Integrated Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy for Veterans with Chronic Pain and Depression

针对患有慢性疼痛和抑郁的退伍军人的综合重复经颅磁刺激以及接受和承诺疗法

• 批准号: 10579640
• 负责人: Matthew Herbert
• 金额: --
• 依托单位: VA SAN DIEGO HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-11-01 至 2024-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10579640
• 关键词: Address; Adherence; Adverse event; Affect; Affective; Area; Attention; Blindness; Brain; Brain region; Clinical; Clinical Trials; Data; Dropout; Electroencephalography; Emotional; Emotions; Enrollment; Future; Goals; Heart; Individual; Intervention; Left; Life; Literature; Living Wills; Measures; Mental Depression; Motivation; Neurologic; Outcome; Pain; Pain intensity; Pain interference; Parietal; Participant; Pathway interactions; Personal Growth; Population; Prefrontal Cortex; Preparation; Protocols documentation; Quality of life; Questionnaires; Randomized; Randomized, Controlled Trials; Regulation; Relative Risks; Research; Role; Schedule; Severities; Spirituality; Stimulus; Suicide prevention; Therapeutic Intervention; Thinking; Treatment outcome; Veterans; Veterans Health Administration; Visit; Work; bodily sensation; brain dysfunction; chronic depression; chronic pain; chronic pain management; chronic pain patient; cognitive control; cognitive function; comorbid depression; comorbidity; effective therapy; efficacy trial; emotion regulation; evidence base; expectation; experience; falls; flexibility; functional disability; functional improvement; functional status; improved; interest; neuroimaging; noninvasive brain stimulation; novel; novel strategies; pain perception; pain reduction; post intervention; psychologic; psychosocial; reducing suicide; remediation; repetitive transcranial magnetic stimulation; satisfaction; social engagement; social relationships; suicidal; suicidal risk; treatment response; willingness

Comorbid depression is highly prevalent in Veterans with chronic pain and contributes to greater pain severity, functional impairment, and suicide risk relative to those with chronic pain alone. Despite the well- known association between chronic pain and depression, current treatments fall short of producing meaningful improvements in function and quality of life in this population. In this application, we propose to address this problem by a novel intervention that combines repetitive Transcranial Magnetic Stimulation (rTMS) and Acceptance and Commitment Therapy (ACT). ACT is an evidence-based psychosocial intervention that improves function in Veterans with chronic pain. However, similar to the broader literature, comorbid depression significantly limits the efficacy of ACT, which may be directly related to dysfunctional brain circuits that maintain depression. rTMS is a non-invasive brain stimulation intervention that is FDA-cleared for the treatment of depression. The most commonly targeted stimulation area is the left dorsolateral prefrontal cortex (DLFPC), a prefrontal brain region involved in cognitive control and emotion regulation. rTMS over the left DLPFC has also been used to reduce pain intensity in patients with chronic pain, as the DLPFC is implicated in the affective processing of painful stimuli. Importantly, while rTMS has been shown to reduce depression severity and pain intensity, it does not directly address function. Thus, the proposed research will integrate rTMS and ACT with the goal of maximizing functional improvement in Veterans with chronic pain and depression. The purpose of this application is to examine the feasibility of a future randomized efficacy trial. A total of 24 Veterans with chronic pain and depression will be randomized into DLPFC-rTMS + ACT or sham-rTMS + ACT conditions. Multiple metrics of feasibility will be assessed, including general interest in the study, willingness to participate, enrollment, retention, drop-out, number of adverse events, and participant blindness to condition, as well as ratings of credibility, expectation, and treatment satisfaction. We will also estimate the preliminary impact of DLPFC-rTMS + ACT and sham-rTMS + ACT on function as measured by reductions in pain interference (primary clinical outcome). The intent of preliminary analyses is to obtain an additional indicator for a future large-scale trial, not to verify group differences. Further, we will include two cognitive control tasks, the Emotion Distractor and Attention-to-Breath tasks, with concurrent EEG recording as a potential objective indicator of treatment response. The study team has previously demonstrated the association between depression severity and DLPFC activity on these tasks. In the proposed study, we will explore the associations between treatment-related change in DLPFC activity and treatment outcomes. Veterans with chronic pain and depression do not have access to effective treatments. To address this need, we seek to examine the feasibility of a novel approach by integrating a somatic and a psychosocial intervention. Our scientific premise is that rTMS over the left DLPFC will remediate hypofunction of prefrontal brain circuits that is necessary to maximize the impact of ACT on function in Veterans with chronic pain and depression. Findings from the proposed research have the potential of substantially increasing the physical and psychosocial functioning of Veterans with chronic pain and depression.

患有慢性疼痛的退伍军人中，共病抑郁症非常普遍，并会加剧疼痛 与仅患有慢性疼痛的患者相比，严重程度、功能障碍和自杀风险。尽管情况良好—— 已知慢性疼痛和抑郁之间存在关联，但目前的治疗方法不足以产生有意义的效果 该人群的功能和生活质量得到改善。在本申请中，我们建议解决这个问题 通过结合重复经颅磁刺激（rTMS）和 接受与承诺疗法（ACT）。 ACT 是一种基于证据的心理社会干预措施，可改善患有慢性病的退伍军人的功能 疼痛。然而，与更广泛的文献类似，共病抑郁症显着限制了 ACT 的疗效， 这可能与维持抑郁症的大脑回路功能失调直接相关。 rTMS 是一种非侵入性 FDA 批准用于治疗抑郁症的脑刺激干预措施。最常见的目标 刺激区域是左背外侧前额皮质（DLFPC），这是一个参与认知的前额大脑区域 控制和情绪调节。左侧 DLPFC 上的 rTMS 也已被用于减轻以下患者的疼痛强度： 慢性疼痛患者，因为 DLPFC 参与疼痛刺激的情感处理。重要的是， 虽然 rTMS 已被证明可以减轻抑郁严重程度和疼痛强度，但它并不能直接解决 功能。因此，拟议的研究将整合 rTMS 和 ACT，以最大限度地提高功能性 改善患有慢性疼痛和抑郁症的退伍军人。 本申请的目的是检查未来随机疗效试验的可行性。总计 24 名患有慢性疼痛和抑郁症的退伍军人将被随机分配到 DLPFC-rTMS + ACT 或假-rTMS + 组 ACT条件。将评估多种可行性指标，包括对研究的普遍兴趣， 参与意愿、入组、保留、退出、不良事件数量和参与者失明 状况以及可信度、期望和治疗满意度的评级。我们还将估计 DLPFC-rTMS + ACT 和 sham-rTMS + ACT 对功能的初步影响（通过减少 疼痛干扰（主要临床结果）。初步分析的目的是获得额外的 未来大规模试验的指标，而不是验证群体差异。此外，我们将包括两个认知 控制任务、情绪干扰和注意力呼吸任务，同时进行脑电图记录作为 治疗反应的潜在客观指标。研究小组此前已证明 抑郁症严重程度与这些任务中 DLPFC 活动之间的关联。在拟议的研究中，我们将 探讨治疗相关的 DLPFC 活动变化与治疗结果之间的关联。 患有慢性疼痛和抑郁症的退伍军人无法获得有效的治疗。为了解决这个问题 需要，我们寻求通过整合躯体和心理社会来检验一种新方法的可行性 干涉。我们的科学前提是，左侧 DLPFC 上的 rTMS 将修复前额叶功能减退 为最大限度地发挥 ACT 对患有慢性疼痛的退伍军人的功能的影响所必需的大脑回路 沮丧。拟议研究的结果有可能大幅提高身体素质 以及患有慢性疼痛和抑郁症的退伍军人的心理社会功能。