NCT02610725

Brief Summary

We are seeking to understand the acceptability of an online yoga class for individuals with mood disorders. MoodNetwork members who are 18 years old or over who have experienced depression, mania, or hypomania are invited to participate. About 200 MoodNetwork participants will take part in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

2.3 years

First QC Date

November 19, 2015

Results QC Date

June 1, 2018

Last Update Submit

September 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Affect Scale

    The PANAS is a 20-item questionnaire that contains two 10-item subscales for positive and negative affect, respectively. The positive affect subscale assesses domains of excitement, enthusiasm, and attentiveness, whereas the negative subscale measures domains of distress, guilt, and irritability. Each subscale score can range from 10-50 where higher scores indicate greater levels of affect.

    Pre- and post-intervention, 40 min

Secondary Outcomes (2)

  • Feasibility/Acceptability Questionnaire

    Post-Intervention

  • Adverse Event Questionnaire

    Post-Intervention

Study Arms (1)

Yoga class

OTHER

A 30 minute online Hatha yoga video intervention will be administered to participants.Participants will only participate in one yoga class and complete follow-up questionnaires.

Other: Hatha yoga

Interventions

Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.

Yoga class

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fluent in English
  • Over age 18
  • Self-report of having experienced depression, mania, or hypomania in their lifetime

You may not qualify if:

  • Any contraindication to exercise (e.g., pregnant, physical injuries or any other reason prohibiting exercise).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Mood DisordersBipolar DisorderDepression

Condition Hierarchy (Ancestors)

Mental DisordersBipolar and Related DisordersBehavioral SymptomsBehavior

Limitations and Caveats

This study utilized a single online yoga class as a pilot to assess feasibility. Results may not fully reflect changes associated with long-term yoga practice.

Results Point of Contact

Title
Louisa G. Sylvia, Ph.D.
Organization
Massachusetts General Hospital

Study Officials

  • Louisa G Sylvia, Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Psychology, Dauten Family Center for Bipolar Treatment Innovation

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

February 20, 2018

Study Completion

February 20, 2018

Last Updated

September 30, 2019

Results First Posted

September 30, 2019

Record last verified: 2019-09

Locations