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.

合并症抑郁症在慢性疼痛的退伍军人中非常普遍，并导致更大的疼痛 相对于仅慢性疼痛的严重性，功能障碍和自杀风险。尽管有很好的 慢性疼痛与抑郁症之间已知的关联，目前的治疗效果没有产生有意义的 该人群的功能和生活质量的改善。在此应用程序中，我们建议解决这个问题 通过新颖的干预措施结合了重复的经颅磁刺激（RTM）和 接受和承诺疗法（ACT）。 ACT是一种基于证据的社会心理干预措施，可改善具有慢性的退伍军人的功能 疼痛。但是，与更广泛的文献相似，合并症的抑郁显着限制了行为的疗效， 可能与维持抑郁症的脑回路功能失调直接相关。 RTMS是无创的 脑刺激干预措施已清除，用于治疗抑郁症。最常见的目标 刺激区域是左侧外侧前额叶皮层（DLFPC），这是一个参与认知的前额叶大脑区域 控制和情绪调节。左DLPFC上的RTM也已用于降低疼痛强度 慢性疼痛患者，因为DLPFC与疼痛刺激的情感处理有关。重要的是， 虽然已显示RTMS可以降低抑郁症的严重程度和疼痛强度，但并未直接解决 功能。因此，拟议的研究将整合RTM并以最大化功能的目的 慢性疼痛和抑郁的退伍军人的改善。 本应用的目的是检查未来随机疗效试验的可行性。总共 有24名患有慢性疼痛和抑郁的退伍军人将被随机分为DLPFC-RTMS + ACT或Sham-RTMS + 行动条件。将评估可行性的多个指标，包括对研究的普遍兴趣， 愿意参加，入学，保留，辍学，不良事件的数量和参与者失明 条件以及信誉，期望和治疗满意度的评级。我们还将估计 DLPFC-RTMS + ACT和Sham-RTMS +对功能的初步影响，如减少 疼痛干扰（主要的临床结果）。初步分析的目的是获得额外 未来大规模试验的指标，不要验证群体差异。此外，我们将包括两个认知 控制任务，情绪干扰器和注意力对呼吸任务，并发脑电图记录为 治疗反应的潜在客观指标。研究团队以前已经证明了 抑郁严重程度与DLPFC活动之间的关联。在拟议的研究中，我们将 探索与治疗相关的DLPFC活性变化与治疗结果之间的关联。 患有慢性疼痛和抑郁的退伍军人无法获得有效的治疗方法。解决这个问题 需要，我们试图通过整合躯体和社会心理来检查新方法的可行性 干涉。我们的科学前提是，左DLPFC上的RTM会补救前额叶的功能不全 最大化ACT对功能的影响所必需的脑电路对慢性疼痛和 沮丧。拟议研究的发现具有大大增加物理的可能性 以及具有慢性疼痛和抑郁的退伍军人的社会心理功能。