Clinical trial NCT04058080: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Major depression
yoga
Bikram yoga
aerobic exercise
complementary and alternative treatment approaches
nontraditional treatment approaches
mindfulness
rumination
stress reactivity
cardiovascular functioning
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Queen's University Senate Advisory Research Committee
First posted: 2019-08-15
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment Response
timeFrame: Psychological pre-treatment assessment, post-treatment assessment (upon completion of 8 week intervention)
measure: Depression remission
timeFrame: Post-treatment assessment (upon completion of 8 week intervention)
Secondary outcomes:
measure: Hassles and Uplifts Scale (HUS)
timeFrame: Psychological pre-treatment assessment, throughout intervention period (weekly for the 8 weeks of intervention)
measure: Ruminative Responses Scale (RRS) of the Response Styles Questionnaire
timeFrame: Psychological pre-treatment assessment, throughout intervention period (bi-weekly for the 8 weeks of intervention)
measure: Philadelphia Mindfulness Scale (PHLMS)
timeFrame: Psychological pre-treatment assessment, throughout intervention period (weekly for 8 weeks of intervention classes)
measure: Heart Rate
timeFrame: Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)
measure: Blood Pressure
timeFrame: Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)
measure: Stress Sensitivity: Salivary Hormone and Trier Social Stress Test (TSST)
timeFrame: Physiological pre-treatment assessment (~30 minutes into the protocol), post-treatment assessment (upon completion of 8 week intervention)
measure: Submaximal Exercise Test
timeFrame: Physiological pre-treatment assessment (after TSST), post-treatment assessment (upon completion of 8 week intervention)
Other outcomes:
Locations:
Study officials:
affiliation: Queen's University
name: Kate Harkness, PhD
role: PRINCIPAL_INVESTIGATOR
References: