A Randomized Controlled Trial of Individual Family Psychoeducational Psychotherapy and Omega-3 Fatty Acids in Youth with Subsyndromal Bipolar Disorder

A Randomized Controlled Trial of Individual Family Psychoeducational Psychotherapy and Omega-3 Fatty Acids in Youth with Subsyndromal Bipolar Disorder
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DOI:
10.1089/cap.2015.0132
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发表时间:
2015-12-01
影响因子:
1.9
通讯作者:
Arnold, L. Eugene
Arnold, L. Eugene
中科院分区:
医学3区
文献类型:
--
作者:
Fristad, Mary A.;Young, Andrea S.;Arnold, L. Eugene

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目的:这项初步研究评估了omega-3脂肪酸补充剂(3)、个体家庭心理教育心理治疗(IF-PEP)及其联合治疗亚综合征双相情感障碍(未另行说明的双相情感障碍[BP-NOS]、循环型情感障碍[CYC])的疗效。研究方法:本研究是一项为期12周的随机试验,采用2x2设计(3 + PEP:n=5; 3 + AM:n = 5;安慰剂+ PEP:n=7;安慰剂+ AM:n=6),比较3例患者与安慰剂以及IF-PEP与主动监测(AM)。通过社区广告和临床医生推荐招募了23名7-14岁患有BP-NOS或CYC的青少年。参与者可以服用稳定的药物来治疗注意力缺陷/多动障碍和睡眠辅助,但不能服用其他精神药物。独立评估者在筛选、基线和2、4、6、9和12周时评估参与者。主要结果测量是儿童情感障碍量表(K-SADS)抑郁和躁狂量表(KMRS)、儿童抑郁量表修订版(CDRS-R)和Young躁狂量表(YMRS)。3/安慰剂条件是双盲的;独立评估者对心理治疗条件不知情。结果:大多数参与者(83%)完成了12周的试验。副作用不常见且轻微。意向治疗分析表明,与安慰剂和AM相比,联合治疗的抑郁症状(KDRS)显著改善(p=0.01,d=1.70)。在各组中,躁狂症状随着时间的推移而改善,但没有显著的治疗效果。IF-PEP对儿童抑郁症的影响与AM相比为中等(d=0.63,CDRS-R)至大(d=1.24,KDRS)。3对抑郁症的疗效为中等(d=0.48,KDRS)。结论:IF-PEP和3耐受性良好,并与BP-NOS和CYC青年的情绪症状改善相关。Clinicaltrials.gov标识符:NCT 01507753
Objective: This pilot study evaluates efficacy of omega-3 fatty acid supplementation (3), individual family psychoeducational psychotherapy (IF-PEP), and their combination in youth with subsyndromal bipolar disorders (bipolar disorder not otherwise specified [BP-NOS], cyclothymic disorder [CYC]). Methods: This study was a 12 week, randomized trial of 3 versus placebo and IF-PEP versus active monitoring (AM) using a 2x2 design (3 + PEP: n=5; 3 + AM: n=5; placebo + PEP: n=7; placebo + AM: n=6). Twenty-three youth ages 7-14 with BP-NOS or CYC were recruited via community advertisements and clinician referrals. Participants could be taking stable medication for attention-deficit/hyperactivity disorder and sleep aids, but no other psychotropics. Independent evaluators assessed participants at screen, baseline, and 2, 4, 6, 9, and 12 weeks. Primary outcome measures were the Kiddie Schedule for Affective Disorders (K-SADS) Depression (KDRS) and Mania (KMRS) Rating Scales, Children's Depression Rating Scale-Revised (CDRS-R), and Young Mania Rating Scale (YMRS). 3/placebo conditions were double-blind; independent evaluators were blind to psychotherapy condition. Results: Most participants (83%) completed the 12 week trial. Side effects were uncommon and mild. Intent-to-treat analyses indicated significant improvement in depressive symptoms (KDRS) for combined treatment relative to placebo and AM (p=0.01, d=1.70). Across groups, manic symptoms improved over time without significant treatment effects. Effect of IF-PEP on child depression compared with AM was medium (d=0.63, CDRS-R) to large (d=1.24, KDRS). Effect of 3 on depression was medium (d=0.48, KDRS). Conclusion: IF-PEP and 3 are well tolerated and associated with improved mood symptoms among youth with BP-NOS and CYC. Clinicaltrials.gov Identifier: NCT01507753