Adjunctive Psychotherapy for Perinatal Bipolar Disorder

围产期双相情感障碍的辅助心理治疗

• 批准号: 8846140
• 负责人: LAUREN M WEINSTOCK
• 金额: $ 24.85万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-05-07 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8846140
• 关键词: Behavior Therapy; Biological; Bipolar Disorder; Birth; Childbirth; Circadian Rhythms; Clinical; Clinical Management; Clinical Trials; Confidence Intervals; Data; Development; Discipline of obstetrics; Disease; Dose; Elements; Evidence based treatment; Face; Health; High Risk Woman; Impairment; Incidence; Intervention; Light; Manic; Manuals; Methods; Moods; Morbidity - disease rate; Mothers; Outcome; Patients; Perinatal; Perinatal Exposure; Pharmaceutical Preparations; Pharmacotherapy; Phase; Pilot Projects; Population; Postpartum Period; Postpartum Women; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Procedures; Prospective Studies; Psychotherapy; Psychotic Disorders; Public Health; Publishing; Randomized; Recurrence; Research; Research Design; Research Proposals; Risk; Safety; Sampling; Small for Gestational Age Infant; Social support; Staging; Symptoms; Testing; Time; Training; Training Programs; Treatment Efficacy; Unipolar Depression; Woman; clinical application; disorder risk; functional outcomes; high risk; improved; interest; interpersonal therapy; medication compliance; offspring; peripartum depression; pilot trial; primary outcome; prophylactic; psychosocial; psychotic symptoms; secondary outcome; social; suicidal risk; treatment as usual

DESCRIPTION (provided by applicant): The perinatal period appears to be especially destabilizing for women with bipolar disorder (BD), with prospective studies revealing mood episode morbidity in up to 70% of pregnant women with the disorder, and risk of postpartum mania in as high as 50% of cases. There are clear negative sequelae of BD for mothers and their offspring, including gross maternal impairment, substantial risk for suicide, high risk of postpartum psychosis, and adverse childbirth outcomes. Yet data concerning the clinical management of BD during the perinatal period are strikingly limited. Pharmacotherapy is complicated due to known teratogenic risks of certain medications, the lack of safety data for others, and difficult treatment decisions, including the decision to discontinue pharmacotherapy, that women and clinicians face in light of limited data. Prophylactic mood stabilization has been widely recommended, yet data suggest that even among women with BD treated with medication, there remains significant risk of mood episode morbidity in the perinatal period. Given the pernicious course of BD in the perinatal period, adjunctive interventions aimed at improving clinical outcomes are critically needed. Interpersonal and Social Rhythm Therapy (IPSRT) is an adjunctive psychosocial intervention that may serve this need, as it: (a) incorporates key elements of Interpersonal Psychotherapy (IPT), which has a strong evidence base for treatment of perinatal depression in unipolar samples, (b) includes a behavioral intervention to stabilize the circadian rhythm disruption that may place perinatal women at high risk for mood and psychotic symptoms, (c) has established efficacy for the treatment of BD in non-perinatal samples, and (d) carries the promise of potential clinical benefit without additional fetal exposure. Yet there are no published studies evaluating the efficacy of IPSRT, or any psychosocial intervention, as an adjunct to pharmacotherapy for BD in the perinatal period. Given its many potential benefits, the primary aim of this R34 Exploratory Research Application (PAR-12-279) is to adapt and pilot IPSRT for perinatal women with BD. The development phase of this study will result in a treatment manual, training manual, and fidelity scales which will be tested in an open trial of 12 pregnant women with BD, treated through the early postpartum. The pilot phase will examine feasibility and acceptability of the proposed recruitment methods, research design, intervention, and interventionist training program by randomizing 40 pregnant women with BD to enhanced treatment as usual (E-TAU) or E-TAU + IPSRT, delivered through the early postpartum. Primary outcomes will be mood and psychotic symptoms up to 16 weeks postpartum. Additional outcomes include medication adherence, maternal functioning, and birth outcomes (secondary), and increased social support and circadian and social rhythm stability (tertiary). This pilot study will lay the groundwork for a larger, stage II clinical trial (R01) to evaluate the efficacy of this intervention for improving clinical and functional outcomes among this high risk, understudied population during the vulnerable transition from pregnancy to the postpartum period.

描述（由申请人提供）：双相情感障碍（BD）女性的围产期似乎尤其不稳定，前瞻性研究显示，高达70%的双相情感障碍孕妇的情绪发作发病率，以及高达50%的产后躁狂风险。BD对母亲及其后代有明显的负面后遗症，包括严重的孕产妇损伤，自杀的高风险，产后精神病的高风险和不良分娩结局。然而，数据有关的临床管理BD在围产期是惊人的有限。药物治疗是复杂的，因为某些药物的已知致畸风险，缺乏其他药物的安全性数据，以及困难的治疗决定，包括妇女和临床医生在有限的数据下面临的停止药物治疗的决定。预防性情绪稳定已被广泛推荐，但数据表明，即使在接受药物治疗的BD女性中，围产期情绪发作的发病率仍然存在显着的风险。鉴于BD在围产期的恶性过程，迫切需要旨在改善临床结局的预防性干预措施。人际和社会节律疗法（IPSRT）是一种可能满足这一需求的持续性心理社会干预，因为它：（a）结合了人际心理治疗（IPT）的关键要素，该疗法在治疗单极样本中的围产期抑郁症方面具有强有力的证据基础，（B）包括行为干预，以稳定可能使围产期妇女处于情绪和精神病症状高风险的昼夜节律紊乱，（c）在非围产期样品中已经确立了治疗BD的功效，并且（d）具有潜在临床益处的前景，而无需额外的治疗。 胎儿暴露。然而，目前还没有发表的研究评估IPSRT或任何心理社会干预作为围产期BD药物治疗的辅助治疗的疗效。鉴于其许多潜在的好处，这个R34探索性研究应用程序（PAR-12-279）的主要目的是适应和试点IPSRT的围产期妇女与BD。本研究的开发阶段将产生治疗手册、培训手册和保真度量表， 在12名患有BD的孕妇的开放试验中进行了测试，通过产后早期进行治疗。试验阶段将通过随机分配40名BD孕妇接受常规强化治疗（E-TAU）或E-TAU + IPSRT，直至产后早期，检查拟议招募方法、研究设计、干预和干预培训计划的可行性和可接受性。主要结果将是产后16周内的情绪和精神病症状。其他结果包括药物依从性，产妇功能和出生结果（次要），以及增加社会支持和昼夜节律和社会节律稳定性（第三）。这项初步研究将为更大规模的II期临床试验（R 01）奠定基础， 评估这种干预措施在从怀孕到产后的脆弱过渡期内改善高风险、研究不足人群的临床和功能结局的有效性。