Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638450
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Clinical Trial for Acupuncture in Adolescents With Emotional Disorders and Insomnia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dense Cranial Electroacupuncture Stimulation Plus Body Acupuncture for Adolescents With Emotional Disorders a Randomized Controlled Trial With Observations on Salivary Oxytocin and Cortisol Changes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an assessor-blinded randomized minimal acupuncture stimulation MAS-controlled trial A total of 148 adolescents aged 15-22 years who have mild to moderate emotional disorders will be recruited They will be randomly assigned to dense cranial electroacupuncture stimulation plus body acupuncture DCEASBA n 74 and MAS n 74 groups for 2 sessions per week for 8 weeks The primary outcome will be assessed using the Beck Anxiety Inventory BAI The secondary outcomes include the Beck Depression Inventory II BDI-II for depression the Pittsburgh Sleep Quality Index PSQI for sleep quality and the World Health Organization Quality of Life-Brief WHOQOL-BREF HK version for the general quality of life Saliva will be collected at baseline and the end of the 8-week study Salivary oxytocin and cortisol will be analyzed A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the two groups and linear regression will be conducted to examine inter-correlations among clinical improvement and changes in biomarker levels Subgroup analysis will be conducted to identify specific effects of DCEASBA
Detailed Description:
Emotional disorders are particularly highly prevalent in adolescents One epidemiological study conducted in Hong Kong local university students has revealed that approximately 70 of students complained of some degree of depression and 54 of anxiety nearly 9 had moderately severe to severe depressive symptoms and 6 had severe anxiety This has become more severe during and post COVID-19 pandemic However psychiatric disorders of youths are often underdiagnosed and vastly undertreated because the condition of most young patients is mild and they fear drugs side effects
A large body of evidence well confirms the benefits and effectiveness of acupuncture in the treatment of various depression and anxiety disorders We have demonstrated the effectiveness of cranial electroacupuncture stimulation plus body acupuncture in the treatment of major depression post-stroke cognitive impairment insomnia obsessive-compulsive disorder and chemotherapy-induced cognitive impairment via a series of clinical trials These results have encouraged us to further conduct a randomized controlled trial to confirm the efficacy of electroacupuncture treatment in young subjects with anxiety and emotional disorders
Salivary oxytocin and cortisol are the two most compelling biomarkers for screenings diagnosis and predicting treatment outcomes in children and adolescents with psychiatric disorders Previous studies showed that electroacupuncture and acupuncture suppressed salivary cortisol levels while anxiety symptoms were alleviated These studies suggest that salivary oxytocin and cortisol could serve as valid biomarkers for predicting the treatment outcomes of acupuncture
A large body of evidence well confirms the benefits and effectiveness of acupuncture in the treatment of various depression and anxiety disorders We have demonstrated the effectiveness of cranial electroacupuncture stimulation plus body acupuncture in the treatment of major depression post-stroke cognitive impairment insomnia obsessive-compulsive disorder and chemotherapy-induced cognitive impairment via a series of clinical trials These results have encouraged us to further conduct a randomized controlled trial to confirm the efficacy of electroacupuncture treatment in young subjects with anxiety and emotional disorders
Salivary oxytocin and cortisol are the two most compelling biomarkers for screenings diagnosis and predicting treatment outcomes in children and adolescents with psychiatric disorders Previous studies showed that electroacupuncture and acupuncture suppressed salivary cortisol levels while anxiety symptoms were alleviated These studies suggest that salivary oxytocin and cortisol could serve as valid biomarkers for predicting the treatment outcomes of acupuncture
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None