Hyperthermic Yoga for Depressive Symptoms

Not Applicable

Completed

Conditions: Major Depressive Disorder
Depression

Interventions: Behavioral: hyperthermic yoga

Registration Number: NCT02607514

Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate yoga arm	hyperthermic yoga	participants will immediately start the 8-week hyperthermic yoga intervention
delayed yoga arm	hyperthermic yoga	participants will wait 8-weeks to start the 8-week hyperthermic yoga intervention

Primary Outcome Measures

Name	Time	Method
Acceptability as Measured by the Acceptability Interview Completed at 8-week Endpoint or Early Termination	at the end of 8-weeks 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?
Feasibility and Tolerability Measured by Percent of the Yoga Group Who Complete a Week 8 Assessment	8-week primary end point	Measured by percent of the yoga group who complete a week 8 assessment
Depressive Symptoms as Measured by the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)	8-week primary endpoint	Inventory of Depressive Symptomatology - Clinician Rated. Scale range: 0-84 (higher = greater depressive symptoms)

Secondary Outcome Measures

Name	Time	Method
Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), Trait, Over 8 Weeks.	8 weeks	Spielberger State-Trait Anxiety Inventory (STAI), Trait. A 40-item commonly used measure that distinguishes between state vs. trait anxiety. Ranges from 0-63 with higher scores indicating more anxiety.
Long Term Effects of Heated Yoga Intervention as Measured by All Primary and Secondary Outcomes After 1 Month Post-intervention.	one month post intervention	see all primary and secondary outcome measures listed here.
Anxiety as Measured by the Spielberger State-Trait Anxiety Inventory (STAI), State, Over 8 Weeks.	8 weeks	Spielberger State-Trait Anxiety Inventory (STAI), State. A 40-item commonly used measure that distinguishes between state vs. trait anxiety. Ranges from 0-63 with higher scores indicating more anxiety.
Sleep as Measured by the Pittsburg Sleep Quality Index (PSQI): A Commonly Used and Well-validated Self-rated Measure of Sleep-quality and Disturbance Over 8-weeks.	8-weeks	Pittsburg Sleep Quality Index (PSQI): A commonly used and well-validated self-rated measure of sleep-quality and disturbance. total score ranges from 0-21 with higher score indicating worse sleep quality.
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	Quality of Life Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Range 0-70 with higher scores indicating greater life satisfaction and enjoyment
General Health as Measured by the Medical Outcomes Study 36-item Short-form Survey (SF-36)	8 weeks	Medical Outcomes Study 36-item short-form survey (SF-36): Assesses bodily pain, general health perception, vitality, social functioning, physical and emotional impediments to role functioning, mental health, and includes an overall physical component scale (PCS) and mental component scale (MCS). scores range from 0-100 with 100 being the best.
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	Medical Outcomes Study 36-item short-form survey (SF-36)86: Assesses bodily pain, general health perception, vitality, social functioning, physical and emotional impediments to role functioning, mental health, and includes an overall physical component scale (PCS) and mental component scale (MCS). Scores range from 0-100 with 100 being the best.
Perceived Stress as Measured by the Perceived Stress Scale (PSS) Over 8 Weeks.	8 weeks	The Perceived Stress Scale (PSS): Measures perceived level of stress. Scale range: 0-40 (higher = more perceived stress)