Clinical trial NCT01652807: Yoga for Stress and Mental Health
Official title: An 8-Week Hatha Yoga Intervention for Stress and Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Stress
Psychological Distress
Depression
Anxiety
Lead sponsor: Southern Methodist University
Sponsor class: OTHER
First posted: 2012-07-30
Enrollment: 52
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Yoga practice appears to reduce stress and associated emotions. Specifically, yoga has been associated with significant decreases in depression, anxiety, and perceived stress. These findings underscore the promise of yoga practice for improving mental health in women prone to stress.

This study aims to examine the feasibility, acceptability, and efficacy of an eight-week Hatha Yoga intervention for improving stress and mental health. To this end, the investigators will recruit 40 women high in stress to receive an 8-week hatha yoga intervention consisting of two weekly 90-minute sessions. At baseline and at post-intervention, participants will undergo several cognitive, emotional, and behavioral assessments, followed by a relaxation time. Primary feasibility outcomes will be the time required to recruit 40 participants, the number of screen failures, participant retention and participant adherence to the study protocol. Acceptability will be evaluated with questionnaires and an interview during the final visit. Primary efficacy outcomes will be group differences in pre- to post-intervention change in perceived stress and various mental health parameters.

Eligibility criteria: Inclusion Criteria:

* 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.
* Capable and willing to give written informed consent, to understand inclusion and exclusion criteria.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Perceived Stress Questionnaire
timeFrame: Weeks 0 (baseline) to 9 (post-intervention)
Secondary outcomes:
measure: Feasibility
timeFrame: Weeks 0 (baseline) to 9 (post-intervention)
measure: Distress Tolerance
timeFrame: Weeks 0 (baseline) to 9 (post-intervention)
Other outcomes:
measure: Depression Symptoms
timeFrame: Weeks 0 (baseline) to 9 (post-intervention)
measure: Anxiety Symptoms (BAI)
timeFrame: Weeks 0 (baseline) to 9 (post-intervention)
measure: Mindfulness
timeFrame: Weeks 0 (baseline) to 9 (post-intervention)
Locations:
city: Dallas
country: United States
facility: Southern Methodist University
state: Texas
Study officials:
affiliation: Associate Professor
name: Jasper Smits, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: