Alpha/Theta Neurofeedback Training as Treatment Method for Individuals With Moderate to Severe Trait Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change from baseline in the State-Trait Anxiety Inventory (STAI) Scale
研究概览
简要总结
This study evaluates if individuals with moderate to high trait anxiety can learn how to self-regulate their brain waves and reduce their trait anxiety in ten sessions of EEG alpha-theta neurofeedback training. Half of the randomly assigned participants will receive alpha/theta neurofeedback training while the other half will receive a two-part control protocol where low beta and beta waves will be uptrained in and downtrained in in successive sessions.
详细描述
Since the late 1960s neurofeedback treatment (NFT) has been used to treat adult individuals with anxiety disorders. Yet most related, evidence-based research studies were conducted between the mid-1970s and late 1990s. Therefore, NFT as an efficacious treatment for anxiety problems remains unclear. The literature research discloses that of few studies, most used sample sizes 10 subjects or less per experimental or control group and results have been mixed: Orne & Paskewitz (1974) and Watson & Herder (1980) found no significant effect sizes for anxiety symptom reduction and Egner, Strawson & Gruzelier (2002) did not find a significant difference in subjective activation level between alpha/theta (A/T) NFT and the sham group. On the other hand, Hardt & Kamiya (1978), Plotkin & Rice (1981), Sargunaraj, Kumaraiah, Mishra, & Kumar (1987), Rice, Blanchard & Purcell (1993), Vanathy, Sharma, & Kumar (1998), Sarkar, Rathee, & Neera (1999), Eismont Lutsyuk ,& Pavlenko (2011), and Gruzelier, Thompson, Redding, Brandt & Steffert (2013) did find a significant anxiety symptom reduction through NFT. The U.S. National Institutes of Health's National Center for Complementary and Integrative Health (NCCIH) at this time does not endorse NFT as an efficacious treatment for anxiety problems.
General hypothesis: A ten-session NFT protocol of up-training alpha (8-11 Hz) and theta (5-7.5 Hz) frequency bands lowers the subjective experience of trait anxiety and elevates mean theta and lowers alpha amplitudes in EEG recordings for individuals with moderate to high trait anxiety (while individuals' subjective experience of trait anxiety and theta/alpha ratios in the sham NFT condition will not change).
Control for treatment expectations and self-efficacy
- There will be no significant differences between the treatment and the sham group in treatment expectations / self efficacy as measured by the Stanford Expectations of Treatment Scale (SETS) and the Rotter Locus of Control Scale.
- There will be no significant differences between the treatment and the sham treatment group pre-and post treatment satisfaction as measured by assessments as measured by the SETS modified outcome scale.
Treatment effect hypotheses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults, age 18 and above
- •scores of >66% on the State Trait Anxiety Inventory (STAI)
排除标准
- •scores >19 on the Beck Depression Inventory (BDI-II)
- •scores > 9 on the Patient Health Questionnaire (PHQ-9)
- •comorbid diagnoses of: Major Depression, Bipolar Disorder, Schizophrenia, Substance Use Disorder, Tic disorders, Seizure Disorders
结局指标
主要结局
Change from baseline in the State-Trait Anxiety Inventory (STAI) Scale
时间窗: 1-2 weeks pre-treatment and at post treatment at end of last treatment session (4-5 weeks)
Change from baseline of symptoms of anxiety to end of treatment after 4-5 weeks. The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more anxious participants.
次要结局
- Theta/alpha (T/A) ratios in EEG recorded at Pz scalp location(pre- and post each of 3 NFB segments (3 eight-minute segments per NFB session) and over the course of 10 sessions (4-5 weeks))
- 19-channel Mini-QEEG(pre-treatment and at post treatment at end of last treatment session (4-5 weeks))
- Change from baseline in Generalized Anxiety Disorder 7-item Scale (GAD-7)(1-2 weeks pre-treatment and at post treatment at end of last treatment session (4-5 weeks))
- Change from baseline in Beck Anxiety Inventory (BAI) Scale(1-2 weeks pre-treatment and at post treatment at end of last treatment session (4-5 weeks))
- Change from baseline in Activation Deactivation Adjective Checklist (AD ACL)(1-2 weeks pre-treatment and at post treatment at end of last treatment session (4-5 weeks))
- Rotter Locus of Control Scale(at end of last NFB treatment session (4-5 weeks))