DepressionNCT02261818
Using Peer Mentors to Deliver Depression Care
A study testing Meetings with peer mentors in people with Depression, run by Johns Hopkins University at 1 site in United States.
Trial summary
Can peer mentors be integrated into depression care to older adults with mental health professional supervision? We will assess whether peer mentors who are lay persons who are in recovery from depression can provide depression care services to older adults with depression. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Meetings with peer mentors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2015
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peer mentors: Inclusion criteria:
- 50 years and older,
- able to give informed consent;
- received basic training in behavioral health,
- history of depression.-
- Patients:
Show all 10Show fewer
- 50 years and older;
- clinically significant depression (defined above);
- able to communicate in English;
- willing to give informed consent
Who cannot join
- Peer mentors: Exclusion criteria:
- meet current diagnostic criteria for Minor or Major Depressive Disorder;
- meet current diagnostic criteria for a psychotic disorder;
- meet current diagnostic criteria for substance abuse or dependence.
- Patients:
- meet diagnostic criteria for mania or hypomania;
Show all 10Show fewer
- meet diagnostic criteria for psychotic syndrome;
- meet diagnostic criteria for alcohol abuse or dependence;
- acutely suicidal or psychotic; and,
- a score on the Mini-Mental State Examination (MMSE) <24.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Phase 1 Study of Using Peers to Deliver Depression Care to Older Adults
Can peer mentors be integrated into depression care to older adults with mental health professional supervision? We will assess whether peer mentors who are lay persons who are in recovery from depression can provide depression care services to older adults with depression. Older adults who are 50 and older will be screened for depression in the clinic and community. Those who meet criteria will be paired with a peer mentor for 8 meetings. Peer mentors will audiorecord their meetings with the patient and the recordings will be analyzed to assess what kinds of communication and behaviors the peer mentors engage in and what among those communications may be associated with relieving depression. The peer mentor will be trained and supervised by a psychiatrist and they will form a team to provide the depression care to the older adult. The study aims to relieve depressive symptoms and engage older adults in care. Both older adults and peer mentors wil be interviewed after the study to assess the strengths and weaknesses of peer mentor delivery of depression care. A manual will be developed describing the process and procedures of the study.
Read the detailed description
Recruitment of peer mentors. We will recruit peer mentors from a community organization who are in recovery and are recommended by the organization and have had basic training in supportive listening and experience working with persons in the community in need of mental health support. We will recruit 10 peer mentors, striving for a balance of men and women, and accounting for attrition, so that at least 5 peer mentors will participate in the project. The study doctor will meet and interview interested peers to screen for eligibility criteria, motivation and aptitude. Persons who do not meet criteria for continued participation in the study will be referred to other volunteer opportunities when appropriate.
Recruitment of patients. Twenty patient participants will be recruited through the internal medicine and psychiatry clinics at Johns Hopkins Bayview Medical Center as well as the community. A research assistant will screen patients for depressive symptoms with the Patient Health Questionnaire-9 (PHQ-9). Patients meeting eligibility criteria will give written informed consent. Eligible patients will be scheduled for another appointment to meet with the study doctor in a private room at offices in the clinical campus.
Training of peer mentors. The PI and research assistant will conduct 5 sessions totaling 20 hours of training for the peer mentors. Training will refine the peer mentor's social support behaviors, which include the use of effective communication skills, rapport building, active listening, and sharing of experiential knowledge, and expression of empathy. Issues of cultural interviewing, cultural competence, patient confidentiality, DSM-IV diagnosis, differentiation of peer and professional roles and patient safety will be addressed. Knowledge regarding how mental health and illness presents itself in old age and the specific developmental problems older adults face will be provided. Training will include review of written materials, lectures, discussion of case studies and role play. Upon completion of the training, peer mentors will be assessed for mental health knowledge and interpersonal skills and those who pass muster will be matched with patients.
The peer mentor role: Activities of the peer mentor with the patient will be structured by the following principles which are derived from important elements of both peer support and psychotherapy and our preliminary work:
Principles to structure peer mentor interactions with patients
- Establish a working relationship
- Establish goals of meetings with patient
- Provide active listening, empathy, reciprocity, mutual respect, provision of emotional support Provide support and encourage work toward patient-identified goals to relieve depression
- Work on patient-identified goals by engaging multiple techniques as appropriate: sharing appropriate coping strategies eg. positive thinking, experiential knowledge, problem solving, consideration of different perspectives.
- Provide psychoeducation. Discuss the kinds of depression services available, medications, psychotherapy Acknowledge socioeconomic contributors to depression
- Provide information on community resources
- Connect to professional clinical services if appropriate The psychiatrist role: Peer mentors will meet with the candidate who is a psychiatrist on a weekly basis. The psychiatrist will provide: (1) clinical leadership and structure by reinforcing the principles of the peer-patient meetings; and (2) supervision and coaching which will involve encouragement, continuing education, training and skill enhancement for the peer mentor. The psychiatrist will guide the peer mentor to ensure that a positive social experience is being provided and to manage the patient in a way that ensures the realization of the patient's goal. The peer mentor will share impressions of patient progress and receive any guidance needed from the psychiatrist.
Study procedures. After patient consent is obtained, the psychiatrist will meet with the patient for a clinical interview so that the psychiatrist can form an impression of the patient and provide relevant guidance to the peer mentor. The patient will then be matched with a peer mentor. The peer mentor will contact the patient by telephone to schedule a meeting and meet with the peer mentor at his home or in the clinic. The peer mentor will meet the patient weekly for 8 one-hour sessions. The peer mentors will meet individually on a weekly basis with the psychiatrist during the study period in a collaborative and supervisory effort regarding the care of the patient Data Analysis. Analysis will involve both quantitative and qualitative methods. We will identify measured factors related to engagement and depression response and remission so that we can understand how the delivery model may need to be tailored or modified. This analysis will consider depression response and remission and engagement as dependent variables, with other variables as predictors or effect modifiers. We will also carry out debriefing interviews with peers and patients in order to look for themes that will call attention to factors that are most salient to patients and peers.
Quantitative analysis. Influential variables will be identified in the statistical models according to association with the dependent variables, namely 1) engagement in depression care defined as two or more sessions attended with the peer mentor, and 2) decrease in depressive symptoms which will be treated as a continuous variable.
Qualitative analysis. We will collect qualitative data to obtain the perspective of peer mentors and patients themselves regarding study processes and mediators from their point of view. Two semi-structured interviews with patients and peer mentors will be conducted by the PI at 4 weeks and upon completion of the study. The purpose will be to obtain feedback regarding positive and negative aspects of the peer delivery model which will provide perspectives different from the expert and valuable for that reason.
ANALYSIS OF PROCESS We will analyze the process of the peer mentor-patient interactions by 1) conducting an interaction analysis which will provide quantitative associations between communication elements and outcomes to determine which elements are salient to the effectiveness of the peer delivery model, and 2) conducting a qualitative analysis of the voice recordings to assess how the peer mentors implement the critical elements and how patients respond to them. The analyses of process will serve to determine the content of the training for peer mentors, the activities peers will perform with patients and manual development.
The Roter Interaction Analysis System (RIAS) is a widely used system for interaction assessment in medical contexts. The RIAS has demonstrated predictive validity to patient satisfaction, patient recall, and improvements in levels of emotional distress. Combined with quantitative process and outcome measures of care, statistical analysis can establish associations between specific communicative thematic categories and patient outcomes.
Data Analysis. We will evaluate the specific interactions between peer and patient employing the RIAS to investigate the specific interactions that are associated with engagement and depression response and remission so that we can refine the training required for peers and develop measures tapping effective interaction strategies. We will also carry out open-ended interviews with patients that complement the RIAS analysis to assess how the peer mentors implement the critical elements and how patients respond.
Quantitative analysis. The voice recordings to be analyzed with the RIAS in Phase 2 are obtained from two sources: (1) 28 voice recordings of peer mentor-patient interactions were obtained in our preliminary work and (2) 160 voice recordings of peer mentor-patient interactions will be obtained in the pilot study proposed in this application. The PI will work with Dr. Roter's laboratory for consultation where coding, reliability testing, and data entry into an SPSS file will occur. We will draw upon our conceptual model as well as incorporate the results of the quantitative and qualitative analysis regarding mediators to construct peer mentor and patient communication profiles which will then be linked to outcomes. Those elements which are associated with outcomes should be the focus of peer mentor training and be integrated into the manual. We will use linear regression to assess the presence, strength, and statistical associations between RIAS categories and outcomes.
Qualitative analysis. The goal of qualitative analysis of the voice recordings will be to enrich the inferences we make using RIAS data to capture the nuances of what is occurring in the peer mentor-patient relationship. The PI and the research assistant will listen to the voice recordings of peer mentor-patient interactions at weeks 1, 4, and 8. They will mark and transcribe sections in the voice recordings that show how interaction elements such as affective exchange take place between the peer mentor and patient, and those sections that provide examples of variations in the methods the peer mentors use and the responses of the patients. The transcriptions will be coded and analyzed for themes. This analysis will contextualize the results of the RIAS analysis and provide knowledge about peer mentor communication and behavior.
Manual development: Knowledge obtained from the study will be developed into a manual which will form the basis for a larger peer mentor study.
- Conditions
- Depression
- Being tested
- Meetings with peer mentors
- Keywords
- depression, aging, health services
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meetings with peer mentorsBehavioural
Peer mentors provide social support to address depressive symptoms
| Study group | Role | What they receive |
|---|---|---|
| Meetings with peer mentors | Other | Peer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources. Receives: Behavioral: Meetings with peer mentors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression With PHQ-9
PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Measured: at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 2015
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.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Hui Joo, Johns Hopkins University
- Investigators
- Jin Hui Joo, MA MA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261818
- Sponsor's protocol ID
- K23MH100705
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2014
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Using Peers to Deliver Depression Care to Older Adults
- ClinicalTrials.gov ID
- NCT02261818
- Acronym / sponsor ID
- K23MH100705
- Conditions
- Depression
- Keywords
- depression, aging, health services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Oct 2014 (estimated)
- Results
- Posted 2 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can peer mentors be integrated into depression care to older adults with mental health professional supervision? We will assess whether peer mentors who are lay persons who are in recovery from depression can provide depression care services to older adults with depression. Older adults who are 50 and older will be screened for depression in the clinic and community. Those who meet criteria will be paired with a peer mentor for 8 meetings. Peer mentors will audiorecord their meetings with the patient and the recordings will be analyzed to assess what kinds of communication and behaviors the peer mentors engage in and what among those communications may be associated with relieving depression. The peer mentor will be trained and supervised by a psychiatrist and they will form a team to provide the depression care to the older adult. The study aims to relieve depressive symptoms and engage older adults in care. Both older adults and peer mentors wil be interviewed after the study to assess the strengths and weaknesses of peer mentor delivery of depression care. A manual will be developed describing the process and procedures of the study.
Detailed description
Recruitment of peer mentors. We will recruit peer mentors from a community organization who are in recovery and are recommended by the organization and have had basic training in supportive listening and experience working with persons in the community in need of mental health support. We will recruit 10 peer mentors, striving for a balance of men and women, and accounting for attrition, so that at least 5 peer mentors will participate in the project. The study doctor will meet and interview interested peers to screen for eligibility criteria, motivation and aptitude. Persons who do not meet criteria for continued participation in the study will be referred to other volunteer opportunities when appropriate.
Recruitment of patients. Twenty patient participants will be recruited through the internal medicine and psychiatry clinics at Johns Hopkins Bayview Medical Center as well as the community. A research assistant will screen patients for depressive symptoms with the Patient Health Questionnaire-9 (PHQ-9). Patients meeting eligibility criteria will give written informed consent. Eligible patients will be scheduled for another appointment to meet with the study doctor in a private room at offices in the clinical campus.
Training of peer mentors. The PI and research assistant will conduct 5 sessions totaling 20 hours of training for the peer mentors. Training will refine the peer mentor's social support behaviors, which include the use of effective communication skills, rapport building, active listening, and sharing of experiential knowledge, and expression of empathy. Issues of cultural interviewing, cultural competence, patient confidentiality, DSM-IV diagnosis, differentiation of peer and professional roles and patient safety will be addressed. Knowledge regarding how mental health and illness presents itself in old age and the specific developmental problems older adults face will be provided. Training will include review of written materials, lectures, discussion of case studies and role play. Upon completion of the training, peer mentors will be assessed for mental health knowledge and interpersonal skills and those who pass muster will be matched with patients.
The peer mentor role: Activities of the peer mentor with the patient will be structured by the following principles which are derived from important elements of both peer support and psychotherapy and our preliminary work:
Principles to structure peer mentor interactions with patients
- Establish a working relationship
- Establish goals of meetings with patient
- Provide active listening, empathy, reciprocity, mutual respect, provision of emotional support Provide support and encourage work toward patient-identified goals to relieve depression
- Work on patient-identified goals by engaging multiple techniques as appropriate: sharing appropriate coping strategies eg. positive thinking, experiential knowledge, problem solving, consideration of different perspectives.
- Provide psychoeducation. Discuss the kinds of depression services available, medications, psychotherapy Acknowledge socioeconomic contributors to depression
- Provide information on community resources
- Connect to professional clinical services if appropriate The psychiatrist role: Peer mentors will meet with the candidate who is a psychiatrist on a weekly basis. The psychiatrist will provide: (1) clinical leadership and structure by reinforcing the principles of the peer-patient meetings; and (2) supervision and coaching which will involve encouragement, continuing education, training and skill enhancement for the peer mentor. The psychiatrist will guide the peer mentor to ensure that a positive social experience is being provided and to manage the patient in a way that ensures the realization of the patient's goal. The peer mentor will share impressions of patient progress and receive any guidance needed from the psychiatrist.
Study procedures. After patient consent is obtained, the psychiatrist will meet with the patient for a clinical interview so that the psychiatrist can form an impression of the patient and provide relevant guidance to the peer mentor. The patient will then be matched with a peer mentor. The peer mentor will contact the patient by telephone to schedule a meeting and meet with the peer mentor at his home or in the clinic. The peer mentor will meet the patient weekly for 8 one-hour sessions. The peer mentors will meet individually on a weekly basis with the psychiatrist during the study period in a collaborative and supervisory effort regarding the care of the patient Data Analysis. Analysis will involve both quantitative and qualitative methods. We will identify measured factors related to engagement and depression response and remission so that we can understand how the delivery model may need to be tailored or modified. This analysis will consider depression response and remission and engagement as dependent variables, with other variables as predictors or effect modifiers. We will also carry out debriefing interviews with peers and patients in order to look for themes that will call attention to factors that are most salient to patients and peers.
Quantitative analysis. Influential variables will be identified in the statistical models according to association with the dependent variables, namely 1) engagement in depression care defined as two or more sessions attended with the peer mentor, and 2) decrease in depressive symptoms which will be treated as a continuous variable.
Qualitative analysis. We will collect qualitative data to obtain the perspective of peer mentors and patients themselves regarding study processes and mediators from their point of view. Two semi-structured interviews with patients and peer mentors will be conducted by the PI at 4 weeks and upon completion of the study. The purpose will be to obtain feedback regarding positive and negative aspects of the peer delivery model which will provide perspectives different from the expert and valuable for that reason.
ANALYSIS OF PROCESS We will analyze the process of the peer mentor-patient interactions by 1) conducting an interaction analysis which will provide quantitative associations between communication elements and outcomes to determine which elements are salient to the effectiveness of the peer delivery model, and 2) conducting a qualitative analysis of the voice recordings to assess how the peer mentors implement the critical elements and how patients respond to them. The analyses of process will serve to determine the content of the training for peer mentors, the activities peers will perform with patients and manual development.
The Roter Interaction Analysis System (RIAS) is a widely used system for interaction assessment in medical contexts. The RIAS has demonstrated predictive validity to patient satisfaction, patient recall, and improvements in levels of emotional distress. Combined with quantitative process and outcome measures of care, statistical analysis can establish associations between specific communicative thematic categories and patient outcomes.
Data Analysis. We will evaluate the specific interactions between peer and patient employing the RIAS to investigate the specific interactions that are associated with engagement and depression response and remission so that we can refine the training required for peers and develop measures tapping effective interaction strategies. We will also carry out open-ended interviews with patients that complement the RIAS analysis to assess how the peer mentors implement the critical elements and how patients respond.
Quantitative analysis. The voice recordings to be analyzed with the RIAS in Phase 2 are obtained from two sources: (1) 28 voice recordings of peer mentor-patient interactions were obtained in our preliminary work and (2) 160 voice recordings of peer mentor-patient interactions will be obtained in the pilot study proposed in this application. The PI will work with Dr. Roter's laboratory for consultation where coding, reliability testing, and data entry into an SPSS file will occur. We will draw upon our conceptual model as well as incorporate the results of the quantitative and qualitative analysis regarding mediators to construct peer mentor and patient communication profiles which will then be linked to outcomes. Those elements which are associated with outcomes should be the focus of peer mentor training and be integrated into the manual. We will use linear regression to assess the presence, strength, and statistical associations between RIAS categories and outcomes.
Qualitative analysis. The goal of qualitative analysis of the voice recordings will be to enrich the inferences we make using RIAS data to capture the nuances of what is occurring in the peer mentor-patient relationship. The PI and the research assistant will listen to the voice recordings of peer mentor-patient interactions at weeks 1, 4, and 8. They will mark and transcribe sections in the voice recordings that show how interaction elements such as affective exchange take place between the peer mentor and patient, and those sections that provide examples of variations in the methods the peer mentors use and the responses of the patients. The transcriptions will be coded and analyzed for themes. This analysis will contextualize the results of the RIAS analysis and provide knowledge about peer mentor communication and behavior.
Manual development: Knowledge obtained from the study will be developed into a manual which will form the basis for a larger peer mentor study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meetings with peer mentors | Other | Behavioral: Meetings with peer mentorsPeer mentors who have experience of depression are trained and supervised to provide social support to older adults to relieve depression. They will provide active listening, empathy, work on a patient-derived goal, psychoeducation and connection to both clinical and community resources. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 50 years and older,
- able to give informed consent;
- received basic training in behavioral health,
- history of depression.-
- 50 years and older;
Key exclusion criteria (10 listed)
- meet current diagnostic criteria for Minor or Major Depressive Disorder;
- meet current diagnostic criteria for a psychotic disorder;
- meet current diagnostic criteria for substance abuse or dependence.
- meet diagnostic criteria for mania or hypomania;
- meet diagnostic criteria for psychotic syndrome;
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 |
|---|---|---|
| Meetings with peer mentorsPeer mentors provide social support to address depressive symptoms | Behavioural | Meetings with peer mentors |
Primary outcome
Depression With PHQ-9
Time frame: at 8 weeks
PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Depression
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
Recruiting
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Survivorship
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.
Jin Hui Joo, MA MA principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meetings with peer mentors in people with Depression, run by Johns Hopkins University at 1 site 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 10 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 2 Oct 2017. 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 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 2 Oct 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?
Depression With PHQ-9 (time frame: at 8 weeks). 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 2 Oct 2017.