Comparing the Efficacy of Sensory Motor Rhythm and Alpha-Theta Increase Protocol of Neurofeedback Training for Generalized Anxiety Disorder

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Comparing the Efficacy of Sensory Motor Rhythm and Alpha-Theta Increase Protocol of Neurofeedback Training for Generalized Anxiety Disorder

https://doi.org/10.21203/rs.3.rs-3197196/v1

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Neurofeedback training is one of the alternative therapies for Generalized anxiety disorder. Although research suggests its effective therapy, there is a lack of studies for comparing different protocols. So, this study aimed at comparing sensory motor rhythm and alpha-theta increase protocol of neurofeedback. In this research, a two-arm randomized trial was conducted to compare two different protocols of neurofeedback. A total of 40 individuals diagnosed with generalized anxiety disorder were assigned to either group which received 15 sessions of alpha-theta increase on Pz and group two received 15 sessions of sensory motor rhythm increase on Cz. Pretest and post-test measurements were taken using Beck Anxiety Inventory, State-Trait Spielberg, and Perceived Stress Scale, and finally data were analyzed using IBM SPSS v24 software. The results of the Wilcoxon test shows both protocols significantly reduced anxiety symptoms, but the alpha-theta protocol was more effective in reducing state anxiety and the sensory motor rhythm protocol was more effective in reducing Beck Anxiety Inventory and Perceived Stress Scale. According to the research, both protocols are effective in reducing anxiety. However, they each have their own advantages in reducing specific anxiety symptoms.

Neurofeedback

Anxiety Disorders

Electroencephalography

Generalized anxiety disorder (GAD) is one of the most prevalent mental disorder in adults, marked by excessive and uncontrollable worry about various events or activities (Association, 2021), It is accompanied by symptoms such as restlessness, irritability, fatigue, difficulty concentrating, problems with sleep, and somatic symptoms (Association, 2021), and it can lead to difficulties in psychosocial functioning and work efficiency (Revicki et al., 2012), along with heightened utilization of healthcare services and medical expenses. Moreover, GAD is linked to utilizing emergency departments as frequently as double the amount compared to patients with a different major psychiatric disorder (Jones et al., 2001). Research has been focused on this disorder due to its widespread prevalence and frequent occurrence in our daily surroundings. It is particularly important to note that studies have shown that GAD tends to develop during mid-adolescence and may persist through adulthood if not properly treated (Huang et al., 2019; Rickwood & Bradford, 2012).

The current treatment guidelines for anxiety disorders contain various pharmacological and non-pharmacological methods (Lam, 2006). But most patients with anxiety disorders do not have access to evidence-based psychotherapies. This lack of access may be due to a shortage of qualified therapists, physicians who are reluctant to recommend evidence-based psychotherapies or have insufficient budgets for non-pharmacological therapies. Furthermore, psychotropic drugs are not consistently efficient and cause side effects (Schulz & Hede, 2018). Overall, despite a variety of treatment choices, full recovery is seldom achieved and it is necessary to investigate new therapeutic alternatives to offer different remedies for individuals suffering from anxiety disorders (Hyde et al., 2019; Shvil et al., 2013) and given the high cost and unfavorable results linked to GAD, an up-to-date critical comparison of the different therapies is crucial (Carl et al., 2020).

Electroencephalographic (EEG) neurofeedback is a method of neuromodulation. During neurofeedback training, the individual acquires the ability to regulate their own brain activity based on operant conditioning, with the goal of enhancing various cognitive states (Herrmann et al., 2016). EEG neurofeedback has been demonstrated to change the long-term neural activity or connections and adjust related symptoms, like excessive behavioral and physiological arousal, which is one of the defining characteristics of anxiety disorders (Cisler et al., 2010; Hyde et al., 2019; Shvil et al., 2013). Noticeably, states of arousal or relaxation are known to be observable by EEG patterns. The EEG measures the electrical activity of neurons in the cerebral cortex by detecting oscillations within various frequency bands (Cohen, 2017). The first oscillation to be discovered is known as the alpha rhythm (8–12 Hz) during a state of relaxed wakefulness. This rhythm can be detected and increases when the eyes are closed (Bazanova & Vernon, 2014). During relaxed wakefulness and decreased motor activity, the sensorimotor cortex shows an increase in amplitude of the sensorimotor rhythms (SMR) which oscillate at 12–15 Hz (Oishi et al., 2007; Zhang et al., 2008).

Studies on neurofeedback and its effects on GAD have shown that it can be an effective treatment in reducing symptoms. Rice et al. released the first neurofeedback research for GAD patients (Rice et al., 1993). Thirty-eight participants underwent either frontal electromyographic biofeedback, EEG neurofeedback to enhance alpha rhythm, and neurofeedback to diminish alpha rhythm. The findings indicated that each group experienced significant decreases in trait scores of The State-Trait Anxiety Inventory. In a recent study conducted by Hou et al., it was found that neurofeedback training focusing on alpha activity over the parietal lobe is effective in reducing anxiety and depressive symptoms in patients with GAD, particularly in relation to the anxiety trait (Hou et al., 2021). Dadashi et al carried out a study to investigate whether increasing the amplitude of alpha and theta brain waves in the occipital region can alleviate symptoms associated with GAD. The findings of their research suggest that this method can help to enhance overall functioning and reduce GAD symptoms (Dadashi et al., 2015).

Although there are documented benefits of EEG neurofeedback training for anxiety disorders, there is limited empirical support. As a result, EEG neurofeedback training has not yet been able to attain the same level of proof as other non-pharmacological therapies that have been more extensively validated, such as cognitive behavioral therapy (CBT), exposure therapy, and eye movement desensitization and reprocessing (EMDR) [22]. Furthermore, there is limited information about which specific protocol is best suited for treating different symptoms. Therefore, the primary objective of this research was to compared two neurofeedback training protocols in order to reduce GAD symptoms. To achieve this goal, we compared the efficacy of two protocols: one aimed at increasing alpha-theta amplitude, and the other focused on SMR.

This trial was a single-center, single-blinded trial with two experimental groups conducted from June 2022 to July 2023. Participants were recruited from Taleghani Hospital in Tehran, IRAN. The study protocol was approved by the Ethics Committee of Shahid Beheshti University of Medical Science (IR.SBMU.MSP.REC. 1401. 161). The flow chart of the trial is visualized in Fig. 1.

2.1. Participants

The study focused on patients with GAD who were admitted to the clinical psychology department of the Taleghani hospital in Tehran, Iran. Total of 40 (20 in each group) volunteered to participants in the study. The participants were informed about the purpose of the study, but they were not given information about the different protocols that were followed in the two groups. All the participants were graduated students and went through the process of signing an informed consent form and providing detailed personal information before the experiment began. All of the participants in this study had normal hearing and vision and were right-handed. None of them had ever undergone neurofeedback sessions before. They were diagnosed with GAD through structural psychiatric interviews and were aged 20 or above with no history of neurological disorders or undergoing other therapies. Participants who started other treatments during the study or missed more than one session were excluded. Twenty patients with GAD were chosen for each group using convenience sampling and then randomly divided into two groups. All potential participants were assigned ID numbers and then randomly assigned to either group one or group two using a randomized generator app.

2.2. Procedure

The research was conducted at Taleghni Hospital's community counseling center, where a single room was dedicated to neurofeedback training sessions to protect the privacy of the participants receiving the training. In addition, individual counseling rooms were used for assessments to ensure privacy. Both groups underwent 15 sessions over five weeks, with each session lasting 30 minutes.

The ProComp system includes three sensors that are applied using neuro conductor gel. The ground sensor on the right ear and reference sensor was placed on the left ear; an active sensor for group one was placed on Pz based on international system of 10–20 and for group two on Cz. Group one received 15 session of alpha (8-12Hz) and theta (4-8Hz) amplitude increase and group two received 15 session of SMR (12-15Hz) increase.

Before neurofeedback training sessions, data collection assessments were conducted to minimize the impact of neurofeedback training as a confounding variable. This is because neurofeedback training has been observed to induce feelings of relaxation during the sessions.

2.3. Scales

The Beck Anxiety Inventory (BAI) is made up of 21 items that use a four-point Likert scale. The scale ranges from "Not at all" to "Severely - it bothered me a lot." The responses are based on symptoms experienced within the past month, including the day of the assessment (Toledano-Toledano et al., 2020).

The Perceived Stress Questionnaire (PSS) was developed in 1983 by Cohen and his colleagues. It consists of a 14-item survey that assesses a person's perceived stress levels within the past month. It evaluates their thoughts and emotions regarding stressful events, their ability to control them, and their coping mechanisms. The PSS measures both psychological pressure and stress experienced by an individual. Additionally, this questionnaire can identify risk factors in behavioral disorders and can indicate the impact of stressful relationships. The higher the score, the greater the perceived stress levels (Lee, 2012).

The Spielberger's state-trait anxiety test (STAI), evaluates two forms of anxiety: state and trait. It consists of 40 questions that distinguish between the two types. The questions for each type of anxiety are grouped separately, with 20 questions for trait anxiety and 20 for state anxiety. In order to finish the test, individuals are required to express their present emotions for the state anxiety scale, as well as their overall, routine emotions for the trait anxiety scale (Balsamo et al., 2013).

2.4. Statistical analysis

Data can be presented using descriptive statistics, which includes mean (S.D) for numerical data and frequency for categorical data. The Shapiro-Wilk test is used to check the normality of data. To compare the differences between the demographic data of groups, the Chi-square and t-test are utilized. The Wilcoxon test is used to compare mean scores before and after treatment, while quad nonparametric ANCOVA is used to compare the effectiveness of treatments between different groups.

Total of 20 subject in each group included in the analysis. Twenty-three participants were men and 17 were female. In total 14 (35%) participants had master degree and 26 (65%) participants had PhD. The distribution of gender (X² = 2.55, P = 0.11) and education (X² = 0.44, P = 0.51) difference between each group had no significant difference. The results of independent t test between age mean of group one (M = 29.45, S. D = 30.70) and group two (M = 30.70, S. D = 5.32) show there is no significant different between groups (t=-0.98. P = 0.32).

According to Shapiro test scores had no normal distribution (p < 0.05). The Wilcoxon test employed to compare the mean scores of participants before and after of training. The mean scores of groups are summarized in Table 1. A Wilcoxon Signed Rank Test for group one indicated that the median post-test ranks were statistically significantly lower that the pretest ranks for BAI (z=-3.93, p = 0.01), STAI (state) (z=-3.92, p = 0.01), STAI (trait) (z=-3.81, p = 0.01), and PSS (z=-3.83, p = 0.01). Furthermore, A Wilcoxon Signed Rank Test for group two indicated that the median post-test ranks were statistically significantly lower that the pretest ranks for BAI (z=-3.96, p = 0.01), state (z=-3.93, p = 0.01), trait (z=-3.43, p = 0.01), and PSS (z=-4.05, p = 0.01).

Table 1. the mean and standard deviation (S.D) of variables

	Group one				Group two
	Pre-test		Post-test		Pre-test		Post- test
Variable	Mean	(S.D)	Mean	(S.D)	Mean	(S.D)	Mean	(S.D)
BAI	19.50	8.58	7.30	7.54	24.80	8.80	14.95	8.48
State	59.75	3.27	51.20	4.43	61.90	4.51	49.00	6.96
Trait	61.70	5.15	54.90	5.03	62.75	5.46	53.00	6.96
NPSS	16.60	2.81	10.05	2.43	18.70	2.31	12.65	2.41

For comparing the two treatment Quade nonparametric ANCOVA employed. The results show there is a significant effect of group on scores of BAI (F (1.38) = 15.73, t=-3.96, p = 0.01), STAI(State) (F (1.38) = 5.73, t = 2.39, p = 0.02) and PSS (F (1.38) = 4.89, t=-2.12, p = 0.03) after controlling pretest scores but not for STAI (Trait) (F (1.38) = 3.31, t = 1.82, p = 0.07).

This study aimed to evaluate two EEG neurofeedback protocols for GAD. A total of 40 individuals were randomly assigned to two groups to achieve this goal. The first group underwent 15 sessions of the alpha-theta increase protocol at Pz, while the second group received 15 sessions of the SMR increase protocol at Cz. According to the results, both protocols were effective, but the alpha-theta increase protocol was found to be more effective in reducing state anxiety compared to the SMR protocol. On the other hand, the SMR protocol was more effective in lowering BAI and PSS compared to the alpha and theta protocols. Moreover, there were no significant differences between the two protocols in diminishing trait anxiety.

Group one which receive alpha-theta protocol shows greater reducing in state anxiety. Which shows how much worry, tension, or apprehension the person experiences in present circumstances. These results were similar with a study by Dadashi et al. shows increase in alpha wave results in reducing symptoms in GAD (Dadashi et al., 2015). Following alpha-theta increase neurofeedback training, the PSS, STAI, and BAI scores of individuals with GAD decreased as anticipated. However, in our study the reduction was more prominent in STAI (state) when compared to the SMR protocol.

Anxiety disorders can be triggered and prolonged by the way individuals process information related to perceived threats. This implies that people with anxiety tend to have a heightened attention towards stimuli that they perceive as threatening, rather than those that are neutral in their surroundings. Such biases are crucial in the onset and perpetuation of anxiety disorders, including GAD (Hou et al., 2021; Mathews & Mackintosh, 2000). According to Mansell's model, anxiety can cause biases in how we process information. The anterior cingulate cortex, lateral prefrontal cortex, and parietal cortex are responsible for controlling attention in this process (Mansell, 2000). Studies utilizing functional magnetic resonance imaging (fMRI) have discovered three unique attentional networks. One is the alerting network, which is triggered in the frontoparietal cortex and thalamus. The second is the orienting network, which displays high activity in the superior parietal region and temporal-parietal junction, with a preference for the right hemisphere. Finally, the executive control network is activated in the anterior cingulate and both the right and left frontal regions (MacDonald et al., 2000). Hou et al. demonstrated the effectiveness of neurofeedback training on the parietal lobe using their model and results (Fan et al., 2005; Hou et al., 2021). Our findings also support the effectiveness of this protocol in treating GAD patients.

Group two, which receives SMR protocol, shows significant reduction in BAI, PSS, and STAI but a greater reduction in BAI and PSS compared to alpha-theta protocol than alpha-theta protocol. BAI contains many items which address somatic symptoms of anxiety, such as wobbliness in one’s legs, feeling dizzy or lightheaded; there are considerable items in BAI that deal with physical symptoms of anxiety, such as shaky legs, dizziness, lightheadedness, feeling unsteady, and breathing problems., and difficulty breathing (Yochim et al., 2010). The PSS mostly measures how individuals think and feel about stressful situations, their capacity to manage them, and their coping strategy (Maroufizadeh et al., 2014).

Research has shown that the SMR training protocol can enhance one's attention. This happens when a person remains still yet alert, and movement in the central scalp regions of the brain hinders their focus (Lubar & Lubar, 1984; Reichert et al., 2016). The frequency range of 12–15 Hz has been shown to have positive effects on anxiety. However, its slower effects, long duration, and individual differences make it less commonly used in clinical settings (Gadea et al., 2020; Gomes et al., 2016; Ros et al., 2009). Neurofeedback using SMR protocol has been proven effective in treating attention-deficit hyperactivity disorder. Additionally, it has been shown to enhance the attentional abilities of healthy individuals (Egner & Gruzelier, 2004; Enriquez-Geppert et al., 2019; Vernon et al., 2003). There could be a plausible explanation for the effectiveness of SMR neurofeedback training. It appears that SMR operates as a bottom-up mechanism within the thalami-cortical circuitry, and the training enhances the inhibitory mechanism of this circuitry. By increasing SMR, it reinforces the body's ability to inhibit unwanted sensory information, resulting in improved somatosensory processing (Egner & Gruzelier, 2004; Reichert et al., 2016). In addition, SMR training could potentially lead to stabilized vigilance through the regulation of the locus coeruleus noradrenergic system (Sinha, 2011). Research has indicated that practicing attention-focused techniques such as yoga and meditation can effectively alleviate symptoms of anxiety (Shreve et al., 2021; Wuthrich et al., 2021). Additionally, lack of focus is a common symptom of anxiety in a clinical setting. The hypothesis suggests that by enhancing attention-related SMR activity, anxiety can be relieved (Blaskovits et al., 2017).

There are some limitations to this study. First, follow-up was impossible because we could not follow up with the participants. Second, neurofeedback training is usually done in more sessions, but our participants could not undergo additional sessions. Increasing the number of sessions could potentially diminish the difference between the two protocols. Also, this study did not employ mock neurofeedback as a control group.

4.1. Conclusion

Based on the results, it has been determined that both the alpha-theta increase and SMR protocol of neurofeedback training are effective in reducing GAD symptoms. However, the SMR protocol is more advantageous in reducing stress and state of anxiety, whereas the alpha-theta protocol is more effective in reducing somatic symptoms. Considering the high costs of treatment, knowing the specific performance of each protocol can help reduce costs and improve the effectiveness of treatment. The results obtained in this study will help choose the specific protocol for each person according to the symptoms.

Consent for publication: This manuscript has been approved for publication by all authors.

Ethics approval: The study protocol was approved by the Ethics Committee of Shahid Beheshti University of Medical Science (IR.SBMU.MSP.REC. 1401. 161).

Conflict of interest: The authors declare no conflict of interest.

Funding/Support: This study was supported by the School of Medicine Shahid Beheshti University of Medical Sciences (grant no 31911).

Authors contributions: SHL, AY, and ASKM conceptualized this research. SHL and HSH acquired the data. SHL analyzed the data. SHL and AY interpreted data. SHL drafted the manuscript with input from all authors. AMA and ASKM supervised the study

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No competing interests reported.

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Comparing the Efficacy of Sensory Motor Rhythm and Alpha-Theta Increase Protocol of Neurofeedback Training for Generalized Anxiety Disorder

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2.4. Statistical analysis

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4.1. Conclusion

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