Hyperthermic Yoga for Depressive Symptoms

NCT02607514 | Completed Results DMC

• 2 other identifiers: 2016P0007045K23AT008043-05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Study is a randomized controlled trial to assess the feasibility, acceptability, efficacy, and mechanisms of action of hyperthermic yoga versus a waitlist control for 80 medically healthy adults with mild to moderate depressive symptoms. The primary aim is to test the acceptability and feasibility of hyperthermic yoga as a treatment for depression. The secondary aim is to examine the effect size/efficacy of hyperthermic yoga for depressive symptoms. The tertiary aim is to explore physiological and psychological mechanisms of action.

Conditions

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)

  Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms)

  8-week primary endpoint

• Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment

  Measured by percent of the yoga group who complete a week 8 assessment

  8-week primary end point

• Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination

  Acceptability Interview: A 19-question qualitative interview assesses perception of ease of participation, program likeability, and perceived benefits of the yoga program. Adapted from DeBoer et al. It was a 1-10 likert scale with 1 = lowest, 10 = highest to rate acceptability of the yoga intervention. These are the items we used: 1) how much did you enjoy the yoga itself?; 2) how much did you enjoy the aftereffects of the yoga?; and 3) how reasonable did you find the time commitment to be?

  at the end of 8-weeks or early termination.

Secondary Outcomes (8)

• Quality of Life as Measured by the Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Over 8 Weeks.

  8-weeks end point

• General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36)

  8 weeks

• Physical Functioning as Measured by the Physical Component Scale (PCS) of the Medical Outcomes Study 36-item Short-form Survey (SF-36) Over 8 Weeks.

  8 weeks

• Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks.

  8 weeks

• Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks.

  8 weeks

Study Arms (2)

immediate yoga arm

EXPERIMENTAL

participants will immediately start the 8-week hyperthermic yoga intervention

Behavioral: hyperthermic yoga

delayed yoga arm

OTHER

participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention

Behavioral: hyperthermic yoga

Interventions

hyperthermic yoga BEHAVIORAL

heated yoga, 90-minutes

Also known as: Bikram Yoga

delayed yoga arm; immediate yoga arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults ages 18-60
• English language proficiency
• Ability to provide informed consent
• Score of \>23 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
• Able and willing to attend two 90-minute hyperthermic yoga sessions per week
• Willingness to keep existing exercise regimen (even if that is sedentary) stable over study course
• Women of childbearing potential must use an acceptable form of birth control
• Membership to the Bikram Yoga Boston and Bikram Yoga Cambridge studios via studio website "Interested in research" option through a centralized portal (this will remain central until January 1, 2017)
• Willingness to adhere to hydration requirements (i.e., an additional four 8 oz servings of water pre- and post-yoga classes)

You may not qualify if:

• Pregnancy or planned pregnancy during study
• History of psychiatric hospitalization within the past year
• Active suicidal intent within the past year ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)
• History of neurologic disorders that could interfere in study participation
• History of bipolar disorder, psychotic disorders, eating disorders, and/or substance abuse or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI)
• Psychotropic medication use that has been stable for \<3 months
• Use of stimulant medications or diet pills during the study, or any pre-workout powders or liquids designed to provide excessive energy
• Active conditions which may also cause depressive symptoms (e.g. epilepsy, hypothyroidism)
• Medical conditions that may make participation unsafe (e.g., diabetes \[I \& II\], cardiovascular disease, hypertension \[\>140 systolic and/or \>90 diastolic\], hypotension \[\<90 systolic and/or \<60 diastolic, during screening\], orthostatic hypotension \[systolic drop of 20 points or 10 point diastolic or heart rate increase by 10\], autoimmune disorders, malignancy, or autonomic dysfunction)
• \> 6 one hour classes of meditation or other mind-body disciplines (e.g., Tai chi or yoga) within the last 6 months
• Current individual or group psychotherapy established for \<3 months
• A subject who in the opinion of the Principal Investigator would not be able to safely complete the study or would jeopardize study integrity
• History of heat intolerance or heat stroke
• Unsafe cardiac status as defined by abnormal ECG reading at screening visit as determined by medical monitor, study doctor, or subject's PCP or cardiologist

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Depression Clinical and Research Program

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Nyer MB, Hopkins LB, Nagaswami M, Norton R, Streeter CC, Hoeppner BB, Sorensen CEC, Uebelacker L, Koontz J, Foster S, Dording C, Giollabhui NM, Yeung A, Fisher LB, Cusin C, Jain FA, Pedrelli P, Ding GA, Mason AE, Cassano P, Mehta DH, Sauder C, Raison CL, Miller KK, Fava M, Mischoulon D. A Randomized Controlled Trial of Community-Delivered Heated Hatha Yoga for Moderate-to-Severe Depression. J Clin Psychiatry. 2023 Oct 23;84(6):22m14621. doi: 10.4088/JCP.22m14621.

  PMID: 37883245 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Maren Nyer
• Organization: Massachusetts General Hospital

mnyer@partners.org

6072796290

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maren Nyer, PhD

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 18, 2015
• Study Start: February 20, 2017
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: November 20, 2025
• Results First Posted: August 27, 2024

Record last verified: 2025-11

Locations

US (1)