Engage & Connect: A Psychotherapy for Postpartum Depression

Официальное название

Engage & Connect: A Novel Social Reward Psychotherapy for Postpartum Depression

Обзор

This randomized controlled trial compares a novel psychotherapy, Engage \& Connect, with a Symptom Review and Psychoeducation intervention, tailored to reduce postpartum depression. The study includes 9-weeks interventions, delivered remotely. It will examine changes in social isolation, processing of social rewards and depression severity over 9 weeks of treatment.

Подробное описание

Postpartum depression is linked with decreased motivation to seek rewarding activities and enjoyment of pleasurable experiences. Social isolation and low perceived social support predict persistence of postpartum depression. Engagement in rewarding social activities with significant others may increase motivation and enjoyment, motivating utilization of a therapy that addresses social isolation and reward response. The investigators developed Engage \& Connect (E\&C), a 9-week psychotherapy program that focuses on increasing meaningful social activities with significant others. This study will be a pilot Randomized Controlled Trial that will compare the 9-week E\&C course for mothers with postpartum depression with a Symptom Review and Psychoeducation condition (SRP) for mothers with postpartum depression.

Вмешательства

• Поведенческое Engage & Connect (E&C)
  Engage \& Connect, is a remotely-delivered extension of Engage psychotherapy. It is aimed to increase engagement in rewarding social activities and in turn, reduce postpartum depression. In each session, the therapist will work with the patient to develop "action plans" to pursue rewarding social activities of their choice with the goal of reducing social isolation.
• Поведенческое Symptom Review and Psychoeducation (SRP)
  SPR is a remotely-delivered intervention aimed to increase knowledge of postpartum depression and monitor mental health changes. In each session, the therapist will review the participant's symptoms and discuss information related to postpartum depression and changes after birth.

Первичные конечные точки

• Change in Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: the EPDS will be measured Weekly for 9 weeks]

Вторичные конечные точки (2)

• Change in Behavioral Activation for Depression Scale (BADS) [Срок оценки: Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)]
• Change in Social Reward Processing on STAR task [Срок оценки: Baseline, Early Treatment (Week 3), Mid-treatment (Week 6) and Post Treatment (Week 9)]

Критерии участия

Критерии включения

• Up to 1 year post-delivery
• Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
• Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 10 weeks.
• Capacity to provide consent for research assessment and treatment.
• Speaks English proficiently

Критерии исключения

• Intent or plan to attempt suicide in the near future
• Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
• Active substance abuse or dependence
• Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy
• History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, persistent depressive disorder, or specific phobia.
• Use of psychotropic drugs or cholinesterase inhibitors other than use of ≤ 0.5 mg of lorazepam daily up to seven times per week.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT05585164 · 22-04024696

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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