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Recruiting NCT06094088

Researching Heat and Yoga for Mood Enhancement

No phase Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Heated Yoga, Non-Heated Yoga.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Examining the Impact of Heated and Non-Heated Yoga on Depression

Overview

This study will examine how doing heated yoga or non-heated yoga affects depression.

Detailed description

The purpose of this study is to investigate the effects of heated and non-heated yoga on depressive symptoms. Previous research trials using heated and non-heated yoga interventions have shown promising results for reducing depression and its related outcomes. However, no studies have directly compared the effects of heated vs. non-heated yoga for depression. The researchers aim to address this gap by conducting a non-inferiority trial comparing heated yoga and non-heated yoga interventions to improve depressive symptoms. Both the heated and non-heated yoga interventions will be conducted in-person by certified yoga instructors. Eligible participants will be adults who do not regularly practice yoga or meditation and are experiencing moderate levels of depression. Assessments will be conducted at baseline, mid-treatment, post-treatment, and follow-up using a secure data capture system.

Interventions

  • Behavioral Heated Yoga
    Heated yoga described in arm/group description
  • Behavioral Non-Heated Yoga
    Non-heated yoga described in arm/group description

Primary outcome measures

  • Patient Health Questionnaire-9 (PHQ-9) [Time frame: Weeks 0, 4, 8, and 20]
Secondary outcome measures (4)
  • The World Health Organization-5 Well-Being Index (WHO-5) [Time frame: Weeks 0, 4, 8, and 20]
  • Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) [Time frame: Weeks 0, 4, 8, and 20]
  • Ruminative Responses Scale (RRS) [Time frame: Weeks 0, 4, 8, and 20]
  • The Five Facet Mindfulness Questionnaire (FFMQ-15) [Time frame: Weeks 0, 4, 8, and 20]

Eligibility criteria

Inclusion criteria

  • adults (18-65 years old)
  • able to provide consent
  • are able to read and understand English
  • PHQ-9 score between 10-20, indicating moderate but not severe depressive symptom severity (27)
  • Must have filled out the waiver for the community-based yoga studio prior to enrolling in the study.

Exclusion criteria

  • have had a bone fracture or joint surgery in the past 6 months
  • not able to walk freely or without difficulty
  • have severe heart failure or lung disease
  • participants endorse an item on the revised Physical Activity Readiness Questionnaire (PAR-Q+) and do not have approval from their treating physician (we will check in with treating physician in the event that participants endorse any item on the PAR-Q+)
  • participants must have a physician responsible for their medical care
  • are pregnant or planning to become pregnant
  • no more than 6 yoga classes in the past 6 months
  • have active suicidal thinking (i.e., PHQ-9 item 9 ≥1 and a positive response to C-SSRS screener items 3, 4, 5, or 6)
  • report manic symptoms (Altman Self-Rating Mania Scale score ≥ 6 (28))
  • are on medications that make dehydration more likely (e.g., lithium, antipsychotics, insulin-dependent)
  • active eating disorders or substance use disorders within the past 12 months
  • antidepressant or psychiatric medications that are initiated less than 8 weeks or a dose change less than 4 weeks prior to screening visit
  • psychotherapy that has been initiated within the past 3 months
  • willingness to keep psychiatric medications and psychotherapy stable throughout the course of the study
  • psychiatric hospitalization within the past year
  • diagnosed with any neurological disorders that would impact participation or make participation unsafe
  • are currently in any active ketamine, ECT, or TMS
  • are unable to follow the study procedures (e.g., not able to travel to the heated or non-heated yoga studios)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Orange Door Collaborative — Cambridge
  • Breathe Yoga Studio — Cambridge

Identifiers

NCT: NCT06094088 · 2023p001916

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗