Clinical trial NCT04754009: The Effects of Trauma-sensitive Yoga and Tai Chi on Mental Health
Official title: The Effects of Trauma-sensitive Yoga and Tai Chi on Mental Health
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Trauma
Depression
Anxiety
Stress
Resilience
Social Support
Alcohol consumption
Lead sponsor: University of Northern Iowa
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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 (e.g., 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 (i.e., 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.

Eligibility criteria: Inclusion Criteria:

•Women 18 years or older with a history of traumatic exposure based on the PTSD Checklist for DSM-5 screening instrument.

Exclusion Criteria

Those who:

* Find themselves frequently having uncontrolled suicidal thoughts.
* Are currently experiencing uncontrolled hallucinations or delusional thinking.
* Are cognitively unable to follow directions.
* Who have a history of sexually abusing others.
* Who have a current diagnosis of Borderline Personality Disorder.

Primary outcomes:
measure: Change in Baseline in Symptoms on the Trauma Symptoms Checklist at Week 12 and 16.
timeFrame: Baseline and Weeks 12 and 16
measure: Change in Baseline in health and mental health ratings on the Medical Outcomes Study Questionnaire Short Form 36 Survey at Week 12 and 16.
timeFrame: Baseline and Weeks 12 and 16
Secondary outcomes:
measure: Change in Baseline Alcohol Consumption on the Alcohol Use Disorders Identification Test (AUDIT questionnaire at week 12 and 16
timeFrame: Baseline and Weeks 12 and 16
measure: Change in Baseline Resilience self-evaluation on the Brief Resilience Scale at week 12 and 16
timeFrame: Baseline and Weeks 12 and 16
measure: Change in Baseline Stress on the Perceived Stress Scale at week 12 and 16
timeFrame: Baseline and Weeks 12 and 16
measure: Change in Baseline Pessimism/Optimism on the Life Orientation Test at week 12 and 16
timeFrame: Baseline and Weeks 12 and 16
measure: Change in Baseline on the perceived socials support Multidimensional Scale of Perceived Social Support at week 12 and 16
timeFrame: Baseline and Weeks 12 and 16
Other outcomes:
Locations:
city: Cedar Falls
country: United States
facility: MercyOne Cedar Falls Medical Center
state: Iowa
Study officials:
References: