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

NCT04754009 | Suspended

• 1 other identifier: 18-0169
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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?

Conditions

Mental Health Wellness 1

Keywords

Trauma; Depression; Anxiety; Stress; Resilience; Social Support; Alcohol consumption

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline and Weeks 12 and 16

• 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).

  Baseline and Weeks 12 and 16

Secondary Outcomes (5)

• Change in Baseline Alcohol Consumption on the Alcohol Use Disorders Identification Test (AUDIT questionnaire at week 12 and 16

  Baseline and Weeks 12 and 16

• Change in Baseline Resilience self-evaluation on the Brief Resilience Scale at week 12 and 16

  Baseline and Weeks 12 and 16

• Change in Baseline Stress on the Perceived Stress Scale at week 12 and 16

  Baseline and Weeks 12 and 16

• Change in Baseline Pessimism/Optimism on the Life Orientation Test at week 12 and 16

  Baseline and Weeks 12 and 16

• Change in Baseline on the perceived socials support Multidimensional Scale of Perceived Social Support at week 12 and 16

  Baseline and Weeks 12 and 16

Study Arms (3)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual

Trauma-Sensitive Yoga + TAU

EXPERIMENTAL

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.

Behavioral: Trauma-Sensitive Yoga + TAU

Chen Style Tai Chi + TAU

EXPERIMENTAL

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.

Behavioral: Chen Style Tai Chi + TAU

Interventions

Trauma-Sensitive Yoga + TAU BEHAVIORAL

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.

Trauma-Sensitive Yoga + TAU

Chen Style Tai Chi + TAU BEHAVIORAL

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.

Chen Style Tai Chi + TAU

Treatment as Usual BEHAVIORAL

Consists of traditional talk therapy for mental health.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-representation of gender identify
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Northern Iowa: lead

Study Sites (1)

MercyOne Cedar Falls Medical Center

Cedar Falls, Iowa, 50613, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Depression; Anxiety Disorders; Alcohol Drinking

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Drinking Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: February 27, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 30, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)