Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754009
Status:
SUSPENDED
Last Update Posted:
2021-02-24
First Post:
2021-02-09
Brief Title:
The Effects of Trauma-sensitive Yoga and Tai Chi on Mental Health
Sponsor:
University of Northern Iowa
Organization:
University of Northern Iowa
Study Overview
Official Title:
The Effects of Trauma-sensitive Yoga and Tai Chi on Mental Health
Status:
SUSPENDED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TSYTC
Brief Summary:
A three-arm randomized control trial design was used to test the effectiveness of 1 Chen Style Tai Chi TC and talk therapy 2 Trauma-Sensitive Yoga and talk therapy in comparison to 3 talk therapy only control group on four self-reported mental health outcomes overall mental health depression anxiety and trauma symptoms Secondary outcomes include self-reported measures of resilience stress social support and alcohol consumption The two research questions driving this research study are as follows
1 Does TSY and talk therapy significantly lower a PTSD symptoms and b comorbid symptoms of anxiety depression and other mental health determinants compared to talk therapy alone
2 Does TC and talk therapy significantly lower a PTSD symptoms and b comorbid symptoms of anxiety depression and other mental health determinants compared to talk therapy alone
1 Does TSY and talk therapy significantly lower a PTSD symptoms and b comorbid symptoms of anxiety depression and other mental health determinants compared to talk therapy alone
2 Does TC and talk therapy significantly lower a PTSD symptoms and b comorbid symptoms of anxiety depression and other mental health determinants compared to talk therapy alone
Detailed Description:
Design This study consists of a three-arm randomized control trial design to test the effectiveness of 1 Chen Style tai chi TC and talk therapy 2 trauma-sensitive yoga TSY and talk therapy in comparison to 3 treatment as usual TAU which typically consists of talk therapy on four primary self-reported mental health outcomes overall mental health depression anxiety and trauma symptoms Secondary outcomes include self-reported measures of resilience stress social support and alcohol consumption Other demographic information will also be collected such as race ethnicity education income family status etc Data collection will consist of three online assessments a pre-test post-test and 1-month follow-up In-person interviews will also be available for participants who choose to discuss their experiences
Recruitment and Sample Participation in these groups requires the following 1 female gender 2 age 18 years or older 3 currently experiencing the symptoms of trauma 4 an insurance carrier who can cover both individual and group mental health sessions most in-state plans can do this 5 paying any co-pays or deductibles associated with individual or group sessions and 6 reliable transportation to and from appointments and group sessions
Recruiting will take place spring 2018 to Spring 2021 Recruitment approaches include flyers social media eg Facebook and use of MercyOne email list-serve Those who are interested in the study will be asked to either click or enter a web link that will bring them to an online screening tool that will screen for trauma symptoms using the PTSD Checklist PCL-2 along with other questions to determine eligibility ie exclusion criteria If the participant 1 screens positive for a history of trauma according the PCL-2 answers yes to questions related to inclusion criteria and answers no to questions related to the exclusion criteria then they will be sent to a screen where they can read the full consent form At the bottom of the page there will be a button that allows them to choose how they want to participate in the study 1 decline to enroll 2 they are interested but would like to speak to a member of the research team 3 they would like to officially enroll in the study
Group Assignment Participants who consent to be enrolled in the study will be randomly assigned to one of the following 1 TSY 2 TC or 3 TAU Both the TSY and TC group classes will be held at the Wellness Center at the MercyOne Cedar Falls Medical Center in Cedar Falls Iowa Each group will meet once a week for 12 weeks for 1-hour sessions
Assessment If assigned to either the TC or TSY groups we will supply participants a schedule that has the dates times and locations of the groups All participants including those in the TAU group will then be sent a web-link to an online pre-test assessment which should take about 20-30 minutes to complete Participants will then attend the TC or TSY once a week for a period of 12 weeks Those who are randomly assigned to the TAU group will be asked to see consistently see a mental health provider for the 12-week study duration It is not specified or dictated how often participants meet with their provider nor what type of therapeutic interventions are to be used
At the end of the 12-week study duration all participants will be sent an online post-test assessment with the same measures found in the pre-test The same assessment will then be provided again in 1-month to assess for diminished effects Participants have the option to participate in interviews where they will be asked questions about their experiences participating in the therapy group and the research study The interviews will be audio recorded and take about 30-40 minutes to complete These interviews are optional and not required to participate in the study
Recruitment and Sample Participation in these groups requires the following 1 female gender 2 age 18 years or older 3 currently experiencing the symptoms of trauma 4 an insurance carrier who can cover both individual and group mental health sessions most in-state plans can do this 5 paying any co-pays or deductibles associated with individual or group sessions and 6 reliable transportation to and from appointments and group sessions
Recruiting will take place spring 2018 to Spring 2021 Recruitment approaches include flyers social media eg Facebook and use of MercyOne email list-serve Those who are interested in the study will be asked to either click or enter a web link that will bring them to an online screening tool that will screen for trauma symptoms using the PTSD Checklist PCL-2 along with other questions to determine eligibility ie exclusion criteria If the participant 1 screens positive for a history of trauma according the PCL-2 answers yes to questions related to inclusion criteria and answers no to questions related to the exclusion criteria then they will be sent to a screen where they can read the full consent form At the bottom of the page there will be a button that allows them to choose how they want to participate in the study 1 decline to enroll 2 they are interested but would like to speak to a member of the research team 3 they would like to officially enroll in the study
Group Assignment Participants who consent to be enrolled in the study will be randomly assigned to one of the following 1 TSY 2 TC or 3 TAU Both the TSY and TC group classes will be held at the Wellness Center at the MercyOne Cedar Falls Medical Center in Cedar Falls Iowa Each group will meet once a week for 12 weeks for 1-hour sessions
Assessment If assigned to either the TC or TSY groups we will supply participants a schedule that has the dates times and locations of the groups All participants including those in the TAU group will then be sent a web-link to an online pre-test assessment which should take about 20-30 minutes to complete Participants will then attend the TC or TSY once a week for a period of 12 weeks Those who are randomly assigned to the TAU group will be asked to see consistently see a mental health provider for the 12-week study duration It is not specified or dictated how often participants meet with their provider nor what type of therapeutic interventions are to be used
At the end of the 12-week study duration all participants will be sent an online post-test assessment with the same measures found in the pre-test The same assessment will then be provided again in 1-month to assess for diminished effects Participants have the option to participate in interviews where they will be asked questions about their experiences participating in the therapy group and the research study The interviews will be audio recorded and take about 30-40 minutes to complete These interviews are optional and not required to participate in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None