Yoga for Stress and Mental Health

NCT01652807 | Completed

• 1 other identifier: 2012-028-DEBL
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at an 8-week hatha yoga intervention for women reporting high levels of stress, a risk factor for various forms of psychopathology.

Conditions

Physiological Stress; Psychological Distress; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Questionnaire

  The PSQ (Levenstein et al., 1993) is a self- report measure of cognitive and emotional reactions to perceived stressful situations. The questionnaire consists of four subscales assessing (1) worries, anxious concern for the future, feelings of desperation and frustration; (2) tension, exhaustion, and lack of relaxation; (3) positive feelings of challenge, joy, energy, and security; and (4) perceived environmental demands, such as lack of time, pressure, and overload.

  Weeks 0 (baseline) to 9 (post-intervention)

Secondary Outcomes (2)

• Feasibility

  Weeks 0 (baseline) to 9 (post-intervention)

• Distress Tolerance

  Weeks 0 (baseline) to 9 (post-intervention)

Other Outcomes (3)

• Depression Symptoms

  Weeks 0 (baseline) to 9 (post-intervention)

• Anxiety Symptoms (BAI)

  Weeks 0 (baseline) to 9 (post-intervention)

• Mindfulness

  Weeks 0 (baseline) to 9 (post-intervention)

Study Arms (2)

Yoga

EXPERIMENTAL

The yoga intervention will last eight weeks and include two 90-minute sessions each week. Each yoga session will consist of the same series of 26 Hatha yoga postures, two breathing exercise, and two savasanas (i.e., a resting/relaxation posture), in a room heated to 104 degrees Fahrenheit, which aids in safe muscle stretching.

Behavioral: Hatha Yoga

Waitlist (Delayed Yoga)

NO INTERVENTION

Participants assigned randomly to the control condition will provided an identical free two-month membership to Bikram Yoga Dallas after the week following their post-intervention session.

Interventions

Hatha Yoga BEHAVIORAL

The yoga intervention will last eight weeks and include two 90-minute sessions each week. Each yoga session will consist of the same series of 26 Hatha yoga postures, two breathing exercise, and two savasanas (i.e., a resting/relaxation posture), in a room heated to 104 degrees Fahrenheit, which aids in safe muscle stretching. Each participant will be given a yoga studio scan card valid for two months, and, like all yoga studio members, they will be required to scan their card prior to their yoga class.

Yoga

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients between the ages of 25 and 45. We only will only include women in this age range due to age-related variations in estrogen levels that effect HPA reactivity in women (Seeman, Singer, Wilkinson \& McEwen, 2001).
• Sedentary as defined by moderate-intensity exercise less than 60 minutes per week (this definition is consistent with that employed in previous studies of exercise interventions; e.g., Dunn et al., 2005; Trivedi et al., 2006). This criterion was selected in order to be able to test the effects of the yoga intervention.
• Written physician approval/medical clearance to participate in an exercise/yoga protocol.

You may not qualify if:

• Have practiced yoga or engaged in other mind-body practices (e.g., tai chi, meditation) regularly (i.e., once a week or more) within the last year.
• Lifetime history of psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia or schizoaffective disorder, or anorexia nervosa.
• Current alcohol or drug dependence.
• Screening BDI ≥ 30 (severe depression).
• Known or suspected to have significant personality dysfunction that could, in the investigator's opinion, interfere with trial participation.
• Currently at risk of self-harm or harm to others, in the Sponsor's opinion, based on clinical interview.
• Currently a psychiatric inpatient; have been hospitalized for a psychiatric condition within the past year.
• Have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction that could interfere with their capacity to participate in the study protocol.
• Body mass index ≥ 40 (in order to screen out individuals with Class III obesity who might be more prone to musculoskeletal injuries than individuals with a BMI \< 40.0) or \< 18.5 (in order to screen out individuals whose hormone levels may be impacted by their low weight).
• Resting blood pressure ≥ 160 systolic and/or 100 diastolic. Individuals currently being treated for high blood pressure and meeting these criteria are eligible.
• Receiving concurrent psychotherapy of any kind.
• Use of any psychotropic medications.
• Positive result on pregnancy test at Screening; plan to become pregnant during the course of the trial.
• Insufficient command of the English language (i.e., they cannot carry on a conversation with an interviewer in the English language or read associated text).

Sponsors & Collaborators

• Southern Methodist University: lead

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75206, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Jasper Smits, Ph.D.

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 30, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

US (1)