Bikram Yoga and Aerobic Exercise for the Treatment of Major Depression

NCT04058080 | Completed

• 1 other identifier: PSYC-132-13
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary goal of this project was to examine the antidepressant effects of yoga as an alternative treatment for depression as compared to no treatment and aerobic exercise. The secondary goal of this project was to examine relevant physiological (i.e., heart rate, blood pressure, cortisol levels) and psychological variables (i.e., perceived hassles, rumination, mindfulness) that may underlie the antidepressant effects of Bikram yoga and aerobic exercise.

Conditions

Depression

Keywords

Major depression; yoga; Bikram yoga; aerobic exercise; complementary and alternative treatment approaches; nontraditional treatment approaches; mindfulness; rumination; stress reactivity; cardiovascular functioning

Outcome Measures

Primary Outcomes (2)

• Treatment Response

  Treatment response was defined as a 50% reduction from pre-treatment assessment and post-treatment assessment on the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 17-item semi-structured interview that assesses the severity of depressive symptoms in the past week. The item ratings range from 0 to 2 or from 0 to 4 depending on the item, with total scores ranging from 0 to 50. Higher scores indicate more severe depressive symptoms.

  Psychological pre-treatment assessment, post-treatment assessment (upon completion of 8 week intervention)

• Depression remission

  Remission was defined according to two criteria: 1. A post-treatment assessment Hamilton Rating Scale for Depression (HAM-D) score of 7 or lower. The HAM-D is a 17-item semi-structured interview that assesses the severity of depressive symptoms in the past week. The item ratings range from 0 to 2 or from 0 to 4 depending on the item, with total scores ranging from 0 to 50. Higher scores indicate more severe depressive symptoms. AND 2. No longer meeting diagnostic criteria for major depression. This was assessed by administering the major depression module of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I/P). The major depression module of the SCID-I/P includes 9 questions corresponding to the 9 criterial symptoms of major depression. Each symptom is coded as 0-absent or 1-present. Total scores can range from 0-9. A total score of 5 or above indicates the presence of major depression. Scores below 5 indicate that the participant no longer meets criteria.

  Post-treatment assessment (upon completion of 8 week intervention)

Secondary Outcomes (7)

• Hassles and Uplifts Scale (HUS)

  Psychological pre-treatment assessment, throughout intervention period (weekly for the 8 weeks of intervention)

• Ruminative Responses Scale (RRS) of the Response Styles Questionnaire

  Psychological pre-treatment assessment, throughout intervention period (bi-weekly for the 8 weeks of intervention)

• Philadelphia Mindfulness Scale (PHLMS)

  Psychological pre-treatment assessment, throughout intervention period (weekly for 8 weeks of intervention classes)

• Heart Rate

  Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)

• Blood Pressure

  Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)

Study Arms (3)

Bikram Yoga

EXPERIMENTAL

Participants in the Bikram yoga group were asked to attend two classes per week for 8 weeks (16 classes in total) at a local affiliated Bikram yoga studio. Certified Bikram yoga teachers instructed all classes using a scripted instructional dialogue. Each 90-min class was held in a temperature-controlled room (40.6 degrees Celsius, 40% humidity). The class opened with a deep breathing exercise and continued with 50 minutes of standing asanas and 40 minutes of floor-based asanas, including a quick, forceful breathing exercise to finish. All but the last asana (i.e., spine-twisting) were performed twice. Savasana, which is a restorative and relaxation posture, was performed between asanas throughout the floor series and at the end of class. The yoga studio regularly offered 22 class times per week, all of which were accessible to participants.

Other: Bikram Yoga

Aerobic Exercise

ACTIVE COMPARATOR

Participants in the aerobic exercise group were asked to attend two group aerobic exercise classes per week for 8 weeks (16 classes in total) at the Kingston Family YMCA. They were provided with a modified schedule of the YMCA group classes, which included only classes with a strong aerobic component and excluded those involving yoga, pilates, or cycling. Selecting these classes was done in consultation with the general manager of the YMCA, who was familiar with each class type. Classes involving the following components were available to participants: choreography-based cardio, aerobics, light muscular conditioning, and stretching; cardio, plyometric, and strength training exercises; high intensity aerobic exercise with intermittent rest periods; circuit-based cardio and strength training exercises; stepper-based exercises; and Latin-inspired dance/fitness. Classes were 50-60 minutes in duration.

Other: Aerobic Exercise

Waitlist

NO INTERVENTION

Waitlisted individuals were not able to access yoga or exercise classes throughout the intervention period but participated in the rest of the study protocol. Following the post-treatment assessment, they received access to the class type of their choosing.

Interventions

Bikram Yoga OTHER

Participants in the Bikram yoga group were asked to attend two classes per week for 8 weeks (16 classes in total) at a local affiliated Bikram yoga studio. Certified Bikram yoga teachers instructed all classes using a scripted instructional dialogue. Each 90-min class was held in a temperature-controlled room (40.6C, 40% humidity). The yoga studio regularly offered 22 class times per week, all of which were accessible to participants.

Bikram Yoga

Aerobic Exercise OTHER

Participants in the aerobic exercise group were asked to attend two group aerobic exercise classes per week for 8 weeks (16 classes in total) at the Kingston Family YMCA. They were provided with a modified schedule of the YMCA group classes, which included only classes with a strong aerobic component and excluded those involving yoga, pilates, or cycling. Classes involving the following components were available to participants: choreography-based cardio, aerobics, light muscular conditioning, and stretching; cardio, plyometric, and strength training exercises; high intensity aerobic exercise with intermittent rest periods; circuit-based cardio and strength training exercises; stepper-based exercises; and Latin-inspired dance/fitness. Classes were 50-60 minutes in duration. Participants were able to attend any of the offered classes each week. Participants had approximately 18-22 classes in total to choose from each week.

Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physically healthy
• Female
• Meet DSM-IV-TR criteria for a current episode of a non chronic, unipolar depressive disorder (i.e., MDD, adjustment disorder with depressed mood, depressive disorder not otherwise specified)

You may not qualify if:

• Presence of a psychotic disorder, bipolar disorder, substance dependence, current suicidality beyond simple ideation
• Presence of a medical condition that could be the cause of depression
• Presence of a a pre-existing physical condition that could interfere with participation in physical activity (e.g., cardiovascular disease, untreated hypertension, etc.)
• Change in the type or dose of antidepressant medication or change in frequency of sessions of psychotherapy/counseling in the previous 3 months
• Pregnant women or women actively trying to become pregnant
• Regular participation in yoga or group exercise classes (i.e., on a biweekly or more basis) during the 3-month period prior to study onset or on a long-term basis in the past 2 years
• A schedule that did not allow for participation in yoga or exercise classes twice per week

Sponsors & Collaborators

• Queen's University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Queen's University Senate Advisory Research Committee: collaborator

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Rumination Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kate Harkness, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 15, 2019
• Study Start: March 12, 2013
• Primary Completion: March 13, 2016
• Study Completion: March 13, 2016
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share