Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture
Study Details
Study Description
Brief Summary
This will be a randomized, single blind study of 6 weeks duration involving the use of auricular acupuncture or sham acupuncture in the adjunctive treatment of depression in college students.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
This will be a randomized, single blind study of 6 weeks duration involving the use of auricular acupuncture or sham acupuncture in the add adjunctive treatment of depression in college students. College students presenting for care at Counseling and Psychological Services, who meet Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria for major depression single episode or recurrent will be included in the trial. Subjects will be randomized into a sham auricular acupuncture group, or a treatment acupuncture group. All subjects who meet the inclusion criteria will be treated with the Selective serotonin reuptake inhibitor (SSRI) Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Some subjects will be treated twice weekly during their follow-up visits with sham auricular acupuncture, some subjects will be treated with micro-currents of electricity in the auricular acupuncture group. The duration of the trial will be 6 weeks.
Auricular acupuncture is a form of acupuncture which utilizes the surface of the external ear to identify points of inflammation in the body. It does this, in this case, by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation or stress. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds. In the case of treatment, there will be an auditory alarm followed by a micro -current dose of electricity. Sham acupuncture will be characterized by the auditory alarm, but no current will be applied to the participants ear.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Auricular Acupuncture + Lexapro Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture. |
Device: Auricular Acupuncture
Auricular acupuncture is a form of acupuncture which utilizes the surface of the external ear to identify points of inflammation in the body. It does this, in this case, by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation or stress. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds.
Other Names:
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Sham Comparator: Sham Auricular Acupuncture + Lexapro Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). |
Drug: Sham Auricular Acupuncture + Lexapro
Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current).
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks [Assessed at baseline and 6 weeks.]
Instrument developed to assess functional impairment in three inter-related domains; work/school, social and family life. Items are scored on a 0 - 10 point scale. Higher scores indicate more functional impairment.
- Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study [Assessed at Baseline and After Treatment, Approximately 6 Weeks later.]
The Behavioral Health Measure - 20 (BHM-20) is a 20-item client-report questionnaire that assesses the three phases of behavioral health: (a) well-being (distress, life satisfaction, motivation), (b) psychological symptoms (depression, anxiety, panic disorder, mood swings associated with bipolar disorder, eating disorder, alcohol/drug abuse, suicidality, risk of violence), and (c) life functioning (work/school, intimate relationships, social relationships, life enjoyment). The BHM-20 assesses the most frequently seen problems in outpatient psychotherapy. Scores range from 0-4. Lower scores indicate more distress.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Meets DSM-V criteria for major depression single episode or recurrent as a primary diagnosis. Participants must have been symptomatic with depression for 2 months or more and less than 18 months.
Exclusion Criteria:
-
a current diagnosis or history of alcohol or substance abuse or dependence that has not been in full and sustained remission for 3 months
-
any current psychiatric diagnosis which is the primary focus of treatment other than major depression
-
current history of mania or hypomania, schizophrenia, or any psychotic disorder, obsessive-compulsive disorder, autism spectrum conditions, organic mental disorders or mental disorders due to a physical condition
-
the participant has a history of lack of response to a previous adequate treatment with 2 antidepressants for major depression at a standard dose for at least a six-week period of time
-
any axis II disorder
-
if the participant is female the participant agrees to use adequate contraception from the signing of the informed consent and throughout the study and for 30 days afterwards. pregnant or lactating females or those intending to become pregnant during the study are excluded
-
if the participant is unlikely to comply with a clinical study protocol or is unsuitable for the study as determined by the principal investigator
-
if the participant has clinically significant unstable physical illness such as neurologic disorders, diabetes, immunologic disorders, or any disturbance of a metabolic nature which may compromise the study
-
the participant has a risk of suicide according to the investigators clinical judgment and according to the screening instruments used in the trial
-
the subject has started receiving formal cognitive psychotherapy within 30 days from screening or plans to initiate such therapy during the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Counseling and Psychological Services | Fort Myers | Florida | United States | 33965 |
Sponsors and Collaborators
- Florida Gulf Coast University
Investigators
- Principal Investigator: John Prater, DO, Counseling and Psychological Services
Study Documents (Full-Text)
None provided.More Information
Publications
- Berman BM, Lao L, Langenberg P, Lee WL, Gilpin AM, Hochberg MC. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee: a randomized, controlled trial. Ann Intern Med. 2004 Dec 21;141(12):901-10.
- Gori L, Firenzuoli F. Ear acupuncture in European traditional medicine. Evid Based Complement Alternat Med. 2007 Sep;4(Suppl 1):13-6. doi: 10.1093/ecam/nem106.
- MacPherson H, Richmond S, Bland M, Brealey S, Gabe R, Hopton A, Keding A, Lansdown H, Perren S, Sculpher M, Spackman E, Torgerson D, Watt I. Acupuncture and counselling for depression in primary care: a randomised controlled trial. PLoS Med. 2013;10(9):e1001518. doi: 10.1371/journal.pmed.1001518. Epub 2013 Sep 24.
- Nixon MK, Cheng M, Cloutier P. An open trial of auricular acupuncture for the treatment of repetitive self-injury in depressed adolescents. Can Child Adolesc Psychiatr Rev. 2003 Feb;12(1):10-2.
- Qu SS, Huang Y, Zhang ZJ, Chen JQ, Lin RY, Wang CQ, Li GL, Wong HK, Zhao CH, Pan JY, Guo SC, Zhang YC. A 6-week randomized controlled trial with 4-week follow-up of acupuncture combined with paroxetine in patients with major depressive disorder. J Psychiatr Res. 2013 Jun;47(6):726-32. doi: 10.1016/j.jpsychires.2013.02.004. Epub 2013 Mar 14.
- Sinyor M, Schaffer A, Levitt A. The sequenced treatment alternatives to relieve depression (STAR*D) trial: a review. Can J Psychiatry. 2010 Mar;55(3):126-35. Review.
- Wang SM, Peloquin C, Kain ZN. The use of auricular acupuncture to reduce preoperative anxiety. Anesth Analg. 2001 Nov;93(5):1178-80, table of contents.
- FloridaGCU
Study Results
Participant Flow
Recruitment Details | Recruitment period began during the summer of 2015 and continued through the spring of 2016. All participants were recruited through Counseling and Psychological Services. |
---|---|
Pre-assignment Detail | Two potential participants immediately dropped from study prior to group assignment related to scheduling and commitment concerns. |
Arm/Group Title | Auricular Acupuncture + Lexapro | Sham Auricular Acupuncture + Lexapro |
---|---|---|
Arm/Group Description | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture. Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds. | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). Sham Auricular Acupuncture + Lexapro: Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). |
Period Title: Overall Study | ||
STARTED | 7 | 6 |
COMPLETED | 7 | 6 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Auricular Acupuncture + Lexipro | Sham Auricular Acupuncture + Lexapro | Total |
---|---|---|---|
Arm/Group Description | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture. Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds. | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). Sham Auricular Acupuncture + Lexapro: Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). | Total of all reporting groups |
Overall Participants | 7 | 6 | 13 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
7
100%
|
6
100%
|
13
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Sex: Female, Male (Count of Participants) | |||
Female |
7
100%
|
1
16.7%
|
8
61.5%
|
Male |
0
0%
|
5
83.3%
|
5
38.5%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
2
28.6%
|
1
16.7%
|
3
23.1%
|
Not Hispanic or Latino |
4
57.1%
|
4
66.7%
|
8
61.5%
|
Unknown or Not Reported |
1
14.3%
|
1
16.7%
|
2
15.4%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
1
16.7%
|
1
7.7%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
White |
5
71.4%
|
4
66.7%
|
9
69.2%
|
More than one race |
2
28.6%
|
1
16.7%
|
3
23.1%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||
United States |
7
100%
|
6
100%
|
13
100%
|
Outcome Measures
Title | Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks |
---|---|
Description | Instrument developed to assess functional impairment in three inter-related domains; work/school, social and family life. Items are scored on a 0 - 10 point scale. Higher scores indicate more functional impairment. |
Time Frame | Assessed at baseline and 6 weeks. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Auricular Acupuncture + Lexipro | Sham Auricular Acupuncture + Lexapro |
---|---|---|
Arm/Group Description | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture. Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds. | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). Sham Auricular Acupuncture + Lexapro: Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). |
Measure Participants | 7 | 6 |
Work / School Domain |
-3.57
(1.03)
|
-1.5
(1.19)
|
Social Life Domain |
-2.29
(1.16)
|
-1.0
(1.20)
|
Family Life Domain |
-3.42
(1.14)
|
-0.17
(0.70)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Auricular Acupuncture + Lexipro, Sham Auricular Acupuncture + Lexapro |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .05 |
Comments | P-value above was calculated. Does not reference threshold for clinical significance. | |
Method | Repeated Measures Analysis of Variance | |
Comments |
Title | Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study |
---|---|
Description | The Behavioral Health Measure - 20 (BHM-20) is a 20-item client-report questionnaire that assesses the three phases of behavioral health: (a) well-being (distress, life satisfaction, motivation), (b) psychological symptoms (depression, anxiety, panic disorder, mood swings associated with bipolar disorder, eating disorder, alcohol/drug abuse, suicidality, risk of violence), and (c) life functioning (work/school, intimate relationships, social relationships, life enjoyment). The BHM-20 assesses the most frequently seen problems in outpatient psychotherapy. Scores range from 0-4. Lower scores indicate more distress. |
Time Frame | Assessed at Baseline and After Treatment, Approximately 6 Weeks later. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Auricular Acupuncture + Lexipro | Sham Auricular Acupuncture + Lexapro |
---|---|---|
Arm/Group Description | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture. Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds. | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). Sham Auricular Acupuncture + Lexapro: Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). |
Measure Participants | 7 | 6 |
Mean (Standard Deviation) [units on a scale] |
0.89
(0.280)
|
0.47
(0.348)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Auricular Acupuncture + Lexipro, Sham Auricular Acupuncture + Lexapro |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | .05 |
Comments | ||
Method | Repeated Measures Analysis of Variance | |
Comments |
Adverse Events
Time Frame | Adverse events were assessed throughout the duration of data collection for each individual (up to 6 weeks from baseline, initial assessment). | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Auricular Acupuncture + Lexipro | Sham Auricular Acupuncture + Lexapro | ||
Arm/Group Description | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants in this group will be treated twice weekly during their follow-up visits with micro-currents of electricity through auricular acupuncture. Auricular Acupuncture: Auricular acupuncture is a form of acupuncture which utilizes the surface ear to identify points of inflammation in the body. It does this by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds. | Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). Sham Auricular Acupuncture + Lexapro: Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current). | ||
All Cause Mortality |
||||
Auricular Acupuncture + Lexipro | Sham Auricular Acupuncture + Lexapro | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | 0/6 (0%) | ||
Serious Adverse Events |
||||
Auricular Acupuncture + Lexipro | Sham Auricular Acupuncture + Lexapro | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | 0/6 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Auricular Acupuncture + Lexipro | Sham Auricular Acupuncture + Lexapro | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | 0/6 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Adam McCabe |
---|---|
Organization | Counseling and Psychological Services |
Phone | 239-590-7950 |
amccabe@fgcu.edu |
- FloridaGCU