DepressionNCT01772498
HRV Biofeedback for Brain Tumour Survivors
A study testing heart rate variability biofeedback in people with Depression and Anxiety, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
This study is designed to take a first step toward testing the efficacy and acceptability of heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress in survivors of Primary Brain Tumour (PBT). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression, Anxiety, Sleep Impairment
- What is being tested?
- heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jun 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be a survivor of a primary, malignant brain tumour (WHO grades II-IV)
- not have undergone any major treatment (chemotherapy, radiation, surgery) for previous three months
- be psychologically distressed as indicated by a score of 11 or over on either the anxiety or depression subscale of the Psychosocial Screening Instrument for Cancer (PSSCAN)
- be functionally capable of engaging in a time consuming study of this kind, (as indicated by a Karnofsky Scale score of 70/100)
Who cannot join
- being incompetent to give consent independently
- being actively suicidal (as per a score of 2 or above on the 1-5 point PSSCAN suicidality measure)
- being actively delusional or psychotic
- being judged, by the PI, to be too acutely distressed to benefit from and/or to successfully complete the intervention (e.g. scoring above 20 on either the depression or anxiety scale of the PSSCAN and/or , in the PI's clinical judgment, being without adequate supports or resources in place to adequately manage their current level of distress successfully enough to benefit from and/or to successfully complete the intervention)
- being currently engaged in psychotherapy or another psychologically based treatment that is specifically designed to ameliorate psychological distress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors
This study is designed to take a first step toward testing the efficacy and acceptability of heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides clients with real time feedback about their heart rate variability (HRV) as a means of teaching them how to breathe in a specific, therapeutic manner.
More specifically, this study has been designed to test several hypothesises. Each hypothesis is based on the prediction that, in a sample of psychologically distressed PBT survivors, a course of 8 HRVB sessions will demonstrate:
Read more
- statistically significant reductions in levels of depression
- statistically significant reductions in levels of anxiety
- statistically significant increases in resting HRV
- that reductions in anxiety and depression will be significantly, negatively correlated with increases in resting HRV
- that the HRVB will be viewed as an acceptable intervention by the participants
In addition to the hypothesises stated above, the study will also investigate in a discovery oriented manner if the HRVB intervention will have positive impacts on the participants:
- levels of sleep impairment
- levels of pain
Read the detailed description
Purpose
This study will test the efficacy and acceptability of heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides clients with real time feedback about their heart rate variability (HRV) as a means of teaching them how to breathe in a specific, therapeutic manner. HRVB has been shown to increase autonomic nervous system efficiency and also to decrease both anxiety and depression.
Background Rationale
Anxiety and depression are two of the strongest drivers of overall quality of life (Q of L) in survivors of primary, malignant brain tumour (PMBT). In a cohort of 73 PMBT survivors, "depression scores alone accounted for more than half of the all variance in Q of L scores" (Pelletier et al, 2003, p. 47). Anxiety symptoms were similarly negatively correlated with over-all Q of L(r = -..72) in brain tumour survivors (Janda et al., 2007). Evidence also suggests that, relative to the general population, brain tumour survivors exhibit much higher rates of both depression (Wellisch et al., 2002)and anxiety (Arnold et al., 2007).
Despite these striking findings around the prevalence and importance of anxiety and depression in the brain tumour population, not a single identified study has used a purely psychological intervention to ameliorate symptoms of depression and/or anxiety in this unique, understandably distressed population. Therefore, research of this kind is urgently needed.
Heart Rate variability Biofeedback
A course of HRVB, or some close variant of it, has shown statistically significant effects on depression and/or anxiety in numerous studies. HRVB has also recently been found to associated with improvements in pain and insomnia, two other common barriers to quality of life in PMBT survivors.
Design
Overview
As a very early stage study, a one group, open label design has been adopted.
Recruitment Process
Participants will be recruited by sending letters to potential participants identified through the BC Cancer Agency registry and by encouraging referrals from local oncologists.
Measures
The primary outcome measures will be resting HRV, the Beck Depression Inventory II, the Trait Anxiety Inventory. Secondary outcome will include the Short Form McGill Pain Questionnaire and the Pittsburgh Sleep Quality Index. Likert scale questionnaires will also be used after the intervention to assess the acceptability of the intervention.
HRVB Protocol
The protocol will involve 8 weekly sessions of up to 60 minutes each, following the general approach described by Lehrer, Vaschillo, \& Vaschillo (2000). Participants will also practice breathing at their resonant frequency for 20 minutes each day at home.
Analysis
Three forms of analysis will be conducted. First, paired t-tests of residualized changes scores and effect sizes (Cohen's d) will be used to analyze pre-post changes on all of the psychometric measures and on the HRV data. Second, correlational analysis will also be used to see if there are expected associations between pre-post changes in emotion, pain and sleep measures relative to pre-post changes in resting HRV indices. Finally, means and standard deviations will be used to assess participants' likert ratings on the acceptability of the intervention.
Plans for Current Findings
Results will be developed for publication in relevant, peer reviewed scientific journals. Results will also be used to develop future research in this line, including studying the effciacy of HRVB with psychologically distressed caregivers of PMBT survivors.
- Conditions
- Depression, Anxiety, Sleep Impairment
- Being tested
- heart rate variability biofeedback
- Keywords
- depression, anxiety, sleep, pain, biofeedback, breathing, resonant
- Medical subject headings
- Depression, Anxiety Disorders, Pain, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate variability biofeedbackBehavioural
Also called resonant frequency biofeedback, RSA biofeedback
| Study group | Role | What they receive |
|---|---|---|
| Heart rate variability biofeedback | Experimental | Heart rate variability biofeedback training administered in eight, individual, weekly, one hour sessions. There will also be 20 minutes a day of resonant frequency breathing to be conducted at home. This intervention involves teaching subjects how to breath at their resonant frequency in a relaxed, diaphramatic manner. Receives: Behavioral: heart rate variability biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in score on Beck Depression Inventory II at 8 weeks
Widely used self report measure to assess for symptoms of depression.
Measured: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Change from baseline scores on trait form of the State Trait Anxiety Inventory (Spielberger et al., 1983)at 8 weeks
The Trait Anxiety Inventory is a widely used self report measure of anxiety symptoms.
Measured: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Change from baseline in resting HRV High Frequency Power
Baseline level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest at pre-intervention compared to level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest recorded aqt post-intervention
Measured: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Resting Low Frequency HRV power (0.04-0.15 Hz)
Baseline level of Low Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest at pre-intervention compared to level of Low Frequency HRV power (0.04-0.15 Hz)measured in ms2/Hz recorded over 5 minutes of rest recorded aqt post-intervention
Measured: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Change in the standard deviation of all NN intervals from baseline in resting heart beat
This metric measures the standard deviation of normal beat-to-beat intervals (SDNN) that are present within the heart rythm. it is a time domain measure of HRV and it serves as a marker of overall adaptability of the nervous system.
Measured: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Subjective Acceptability ratings
This will be a 5 point Likert scale asking how acceptable the participants found the experience of particiapting in the intervention to be , from "not at all acceptable" to "very acceptable".
Measured: To be completed immediately post-intervention (8 weeks after the intiation of training)
Secondary outcomes (2)
Change from baseline score on the Short Form McGill Pain Questionnaire (SFMPQ)(Melzack, 1987)
The SFMPQ is a widely used measure of pain related experience.
Measured: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Change from baseline in scores on the Pittsburgh Sleep Quality Index (Buysse et al., 1989)
The Pittsburgh Sleep Quality Index (Buysse et al., 1989)is a widely used self report measure of sleep quality.
Measured: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Wolfgang Linden, PhD, Principal investigator, UBC Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772498
- Sponsor's protocol ID
- HRVB-123
- Status last verified
- May 2015
- First submitted
- 4 Dec 2012
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pelletier G, Verhoef MJ, Khatri N, Hagen N. Quality of life in brain tumor patients: the relative contributions of depression, fatigue, emotional distress, and existential issues. J Neurooncol. 2002 Mar;57(1):41-9. doi: 10.1023/a:1015728825642.
PubMed 12125966Janda M, Steginga S, Langbecker D, Dunn J, Walker D, Eakin E. Quality of life among patients with a brain tumor and their carers. J Psychosom Res. 2007 Dec;63(6):617-23. doi: 10.1016/j.jpsychores.2007.06.018.
PubMed 18061752Wellisch DK, Kaleita TA, Freeman D, Cloughesy T, Goldman J. Predicting major depression in brain tumor patients. Psychooncology. 2002 May-Jun;11(3):230-8. doi: 10.1002/pon.562.
PubMed 12112483Arnold SD, Forman LM, Brigidi BD, Carter KE, Schweitzer HA, Quinn HE, Guill AB, Herndon JE 2nd, Raynor RH. Evaluation and characterization of generalized anxiety and depression in patients with primary brain tumors. Neuro Oncol. 2008 Apr;10(2):171-81. doi: 10.1215/15228517-2007-057. Epub 2008 Feb 26.
PubMed 18314416Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000 Sep;25(3):177-91. doi: 10.1023/a:1009554825745.
PubMed 10999236
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability Biofeedback for Psychologically Distressed Brain Tumour Survivors
- ClinicalTrials.gov ID
- NCT01772498
- Acronym / sponsor ID
- HRVB-123
- Conditions
- Depression, Anxiety, Sleep Impairment
- Keywords
- depression, anxiety, sleep, pain, biofeedback, breathing, resonant
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 Jan 2013 (estimated)
- 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.
This study is designed to take a first step toward testing the efficacy and acceptability of heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides clients with real time feedback about their heart rate variability (HRV) as a means of teaching them how to breathe in a specific, therapeutic manner.
More specifically, this study has been designed to test several hypothesises. Each hypothesis is based on the prediction that, in a sample of psychologically distressed PBT survivors, a course of 8 HRVB sessions will demonstrate:
- statistically significant reductions in levels of depression
- statistically significant reductions in levels of anxiety
- statistically significant increases in resting HRV
- that reductions in anxiety and depression will be significantly, negatively correlated with increases in resting HRV
- that the HRVB will be viewed as an acceptable intervention by the participants
In addition to the hypothesises stated above, the study will also investigate in a discovery oriented manner if the HRVB intervention will have positive impacts on the participants:
- levels of sleep impairment
- levels of pain
Detailed description
Purpose
This study will test the efficacy and acceptability of heart rate variability biofeedback (HRVB) as a means of ameliorating psychological distress in survivors of Primary Brain Tumour (PBT). HRVB is a biofeedback approach that provides clients with real time feedback about their heart rate variability (HRV) as a means of teaching them how to breathe in a specific, therapeutic manner. HRVB has been shown to increase autonomic nervous system efficiency and also to decrease both anxiety and depression.
Background Rationale
Anxiety and depression are two of the strongest drivers of overall quality of life (Q of L) in survivors of primary, malignant brain tumour (PMBT). In a cohort of 73 PMBT survivors, "depression scores alone accounted for more than half of the all variance in Q of L scores" (Pelletier et al, 2003, p. 47). Anxiety symptoms were similarly negatively correlated with over-all Q of L(r = -..72) in brain tumour survivors (Janda et al., 2007). Evidence also suggests that, relative to the general population, brain tumour survivors exhibit much higher rates of both depression (Wellisch et al., 2002)and anxiety (Arnold et al., 2007).
Despite these striking findings around the prevalence and importance of anxiety and depression in the brain tumour population, not a single identified study has used a purely psychological intervention to ameliorate symptoms of depression and/or anxiety in this unique, understandably distressed population. Therefore, research of this kind is urgently needed.
Heart Rate variability Biofeedback
A course of HRVB, or some close variant of it, has shown statistically significant effects on depression and/or anxiety in numerous studies. HRVB has also recently been found to associated with improvements in pain and insomnia, two other common barriers to quality of life in PMBT survivors.
Design
Overview
As a very early stage study, a one group, open label design has been adopted.
Recruitment Process
Participants will be recruited by sending letters to potential participants identified through the BC Cancer Agency registry and by encouraging referrals from local oncologists.
Measures
The primary outcome measures will be resting HRV, the Beck Depression Inventory II, the Trait Anxiety Inventory. Secondary outcome will include the Short Form McGill Pain Questionnaire and the Pittsburgh Sleep Quality Index. Likert scale questionnaires will also be used after the intervention to assess the acceptability of the intervention.
HRVB Protocol
The protocol will involve 8 weekly sessions of up to 60 minutes each, following the general approach described by Lehrer, Vaschillo, \& Vaschillo (2000). Participants will also practice breathing at their resonant frequency for 20 minutes each day at home.
Analysis
Three forms of analysis will be conducted. First, paired t-tests of residualized changes scores and effect sizes (Cohen's d) will be used to analyze pre-post changes on all of the psychometric measures and on the HRV data. Second, correlational analysis will also be used to see if there are expected associations between pre-post changes in emotion, pain and sleep measures relative to pre-post changes in resting HRV indices. Finally, means and standard deviations will be used to assess participants' likert ratings on the acceptability of the intervention.
Plans for Current Findings
Results will be developed for publication in relevant, peer reviewed scientific journals. Results will also be used to develop future research in this line, including studying the effciacy of HRVB with psychologically distressed caregivers of PMBT survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart rate variability biofeedback | Experimental | Behavioral: heart rate variability biofeedbackHeart rate variability biofeedback training administered in eight, individual, weekly, one hour sessions. There will also be 20 minutes a day of resonant frequency breathing to be conducted at home. This intervention involves teaching subjects how to breath at their resonant frequency in a relaxed, diaphramatic manner. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be a survivor of a primary, malignant brain tumour (WHO grades II-IV)
- not have undergone any major treatment (chemotherapy, radiation, surgery) for previous three months
- be psychologically distressed as indicated by a score of 11 or over on either the anxiety or depression subscale of the Psychosocial Screening Instrument for Cancer (PSSCAN)
- be functionally capable of engaging in a time consuming study of this kind, (as indicated by a Karnofsky Scale score of 70/100)
Key exclusion criteria (5 listed)
- being incompetent to give consent independently
- being actively suicidal (as per a score of 2 or above on the 1-5 point PSSCAN suicidality measure)
- being actively delusional or psychotic
- being judged, by the PI, to be too acutely distressed to benefit from and/or to successfully complete the intervention (e.g. scoring above 20 on either the depression or anxiety scale of the PSSCAN and/or , in the PI's clinical judgment, being without adequate supports or resources in place to adequately manage their current level of distress successfully enough to benefit from and/or to successfully complete the intervention)
- being currently engaged in psychotherapy or another psychologically based treatment that is specifically designed to ameliorate psychological distress
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 |
|---|---|---|
| heart rate variability biofeedbackAlso: resonant frequency biofeedback, RSA biofeedback | Behavioural | Heart rate variability biofeedback |
Primary outcome
Change from baseline in score on Beck Depression Inventory II at 8 weeks
Time frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Widely used self report measure to assess for symptoms of depression.
Change from baseline scores on trait form of the State Trait Anxiety Inventory (Spielberger et al., 1983)at 8 weeks
Time frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
The Trait Anxiety Inventory is a widely used self report measure of anxiety symptoms.
Change from baseline in resting HRV High Frequency Power
Time frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Baseline level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest at pre-intervention compared to level of High Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest recorded aqt post-intervention
Resting Low Frequency HRV power (0.04-0.15 Hz)
Time frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Baseline level of Low Frequency HRV power (0.15-0.4 Hz) measured in ms2/Hz recorded over 5 minutes of rest at pre-intervention compared to level of Low Frequency HRV power (0.04-0.15 Hz)measured in ms2/Hz recorded over 5 minutes of rest recorded aqt post-intervention
Change in the standard deviation of all NN intervals from baseline in resting heart beat
Time frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
This metric measures the standard deviation of normal beat-to-beat intervals (SDNN) that are present within the heart rythm. it is a time domain measure of HRV and it serves as a marker of overall adaptability of the nervous system.
Subjective Acceptability ratings
Time frame: To be completed immediately post-intervention (8 weeks after the intiation of training)
This will be a 5 point Likert scale asking how acceptable the participants found the experience of particiapting in the intervention to be , from "not at all acceptable" to "very acceptable".
2 secondary outcomes
Change from baseline score on the Short Form McGill Pain Questionnaire (SFMPQ)(Melzack, 1987)
Time frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Change from baseline in scores on the Pittsburgh Sleep Quality Index (Buysse et al., 1989)
Time frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Background: PubMed 12125966Pelletier G, Verhoef MJ, Khatri N, Hagen N. Quality of life in brain tumor patients: the relative contributions of depression, fatigue, emotional distress, and existential issues. J Neurooncol. 2002 Mar;57(1):41-9. doi: 10.1023/a:1015728825642.
- Background: PubMed 18061752Janda M, Steginga S, Langbecker D, Dunn J, Walker D, Eakin E. Quality of life among patients with a brain tumor and their carers. J Psychosom Res. 2007 Dec;63(6):617-23. doi: 10.1016/j.jpsychores.2007.06.018.
- Background: PubMed 12112483Wellisch DK, Kaleita TA, Freeman D, Cloughesy T, Goldman J. Predicting major depression in brain tumor patients. Psychooncology. 2002 May-Jun;11(3):230-8. doi: 10.1002/pon.562.
- Background: PubMed 18314416Arnold SD, Forman LM, Brigidi BD, Carter KE, Schweitzer HA, Quinn HE, Guill AB, Herndon JE 2nd, Raynor RH. Evaluation and characterization of generalized anxiety and depression in patients with primary brain tumors. Neuro Oncol. 2008 Apr;10(2):171-81. doi: 10.1215/15228517-2007-057. Epub 2008 Feb 26.
- Background: PubMed 10999236Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000 Sep;25(3):177-91. doi: 10.1023/a:1009554825745.
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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.
Wolfgang Linden, PhD principal investigator
UBC Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart rate variability biofeedback in people with Depression and Anxiety, run by British Columbia Cancer Agency at 1 site in Canada.
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 4 inclusion and 5 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: paused, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Change from baseline in score on Beck Depression Inventory II at 8 weeks (time frame: comparison of scores immediately pre-intervention and then immediately post-intervention (8 weeks later)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772498, which also lists 5 linked publications.
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 6 May 2015.