Jun 28, 20237 min read

Evidence-Based Practice Preview: Part 2

Updated: Jul 2, 2023

AAPB will release Evidence-Based Practice in Biofeedback and Neurofeedback (4th ed.) in late Summer 2023. This series highlights several of its findings to encourage you to purchase EBP4 and recommend it to your colleagues.

This installment covers Depression, Diabetes, Erectile Dysfunction, Generalized Anxiety Disorder, Hypertension, and Low Back Pain.

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Evidence-Based Practice Efficacy Criteria

EBP4 assigned efficacy ratings from Level 1 (not empirically supported) to Level 5 (efficacious and specific).

Depression

Major Depressive Disorder (MDD) is one of the most common mental disorders in the United States. MDD can result in severe impairments that interfere with or limit one’s ability to carry out major life activities.

The National Survey on Drug Use and Health (NSDUH) defines a significant depressive episode as a minimum 2-week phase during which an individual encounters feelings of depression or

a lack of enjoyment in their usual activities.

During this period, a person must also exhibit a majority of symptoms, including sleep, diet, energy levels, focus, or self-esteem.

The 2020 National Survey on Drug Use and Health (NSDUH) found:

About 8.4% of U.S. adults experienced a MDD episode in the last year.
MDD was more prevalent in women (10.5%) than men (6.2%).
MDD prevalence was highest among those aged 18-25 (17.0%).

Based on 10 RCTs, Zachary Meehan, Fred Shaffer, and Christopher Zerr rated BFB and NFB for MDD as efficacious and specific. BFB treatments included HRV increase. NFB interventions included alpha asymmetry reduction, alpha/theta increase, and real-time functional MRI (rtfMRI) to increase left or right ventromedial prefrontal cortex, insula, dorsolateral prefrontal cortex, medial temporal lobe, or orbitofrontal cortex activity. Participants achieved decreased behavioral inhibition, depression symptoms and severity, and state and trait anxiety.

Diabetes

Patients diagnosed with diabetes mellitus (DM) fail to produce or utilize insulin.

DM can involve hyperglycemia (elevated blood sugar), microvascular lesions of the retina, kidneys, peripheral nerves, and cardiovascular disease disorders (Rhoades & Bell, 2013).

About 30 million Americans have diabetes; 7 million of these do not know their condition. An additional 84 million adults have elevated blood sugars that increase their risk of progressing to diabetes. Under 10% of cases are Type 1 diabetes with childhood or teenage onset (Living Well with Diabetes, 2018).

Based on six RCTs, Fred Shaffer rated biofeedback for glycemic control as efficacious and specific.

Clinicians provided EMG and TEMP BART, in which clients learned to decrease EMG and increase hand temperature. Participants reduced blood glucose, hemoglobin A1c, and STAI-State scores. Glucose and insulin tolerance did not change.

Erectile Dysfunction

Erectile dysfunction (ED) refers to the inability to sufficiently achieve or sustain a penile erection for sexual intercourse (Shamloul & Ghanem, 2013). The etiology for ED can be neurogenic, psychogenic, endocrinologic, or iatrogenic. A cross-sectional epidemiological study in the USA found that as many as 18.4% of men over 20 years may experience ED (Selvin et al., 2007). Several studies support higher prevalence rates of ED among those with diabetes, hypertension, and major depression (e.g., Seftel et al., 2004).

ED can also be the consequence of surgery despite the advanced techniques developed to preserve the integrity of the nerves responsible for regulating erections (Burnett et al., 2007). Radical prostatectomy, a common surgical procedure for localized prostate cancer, causes ED in 26-100% of patients (Burnett et al., 2007; Walsh et al., 1987) due to neurovascular bundle injury and other mechanisms (Dubbelman et al., 2006).

The etiology of non-iatrogenic ED is complex and poorly understood. In men, the ischiocavernosus muscle and bulbospongiosus pelvic-floor muscle are active during sexual intercourse. Contraction of the ischiocavernosus muscle produces rigidity during the muscular phase of erection.

Meehan and Shaffer (2023) rated EMG biofeedback as efficacious and specific for treating ED. Two independent RCTs, one for participants after RP (Prota et al., 2012) and one for non-iatrogenic ED (Dorey et al., 2004, 2005), demonstrated that interventions that combine pelvic-floor muscle exercises, EMG biofeedback, and electrical stimulation could restore or improve erectile function. These RCTs found that the investigational treatment was statistically superior to alternative bona fide treatments (pelvic floor contraction exercises and lifestyle counseling). The studies were conducted in independent research settings.

Generalized Anxiety Disorder

Generalized Anxiety Disorder (GAD) involves excessive anxiety and concern related to a wide range of events or activities, such as job performance or academic achievement, which persist on most days for at least 6 months.

GAD patients struggle to manage their worries, potentially leading to disruptions in social interactions, work commitments, or other aspects of daily life.

The National Comorbidity Survey Replication (NCS-R) reported GAD prevalence in the previous year among U.S. adults aged 18 and above:

About 2.7% of U.S. adults experienced GAD in the last year.
GAD was more prevalent in women (3.4%) than men (1.9%).
5.7% of U.S. adults will face GAD at some point in their lifetime.

Based on five RCTs, Donald Moss and Matthew Watkins rated BFB and NFB for GAD as efficacious.

The BFB interventions included HR decrease, HRV increase, SCL decrease, SEMG decrease, and virtual reality (VRB). The NF interventions included alpha increase and alpha/theta increase. Participants decreased HR, SCL, state and trait anxiety, and HR reactivity to stress. They increased HRV measures (HF and LF power) and theta power.

Hypertension

Hypertension is elevated blood pressure (BP).

Based on the 2017 American College of Cardiology American Heart Association Task Force on Clinical Practice Guidelines, Stage 1 hypertension involves systolic BP (SBP) 130-139 mmHg and/or diastolic BP (DBP) 80-89 mmHg.

One-third of Americans and two-thirds over 60 are hypertensive (Benjamin et al., 2018). African Americans and patients diagnosed with diabetes have a higher prevalence of hypertension. Patients with elevated BP may progress to hypertension without lifestyle and drug intervention (Huether et al., 2020).

While elevated BP can be "silent," diverse symptoms like blurred vision and swelling ankles (edema) may accompany this chronic health condition.

Angele McGrady assigned a rating of efficacious to hypertension based on three RCTs for essential hypertension and five for pre-hypertension treatments. The biofeedback interventions trained participants to lower electrodermal and SEMG activity, and SBP, and increase HRV.

Participants lowered DBP and SBP, and increased baroreflex sensitivity (BRS). BRS would be high if the baroreflex system reacts strongly to a small BP change. If it reacts weakly, BRS would be low.

Low Back Pain

Chronic low back pain may involve paravertebral muscle misuse causing ligament strain, muscle tear, spinal facet injury, disk prolapse (protrusion), and psychological processes.

Clinicians often observe a cycle of injury, protective bracing, and chronic contraction that produces muscle asymmetry and a restricted range of motion.

About 80% of Americans suffer low back pain during their lifetime. Low back pain temporarily disables 3-4% and permanently disables 1% of working-age Americans. The annual prevalence of low back pain in the United States is 15-20% (Wheeler, 2014). Based on four RCTs, Saul Rosenthal rated biofeedback for chronic low back pain as efficacious. Clinicians trained clients to reduce SEMG, stabilize the trunk, and relax (BART). Participants improved on depression, distress, pain intensity, disability, pain cognitions, and muscle activation.

Quiz

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Glossary

Alpha asymmetry: a protocol that trains depressed clients to decrease left frontal alpha with respect to the right frontal alpha.

Alpha-theta protocol: a protocol to slow the EEG to the 6-9 Hz crossover region while maintaining alertness. Baroreflex sensitivity (BRS): a physiological parameter that quantifies the responsiveness of the baroreflex system, indicating how rapidly and effectively the cardiovascular system adjusts heart rate and vascular resistance in response to changes in blood pressure. Biofeedback-assisted relaxation training (BART): biofeedback combined with relaxation procedures.

Chronic low back pain: recurrent or persistent pain in the lower back region, typically lasting over 3 months. Often idiopathic, but it may be associated with underlying structural or functional abnormalities.

Generalized Anxiety Disorder (GAD): a psychiatric disorder characterized by chronic, excessive, and uncontrolled worry about everyday life events.

Heart rate variability (HRV): a measure of the variation in time between each heartbeat, used as an index of autonomic nervous system function.

High-frequency (HF) power: a HRV frequency range from 0.15-0.40 Hz that represents the inhibition and activation of the vagus nerve by breathing (respiratory sinus arrhythmia). Hypertension: a chronic medical condition characterized by persistently elevated blood pressure, typically defined as a systolic blood pressure ≥ 130 mmHg or a diastolic blood pressure ≥ 80 mmHg.

Level 4: efficacious.

Level 5: efficacious and specific.

Low-frequency (LF) power: a HRV frequency range of 0.04-0.15 Hz that may represent the influence of PNS and baroreflex activity (when breathing at the RF).

Major Depressive Disorder (MDD): a psychiatric disorder characterized by persistent and pervasive low mood, loss of interest or pleasure, and other physical and cognitive symptoms that significantly impair daily functioning.

Stage 1 hypertension: a systolic blood pressure of 130-139 mmHg or a diastolic blood pressure of 80-89 mmHg.

References

Benjamin, E. J., Virani, S. S., Callaway, C. W., Chamberlain, A. M., Chang, A. R., Cheng, S., Chiuve, S. E., Cushman, M., Delling, F. N., Deo, R., de Ferranti, S. D., Ferguson, J. F., Fornage, M., Gillespie, C., Isasi, C. R., Jiménez, M. C., Jordan, L. C., Judd, S. E., Lackland, D., Lichtman, J. H., … American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee (2018). Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation, 137(12), e67–e492. https://doi.org/10.1161/CIR.0000000000000558

Huether, S. E., & McCance, K. L., and Brashers, V. L. (2020). Understanding pathophysiology (7th ed.). Mosby.

McGrady, A. (2023). Hypertension. In I. Khazan, F. Shaffer, D. Moss, R. Lyle, & S. Rosenthal (Eds). Evidence-based practice in biofeedback and neurofeedback (4th ed.). Association for Applied Psychophysiology and Biofeedback. Meehan, Z. M., Shaffer, F., & Zerr, C. L. (2023). Depression. In I. Khazan, F. Shaffer, D. Moss, R. Lyle, & S. Rosenthal (Eds). Evidence-based practice in biofeedback and neurofeedback (4th ed.). Association for Applied Psychophysiology and Biofeedback.

Moss, D., & Watkins, M. (2023). Anxiety and anxiety disorders. In I. Khazan, F. Shaffer, D. Moss, R. Lyle, & S. Rosenthal (Eds). Evidence-based practice in biofeedback and neurofeedback (4th ed.). Association for Applied Psychophysiology and Biofeedback.

National Survey on Drug Use and Health (NSDUH). Retrieved from https://www.samhsa.gov/data/release/2020-national-survey-drug-use-and-health-nsduh-releases

Shaffer, F. (2023). Diabetes mellitus. In I. Khazan, F. Shaffer, D. Moss, R. Lyle, & S. Rosenthal (Eds). Evidence-based practice in biofeedback and neurofeedback (4th ed.). Association for Applied Psychophysiology and Biofeedback.

Whelton, P. K., Carey, R. M., Aronow, W. S., Casey, D. E., Jr, Collins, K. J., Dennison Himmelfarb, C., DePalma, S. M., Gidding, S., Jamerson, K. A., Jones, D. W., MacLaughlin, E. J., Muntner, P., Ovbiagele, B., Smith, S. C., Jr, Spencer, C. C., Stafford, R. S., Taler, S. J., Thomas, R. J., Williams, K. A., Sr, Williamson, J. D., … Wright, J. T., Jr (2018). 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/ PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension, 71(6), e13–e115. https://doi.org/10.1161/HYP.0000000000000065