Using Aromatherapy in Substance Use Disorder

Study Overview
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Brief Summary
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The purpose of this clinical trial study is to see if Bergamot, an aroma therapy essential oil, has any effect on comfort, ease, and stress. Participants will be asked to use a bergamot aroma inhaler, which is a small tube about the size of a lipstick container, at least three times a day for one week. Comfort, ease, and stress will be measured with self-report survey at the beginning and at the end of the week. In addition, participants will be asked to complete a daily logbook to record use of the inhaler. The study lasts for one week (7 days). The aims of this study are to explore the effects of Bergamot essential oil on comfort, ease, and stress in adults in a SUD treatment program, and to evaluate the feasibility of this type of aroma therapy intervention.

Detailed Description
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Statement of purpose: The purpose of the study is to examine the effect of an aromatic intervention using bergamot essential oil on comfort, ease, and stress in adults in a SUD recovery program Research Question: What are differences in comfort, ease, and stress for persons in a substance use disorder program who receive aromatic intervention and for those who do not? Conceptual framework: An integrated theoretical framework combining the theory of comfort (Kolcaba, 2003) and the concept of welcoming ease (Reven, 2022) will be used as theoretical guidance for this study. Aims and Objectives: Specific Aim #1: Evaluate the feasibility and acceptability of an aromatherapy intervention by examining recruitment, enrollment and retention rates, intervention fidelity, and cost analysis. Specific Aim #2: Pilot test bergamot essential oil intervention with adults in a substance use disorder recovery program. Background: Appalachia is at the epicenter of the opioid addiction crisis with hardly a family left untouched by the devastating consequences. Those who make it to recovery programs are often plagued by anxiety and depression. Those in treatment have identified increasing the level of comfort during substance use recovery as vital. Integrating aromatherapy could help improve perception of comfort and reduce stress thus enhancing recovery program progression. Methods: The study uses a parallel-randomized control group comparison design. Data will be collected from participants daily and post intervention. For Aim #1, descriptive and bivariate analysis will be conducted. Statistical assumptions will be tested. Sample demographics will be reported. For Aim #2, descriptive statistics will be used as well as participant recruitment, enrollment, and retention rates. Reasons for non-participation and attrition will be recorded. Percentage of intervention consistency will be calculated and cost of the intervention will be determined. Timeline: The proposed study would begin as soon as grant funding is available with projected timeline being August 2022 to December 2023.

Official Title
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Using Aromatherapy for Comfort, Ease, and Stress for Adults Being Treated for Substance Use Disorder in North Central Appalachia: A Randomized Controlled Trial

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Other: Aroma Inhaler with Bergamot essential oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants can be at any level of treatment, including peer recovery coach program (at West Virginia University Comprehensive Opioid Addiction Treatment [COAT] program) All participants must be alert and oriented Provide written consent Able to read and write English Exclusion Criteria: Have a medical history of asthma or other serious respiratory disease Known allergy to citrus. Dislike of Bergamot

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Adults (>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. | Other: Aroma Inhaler with Bergamot essential oil<br>* The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.<br>|
| No Intervention: Control Group<br>Adults (>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine Feasibility (participant recruitment) | Determine feasibility by assessing the number of participants recruited. | Up to 18 months | 
| Examine Feasibility (participant enrollment) | Determine feasibility by assessing how many participants enroll. | Up to 18 months | 
| Examine Feasibility (participant retention) | Determine feasibility by assessing count of participants retained. | Up to 18 months | 
| Examine Acceptability of the intervention | Determine acceptability by assessing participant feedback through use of a visual analog scale (VAS) where 0 means the least comfortable and 100 means the most comfortable. | Up to 7 days | 
| Examine Fidelity of the intervention | Determine fidelity by assessing the count of participants that completed the intervention as directed as shown in the daily logbook. | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived Comfort level | The concept of comfort is operationalized by the Generalized Comfort Questionnaire (GCQ). This incorporates a Likert scale from 1 to 6 with 1 being the least comfortable and 6 being the most comfortable. The investigators are looking at a change in comfort from before the intervention to after the intervention. | Pre test prior to day 1 to Post test after 1 week | 
| Change in perceived Ease level | The concept of ease is measured using the Ease measure. This is assessed using a Likert scale from 1 to 4 with 1 being the least amount of ease and 4 being the highest amount of ease. The investigators are looking at a change in ease from before the intervention to after the intervention. | Pre test prior to day 1 to Post test after 1 week | 
| Change in perceived Stress level | The concept of stress is measured using the Depression, Anxiety, and Stress Scale (DASS), short version 21-questions. This is assessed using a Likert scale from 0 to 3 with 0 being the least amount of stress and 3 being the highest amount of stress. The investigators are looking at a change in stress from before the intervention to after the intervention. | Pre test prior to day 1 to Post test after 1 week | 
| Visual Analogue Scale to assess daily perceived Comfort | The Visual Analogue Scale (VAS) is used as a daily measure of comfort. It provides validation for the GCQ using a 100mm line where Comfort is rated using a mark on the line between 0 and 100 I feel as comfortable as possible with 0 being the least comfortable and 100 being the most comfortable. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social and behavioral, randomized, questionnaires, aroma therapy