Holistic Approaches to Depression

Depression Clinical Trial

— HAD  

Official title:

Holistic Approaches to Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384916
• Other study ID #: NR012005
• Secondary ID: 1R01NR012005-01A
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2011
• Last updated: April 12, 2016
• Start date: June 2011
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. No current hazardous drug/ alcohol use.

3. 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.

4. Benefit from current treatment. Participants must report at least some benefit from their current antidepressant.

5. No significant suicidality, defined by a QIDS item #12 score < 2 or PI judgement.

6. Currently taking an antidepressant for depression, at a minimally therapeutic dose. Participant has been taking an antidepressant for at least 8 weeks.

7. Antidepressant dose has not changed in the 4 weeks prior to study entry; Not planning to change antidepressant dosage in next 10 weeks.

8. (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.

9. Medically cleared for moderate exercise, documented by a note from their primary care provider.

10. Not pregnant or planning on becoming pregnant in the next year.

11. 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.

12. Does not practice meditation at home weekly or more often.

13. Understands English sufficiently well to complete study assessment.

14. 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Yoga
2x weekly
• Healthy Living Workshop
2x weekly

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick Inventory of Depressive Symptoms (QIDS)	Depression	End of acute phase (10 weeks)	Yes

External Links

•   Link