Physiological StressNCT01652807
Yoga for Stress and Mental Health
A study testing Hatha Yoga in people with Physiological Stress and Psychological Distress, run by Southern Methodist University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress, Psychological Distress, Depression
- What is being tested?
- Hatha Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An 8-Week Hatha Yoga Intervention for Stress and Mental Health
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.
Read the 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.
- Conditions
- Physiological Stress, Psychological Distress, Depression, Anxiety
- Being tested
- Hatha Yoga
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hatha YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 0 (baseline) to 9 (post-intervention)
Secondary outcomes (2)
Feasibility
Feasibility and acceptability of a yoga intervention for stress-induced eating. This interview, constructed by the PI, assesses participants' perceptions of ease of participation, program likeability, and perceived benefits of the yoga program. The interview consists of 16 open-ended questions.
Measured: Weeks 0 (baseline) to 9 (post-intervention)
Distress Tolerance
The DTS (Simons \& Gaher, 2005) is a 15-item self- report measure of physical and psychological distress tolerance.
Measured: Weeks 0 (baseline) to 9 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasper Smits, Ph.D., Southern Methodist University
- Investigators
- Jasper Smits, Ph.D., Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652807
- Sponsor's protocol ID
- 2012-028-DEBL
- Status last verified
- Jan 2015
- First submitted
- 23 Jul 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-Week Hatha Yoga Intervention for Stress and Mental Health
- ClinicalTrials.gov ID
- NCT01652807
- Acronym / sponsor ID
- 2012-028-DEBL
- Conditions
- Physiological Stress, Psychological Distress, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Hatha YogaThe 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. |
| 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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hatha YogaThe 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. | Behavioural | Yoga |
Primary outcome
Perceived Stress Questionnaire
Time frame: Weeks 0 (baseline) to 9 (post-intervention)
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.
2 secondary outcomes
Feasibility
Time frame: Weeks 0 (baseline) to 9 (post-intervention)
Distress Tolerance
Time frame: Weeks 0 (baseline) to 9 (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasper Smits, Ph.D. principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha Yoga in people with Physiological Stress and Psychological Distress, run by Southern Methodist University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Questionnaire (time frame: Weeks 0 (baseline) to 9 (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.