periods of stress, paced breathing, and relaxation. Social support was measured with the Social Support Questionnaire. RESULTS: After controlling for age, which is strongly related to HRV, both satisfaction with social support (F = 5.7, significance = 0.002) and its interaction with age (F = 7.8, significance <0.001) were associated with high-frequency HRV, which measures parasympathetic modulation of heart rate. Social support was associated with higher levels of high-frequency HRV at almost all points in the stress protocol. Neither age nor social support was associated with differences in the LF/HF ratio, which measures sympathetic modulation of heart rate. CONCLUSIONS: Social support is related to parasympathetic activity in UC. Given previous evidence of an antiinflammatory role for the parasympathetic nervous system, this suggests that autonomic function could serve as a mediating link between social support and reduced inflammatory activity.

The impact of ulcerative colitis is greater in unmarried and young patients.

GOALS: To determine whether the perceived impact of ulcerative colitis (UC) on activities of living (illness intrusiveness) is greater for people who are not living in a married or common-law relationship. BACKGROUND: In general, social and occupational achievement is not greatly impaired by UC, yet patients, especially young adults, often have interpersonal concerns. METHODS: One hundred fifty-five outpatients with UC were assessed for disease activity, and completed self-reports of marital status, income, social support and illness intrusiveness. RESULTS: Fifty-one patients (32.9%) were single, separated or divorced, and 104 patients (67.1%) were married or in common-law relationships. Compared with those who were married or in common-law relationships, single or separated patients were younger, had a lower household income, had lived with UC for fewer years and were less satisfied with social support. Among 135 patients in remission, marital status was significantly associated with illness intrusiveness, controlling for age, income and perceived social support (F=5.73; P=0.02). Low social support (F=4.94; P=0.03) and younger age (F=7.24; P=0.008) were independently associated with illness intrusiveness. Single patients in remission reported illness intrusiveness of similar severity to that reported by patients with active disease. CONCLUSIONS: The perceived impact of UC on the lives of patients is greater in those who are not married or living in common-law relationships. Youth, single status and lower social support commonly coexist, and exert additive effects on the functional impact of UC. Resources to improve social support should be directed toward this group of patients.

Supportive-expressive group psychotherapy for persons with inflammatory bowel disease.

OBJECTIVE: Supportive-expressive (SE) group psychotherapy is designed to be applicable to medically ill populations. In this open trial, SE therapy was adapted for use in treating inflammatory bowel disease (IBD). METHOD: Thirty subjects with Crohn's disease (CD) or ulcerative colitis (UC) were enrolled in 4 psychotherapy groups. Each group met weekly for 20 weeks to discuss emotional and interpersonal issues associated with illness. Physical and psychological variables were measured at the onset and at the finish of the group sessions. RESULTS: There was no mean group change in quality of life (QL), anxiety, or depression over the course of treatment, although there was a mean group reduction in maladaptive coping. CONCLUSION: Although the trial was uncontrolled and the sample size small, which limits interpretation, the results are consistent with an ineffective intervention. Because a null result would be consistent with previously reported psychotherapeutic trials in cases of IBD, and because SE therapy has been effective in treating other medically ill populations, we discuss characteristics of IBD that may account for a relative resistance to psychotherapeutic support.

Using attachment theory to understand illness behavior.

This article examines a model of illness as a stressor that activates an individual's characteristic attachment behaviors. These behaviors are the result of the attachment system, a mammalian trait that exists in order to maximize the odds of survival of an infant born without the necessary maturation for immediate independence. Attachment concepts, such as attachment style, coherence, and reflective functioning, are briefly explained, followed by examples of their application to the psychological management of patients with medical or surgical illness. Attachment theory provides a unique, simple, and pragmatically useful model for understanding the particular ways that individuals can feel and react when stressed by illness, and how the professional may help manage that distress.

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.

Concerns of patients with inflammatory bowel disease: results from a clinical population.

OBJECTIVE: The impact of chronic illness is influenced not just by physical symptoms but also by psychosocial factors. The aim of this study was to determine the concerns of inflammatory bowel disease (IBD) patients in a clinical sample, if concerns differ between patients from varied clinical and demographic variables, and if concerns influence well-being beyond the influence of physical symptoms. METHODS: Subjects (n = 259) completed a validated measure of concerns specific to IBD and provided demographic and disease-related information. RESULTS: The most intense concerns involved both physical (e.g., energy level) and psychosocial issues (e.g., achieving full potential). There were numerous differences in disease concerns based on ability to work but none based on disease duration. Factor analysis yielded three indices: body image and interpersonal concerns, general physical impact, and disease stigma. Age and education only affected certain concern indices in subgroups of patients. Greater concerns negatively influenced well-being beyond the influence of physical symptoms. CONCLUSION: Psychosocial factors, in addition to physical symptoms, play an important role on the impact of illness in patients with IBD.

Coping behavior and social support contribute independently to quality of life after surgery for inflammatory bowel disease.

PURPOSE: The purpose of this study was to examine the association between coping behavior at the time of surgery and inflammatory bowel disease-related quality of life after surgery. We also investigated the relationship between perceived social support and both coping style and postsurgical quality of life. Finally, the value of the Medical Outcomes Study Social Support Scale for preoperative screening was assessed. METHODS: Eighty-six subjects who had surgery during a 12-month period completed the Inflammatory Bowel Disease Questionnaire, the Ways of Coping, a measure of inflammatory bowel disease symptom severity, and the Medical Outcomes Study Social Support Scale. Analysis of variance was used to test an association between Ways of Coping score and membership in a high quality of life (Inflammatory Bowel Disease Questionnaire > mean) or low quality of life (Inflammatory Bowel Disease Questionnaire < mean) cohort. Comparison of group means between the high quality of life and low quality of life cohorts identified Ways of Coping behavior scales that differed between the high quality of life and low quality of life cohorts. Stepwise linear regression analysis was then used to determine the independent contribution of 1) current inflammatory bowel disease symptoms, 2) current perceived social support, and 3) identified coping behaviors (self-control, self-blame, and escape, summed as a single index named "maladaptive coping") to postsurgical quality of life. The sensitivity, specificity, and negative predictive value of the Medical Outcomes Study Social Support Scale were assessed. RESULTS: The lower quality of life group distinguished itself by more frequent use of maladaptive coping. Regression analysis revealed that current inflammatory bowel disease-related symptoms, current perceived social support, and maladaptive coping behaviors at the time of surgery each made a highly significant independent contribution to postsurgical quality of life. The sensitivity of the Medical Outcomes Study Social Support Scale in identifying patients with poor postsurgical quality of life was 81 percent, and the specificity was 77 percent. The negative predictive value was 93 percent. CONCLUSIONS: Three coping behaviors which seem to be maladaptive (self-control, self-blame, and escape) are associated with lower quality of life after surgery for inflammatory bowel disease. These coping behaviors make a contribution to postsurgical quality of life independent of the negative effect on quality of life of inflammatory bowel disease symptoms. Perceived social support is a third factor that makes an independent contribution to postsurgical quality of life. The Medical Outcomes Study Social Support Scale has properties associated with an effective screening tool and merits further investigation as an instrument to screen presurgically for individuals at higher risk of poor subjective outcome of inflammatory bowel disease surgery.

Concerns of patients with inflammatory bowel disease: a review of emerging themes.

Idiopathic, chronic inflammatory bowel disease (IBD) refers to two diseases-ulcerative colitis (UC) and Crohn's disease (CD). Despite an abundant literature discussing the pathophysiology and treatment of these diseases, little if any empirical studies have focused on patients' subjective experiences with their diseases. The purpose of this paper was to identify and discuss the concerns of individuals with IBD and to suggest that the integration of concerns in clinical management is necessary for a comprehensive understanding of these chronic and debilitating diseases. In addition, case studies were included to highlight the concerns of people with IBD. Our review of the literature identified eight categories of concerns for individuals with IBD. They included loss of energy, loss of control, body image, isolation and fear, not reaching full potential, feeling dirty, and lack of information from the medical community. In conclusion, we argue that the efficacy of treatment for IBD would be greatly improved if psychosocial issues were to be integrated into treatment protocols.

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.

Insecure attachment in a subgroup with ulcerative colitis defined by ANCA status.

This study is the first test of the novel hypothesis that perinuclear anti-neutrophil cytoplasmic antibody (p-ANCA) marks an etiological division between stress-susceptible and stress-neutral ulcerative colitis. Subjects were 47 UC patients with known p-ANCA status (19 p-ANCA-positive, 28 p-ANCA-absent). Controls were 77 university students. Subjects and controls completed the Reciprocal Attachment Questionnaire. Subjects were categorized as avoidant/nonavoidant and anxious/nonanxious based on scores for compulsive self-reliance and compulsive care seeking, respectively. A higher prevalence of avoidant attachment was present in p-ANCA-absent (58.6%) than p-ANCA-positive subjects (22.2%, chi-square = 5.95, P < 0.02). There was no difference in the prevalence of anxious attachment between p-ANCA-absent and p-ANCA-positive subjects. There was no difference in clinical and psychiatric variables between groups. This finding provides support for a psychobiological contribution to UC in a subgroup identified by the absence of p-ANCA.

Panic disorder associated with gastrointestinal disease: review and hypotheses.

An association between panic disorder and functional gastrointestinal disease has emerged since the introduction of reliable diagnostic criteria, first for psychiatric disorders and more recently for functional gastrointestinal disorders. At the same time, a more rigorous review of methodology of older reports linking structural gastrointestinal diseases such as peptic ulcer and inflammatory bowel disease to psychiatric illness has cast doubt on the validity of their association. In this review original articles reporting an association between panic disorder and globus, functional chest pain of presumed esophageal origin, functional dyspepsia, and irritable bowel syndrome are critically reviewed and it is concluded that panic disorder is overrepresented in noncardiac chest pain and irritable bowel syndrome. Original reports of the prevalence of panic disorder in structural gastrointestinal disease are reviewed and it is concluded that they do not support an association with panic. Hypotheses explaining the statistical link of panic disorder and functional gastrointestinal disease are discussed.

Health-related concerns of people who receive psychological support for inflammatory bowel disease.

BACKGROUND: People with inflammatory bowel disease (IBD) cope with a number of disease-specific concerns, which may result in referrals for supportive counselling. OBJECTIVE: To determine differences between the health-related concerns of people with IBD who seek counselling or are referred for psychiatric assessment and those who have no recent contact with counselling or psychiatry. METHODS: Forty-five consecutive patients with IBD referred for psychiatric consultation and 31 IBD out-patients who had recent counselling were compared with 190 IBD out-patients at the same hospital with no recent history of counselling. Disease-related concerns, demographic data and perceived symptom severity were assessed with self-report instruments. RESULTS: Counselling patients had greater overall intensity of concern. Counselling patients differed from noncounselling patients on several measures related to illness severity and were more likely to be female. Correcting statistically for illness severity and sex, the counselled patients had significantly higher levels of concern about being a burden, pain and suffering, feeling out of control, financial difficulties, feeling alone, sexual performance, feeling dirty or smelly and being treated as different. CONCLUSIONS: Beyond the intensity of their physical suffering, patients who seek counselling report a pattern of concern in which interpersonal and emotional concerns are prominent compared with those of out-patients who do not seek counselling. Clinicians should be aware of interpersonal concerns, which may increase the need for empathic support. Psychosocial interventions in IBD may be indicated without respect to psychiatric comorbidity.

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.

Effect of intervention in inflammatory bowel disease on health-related quality of life: a critical review.

UNLABELLED: Health-related quality of life (HRQOL) is a quantitative measurement of subjective perception of health state, including emotional and social aspects. It can be reliably measured with several valid instruments. Previous reviews of the literature suggested inadequate attention to HRQOL in studies of interventions in inflammatory bowel disease. PURPOSE: This study was undertaken to assess the current status of the quality of measurement of HRQOL in studies of inflammatory bowel disease and to review the clinical conclusions warranted by the literature. METHOD: Medicine was searched for articles relating to ulcerative colitis, Crohn's disease, or inflammatory bowel disease and quality of life since 1981. The articles found were reviewed for citations of further articles. The adequacy of HRQOL measure was assessed and graded, and the study design was categorized to assess the strength of the literature on the whole. RESULTS: A trend was found toward higher quality of HRQOL measurement in the period 1988 to 1994 compared with 1981 to 1987. Most of the improvement was because of increased use of standardized and multidomain but unvalidated and unpublished questionnaires for measurement. CONCLUSIONS: Confidence in the following clinical conclusions in studies of surgical interventions in inflammatory bowel disease is limited by study design: that pelvic pouch is not inferior to ileostomy, that specific domains of HRQOL are differentially affected by different surgical procedures, and (with less confidence) that surgery is helpful in Crohn's disease. Medical studies have demonstrated that high quality HRQOL measures can be integrated into randomized, prospective trials. Clinically equivalent treatments have shown differential effects or HRQOL: 9 mg daily of budesonide is superior to 15 mg, and hydrocortisone foam enemas are superior to prednisolone. Home parenteral nutrition has received modest support, limited again by study design. It is recommended that standard tests of HRQOL be used to increase comparability of studies and to increase the quality of this literature in general. In particular the Inflammatory Bowel Disease Questionnaire, Rating Form of Inflammatory Bowel Disease Concerns, and Direct Questioning of Objectives are recommended.