Wright Kim, Palmer Gemma, Javaid Mahmood, Mostazir Mohammod, Lynch Tom
1Department of Psychology, Washington Singer Labs., University of Exeter, Perry Road, Exeter, EX4 4QG UK.
2Biomedical Informatics Hub, University of Exeter, Perry Road, Exeter, EX4 4QG UK.
Pilot Feasibility Stud. 2020 Apr 15;6:46. doi: 10.1186/s40814-020-00586-1. eCollection 2020.
We sought to evaluate the acceptability of a psychological therapy programme (Therapy for Inter-episode Mood Variability in Bipolar Disorder (ThrIVe-B)) for individuals with ongoing bipolar mood instability and the feasibility and acceptability of potential trial procedures. We also evaluated the performance of clinical and process outcome measures and the extent to which the programme potentially represents a safe and effective intervention.
We conducted an open (uncontrolled) trial in which 12 individuals with a bipolar spectrum diagnosis commenced the ThrIVe-B programme after completing baseline assessments. The programme comprised 16 group skills training sessions plus individual sessions and a supporting smartphone application. Follow-up assessments were at therapy end-point and 6 months post-treatment.
Nine participants completed treatment. Ten provided end-of-treatment data; of these, nine were satisfied with treatment. Interviews with participants and clinicians indicated that the treatment was broadly feasible and acceptable, with suggestions for improvements to content, delivery and study procedures. Exploration of change in symptoms was consistent with the potential for the intervention to represent a safe and effective intervention.
Conducting further evaluation of this approach in similar settings is likely to be feasible, whilst patient reports and the pattern of clinical change observed suggest this approach holds promise for this patient group. Future research should include more than one study site and a comparison arm to address additional uncertainties prior to a definitive trial.
Trial Registration: ClinicalTrials.gov NCT02637401; registered 22.12.15 (retrospectively registered).
我们试图评估一种心理治疗方案（双相情感障碍发作间期情绪变异性治疗（ThrIVe-B））对患有持续性双相情感障碍情绪不稳定个体的可接受性，以及潜在试验程序的可行性和可接受性。我们还评估了临床和过程结局指标的表现，以及该方案在多大程度上可能代表一种安全有效的干预措施。
我们进行了一项开放（非对照）试验，12名双相情感障碍谱系诊断患者在完成基线评估后开始ThrIVe-B方案。该方案包括16次团体技能培训课程、个体治疗课程以及一款配套的智能手机应用程序。随访评估在治疗终点和治疗后6个月进行。
9名参与者完成了治疗。10名提供了治疗结束时的数据；其中9名对治疗满意。对参与者和临床医生的访谈表明，该治疗总体上是可行且可接受的，并对内容、实施方式和研究程序提出了改进建议。对症状变化的探索与该干预措施可能代表一种安全有效干预措施的可能性一致。
在类似环境中对该方法进行进一步评估可能是可行的，而患者报告和观察到的临床变化模式表明该方法对这一患者群体有前景。未来研究应包括多个研究地点和一个对照组，以在进行确定性试验之前解决其他不确定性问题。
试验注册：ClinicalTrials.gov NCT02637401；于2015年12月22日注册（追溯注册）。
