DepressionNCT04058080
Bikram Yoga and Aerobic Exercise for the Treatment of Major Depression
A study testing Bikram Yoga and Aerobic Exercise in people with Depression, run by Queen's University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Bikram Yoga and Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 12 Mar 2013to 13 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Randomized Controlled Trial of Bikram Yoga and Aerobic Exercise for the Treatment of Major Depression: Efficacy and Underlying Mechanisms
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Bikram Yoga, Aerobic Exercise
- Keywords
- Major depression, yoga, Bikram yoga, aerobic exercise, complementary and alternative treatment approaches, nontraditional treatment approaches, mindfulness, rumination, stress reactivity, cardiovascular functioning
- Medical subject headings
- Depression, Depressive Disorder, Major, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bikram YogaOther
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.
Aerobic ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Psychological pre-treatment assessment, post-treatment assessment (upon completion of 8 week intervention)
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.
Measured: Post-treatment assessment (upon completion of 8 week intervention)
Secondary outcomes (7)
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.
Measured: Psychological pre-treatment assessment, throughout intervention period (weekly for the 8 weeks of intervention)
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.
Measured: Psychological pre-treatment assessment, throughout intervention period (bi-weekly for the 8 weeks of intervention)
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.
Measured: Psychological pre-treatment assessment, throughout intervention period (weekly for 8 weeks of intervention classes)
Heart Rate
Heart rate (HR) was assessed using three ECG electrodes on the chest and abdomen.
Measured: Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)
Blood Pressure
Mean arterial pressure (MAP) was assessed using an automated blood pressure device called a finger photoplethysmography.
Measured: Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)
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.
Measured: Physiological pre-treatment assessment (~30 minutes into the protocol), post-treatment assessment (upon completion of 8 week intervention)
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.
Measured: Physiological pre-treatment assessment (after TSST), post-treatment assessment (upon completion of 8 week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start12 Mar 2013
- Primary completion13 Mar 2016
- Study completion13 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Queen's University Senate Advisory Research Committee
- Responsible party
- Principal investigator, Dr. Kate Harkness, Queen's University
- Investigators
- Kate Harkness, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058080
- Sponsor's protocol ID
- PSYC-132-13
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Bikram Yoga and Aerobic Exercise for the Treatment of Major Depression: Efficacy and Underlying Mechanisms
- ClinicalTrials.gov ID
- NCT04058080
- Acronym / sponsor ID
- PSYC-132-13
- Conditions
- Depression
- Keywords
- Major depression, yoga, Bikram yoga, aerobic exercise, complementary and alternative treatment approaches, nontraditional treatment approaches, mindfulness, rumination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Queen's University Senate Advisory Research Committee
- Study start
- 12 Mar 2013 (actual)
- Primary completion
- 13 Mar 2016 (actual)
- Study completion
- 13 Mar 2016 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bikram Yoga | Experimental | Other: Bikram YogaParticipants 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. |
| Aerobic Exercise | Active comparator | Other: Aerobic ExerciseParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bikram YogaParticipants 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. | Other | Bikram Yoga |
| Aerobic ExerciseParticipants 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. | Other | Aerobic Exercise |
Primary outcome
Treatment Response
Time frame: Psychological pre-treatment assessment, post-treatment assessment (upon completion of 8 week intervention)
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
Time frame: Post-treatment assessment (upon completion of 8 week intervention)
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.
7 secondary outcomes
Hassles and Uplifts Scale (HUS)
Time frame: Psychological pre-treatment assessment, throughout intervention period (weekly for the 8 weeks of intervention)
Ruminative Responses Scale (RRS) of the Response Styles Questionnaire
Time frame: Psychological pre-treatment assessment, throughout intervention period (bi-weekly for the 8 weeks of intervention)
Philadelphia Mindfulness Scale (PHLMS)
Time frame: Psychological pre-treatment assessment, throughout intervention period (weekly for 8 weeks of intervention classes)
Heart Rate
Time frame: Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)
Blood Pressure
Time frame: Physiological pre-treatment assessment (within 30 minutes of start), post-treatment assessment (upon completion of 8 week intervention)
Stress Sensitivity: Salivary Hormone and Trier Social Stress Test (TSST)
Time frame: Physiological pre-treatment assessment (~30 minutes into the protocol), post-treatment assessment (upon completion of 8 week intervention)
Submaximal Exercise Test
Time frame: Physiological pre-treatment assessment (after TSST), post-treatment assessment (upon completion of 8 week intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Harkness, PhD principal investigator
Queen's University
Questions about this trial
What is this clinical trial studying?
A study testing Bikram Yoga and Aerobic Exercise in people with Depression, run by Queen's University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Response (time frame: Psychological pre-treatment assessment, post-treatment assessment (upon completion of 8 week intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.