DepressionPhase 2HADNCT01384916
Holistic Approaches to Depression
A Phase 2 study testing Yoga and Healthy Living Workshop in people with Depression, run by Butler Hospital at 1 site in United States.
Trial summary
The purpose of the study is to investigate whether yoga or a health education group alleviate depressive symptoms for an individual with a partial response to antidepressant medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Yoga and Healthy Living Workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2015
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for major depressive disorder (MDD) within the past two years; no history of bipolar disorder, schizophrenia, or psychotic symptoms in one's lifetime.
- No current hazardous drug/ alcohol use.
- Depression symptom severity. Participants must have a Quick Inventory of Depressive Symptoms (QIDS) score greater than or equal to 8 and less than or equal to 17.
- Benefit from current treatment. Participants must report at least some benefit from their current antidepressant.
- No significant suicidality, defined by a QIDS item #12 score < 2 or PI judgement.
- Currently taking an antidepressant for depression, at a minimally therapeutic dose. Participant has been taking an antidepressant for at least 8 weeks.
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- Antidepressant dose has not changed in the 4 weeks prior to study entry; Not planning to change antidepressant dosage in next 10 weeks.
- (If in psychotherapy). Therapist and therapy frequency has not changed in the past 6 weeks AND not planning to change it in the next 3 months.
- Medically cleared for moderate exercise, documented by a note from their primary care provider.
- Not pregnant or planning on becoming pregnant in the next year.
- Naïve to study interventions. Participants cannot have had > 4 single sessions (or > 8 total hours class time) of yoga, other classes in "mindful exercise," (e.g., qigong, tai chi), mindfulness based stress reduction, or health education in the past year or >8 single classes of yoga within the past 2 years of the same. Participants can not have practiced yoga at least once per week for 8 weeks in a row in the past 5 years.
- Does not practice meditation at home weekly or more often.
- Understands English sufficiently well to complete study assessment.
- Biomarker exclusions. Participants who are taking oral steroids, insulin or oral hypoglycemic agents, or oral antibiotics, or who refuse blood draws, will not participate in the biomarker component of the study; however, they may participate in the rest of the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate whether yoga or a health education group alleviate depressive symptoms for an individual with a partial response to antidepressant medication.
- Conditions
- Depression
- Being tested
- Yoga, Healthy Living Workshop
- Keywords
- depression, yoga, health education, antidepressant
- Medical subject headings
- Depression, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
2x weekly
Healthy Living WorkshopBehavioural
2x weekly
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Not described Receives: Behavioral: Yoga |
| Health education | Active comparator | Not described Receives: Behavioral: Healthy Living Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick Inventory of Depressive Symptoms (QIDS)
Depression
Measured: End of acute phase (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Lisa A Uebelacker, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384916
- Sponsor's protocol ID
- NR012005
- Other IDs
- 1R01NR012005-01A1
- Acronym
- HAD
- Status last verified
- Apr 2016
- First submitted
- 28 Jun 2011
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nugent NR, Brick L, Armey MF, Tyrka AR, Ridout KK, Uebelacker LA. Benefits of Yoga on IL-6: Findings from a Randomized Controlled Trial of Yoga for Depression. Behav Med. 2021 Jan-Mar;47(1):21-30. doi: 10.1080/08964289.2019.1604489. Epub 2019 May 29.
PubMed 31141465
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Approaches to Depression
- ClinicalTrials.gov ID
- NCT01384916
- Acronym / sponsor ID
- HAD / NR012005
- Conditions
- Depression
- Keywords
- depression, yoga, health education, antidepressant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jun 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Jun 2011 (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 the study is to investigate whether yoga or a health education group alleviate depressive symptoms for an individual with a partial response to antidepressant medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga |
| Health education | Active comparator | Behavioral: Healthy Living Workshop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Meets criteria for major depressive disorder (MDD) within the past two years; no history of bipolar disorder, schizophrenia, or psychotic symptoms in one's lifetime.
- No current hazardous drug/ alcohol use.
- Depression symptom severity. Participants must have a Quick Inventory of Depressive Symptoms (QIDS) score greater than or equal to 8 and less than or equal to 17.
- Benefit from current treatment. Participants must report at least some benefit from their current antidepressant.
- No significant suicidality, defined by a QIDS item #12 score < 2 or PI judgement.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Yoga2x weekly | Behavioural | Yoga |
| Healthy Living Workshop2x weekly | Behavioural | Health education |
Primary outcome
Quick Inventory of Depressive Symptoms (QIDS)
Time frame: End of acute phase (10 weeks)
Depression
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 13 Apr 2016.
- Derived from this study: PubMed 31141465Nugent NR, Brick L, Armey MF, Tyrka AR, Ridout KK, Uebelacker LA. Benefits of Yoga on IL-6: Findings from a Randomized Controlled Trial of Yoga for Depression. Behav Med. 2021 Jan-Mar;47(1):21-30. doi: 10.1080/08964289.2019.1604489. Epub 2019 May 29.
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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.
Lisa A Uebelacker, PhD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yoga and Healthy Living Workshop in people with Depression, run by Butler Hospital 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 14 inclusion and 0 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 13 Apr 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quick Inventory of Depressive Symptoms (QIDS) (time frame: End of acute phase (10 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384916, which also lists 1 linked publication.
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 13 Apr 2016.