DepressionNCT01599585
A Randomized Controlled Trial of In-Home Tele-Behavioral Health Care Utilizing Behavioral Activation for Depression
A study testing Behavioral Activation in people with Depression, run by National Center for Telehealth and Technology at 2 sites in United States.
Trial summary
This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major and Minor Depressive Disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current Major Depressive or Minor Depressive Disorder
- High-speed internet/network access at home (384kbs minimum)
- Informed consent
- Fluent in the English language
Who cannot join
- Currently undergoing psychotherapy for depression
- less than 18 or greater than 65 year of age
- Active psychotic symptoms/disorders as determined by the SCID for DSM-IV
- Dysthymic Disorder
- Current suicidal ideation with intent or recent (within six months) history of a suicide attempt
- History of Organic Mental Disorder
Show all 10Show fewer
- Current substance dependence as determined by the SCID (lifetime substance dependence or substance abuse will not be excluded)
- History of violence or poor impulse control causing potential risk to staff or others
- Significant ongoing stressors that require urgent crisis intervention
- Having a living arrangement that will not permit the use of a private space to participate in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Portland VA Medical Center
Portland, Oregon, 97207
National Center for Telehealth and Technology
Tacoma, Washington, 98431
About this study
Official title: A Randomized Controlled Trial of In-Home Tele-behavioral Health Care Utilizing Behavioral Activation for Depression
This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and depression as in-person BA treatment for depression.
- Conditions
- Depression
- Being tested
- Behavioral Activation
- Keywords
- Depression, Behavioral Activation, Tele-medicine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Also called BA
Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
| Study group | Role | What they receive |
|---|---|---|
| In Home | Experimental | Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. Receives: Behavioral: Behavioral Activation |
| In-Person | Active comparator | Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth \& Technology. Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Hopelessness Scale (BHS)
The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Measured: Post treatment - Week 8
Secondary outcomes (16)
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Measured: Treatment Session Week 1
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Measured: Baseline
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Measured: Treatment Session Week 2
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Measured: Treatment Session Week 3
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Measured: Treatment Session Week 4
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Measured: Treatment Session Week 5
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Measured: Treatment Session Week 6
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Measured: Treatment Session Week 7
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Measured: Treatment Session Week 8
Adverse Events
Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.
Measured: 3 month follow up
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome
Measured: Midpoint- Week 4
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Measured: Post Treatment- Week 8
Beck Depression Inventory -II (BDI-II)
The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.
Measured: 3 month follow up
Beck Hopelessness Scale (BHS)
The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Measured: Baseline
Beck Hopelessness Scale (BHS)
The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Measured: Midpoint- Week 4
Beck Hopelessness Scale (BHS)
The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
Measured: 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Telehealth and Technology
- Sponsor type
- US federal agency
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- Gregory A Gahm, PhD, Principal investigator, National Center for Telehealth and TechnologyDavid D Luxton, PhD, Principal investigator, National Center for Telehealth & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599585
- Sponsor's protocol ID
- W81XWH-11-2-0118
- Other IDs
- W81XWH-11-2-0118
- Status last verified
- Mar 2017
- First submitted
- 11 May 2012
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lewinsohn PM, Graf M. Pleasant activities and depression. J Consult Clin Psychol. 1973 Oct;41(2):261-8. doi: 10.1037/h0035142. No abstract available.
PubMed 4147832Egede LE, Frueh CB, Richardson LK, Acierno R, Mauldin PD, Knapp RG, Lejuez C. Rationale and design: telepsychology service delivery for depressed elderly veterans. Trials. 2009 Apr 20;10:22. doi: 10.1186/1745-6215-10-22.
PubMed 19379517Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.
PubMed 4436473Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73. doi: 10.1016/0005-7967(96)00033-2.
PubMed 8870294Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Davila-Roman VG, Steinmeyer BC, Hogue CW Jr. Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Arch Gen Psychiatry. 2009 Apr;66(4):387-96. doi: 10.1001/archgenpsychiatry.2009.7.
PubMed 19349308Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
PubMed 10245370Mackenzie CS, Gekoski WL, Knox VJ. Age, gender, and the underutilization of mental health services: the influence of help-seeking attitudes. Aging Ment Health. 2006 Nov;10(6):574-82. doi: 10.1080/13607860600641200.
PubMed 17050086Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.
PubMed 8991972King R. Cognitive therapy of depression. Aaon Beck, John Rush, Brian Shaw, Gary Emery. New York: Guilford, 1979. Aust N Z J Psychiatry. 2002 Apr;36(2):272-5. doi: 10.1046/j.1440-1614.2002.t01-4-01015.x. No abstract available.
PubMed 11982560Lewinsohn, PM, Biglan, A, Zeiss, AS. Behavioral treatment of depression. The behavioral management of anxiety, depression and pain. (pp.91-46. New York; Bunner/Mazel
Lewinsohn, PM, Gotlib, IH. Behavioral theory and treatment of depression. In E.E. Beckham and W.R. Leber (Eds). Handbook of depression (pp.352-375) New York: Guildford, 1995
Jacobson, NS, Martell, CR and Dimidjian, S. Behavioral activation therapy for depression: Returning to contextual roots. Clinical Psychology: Science and Practice 8(3):255-270, 2002
First, MB, Spitzer RL, Gibbon, M and Williams, JBW. Structured Clinical Interview for DSM-IV Axis Disorders. Arlington, VA: American Psychiatric Press. 2002
Hopko DR, Lejuez CW, LePage JP, Hopko SD, McNeil DW. A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. Behav Modif. 2003 Sep;27(4):458-69. doi: 10.1177/0145445503255489.
PubMed 12971122
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of In-Home Tele-behavioral Health Care Utilizing Behavioral Activation for Depression
- ClinicalTrials.gov ID
- NCT01599585
- Acronym / sponsor ID
- W81XWH-11-2-0118
- Conditions
- Depression
- Keywords
- Depression, Behavioral Activation, Tele-medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- National Center for Telehealth and TechnologyUS federal agency
- Collaborators
- VA Office of Research and Development
- Study start
- May 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effectiveness of a web-based behavioral activation(BA) treatment for depression by comparing it to in-person BA treatment in Soldiers and Veterans with Major and Minor Depressive Disorder. We will test the hypothesis that 8 sessions of in-home BA delivered via a webcam will be as safe and effective in reducing symptoms of hopelessness and depression as in-person BA treatment for depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In Home | Experimental | Behavioral: Behavioral ActivationParticipants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology. |
| In-Person | Active comparator | Behavioral: Behavioral ActivationParticipants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth \& Technology. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current Major Depressive or Minor Depressive Disorder
- High-speed internet/network access at home (384kbs minimum)
- Informed consent
- Fluent in the English language
Key exclusion criteria (10 listed)
- Currently undergoing psychotherapy for depression
- less than 18 or greater than 65 year of age
- Active psychotic symptoms/disorders as determined by the SCID for DSM-IV
- Dysthymic Disorder
- Current suicidal ideation with intent or recent (within six months) history of a suicide attempt
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 |
|---|---|---|
| Behavioral ActivationAlso: BABehavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies. | Behavioural | In Home, In-Person |
Primary outcome
Beck Hopelessness Scale (BHS)
Time frame: Post treatment - Week 8
The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.
16 secondary outcomes
Adverse Events
Time frame: Treatment Session Week 1
Beck Depression Inventory -II (BDI-II)
Time frame: Baseline
Adverse Events
Time frame: Treatment Session Week 2
Adverse Events
Time frame: Treatment Session Week 3
Adverse Events
Time frame: Treatment Session Week 4
Adverse Events
Time frame: Treatment Session Week 5
Adverse Events
Time frame: Treatment Session Week 6
Adverse Events
Time frame: Treatment Session Week 7
Adverse Events
Time frame: Treatment Session Week 8
Adverse Events
Time frame: 3 month follow up
Beck Depression Inventory -II (BDI-II)
Time frame: Midpoint- Week 4
Beck Depression Inventory -II (BDI-II)
Time frame: Post Treatment- Week 8
Beck Depression Inventory -II (BDI-II)
Time frame: 3 month follow up
Beck Hopelessness Scale (BHS)
Time frame: Baseline
Beck Hopelessness Scale (BHS)
Time frame: Midpoint- Week 4
Beck Hopelessness Scale (BHS)
Time frame: 3 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 4147832Lewinsohn PM, Graf M. Pleasant activities and depression. J Consult Clin Psychol. 1973 Oct;41(2):261-8. doi: 10.1037/h0035142. No abstract available.
- Background: PubMed 19379517Egede LE, Frueh CB, Richardson LK, Acierno R, Mauldin PD, Knapp RG, Lejuez C. Rationale and design: telepsychology service delivery for depressed elderly veterans. Trials. 2009 Apr 20;10:22. doi: 10.1186/1745-6215-10-22.
- Background: PubMed 4436473Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.
- Background: PubMed 8870294Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73. doi: 10.1016/0005-7967(96)00033-2.
- Background: PubMed 19349308Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Davila-Roman VG, Steinmeyer BC, Hogue CW Jr. Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Arch Gen Psychiatry. 2009 Apr;66(4):387-96. doi: 10.1001/archgenpsychiatry.2009.7.
- Background: PubMed 10245370Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
- Background: PubMed 17050086Mackenzie CS, Gekoski WL, Knox VJ. Age, gender, and the underutilization of mental health services: the influence of help-seeking attitudes. Aging Ment Health. 2006 Nov;10(6):574-82. doi: 10.1080/13607860600641200.
- Background: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
- Background: PubMed 8991972Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.
- Background: PubMed 11982560King R. Cognitive therapy of depression. Aaon Beck, John Rush, Brian Shaw, Gary Emery. New York: Guilford, 1979. Aust N Z J Psychiatry. 2002 Apr;36(2):272-5. doi: 10.1046/j.1440-1614.2002.t01-4-01015.x. No abstract available.
- BackgroundLewinsohn, PM, Biglan, A, Zeiss, AS. Behavioral treatment of depression. The behavioral management of anxiety, depression and pain. (pp.91-46. New York; Bunner/Mazel
- BackgroundLewinsohn, PM, Gotlib, IH. Behavioral theory and treatment of depression. In E.E. Beckham and W.R. Leber (Eds). Handbook of depression (pp.352-375) New York: Guildford, 1995
- 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.
Gregory A Gahm, PhD principal investigator
National Center for Telehealth and Technology
David D Luxton, PhD principal investigator
National Center for Telehealth & Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation in people with Depression, run by National Center for Telehealth and Technology at 2 sites in United States.
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 10 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 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Beck Hopelessness Scale (BHS) (time frame: Post treatment - Week 8). 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 NCT01599585, which also lists 22 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 16 Jun 2017.