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The Effects of Trauma-sensitive Yoga and Tai Chi on Mental Health (TSY/TC)

Primary Purpose

Mental Health Wellness 1

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma-Sensitive Yoga + TAU
Chen Style Tai Chi + TAU
Treatment as Usual
Sponsored by
University of Northern Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Wellness 1 focused on measuring Trauma, Depression, Anxiety, Stress, Resilience, Social Support, Alcohol consumption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • MercyOne Cedar Falls Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Treatment as Usual (TAU)

Trauma-Sensitive Yoga + TAU

Chen Style Tai Chi + TAU

Arm Description

Participants assigned to treatment as usual group are required to see a mental health professional for the 12 week treatment period. How often they seek counseling is up to the participant.

Participants assigned to the Trauma-Sensitive Yoga group will attend a 1-hour long session of yoga once a week for 12 weeks. Participants will be required to concurrently see a mental health professional for the 12 week treatment period. How often they seek counseling is up to the participant.

Participants assigned to the Chen Style Tai Chi group will attend a 1-hour long session of tai chi once a week for 12 weeks. Participants will be required to concurrently see a mental health professional for the 12 week treatment period. How often they seek counseling is up to the participant.

Outcomes

Primary Outcome Measures

Change in Baseline in Symptoms on the Trauma Symptoms Checklist at Week 12 and 16.
The Trauma Symptom Checklist is a validated, self-reported instrument assessing the frequency of a variety of trauma and trauma-related symptoms in the last month. Subscales include anxiety, depression, dissociation, sexual abuse trauma index, sexual problems, and sleep disturbances. Possible scores range from 0 (never occurring) to 3 (often occurring). Change = (Week 12 and 16 score - Baseline Score).
Change in Baseline in health and mental health ratings on the Medical Outcomes Study Questionnaire Short Form 36 Survey at Week 12 and 16.
Questionnaire Short Form 36 Survey is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. The Questionnaire Short Form 36 Survey has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability. Change = (Week 12 and 16 score - Baseline Score).

Secondary Outcome Measures

Change in Baseline Alcohol Consumption on the Alcohol Use Disorders Identification Test (AUDIT questionnaire at week 12 and 16
The Alcohol Consumption on the Alcohol Use Disorders Identification Test questionnaire is designed to help in the self assessment of alcohol consumption and to point out any implications for the person's health and wellbeing now and in the future. Scores for each question range from 0 to 4, with the first response for each question (e.g., never) scoring 0, the second (e.g., less than monthly) scoring 1, the third (e.g., monthly) scoring 2, the fourth (e.g., weekly) scoring 3, and the last response (eg. daily or almost daily) scoring 4. For questions 9 and 10, which only have three responses, the scoring is 0, 2 and 4 (from left to right). Lower scores = less alcohol consumption, higher scores = higher alcohol consumption. Change = (Week 12 and 16 score - Baseline Score).
Change in Baseline Resilience self-evaluation on the Brief Resilience Scale at week 12 and 16
The Brief Resilience Scale assesses the ability to bounce back or recover from stress. The scale consists of 6 questions, with questions 1, 3, and 5 that range from 1 (strongly disagree) to 5 (strongly agree). Questions 2, 4, 6 are rated inversely. Scoring includes adding the responses varying from 1-5 for all six items giving a range from 6-30. Divide the total sum by the total number of questions answered. Lower scores = less perceived resiliency, higher scores = higher perceived resiliency. Change = (Week 12 and 16 score - Baseline Score).
Change in Baseline Stress on the Perceived Stress Scale at week 12 and 16
The Perceived Stress Scale is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Lower scores = less perceived stress, higher scores = higher perceived stress. Change = (Week 12 and 16 score - Baseline Score).
Change in Baseline Pessimism/Optimism on the Life Orientation Test at week 12 and 16
The Life Orientation Test is a 10-item scale that measures how optimistic or pessimistic people feel about the future. Of the 10 items, 3 items measure optimism, 3 items measure pessimism, and 4 items serve as fillers. Respondents rate each item on a 4-point scale: 0 = strongly disagree, 1 = disagree, 2 = neutral, 3 = agree, and 4 = strongly agree. Lower scores = more pessimistic, higher scores = more optimistic Change = (Week 12 and 16 score - Baseline Score).
Change in Baseline on the perceived socials support Multidimensional Scale of Perceived Social Support at week 12 and 16
The Multidimensional Scale of Perceived Social Support is a brief research tool designed to measure perceptions of support from 3 sources: Family, Friends, and a Significant Other. The scale is comprised of a total of 12 items, with 4 items for each subscale. Respondents rate each item from a 1-7 scale, with lower scores = less perceived social support, higher scores = more perceived social support. Change = (Week 12 and 16 score - Baseline Score).

Full Information

First Posted
February 9, 2021
Last Updated
February 22, 2021
Sponsor
University of Northern Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT04754009
Brief Title
The Effects of Trauma-sensitive Yoga and Tai Chi on Mental Health
Acronym
TSY/TC
Official Title
The Effects of Trauma-sensitive Yoga and Tai Chi on Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Suspended
Why Stopped
COVID-19
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Northern Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1
Keywords
Trauma, Depression, Anxiety, Stress, Resilience, Social Support, Alcohol consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
Participants assigned to treatment as usual group are required to see a mental health professional for the 12 week treatment period. How often they seek counseling is up to the participant.
Arm Title
Trauma-Sensitive Yoga + TAU
Arm Type
Experimental
Arm Description
Participants assigned to the Trauma-Sensitive Yoga group will attend a 1-hour long session of yoga once a week for 12 weeks. Participants will be required to concurrently see a mental health professional for the 12 week treatment period. How often they seek counseling is up to the participant.
Arm Title
Chen Style Tai Chi + TAU
Arm Type
Experimental
Arm Description
Participants assigned to the Chen Style Tai Chi group will attend a 1-hour long session of tai chi once a week for 12 weeks. Participants will be required to concurrently see a mental health professional for the 12 week treatment period. How often they seek counseling is up to the participant.
Intervention Type
Behavioral
Intervention Name(s)
Trauma-Sensitive Yoga + TAU
Intervention Description
Trauma-Sensitive Yoga is a movement-based approach that are used to integrate both mind and body, and promote body awareness and acceptance for those who have been exposed to traumatic events and currently experience trauma symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Chen Style Tai Chi + TAU
Intervention Description
Chen Style Practical Method tai chi is a martial art that is used as a form of self-defense and to maintain physical health and well-being.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Intervention Description
Consists of traditional talk therapy for mental health.
Primary Outcome Measure Information:
Title
Change in Baseline in Symptoms on the Trauma Symptoms Checklist at Week 12 and 16.
Description
The Trauma Symptom Checklist is a validated, self-reported instrument assessing the frequency of a variety of trauma and trauma-related symptoms in the last month. Subscales include anxiety, depression, dissociation, sexual abuse trauma index, sexual problems, and sleep disturbances. Possible scores range from 0 (never occurring) to 3 (often occurring). Change = (Week 12 and 16 score - Baseline Score).
Time Frame
Baseline and Weeks 12 and 16
Title
Change in Baseline in health and mental health ratings on the Medical Outcomes Study Questionnaire Short Form 36 Survey at Week 12 and 16.
Description
Questionnaire Short Form 36 Survey is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. The Questionnaire Short Form 36 Survey has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability. Change = (Week 12 and 16 score - Baseline Score).
Time Frame
Baseline and Weeks 12 and 16
Secondary Outcome Measure Information:
Title
Change in Baseline Alcohol Consumption on the Alcohol Use Disorders Identification Test (AUDIT questionnaire at week 12 and 16
Description
The Alcohol Consumption on the Alcohol Use Disorders Identification Test questionnaire is designed to help in the self assessment of alcohol consumption and to point out any implications for the person's health and wellbeing now and in the future. Scores for each question range from 0 to 4, with the first response for each question (e.g., never) scoring 0, the second (e.g., less than monthly) scoring 1, the third (e.g., monthly) scoring 2, the fourth (e.g., weekly) scoring 3, and the last response (eg. daily or almost daily) scoring 4. For questions 9 and 10, which only have three responses, the scoring is 0, 2 and 4 (from left to right). Lower scores = less alcohol consumption, higher scores = higher alcohol consumption. Change = (Week 12 and 16 score - Baseline Score).
Time Frame
Baseline and Weeks 12 and 16
Title
Change in Baseline Resilience self-evaluation on the Brief Resilience Scale at week 12 and 16
Description
The Brief Resilience Scale assesses the ability to bounce back or recover from stress. The scale consists of 6 questions, with questions 1, 3, and 5 that range from 1 (strongly disagree) to 5 (strongly agree). Questions 2, 4, 6 are rated inversely. Scoring includes adding the responses varying from 1-5 for all six items giving a range from 6-30. Divide the total sum by the total number of questions answered. Lower scores = less perceived resiliency, higher scores = higher perceived resiliency. Change = (Week 12 and 16 score - Baseline Score).
Time Frame
Baseline and Weeks 12 and 16
Title
Change in Baseline Stress on the Perceived Stress Scale at week 12 and 16
Description
The Perceived Stress Scale is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. Lower scores = less perceived stress, higher scores = higher perceived stress. Change = (Week 12 and 16 score - Baseline Score).
Time Frame
Baseline and Weeks 12 and 16
Title
Change in Baseline Pessimism/Optimism on the Life Orientation Test at week 12 and 16
Description
The Life Orientation Test is a 10-item scale that measures how optimistic or pessimistic people feel about the future. Of the 10 items, 3 items measure optimism, 3 items measure pessimism, and 4 items serve as fillers. Respondents rate each item on a 4-point scale: 0 = strongly disagree, 1 = disagree, 2 = neutral, 3 = agree, and 4 = strongly agree. Lower scores = more pessimistic, higher scores = more optimistic Change = (Week 12 and 16 score - Baseline Score).
Time Frame
Baseline and Weeks 12 and 16
Title
Change in Baseline on the perceived socials support Multidimensional Scale of Perceived Social Support at week 12 and 16
Description
The Multidimensional Scale of Perceived Social Support is a brief research tool designed to measure perceptions of support from 3 sources: Family, Friends, and a Significant Other. The scale is comprised of a total of 12 items, with 4 items for each subscale. Respondents rate each item from a 1-7 scale, with lower scores = less perceived social support, higher scores = more perceived social support. Change = (Week 12 and 16 score - Baseline Score).
Time Frame
Baseline and Weeks 12 and 16

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-representation of gender identify
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
MercyOne Cedar Falls Medical Center
City
Cedar Falls
State/Province
Iowa
ZIP/Postal Code
50613
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Trauma-sensitive Yoga and Tai Chi on Mental Health

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