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Bikram Yoga and Aerobic Exercise for the Treatment of Major Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bikram Yoga
Aerobic Exercise
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Major depression, yoga, Bikram yoga, aerobic exercise, complementary and alternative treatment approaches, nontraditional treatment approaches, mindfulness, rumination, stress reactivity, cardiovascular functioning

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Bikram Yoga

    Aerobic Exercise

    Waitlist

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    Depression remission
    Remission was defined according to two criteria: 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 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.

    Secondary Outcome Measures

    Hassles and Uplifts Scale (HUS)
    The Hassles and Uplifts Scale (HUS) examines commonly encountered events that may be considered irritants (i.e., hassles) and/or positive experiences (i.e., uplifts). More specifically, participants were asked to give weekly ratings of 53 events based on how much each event was a hassle and how much each event was an uplift in the previous week with the following scale: 0 = None or not applicable, 1 = Somewhat, 2 = Quite a bit, 3 = A great deal. Scores across items were summed to give separate cumulative scores for hassles and uplifts. For the purposes of this study, only hassles were examined in subsequent analyses. The range of possible scores for hassles is 0 to 159, with a higher score indicating greater hassles.
    Ruminative Responses Scale (RRS) of the Response Styles Questionnaire
    The Ruminative Responses Scale (RRS) of the Response Styles Questionnaire was administered to assess the tendency to ruminate in response to depressive symptoms. The RRS has 22 items, rated on a 4-point scale ranging from 1 (almost never) to 4 (almost always) and asks respondents to indicate what they "generally do when feeling down, sad, or depressed". In this study, instructions were modified slightly in that participants were asked to indicate their general tendencies within a specific time frame (i.e., during the past 2 weeks). An overall score was computed by summing responses across all items. The range of possible scores on this scale is 22 to 88, with a higher score indicating more rumination.
    Philadelphia Mindfulness Scale (PHLMS)
    The 20-item Philadelphia Mindfulness Scale (PHLMS) was used to asses two components of mindfulness, present-moment awareness and acceptance. Participants responded to each item on 5-point scale, ranging from 1 (Never) to 5 (Very Often). Scores across items were summed to give separate cumulative scores for awareness and acceptance. Prior to calculating the acceptance score, all acceptance-related items were reverse coded. Scores for awareness and acceptance range from 10 to 50, with higher scores indicate higher awareness or acceptance.
    Heart Rate
    Heart rate (HR) was assessed using three ECG electrodes on the chest and abdomen.
    Blood Pressure
    Mean arterial pressure (MAP) was assessed using an automated blood pressure device called a finger photoplethysmography.
    Stress Sensitivity: Salivary Hormone and Trier Social Stress Test (TSST)
    Participants were required to explain why they deserved a particular job opportunity after being recently fired or defend themselves against a false accusation of shoplifting. Immediately following the speech task, participants underwent a mental arithmetic task in which they were asked to serially subtract 13 from a 4-digit prime number. Saliva samples were collected 8 times throughout the test.
    Submaximal Exercise Test
    In this test, participants exercised on a cycle ergometer while their heart rate was monitored. This test was used to estimate maximal oxygen uptake.

    Full Information

    First Posted
    August 1, 2019
    Last Updated
    August 19, 2019
    Sponsor
    Queen's University
    Collaborators
    Canadian Institutes of Health Research (CIHR), Queen's University Senate Advisory Research Committee
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04058080
    Brief Title
    Bikram Yoga and Aerobic Exercise for the Treatment of Major Depression
    Official Title
    Randomized Controlled Trial of Bikram Yoga and Aerobic Exercise for the Treatment of Major Depression: Efficacy and Underlying Mechanisms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 12, 2013 (Actual)
    Primary Completion Date
    March 13, 2016 (Actual)
    Study Completion Date
    March 13, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Queen's University
    Collaborators
    Canadian Institutes of Health Research (CIHR), Queen's University Senate Advisory Research Committee

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Participants attended two pre-treatment appointments. The first pre-treatment appointment was a 2-hour psychological assessment in which the study and its protocol were explained at length and consent was collected. Participants then completed a battery of measures, including a medical screening interview, a demographic interview, the full Structured Clinical Interview for DSM-IV Axis I Disorders, and the Hamilton Rating Scale for Depression. Participants also completed self-report psychological measures during the psychological assessment. After completion of this appointment, participants were given instructions to avoid specific substances or activities for a minimum length of time before the second pre-treatment appointment. The second pre-treatment appointment was a 3-hour physiological assessment which was completed within 1 week of the psychological assessment. The first 30 minutes of this appointment were used to set-up the physiological measurements and allow enough time for participants to become familiarized and comfortable with the laboratory setting. Following this, a carefully timed experimental protocol was followed, during which heart rate and mean arterial pressure were measured and recorded continuously. The participants also completed a stress task and their saliva was collected. The participants also engaged in the Submaximal Cycle Ergometer Test. At the end of the physiological assessment, participants were randomly assigned via a computer-generated random sequence to one of the treatment conditions. Group assignment was revealed via sealed envelopes that had been previously prepared by research personnel. Participants who were in the waitlist group were offered yoga or aerobic classes after the completion of the study protocol. Participants in the yoga and aerobic exercise groups then attended 2 classes per week of either yoga or aerobic exercise for 8 weeks. Following completion of the intervention period, participants attended a 3½ hr post-treatment assessment in which all measures of the physiological pre-treatment assessment were repeated. Additionally, participants were administered the Mood Module of the SCID-I/P and the HAM-D to assess changes in diagnostic status and depression severity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    Major depression, yoga, Bikram yoga, aerobic exercise, complementary and alternative treatment approaches, nontraditional treatment approaches, mindfulness, rumination, stress reactivity, cardiovascular functioning

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bikram Yoga
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Aerobic Exercise
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Waitlist
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Bikram Yoga
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Aerobic Exercise
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Treatment Response
    Description
    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.
    Time Frame
    Psychological pre-treatment assessment, post-treatment assessment (upon completion of 8 week intervention)
    Title
    Depression remission
    Description
    Remission was defined according to two criteria: 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 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.
    Time Frame
    Post-treatment assessment (upon completion of 8 week intervention)
    Secondary Outcome Measure Information:
    Title
    Hassles and Uplifts Scale (HUS)
    Description
    The Hassles and Uplifts Scale (HUS) examines commonly encountered events that may be considered irritants (i.e., hassles) and/or positive experiences (i.e., uplifts). More specifically, participants were asked to give weekly ratings of 53 events based on how much each event was a hassle and how much each event was an uplift in the previous week with the following scale: 0 = None or not applicable, 1 = Somewhat, 2 = Quite a bit, 3 = A great deal. Scores across items were summed to give separate cumulative scores for hassles and uplifts. For the purposes of this study, only hassles were examined in subsequent analyses. The range of possible scores for hassles is 0 to 159, with a higher score indicating greater hassles.
    Time Frame
    Psychological pre-treatment assessment, throughout intervention period (weekly for the 8 weeks of intervention)
    Title
    Ruminative Responses Scale (RRS) of the Response Styles Questionnaire
    Description
    The Ruminative Responses Scale (RRS) of the Response Styles Questionnaire was administered to assess the tendency to ruminate in response to depressive symptoms. The RRS has 22 items, rated on a 4-point scale ranging from 1 (almost never) to 4 (almost always) and asks respondents to indicate what they "generally do when feeling down, sad, or depressed". In this study, instructions were modified slightly in that participants were asked to indicate their general tendencies within a specific time frame (i.e., during the past 2 weeks). An overall score was computed by summing responses across all items. The range of possible scores on this scale is 22 to 88, with a higher score indicating more rumination.
    Time Frame
    Psychological pre-treatment assessment, throughout intervention period (bi-weekly for the 8 weeks of intervention)
    Title
    Philadelphia Mindfulness Scale (PHLMS)
    Description
    The 20-item Philadelphia Mindfulness Scale (PHLMS) was used to asses two components of mindfulness, present-moment awareness and acceptance. Participants responded to each item on 5-point scale, ranging from 1 (Never) to 5 (Very Often). Scores across items were summed to give separate cumulative scores for awareness and acceptance. Prior to calculating the acceptance score, all acceptance-related items were reverse coded. Scores for awareness and acceptance range from 10 to 50, with higher scores indicate higher awareness or acceptance.
    Time Frame
    Psychological pre-treatment assessment, throughout intervention period (weekly for 8 weeks of intervention classes)
    Title
    Heart Rate
    Description
    Heart rate (HR) was assessed using three ECG electrodes on the chest and abdomen.
    Time Frame
    Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)
    Title
    Blood Pressure
    Description
    Mean arterial pressure (MAP) was assessed using an automated blood pressure device called a finger photoplethysmography.
    Time Frame
    Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)
    Title
    Stress Sensitivity: Salivary Hormone and Trier Social Stress Test (TSST)
    Description
    Participants were required to explain why they deserved a particular job opportunity after being recently fired or defend themselves against a false accusation of shoplifting. Immediately following the speech task, participants underwent a mental arithmetic task in which they were asked to serially subtract 13 from a 4-digit prime number. Saliva samples were collected 8 times throughout the test.
    Time Frame
    Physiological pre-treatment assessment (~30 minutes into the protocol), post-treatment assessment (upon completion of 8 week intervention)
    Title
    Submaximal Exercise Test
    Description
    In this test, participants exercised on a cycle ergometer while their heart rate was monitored. This test was used to estimate maximal oxygen uptake.
    Time Frame
    Physiological pre-treatment assessment (after TSST), post-treatment assessment (upon completion of 8 week intervention)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kate Harkness, PhD
    Organizational Affiliation
    Queen's University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Bikram Yoga and Aerobic Exercise for the Treatment of Major Depression

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