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.

The effect of group psychosocial support on survival in metastatic breast cancer.

BACKGROUND: Supportive-expressive group therapy has been reported to prolong survival among women with metastatic breast cancer. However, in recent studies, various psychosocial interventions have not prolonged survival. METHODS: In a multicenter trial, we randomly assigned 235 women with metastatic breast cancer who were expected to survive at least three months in a 2:1 ratio to an intervention group that participated in weekly supportive-expressive group therapy (158 women) or to a control group that received no such intervention (77 women). All the women received educational materials and any medical or psychosocial care that was deemed necessary. The primary outcome was survival; psychosocial function was assessed by self-reported questionnaires. RESULTS: Women assigned to supportive-expressive therapy had greater improvement in psychological symptoms and reported less pain (P=0.04) than women in the control group. A significant interaction of treatment-group assignment with base-line psychological score was found (P

Lessons learned from enrollment in the BEST study--a multicenter, randomized trial of group psychosocial support in metastatic breast cancer.

The BEST study, a multicenter randomized trial of group psychosocial support in metastatic breast cancer, had several unusual features that may have influenced recruitment, notably the group nature of the intervention and the need for close collaboration between medical and psychosocial investigators. The recruitment process was examined in light of these features. Establishment of study centers was facilitated by involvement of experienced medical investigators who had successfully collaborated in previous research projects. Systematic evaluation of potential subjects or direct recruitment by psychosocial investigators optimized recruitment; however, the group nature of the intervention prolonged recruitment. Overall, 652 women were approached and 237 (43.3% of those medically eligible) randomized. Using population-based estimates, 24.3% of women with metastatic breast cancer were assessed for the study and 8.7% randomized. A randomization ratio of 2:1 was required to form and maintain groups. Competing clinical trials were the greatest barrier to recruitment. Five lessons were learned during recruitment for this trial: (1) multicenter randomized trials of psychosocial interventions are feasible, even in very ill patients, (2) the use of a group intervention effectively increased the required sample size by 50%, (3) similarity of randomization rates suggests that generalizability of study results will probably be comparable to that of other randomized cancer trials, (4) multidisciplinary collaborations and involvement of experienced researchers facilitated enrollment, and (5) most challenges encountered in recruitment were similar to those seen in all clinical trials.

The rationale and foundations of group psychotherapy for women with metastatic breast cancer.

Group psychotherapy has become an important modality of intervention in contemporary psychooncology. This article reviews and describes the rationale and foundations for group psychotherapy for women with metastatic breast cancer. It emerges from a replication study of an earlier study performed by Spiegel (Spiegel, Bloom, Kraemer & Gottheil, 1989), which demonstrated that participation in structured group psychotherapy resulted in improved psychosocial adjustment and a significant survival effect on women with metastatic breast cancer. Other intervention studies, psychosocial effects of psychosocial interventions, as well as psychosocial variables associated with the course of illness, are described. The contribution of existential considerations in psychotherapy is also articulated as a component of the group-supportive expressive intervention. Clinical illustrations, emerging from ongoing treatment groups, are used to demonstrate theoretical concepts.

Attitudes of Canadian oncology practitioners toward psychosocial interventions in clinical and research settings in women with breast cancer.

The aim of this study was to survey Canadian oncology practitioners' attitudes toward psychosocial concerns and issues in women with breast cancer. Surveys were mailed to 351 medical, radiation and surgical oncologists and 375 oncology nurses. Standard questionnaires assessed attitudes towards psychosocial issues in women with primary and metastatic breast cancer and evaluated the practitioners' willingness to refer women to psychosocial intervention trials in the presence and absence of competing drug trials. Responses were obtained from 74% of those surveyed. Respondents reported being aware of the common occurrence of psychosocial problems in women with metastatic breast cancer, however, physicians were less likely than nurses to offer these women psychosocial support on a prophylactic basis (p < 0.0001) and they expressed greater concern than nurses about scientific validity of (p = 0.0003), and potential psychological damage from (p = 0.005), psychosocial support groups. Nurses were more likely than physicians to favour a study investigating group psychosocial support over competing drug studies (p < or = 0.003) in the metastatic setting. Physicians were less likely than nurses to deal with weight problems prophylactically in women with primary breast cancer (p = 0.0009) and they expressed greater concern over scientific validity of psychosocial interventions addressing weight than nurses (p = 0.0008); nurses were more concerned about excessive expectations of patients regarding potential benefits of such interventions (p < 0.0001). Regardless, nurses were more likely than physicians to favour a psychosocial intervention study focused on weight management over drug studies in pre- (p = 0.0006) and postmenopausal women (p = 0.05) with primary breast cancer. Canadian oncology practitioners are aware of the common occurrence of psychosocial distress in women with breast cancer. Physicians and nurses assigned differing priorities to psychosocial interventions in both clinical and research situations.

Some observations on the subjective experience of neophyte group therapy trainees.

Neophyte group therapy trainees often encounter significant difficulties in their initial experiences as group therapists. In this article, we report and discuss the results of a semistructured interview conducted with each of 16 neophyte group therapy trainees in an academic training program. The interview focused on the trainees' subjective experiences related to their initial training and group therapy clinical practice, with particular emphasis on their satisfaction with their training, and the role and impact of supervision. All trainees reported strong emotional reactions to their group experience and numerous technical concerns. However, trainees reported a broad range of degrees of satisfaction with their training Overall satisfaction with training strongly paralleled satisfaction with supervision and the supervisory relationship. Recommendations for improving the group therapy training experience that emerge from the evaluation of the trainees' subjective experiences are suggested.

The interpersonal approach to group psychotherapy.

The interpersonal model of group psychotherapy emphasizes the critical nature of peer interactions and consequent dynamic interpersonal learning. The author illustrates basic concepts of the model through a series of clinical vignettes. The central importance of the group as a social microcosm, cohesion and group process, here-and-now activation, and corrective emotional experience are documented, as is the role of the therapist in facilitating interpersonal feedback and effective therapeutic work.

Towards an integrated model of group psychotherapy with the elderly.

Three current approaches to the group therapy of the cognitively intact, depressed elderly are reviewed. Examination of the strengths and limitations of these three models--self psychology, developmental considerations such as reminiscing and life review, and cognitive-behavioral therapies--points in the direction of the usefulness of an integrated model. The main objectives of an integrated approach include: stabilization of the individual's sense of self, establishment of interpersonal competence, and enhanced mastery over the affects of depression and demoralization. Clinical illustrations are provided to demonstrate the practical considerations in this model of group therapy.

Group psychotherapy of the characterologically difficult patient.

A broad range of characterologically difficult patients present for treatment in psychotherapy groups. Despite different clinical presentations, including features of the schizoid, borderline, and narcissistic personality disorders, these patients share a common developmental failing. Specifically, these individuals have failed to attain object constancy and the associated stable internalization of tolerably ambivalent representations of the self, and of the other, in relationship with one another. Splitting mechanisms predominate over integrative ones, as primitive defenses are utilized to deal with the individual's powerful needs and fears related to engagement and intimacy. These maladaptive interpersonal styles are clearly illuminated in group therapy, but often to the exclusion of the latent, intrapsychic derivatives of this behavior, with detrimental effects. This paper examines the group therapy of such patients from the perspective of object relations and self psychology theories, models that provide the essential link between the interpersonal and the intrapsychic worlds.

Therapeutic milieu: a dynamic approach.

This paper deals with the establishment of a therapeutic milieu in an acute care general hospital setting. The rationale and structure are defined, and dynamic considerations are elaborated. Conclusions are drawn from our experience suggesting that the therapeutic milieu is a viable and a more effective treatment delivery system than that provided by conventional inpatient units.