Mood DisordersNCT02610725

Online Yoga for Individuals With Mood Disorders

A study testing Hatha yoga in people with Mood Disorders and Bipolar Disorder, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Mood Disorders, Bipolar Disorder, Depression
What is being tested?: Hatha yoga
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 281 participants
Where: 1 siteUnited States
Study dates: Nov 2015to 20 Feb 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Read the detailed description

Yoga practitioners view yoga as a way to promote good physical and mental health, rather than as a treatment for poor health. This world view may be appealing to patients, especially those concerned with the stigma of conventional mental health treatment, or with the narrow focus on decreasing symptoms (instead of a broader focus on living to one's full potential) that defines much of conventional mental health treatment. Yoga classes are widely available and relatively inexpensive compared to other depression treatments. Yoga can be practiced at home with the aid of video recordings or books. We propose to examine the acceptability and feasibility of online yoga practice for individuals with depression, mania, or hypomania.

Conditions: Mood Disorders, Bipolar Disorder, Depression
Being tested: Hatha yoga
Medical subject headings: Mood Disorders, Bipolar Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02610725
Study group	Role	What they receive
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. Receives: Other: Hatha yoga

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Pre- and post-intervention, 40 min

Secondary outcomes (2)

Feasibility/Acceptability Questionnaire
This measure was developed for this study. It includes a Likert Scale item assessing how much participants liked the class (1 "Disliked it very much" to 10 "Liked it very much"). It also collects qualitative feedback on what they liked, disliked, as well as any other commentary. Quantitative data from Likert items are the secondary outcome reported.
Measured: Post-Intervention
Adverse Event Questionnaire
A free response survey asking for detail on any pain or injuries that may be relevant or related to the online yoga class
Measured: Post-Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201520 Feb 2018

First posted20 Nov 2015 (estimated)
Study startNov 2015
Primary completion20 Feb 2018
Study completion20 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Mood DisordersStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 281 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02610725
Sponsor's protocol ID: 2015P001362
Status last verified: Sep 2019
First submitted: 19 Nov 2015
Last updated: 30 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Mood Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Online Yoga for Individuals With Mood Disorders
ClinicalTrials.gov ID: NCT02610725
Acronym / sponsor ID: 2015P001362
Conditions: Mood Disorders, Bipolar Disorder, Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 281 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Brown University
Study start: Nov 2015 (actual)
Primary completion: 20 Feb 2018 (actual)
Study completion: 20 Feb 2018 (actual)
First posted: 20 Nov 2015 (estimated)
Results: Posted 30 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Yoga class	Other	Other: Hatha yogaA 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

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
Hatha yogaParticipants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.	Other	Yoga class

Primary outcome

Positive and Negative Affect Scale
Time frame: Pre- and post-intervention, 40 min
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.

2 secondary outcomes

Feasibility/Acceptability Questionnaire
Time frame: Post-Intervention
Adverse Event Questionnaire
Time frame: Post-Intervention

Results and safety

Results posted to the registry on 30 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Yoga Class	281	75

Primary outcome: Positive and Negative Affect Scale

Time frame: Pre- and post-intervention, 40 min. Mean (Standard Deviation). Unit: units on a scale

Measure	Yoga Class n = 140
Positive Affect Pre-Intervention	23.39 (7.95)
Positive Affect Post-Intervention	25.38 (9.40)
Negative Affect Pre-Intervention	22.99 (8.83)
Negative Affect Post-Intervention	15.21 (7.04)

Yoga Class: Mean Difference (Final Values): -2.10 (95% CI -3.73 to -0.46), p = 0.013, t-test, 2 sided
Yoga Class: Mean Difference (Final Values): 6.06 (95% CI 4.10 to 8.02), p <0.001, t-test, 2 sided

Population analysed: 140 participants completed the PANAS at pre-intervention. 52 had valid data at post-intervention

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 40 minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Yoga Class	0 of 281 (0%)	12 of 281 (4.3%)	0 of 281

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Mood Disorders

Recruiting
Unified Protocol in Penitentiary Facilities
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Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder

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.

Louisa G Sylvia, Ph.D. principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hatha yoga in people with Mood Disorders and Bipolar Disorder, run by Massachusetts General 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 3 inclusion and 1 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 30 Sep 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Positive and Negative Affect Scale (time frame: Pre- and post-intervention, 40 min). 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 NCT02610725.

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 30 Sep 2019.