DepressionNCT02630758
Mindfulness-Based Yoga Intervention for Women With Depression
A study testing Mindfulness-based Yoga in people with Depression and Depressive Symptoms, run by University of Minnesota.
Trial summary
The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Depressive Symptoms
- What is being tested?
- Mindfulness-based Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to May 2014
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- a personal history of depression (i.e., ever being told by a healthcare provider that they had depression or given an antidepressant for depression)
- able to read and write in the English language
- able to commit to two sessions (yoga or walking) per week for 12 weeks
- demonstrate a willingness to be randomly assigned to either of the study arms
- be yoga naïve, defined as not taking more than four yoga classes in the past two years and not more than one class in the past month.
Who cannot join
- individuals with a history of bipolar disorder or schizophrenia and/or who had been hospitalized for a psychiatric disorder within six months prior to the eligibility screening
- individuals not providing signed informed consent
- individuals reporting any other health problems that would interfere with regular yoga practice or walking sessions
- individuals who engaged in more than 90 minutes of moderate intensity physical activity per week during the month prior to the eligibility screening.
About this study
The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women.
Read the detailed description
This study was a prospective, randomized controlled intervention pilot study conducted in a metropolitan city in the upper Midwest of the United States. Forty women who met the criteria for depression based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (SCID-I; First, Spitzer, Gibbon, \& Williams, 1997)were randomized to an experimental mindfulness-based yoga condition (n=20) or a walking control condition (n=20). Both programs were home-based motivational sessions delivered over the telephone and lasted 12 weeks. Assessments were conducted at baseline, three months (i.e., post-intervention), one-month follow-up (i.e., one month after the intervention ended). Participants were instructed to continue their usual depression care. The primary dependent variable was depressive symptoms based on the Beck Depression Inventory (BDI). The secondary dependent variable was rumination scores on the Ruminative Responses Scale (RRS). This protocol was approved by the University of Minnesota's Institutional Review Board (IRB). Participants completed informed consent forms sent through the mail; consent to participate in physical activity was also obtained from the participant's healthcare provider. Recruitment for this trial occurred from February, 2013 to January, 2014 and follow-up assessments were completed by May, 2014.
- Conditions
- Depression, Depressive Symptoms
- Being tested
- Mindfulness-based Yoga, Walking Control Condition
- Keywords
- depression, yoga, mindfulness
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based YogaBehavioural
See study arm description.
Walking Control ConditionBehavioural
See study arm description.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Yoga | Experimental | Participants in the 12-week mindfulness-based yoga condition were guided by a gentle yoga DVD that included postures (asanas), pranayama (breathing exercises), and relaxation (meditation). Participants were asked to complete 60-75 minutes of the DVD twice per week and were encouraged to do more if they were interested.
Following the initial baseline assessment and randomization telephone interview, participants in the yoga group completed weekly 15-minute telephone sessions for the first month and bi-weekly telephone sessions for the second and third for a total of eight sessions over the 12 weeks. The mindfulness telephone sessions were modified from the Mindfulness-Based Stress Reduction. Receives: Behavioral: Mindfulness-based Yoga |
| Walking Control Group | Active comparator | The 12-week walking control condition included twice-weekly home practice with a 65-minute walking DVD (Sansone, 2008) and eight telephone sessions with the telephone counselor.
Participants were asked to complete 60 minutes of the DVD (or other walking) twice weekly and encouraged to do more if they were interested.
Participants received telephone sessions on the same schedule as the yoga condition. The education sessions covered a variety of health and wellness related topics. Receives: Behavioral: Walking Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Change from Baseline Depression at 3 months
Measured: 3 months
Secondary outcomes (5)
Ruminative Responses Scale
Change from Baseline Rumination at 3 months
Measured: 3 months
Five Facet Mindfulness Questionnaire
Change from Baseline Mindfulness at 3 months
Measured: 3 months
Perceived Stress Scale
Change from Perceived Stress at 3 months
Measured: 3 months
Pittsburgh Sleep Scale
Change from Baseline Sleep at 3 months
Measured: 3 months
Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form
Change from Baseline Quality of LIfe Enjoyment and Satisfaction at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth A Lewis, PHD, L.P., Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630758
- Sponsor's protocol ID
- 1203P11124
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Yoga Intervention for Women With Depression
- ClinicalTrials.gov ID
- NCT02630758
- Acronym / sponsor ID
- 1203P11124
- Conditions
- Depression, Depressive Symptoms
- Keywords
- depression, yoga, mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Dec 2015 (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.
The purpose of this study was to examine the efficacy of a 12-week mindfulness-based yoga intervention on depressive symptoms and rumination among depressed women.
Detailed description
This study was a prospective, randomized controlled intervention pilot study conducted in a metropolitan city in the upper Midwest of the United States. Forty women who met the criteria for depression based on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders IV (SCID-I; First, Spitzer, Gibbon, \& Williams, 1997)were randomized to an experimental mindfulness-based yoga condition (n=20) or a walking control condition (n=20). Both programs were home-based motivational sessions delivered over the telephone and lasted 12 weeks. Assessments were conducted at baseline, three months (i.e., post-intervention), one-month follow-up (i.e., one month after the intervention ended). Participants were instructed to continue their usual depression care. The primary dependent variable was depressive symptoms based on the Beck Depression Inventory (BDI). The secondary dependent variable was rumination scores on the Ruminative Responses Scale (RRS). This protocol was approved by the University of Minnesota's Institutional Review Board (IRB). Participants completed informed consent forms sent through the mail; consent to participate in physical activity was also obtained from the participant's healthcare provider. Recruitment for this trial occurred from February, 2013 to January, 2014 and follow-up assessments were completed by May, 2014.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Yoga | Experimental | Behavioral: Mindfulness-based YogaParticipants in the 12-week mindfulness-based yoga condition were guided by a gentle yoga DVD that included postures (asanas), pranayama (breathing exercises), and relaxation (meditation). Participants were asked to complete 60-75 minutes of the DVD twice per week and were encouraged to do more if they were interested. Following the initial baseline assessment and randomization telephone interview, participants in the yoga group completed weekly 15-minute telephone sessions for the first month and bi-weekly telephone sessions for the second and third for a total of eight sessions over the 12 weeks. The mindfulness telephone sessions were modified from the Mindfulness-Based Stress Reduction. |
| Walking Control Group | Active comparator | Behavioral: Walking Control ConditionThe 12-week walking control condition included twice-weekly home practice with a 65-minute walking DVD (Sansone, 2008) and eight telephone sessions with the telephone counselor. Participants were asked to complete 60 minutes of the DVD (or other walking) twice weekly and encouraged to do more if they were interested. Participants received telephone sessions on the same schedule as the yoga condition. The education sessions covered a variety of health and wellness related topics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- a personal history of depression (i.e., ever being told by a healthcare provider that they had depression or given an antidepressant for depression)
- able to read and write in the English language
- able to commit to two sessions (yoga or walking) per week for 12 weeks
- demonstrate a willingness to be randomly assigned to either of the study arms
Key exclusion criteria (4 listed)
- individuals with a history of bipolar disorder or schizophrenia and/or who had been hospitalized for a psychiatric disorder within six months prior to the eligibility screening
- individuals not providing signed informed consent
- individuals reporting any other health problems that would interfere with regular yoga practice or walking sessions
- individuals who engaged in more than 90 minutes of moderate intensity physical activity per week during the month prior to the eligibility screening.
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 |
|---|---|---|
| Mindfulness-based YogaSee study arm description. | Behavioural | Mindfulness-based Yoga |
| Walking Control ConditionSee study arm description. | Behavioural | Walking Control Group |
Primary outcome
Beck Depression Inventory
Time frame: 3 months
Change from Baseline Depression at 3 months
5 secondary outcomes
Ruminative Responses Scale
Time frame: 3 months
Five Facet Mindfulness Questionnaire
Time frame: 3 months
Perceived Stress Scale
Time frame: 3 months
Pittsburgh Sleep Scale
Time frame: 3 months
Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form
Time frame: 3 months
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 15 Dec 2015.
- Individual participant dataSharing planned: No
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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.
Beth A Lewis, PHD, L.P. study chair
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Yoga in people with Depression and Depressive Symptoms, run by University of Minnesota.
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 6 inclusion and 4 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 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Beck Depression Inventory (time frame: 3 months). 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 15 Dec 2015.