Conceived and designed the experiments: KC OS DP EJM DS. Performed the experiments: KC OS DP. Analyzed the data: KC OS EJM QZ DS. Wrote the paper: KC OS DP EJM BB QZ DS.
The authors have declared that no competing interests exist.
Anxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial.
Employees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC) (n = 41) or standardized psychotherapy intervention (PT) (n = 40) over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (
Seventy-five participants (93%) were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001) in the NC group and 30.5% (p<0.0001) in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003). Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions were observed in either group.
Many patients seek alternatives and/or complementary care to conventional anxiety treatments. To date, no study has evaluated the potential of a naturopathic treatment protocol to effectively treat anxiety. Knowledge of the efficacy, safety or risk of natural health products, and naturopathic treatments is important for physicians and the public in order to make informed decisions.
Both NC and PT led to significant improvements in patients' anxiety. Group comparison demonstrated a significant decrease in anxiety levels in the NC group over the PT group. Significant improvements in secondary quality of life measures were also observed in the NC group as compared to PT. The whole system of naturopathic care for anxiety needs to be investigated further including a closer examination of the individual components within the context of their additive effect.
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Anxiety disorders are among the most prevalent type of psychiatric disorder with an estimated lifetime incidence ranging between 7.9% and 14.5% worldwide
Several studies have demonstrated the economic repercussions of widespread anxiety in the workplace
Although complementary and alternative medicine (CAM) treatments are popular in the general population
Naturopathic medicine (also known as naturopathy) is a school of medical philosophy and practice that seeks to improve health and treat disease chiefly by assisting the body's innate capacity to recover from illness and injury. This alternative medical system of care employs the use of many CAM therapies including acupuncture, herbal medicine, osteopathy, nutrition, homeopathy, and lifestyle counseling
Behavioral interventions such as diaphragmatic breathing have been shown to reduce anxiety levels and improve coping capability in stressful situations
The major biochemical constituents of
Theoretically, the withanolides serve as important hormone precursors which may be convertible into human physiologic hormones as needed.
Most studies on
A study showing the role of a
Naturopathic treatment generally includes suggested alterations in patients' diet. Diets high in stimulants have been linked to symptoms of anxiety. Reducing stimulants such as caffeine, chocolate, nicotine, refined sugars will reduce incidence and severity of anxiety
We aimed to determine the effectiveness of naturopathic interventions on anxiety symptoms and general health as compared to a standardized psychotherapy intervention, utilizing a randomized controlled pragmatic trial based on whole systems research trial design
This research was conducted according to the principles expressed in the Declaration of Helsinki and received approval and oversight from the research ethics board of The Canadian College of Naturopathic Medicine and Health Canada's Natural Health Products Directorate Clinical Trial Division. Study products were manufactured and dispensed to participants under Good Manufacturing Practices and met Health Canada criteria for quality
The protocol for this trial and supporting CONSORT checklist are available as supporting information; see
For this study a team of naturopathic doctors at the Canadian College of Naturopathic Medicine and its associated teaching clinic (the Robert Schad Naturopathic Clinic) in Toronto, Canada provided expert advice in designing a typical (but not necessarily superlative) naturopathic intervention for anxiety symptoms. The psychotherapy intervention was chosen based on previous studies demonstrating its effectiveness
The study took place from March to July 2006 at two locations of the Canada Post Corporation (CPC) in Ontario, Canada. Canada Post employees who are members of the Canadian Union of Postal Workers (CUPW) were recruited through poster advertising. Interested employees received an information package that included a sample informed consent form, background information explaining the purpose of the study, a description of the intended care as per study protocol, a question and answer sheet regarding study participation, and contact information for study enrolment. Participants came from a range of occupations including mail carriers, transport drivers, and mail processors. Baseline characteristics of the participants are discussed below and summarized in
Parameter | Naturopathic Care (NC) | Psychotherapy (PT) | P value |
Gender | 26 Female∶15 Male | 25 Female∶15 Male | 0.93 |
Age | 52.02±10.95 | 51.28±8.18 | 0.73 |
BMI | 28.25±3.70 | 29.02±5.08 | 0.43 |
Number of people using anxiety medication | 6 | 7 | 0.73 |
BAI score | 23.54±10.13 | 23.45±11.82 | 0.97 |
Number of current smokers | 11 | 8 | 0.24 |
Caffeine doses/wk |
11.78 | 15.91 | 0.209 |
Caffeine doses were calculated based on reported consumption level of caffeinated drinks; 7 oz.Coffee = 1.0; 1 serving cola = 1, tea = 0.5.
Values are shown±Std Deviation.
All potential study participants were required to provide written informed consent and to undergo a 1-hour assessment with a naturopathic doctor (ND) including a non-structured psychiatric interview according to DSM-IV criteria. Self-assessed anxiety levels were quantified using the Beck Anxiety Inventory (BAI) following this interview, and participants were centrally randomized to treatment or control group following collection of this data. Participants' BAI score was utilized to screen for those who exhibited ‘moderate’ or ‘greater’ anxiety. In addition, the Beck Depression Inventory (BDI) was used to screen participants for conjoint depression as per exclusion criteria
Participants were excluded if they could not comply with the study protocol, had mild or no anxiety at the time of assessment (BAI score<10), suffered from concomitant mild to severe depression (BDI score>10), were currently taking prescription medication that required
Two licensed naturopathic doctors conducted enrollment and provided on site delivery of care (OS, KC). This study was a randomized pragmatic control trial comparing naturopathic care to standard first-line treatment for anxiety (psychotherapy). The treatment interventions were planned for 12 weeks. After participants were considered eligible and baseline information collected, they were randomized using age and gender matched stratification to either naturopathic care (active group) (NC) or psychotherapy (control group)(PT) from one of the two practitioners (OS, KC) by an independent third party (DS) using a computer generated randomization sequence. Assignment to practitioner was based on chronology and by alternating back and forth between the practitioners at the time of enrollment (i.e. prior to any mutual knowledge or relationship of the patient and practitioner). Allocation concealment using central randomization was preserved up to the point of treatment. Although the analysts and participants were blinded to treatment allocation, and supplements were delivered using opaque, matched pills for all the supplements and placebo used, it was not possible to mask the interventions from the participants or the clinicians delivering care. Care was taken in the informed consent to ensure that participant blinding was preserved and thus keep expectation biases as equal as possible in both treatment groups.
Participants receiving naturopathic care were seen once per week for 30 minutes to receive specific treatment for anxiety over a period of 12 weeks. A licensed naturopathic doctor with more than 4 years of experience administered the treatments during these sessions. During the treatment sessions, data on patients' lifestyle and diet was obtained, and diaphragmatic deep breathing exercises were performed. Lifestyle and nutritional counseling specific to the individual patient was given with special emphasis on reducing intake of stimulants (caffeine, cigarettes, chocolate), eating small, meals at regular intervals, and increasing consumption of fruit, fish, vegetables, nuts, and whole grains. Participants were encouraged to exercise on a regular basis. Two supplements were provided for participants to take throughout the trial: 1) the herb
Although individualized treatment of patients is a highly emphasized tenet that governs the practice of naturopathic medicine, this ‘generalized’ treatment protocol was designed by a group of experienced naturopathic doctors at a naturopathic educational institution for the purposes of this trial. Consideration was given to the overall concerns and typical needs of this population of participants in drafting the naturopathic treatment protocol, including the need to address generalized anxiety, physical and mental strain, improper sleeping schedules, a holistic view of health, overuse of stimulating substances, and support optimal health within the context of the workplace. Characteristics of the Canada Post population as well as the experiences of two naturopathic doctors (OS, KC) involved in a previous trial provided the basis for the study intervention
Participants randomized to this control group received psychotherapy consisting of patient directed counseling and cognitive behavioural therapy for 30 minutes each week for 12 weeks for anxiety as well as matched placebo pills. During these sessions, participants received cognitive restructuring exercises for the symptoms of anxiety delivered by a practitioner with 5 years of training and experience in cognitive behavioural therapy. In addition, participants were educated on the importance of maintaining a healthy diet, reducing stimulants (caffeine and tobacco), and taught a deep breathing exercise at the start of the trial. In an effort to provide effective control measures, participants in this group were asked about their dietary habits and stimulant use throughout the trial with no continued dietary or lifestyle counseling. Essentially, this meant that participants were made aware of the importance of these issues without ongoing advice. Participants were encouraged to exercise. Opaque, matched placebo pills (2 pills, taken twice daily) consisting of an inert fiber substance were administered and participant compliance was assessed identically to that of the naturopathic group. Careful consideration was given in the design of the treatments to provide an effective treatment for anxiety while creating an adequately matched ‘placebo’ to the active group As such, the control group treatments contained an element of individualized counseling, therapeutic doctor-patient relationship, patient education, a mind-body exercise, patient motivation and a ‘pill’. Treatments involving individualized recommendations were made at the discretion of the investigator providing study care.
The primary outcome for this study was the
Secondary outcome measures included three questionnaires related to quality of life administered at 4, 8 and 12-week time points:
In addition, a series of 7-point visual analogue scale (VAS) questions were administered at 4, 8, and 12-week time points to measure participants subjective impressions of their own: compliance to the treatment protocol; benefit from the treatment; how well the study treatments met their expectations for treating their anxiety; interest in pursuing treatments; and ability to cope with stress since starting study treatments. Higher scores on the VAS corresponded to greater positive subjective impression in the individual parameter. Although the study was not powered to measure significance in these VAS measures, it was expected that group comparison would allow inference on the nature and variance in the non-specific effects between active and control group. We hypothesized that minimal inter-group differences in these parameters would correspond to a high correlation in non-specific effects between the two groups; essentially well-matched comparator treatments
All analyses were performed by a statistician (QZ) under blinded conditions using SAS/STAT (Version 9.1, Cary, NC). The data at baseline visit and week 12 visit were summarized by mean and standard deviation. When the missing data occurred at week 12, its value was replaced by the value at week 8 as part of intention to treat analysis. For each group, the treatment effect at week 12 was compared to the baseline and assessed by the paired t-test. The mean difference, its 95% confidence interval and p-value were reported. The difference of the treatment effect between the NC group and the PT group was compared by the independent t-test. The mean difference of the treatment effect, its 95% confidence interval and p-value are reported. The decision to not conduct a sensitivity analysis between per-protocol and intention to treat was made prior to the conduct of the study and then re-evaluated post hoc. This decision was based on the low number of dropouts prior to week 8 and minimal adverse reactions expected.
In order to determine a 20% reduction in anxiety scores, and assuming a population standard deviation of 20%, we calculated a sample size of 37 was necessary in each arm, providing 80% power at a 5% alpha value
All patients with available data were analyzed according to the arm to which they were randomized using intention-to-treat. We summarized the baseline data and the data at week 12 by mean and standard deviation. For any missing data at week 12, we carried forward the value at week 8. The means over the 12-week period were plotted for the outcomes of BAI, SF-36, and FQ component separately. To assess the treatment effect for each group we calculated the mean change in scores between groups at week 12 and the baseline. We also calculated the mean changes between groups to examine the group effect. The statistical significance of the changes for each group were tested using the paired t-test; the exact 2-sided p-value is reported. To compare the change scores between groups, the two-sample t-test was performed. All p-values are 2-sided. Statistical analyses were done with the SAS (version 9.1) software package.
Outcomes reported from these analyses include: FQ dimension score, weight and BMI (
Outcomes | Group | Baseline Mean±Std (N) | Week 12* Mean±Std (N) | Change at 12 wks from baseline Mean (95%CI) (N, p-value) | Difference of changes between groups Mean (95%CI) P-value |
FQ Subjective | NC | 66.55±17.96 (41) | 47.17±20.52 (36) | −20.39 (−26.41, −14.37) (36, <0.0001) | −18.01(−25.16, −10.85) <0.0001 |
PT | 65.98±15.79 (40) | 63.23±15.01 (39) | −2.38 (−6.63, 1.87) (39, 0.2634) | ||
FQ physical | NC | 52.03±21.96 (41) | 38.89±18.69 (36) | −14.29 (−20.63, −7.95) (36, <0.0001) | −13.19 (−21.85, −4.52) 0.0033 |
PT | 55.12±23.08 (40) | 53.60±17.23 (39) | −1.10 (−7.22, 5.02) (39, 0.7182) | ||
FQ Motivation | NC | 56.79±19.82 (41) | 39.48±16.49 (36) | −18.95 (−26.30, −11.60) (36, <0.0001) | −20.32 (−29.05, −11.59) <0.0001 |
PT | 52.23±17.09 (40) | 53.57±13.56 (39) | 1.37 (−3.81, 6.56) (39, 0.5946) | ||
FQ Concentration | NC | 61.74±17.37 (41) | 45.24±19.34 (36) | −17.14 (−23.75, −10.54) (36, <0.0001) | −17.51 (−25.89, −9.13) <0.0001 |
PT | 56.00±17.93 (40) | 55.82±20.44 (39) | 0.37 (−5.10, 5.83) (39, 0.8928) | ||
Weight | NC | 76.60±13.16 (41) | 74.76±12.22 (36) | −1.98 (−2.85, −1.11) (36, <0.0001) | −1.47 (−2.64, −0.30) 0.0146 |
PT | 81.13±18.96 (40) | 80.42±19.06 (39) | −0.51 (−1.32, 0.30) (39, 0.2089) | ||
BMI | NC | 28.25±3.70 (41) | 27.53±3.14 (36) | −0.75 (−1.08, −0.42) (36, <0.0001) | −0.56 (−1.00, −0.12) 0.0128 |
PT | 29.02±5.08 (40) | 28.80±5.08 (39) | −0.19 (−0.49, −0.11) (39, 0.2136) |
Week 12* - the week 8 value was used for week 12 if the week 12 data was missing.
NC = Naturopathic Care; PT = Psychotherapy.
Outcomes | Group | Baseline Mean±Std (N) | Week 12* Mean±Std (N) | Change at 12 wks from baseline Mean (95%CI) (N, p-value) | Difference of changes between groups Mean (95%CI) P-value |
BAI total score | NC | 23.54±10.13 (41) | 10.89±11.69 (36) | −13.31(−16.51, −10.12) (36, <0.0001) | −6.16 (−10.24, −2.08)0.0036 |
PT | 23.45±11.82 (40) | 16.28±10.89 (39) | −7.15 (−9.84, −4.47) (39, <0.0001) | ||
MY-MOP Symptom 1 | NC | 5.20±1.25 (41) | 2.88±1.25 (36) | −2.24 (−2.75, −1.72) (36, <0.0001) | −1.77 (−2.59, −0.95) <0.0001 |
PT | 4.43±1.45 (40) | 3.97±1.53 (39) | −0.46 (−1.10, 0.17) (39, 0.1492) | ||
MY-MOP Symptom 2 | NC | 4.78±1.23 (40) | 2.790±1.49 (34) | −1.94 (−2.43, −1.45) (34, <0.0001) | −1.08 (−1.90, −0.25) 0.0115 |
PT | 4.84±1.69 (38) | 3.87±1.36 (38) | −0.86 (−1.53, −0.20) (37, 0.0126) | ||
Compliance (VAS measure) |
NC | 4.79±1.51 (40) | 5.29±0.94 (36) | 0.66 (0.30, 1.01) (35, 0.0006) | 0.28 (−0.16, 0.71) 0.2071 |
PT | 4.92±1.24 (39) | 5.37±1.16 (39) | 0.38 (0.11, 0.65) (38, 0.0066) | ||
Benefit |
NC | 4.70±1.80 (40) | 5.79±0.92 (36) | 1.24 (0.67, 1.82) (35, 0.0001) | 1.14 (0.46, 1.82) 0.0014 |
PT | 4.58±1.47 (40) | 4.74±1.23 (39) | 0.10 (−0.31, 0.51) (39, 0.6164) | ||
Interest |
NC | 5.60±1.44 (39) | 5.76±1.24 (36) | 0.264 (−0.23, 0.76) (34, 0.2870) | 0.008 (−0.64, 0.65) 0.9795 |
PT | 5.08±1.59 (40) | 5.28±1.23 (39) | 0.256 (−0.17, 0.69) (39, 0.2351) | ||
Expectation |
NC | 4.80±1.59 (40) | 5.57±1.09 (36) | 1.01 (0.49, 1.54) (35, 0.0004) | 0.73 (0.08, 1.38) 0.0272 |
PT | 4.55±1.32 (40) | 4.77±1.17 (39) | 0.28 (−0.13, 0.69) (39, 0.1722) | ||
Stress |
NC | 5.00±1.26 (40) | 5.83±0.85 (36) | 0.91 (0.48, 1.35) (35, 0.0001) | 0.81 (0.24, 1.37) 0.0055 |
PT | 4.41±1.23 (39) | 4.45±1.11 (38) | 0.10 (−0.27, 0.49) (37, 0.5646) |
Week 12* - the week 8 value will be used for week 12 If missing value is occurred at week 12.
- week 4 was considered baseline for these outcome measures.
NC = Naturopathic Care; PT = Psychotherapy.
Outcomes SF-36 | Group | Baseline Mean±Std (N) | Week 12* Mean±Std (N) | Change at 12 wks from baseline Mean (95%CI) (N, p-value) | Difference of changes between groups Mean (95% CI) P-value |
Aggregate physical component | NC | 46.23±7.99 (36) | 49.83±7.24 (34) | 3.76 (1.28, 6.23) (32, 0.0042) | 3.26 (−0.15, 6.66) 0.0608 |
PT | 45.51±8.82 (39) | 46.59±7.98 (38) | 0.50(−1.91, 2.91) (37, 0.6768) | ||
Aggregate mental component | NC | 38.97±9.81 (36) | 50.92±7.29 (34) | 12.56 (9.02, 16.10) (32, <0.0001) | 10.34 (5.21, 15.46) 0.0001 |
PT | 39.03±9.95 (39) | 41.54±10.61 (38) | 2.23 (−1.54, 5.99) (37, 0.2378) | ||
Physical functioning | NC | 44.15±10.95 (41) | 50.43±8.73 (36) | 5.61 (3.10, 8.13) (36, <0.0001) | 4.88 (0.99, 8.76) 0.0145 |
PT | 44.69±11.19 (40) | 46.02±11.44 (39) | 0.73 (−2.27, 3.74) (39, 0.6334) | ||
Role physical | NC | 44.99±7.88 (39) | 48.62±8.41 (36) | 4.34(1.61, 7.07) (35,0.0028) | (−0.11, 7.78) 0.0564 |
PT | 44.18±9.49 (40) | 44.86±8.92 (39) | 0.50 (−2.40, 3.41) (39, 0.7181) | ||
Bodily pain | NC | 40.55±8.63 (39) | 48.04±7.93 (35) | 7.77 (5.30, 10.24) (41, <0.0001) | 4.40 (0.96, 7.85) 0.0130 |
PT | 41.07±9.66 (40) | 45.06±8.41 (38) | 3.36 (0.89, 5.84) (40, 0.0091) | ||
General health | NC | 43.03±9.95 (40) | 49.91±9.38 (35) | 6.70 (3.74, 9.65) (35, <0.0001) | 7.13 (3.34, 10.92) 0.0004 |
PT | 43.77±8.74 (40) | 43.49±7.13 (39) | −0.43 (−2.95, 2.08) (39, 0.7286) | ||
Vitality | NC | 42.50±9.88 (41) | 53.31±10.08 (36) | 11.27 (7.46,15.09) (36, <0.0001) | 9.43 (4.77, 14.09) 0.0001 |
PT | 42.10±8.37 (40) | 44.17±8.65 (39) | 1.84 (−1.05, 4.73) (39, 0.2046) | ||
Social functioning | NC | 37.90±11.32 (40) | 48.12±7.85 (35) | 10.27 (6.06, 14.48) (34, <0.0001) | 7.40 (2.07, 12.72) 0.0072 |
PT | 38.95±11.19 (39) | 42.31±9.64 (39) | 2.87 (−0.61, 6.35) (38, 0.1031) | ||
Role emotional | NC | 39.65±8.48 (40) | 48.54±8.80 (36) | 9.22 (5.40, 13.04) (35, <0.0001) | 7.42 (1.86, 12.99) 0.0096 |
PT | 40.33±10.64 (40) | 42.32±13.13 (39) | 1.79 (−2.32, 5.91) (39, 0.3833) | ||
Mental health | NC | 40.22±10.75 (40) | 48.83±11.03 (36) | 9.49 (5.63, 13.36) (35, <0.0001) | 6.84 (1.69, 12.10) 0.0102 |
PT | 40.79±9.06 (40) | 43.65±9.55 (39) | 2.60 (−1.03, 6.23) (39, 0.1553) |
Week 12* - the value at week 8 was used for week 12 If the missing value was occurred.
NC = Naturopathic Care; PT = Psychotherapy.
Type | NC | PT |
Gastrointestinal upset | 2 | 2 |
Overstimulation | 2 | 2 |
Rash | 0 | 1 |
‘Feeling warm’ | 1 | 0 |
Increased frequency of nocturnal night cramps | 1 | 1 |
Mild hair loss | 1 | 1 |
NC = Naturopathic Care; PT = Psychotherapy.
Randomization was stratified based on age and gender. Both treatment groups had similar characteristics including baseline BAI score, number of users of prescription anxiety medication, and use of stimulants (number of smokers, use of caffeine).
Study treatments were well received, as shown by expectation scores demonstrated by the VAS and good compliance rates in both groups. The mean total of missed supplements was 6.83 pills (94.3%) in the NC group and 6.43 pills (94.6%) in the PT group throughout the 12-week duration of the trial.
Significant improvements from baseline on the primary outcomes measure (BAI) were seen in both the naturopathic (−13.31; p-value<0.0001) and psychotherapy (−7.15; p-value<0.0001) groups (see
22 (25%) of participants were willing to give consent for the researchers to access absenteeism and data on health care expenditures under the employee health benefits insurance program. A sample size this small proved to be unsuitable for cost-effectiveness analysis and is a limitation of the research study. This limitation based on participation may, in part, be due to increased apprehension surrounding issues of informed consent and researcher access to this information in the study's population.
Our results should be of interest to patients, clinicians and workplace-related health services alike. Results of this study indicate a significant reduction in anxiety level from the use of either naturopathic care or a standardized psychotherapy intervention in this workplace setting. These results are consistent with systematic reviews on the short-term efficacy of counseling in the treatment of anxiety
Our study demonstrates that naturopathic treatments, cognitive behavioral therapy and counseling have a significant effect on decreasing the symptoms of anxiety. In addition, naturopathic treatments including dietary changes and the herb
This was a pragmatic randomized controlled trial, and as such, it is difficult to ascertain the precise effect of each of the component therapies of the NC and PT treatment packages. Future research trials employing a multi-factorial design would assist in isolating and characterizing the effects of single and combination treatments.
Maintaining internal and external validity in pragmatic RCTs is a challenge
Internal validity was achieved by: attempting to account for non-specific effects of treatments in both groups; absence of assessment bias; and preventing contamination
Although a statistically significant difference in reduction of anxiety symptoms was observed between NC and PT treatment, we observed some methodological challenges based on our study population and study design. Sample size calculation was based on detecting a clinically and statistically significant effect size (±20%) on BAI scores from baseline, however both the NC and PT groups demonstrated significant reductions in BAI scores (NC 56.5%, PT 30.5%) thus minimizing the ability to detect the differential effect size
Additionally, it should be highlighted that this study investigated changes in patient-reported symptoms of anxiety. Future studies would need to employ the use of blinded independent assessment of this disorder using a structured diagnostic interview based on DMS-IV criteria (SCID) throughout the study to gather non-patient rated information relating to anxiety.
Naturopathic treatment including
CONSORT checklist
(0.05 MB DOC)
Trial Protocol
(0.45 MB DOC)
The authors wish to thank the corporate members and the Union members of the planning committee at the Canada Post Corporation and the Canadian Union of Postal Workers, Swiss Herbals Inc. for supplying study product free of charge, as well as the Scientific Review Board of the Canadian College of Naturopathic Medicine for assistance in the design of this study.