Holistic Approaches to Depression (HAD)
Primary Purpose
Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Yoga
Healthy Living Workshop
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring depression, yoga, health education, antidepressant
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Yoga
Health education
Arm Description
Outcomes
Primary Outcome Measures
Quick Inventory of Depressive Symptoms (QIDS)
Depression
Secondary Outcome Measures
Full Information
NCT ID
NCT01384916
First Posted
June 28, 2011
Last Updated
April 12, 2016
Sponsor
Butler Hospital
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01384916
Brief Title
Holistic Approaches to Depression
Acronym
HAD
Official Title
Holistic Approaches to Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, yoga, health education, antidepressant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Experimental
Arm Title
Health education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
2x weekly
Intervention Type
Behavioral
Intervention Name(s)
Healthy Living Workshop
Intervention Description
2x weekly
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptoms (QIDS)
Description
Depression
Time Frame
End of acute phase (10 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A Uebelacker, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31141465
Citation
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.
Results Reference
derived
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Holistic Approaches to Depression
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