DepressionNCT02242669
Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders
An observational study of Depression and Bipolar Disorders, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this study to evaluate peer-led mutual help organizations (MHOs) that target individuals with psychiatric diagnoses such as mood disorders, and provide evidence either supporting the expansion of such groups and the development and testing of clinical procedures, or point toward reevaluation and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Bipolar Disorders, Mood Disorders
- How many people
- 371 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2014to Apr 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit participants from a large DBSA chapter at McLean Hospital. Subjects will be recruited at the beginning of the weekly meetings, through flyers, the DBSA website, and word of mouth. 200 current DBSA members and 60 new DBSA members will be assessed for Aims 1 and 2, respectively. 100 people who have never attended a DBSA will be assessed for Aim 3 and will be recruited from MGH and McLean Hospitals through the use of flyers, clinic announcements, and via our online clinical and research infrastructures. Participants in all Aims must be 18 years or older and self-report a diagnosis of any type of mood disorder. For Aims 1 and 2, participants must have attended at least one DBSA meeting.
Who may be able to join
- Aim 1:
- 18 years of age or older
- Self-report a diagnosis of any type of mood disorder
- Attend DBSA meetings
- Aim 2:
- 18 years of age or older
Show all 12Show fewer
- Self-report a diagnosis of any type of mood disorder
- Have attended their first meeting in the past month
- Aim 3:
- 18 years of age or older
- Self-report a diagnosis of any type of mood disorder
- Have never attended a DBSA meeting
Who cannot join
- Aim 1:
- Do not report a diagnosis of any type of mood disorder
- Have not attended a DBSA meeting
- Aim 2:
- Do not report a diagnosis of any type of mood disorder
- Have not attended a DBSA meeting
Show all 10Show fewer
- Have attended their first meeting prior to a month before their assessment
- Aim 3:
- Do not report a diagnosis of any type of mood disorder
- Have attended a DBSA meeting
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLean Hospital
Belmont, Massachusetts, 02478
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study to evaluate peer-led mutual help organizations (MHOs) that target individuals with psychiatric diagnoses such as mood disorders, and provide evidence either supporting the expansion of such groups and the development and testing of clinical procedures, or point toward reevaluation and development of alternative low-cost, community based approaches to promoting recovery among individuals suffering from these disorders.
Read the detailed description
Participants will include up to 200 participants from The Depression and Bipolar Support Alliance (DBSA) for Aim 1. Aim 1 will measure characteristics of current DBSA members through cross-sectional surveys of demographics, clinical use history, and involvement in DBSA. 60 new DBSA members who began attending in the past month will be enrolled for Aim 2. Aim 3 will consist of 100 matched controls of people who have never attended a DBSA meeting. Assessments will be completed at McLean Hospital, in which a study staff member will thoroughly explain the study to participants. If participants are eligible for Aim 2, study staff will receive written consent from the participant.
- Conditions
- Depression, Bipolar Disorders, Mood Disorders
- Medical subject headings
- Depression, Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AIM 1 | 200 current DBSA participants. | |
| AIM 2 | 60 new DBSA attendees with mood disorders who have attended their first meeting in the past month. | |
| AIM 3 | 100 matched control group individuals with mood disorders with no current or prior exposure to DBSA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systematically gather empirical estimates of the characteristics of current DBSA participants through a cross-sectional survey of demographics, clinical service, and past and current DBSA attendance, involvement, and subjective benefits.
The goal is to describe and characterize DBSA participants and obtain information on subjective benefits.
Measured: Up to 24 months
Provide estimates of rates of attendance, retention in, and discontinuation from DBSA for new DBSA members with mood disorders.
Determine which DBSA participants are more likely to attend more frequently/become more engaged.
Measured: Up to 24 months
Conduct a prospective between-group investigation comparing new DBSA members to a matched control group with no prior exposure to DBSA in order to test for beneficial affects of DBSA over a 6-month follow up.
Compare new DBSA members to a matched control group in order to test for any potential incremental beneficial effects from DBSA participation.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2017
- Study completionApr 2017
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.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, John F. Kelly, Massachusetts General Hospital
- Investigators
- John F Kelly, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242669
- Sponsor's protocol ID
- 2014P000153
- Other IDs
- R21MH101271-02
- Status last verified
- Aug 2017
- First submitted
- 18 Aug 2014
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Outcomes, Reducing Costs: Evaluating Peer Support for Mood Disorders
- ClinicalTrials.gov ID
- NCT02242669
- Acronym / sponsor ID
- 2014P000153
- Conditions
- Depression, Bipolar Disorders, Mood Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Sep 2014 (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.
The purpose of this study to evaluate peer-led mutual help organizations (MHOs) that target individuals with psychiatric diagnoses such as mood disorders, and provide evidence either supporting the expansion of such groups and the development and testing of clinical procedures, or point toward reevaluation and development of alternative low-cost, community based approaches to promoting recovery among individuals suffering from these disorders.
Detailed description
Participants will include up to 200 participants from The Depression and Bipolar Support Alliance (DBSA) for Aim 1. Aim 1 will measure characteristics of current DBSA members through cross-sectional surveys of demographics, clinical use history, and involvement in DBSA. 60 new DBSA members who began attending in the past month will be enrolled for Aim 2. Aim 3 will consist of 100 matched controls of people who have never attended a DBSA meeting. Assessments will be completed at McLean Hospital, in which a study staff member will thoroughly explain the study to participants. If participants are eligible for Aim 2, study staff will receive written consent from the participant.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIM 1 | – | –200 current DBSA participants. |
| AIM 2 | – | –60 new DBSA attendees with mood disorders who have attended their first meeting in the past month. |
| AIM 3 | – | –100 matched control group individuals with mood disorders with no current or prior exposure to DBSA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit participants from a large DBSA chapter at McLean Hospital. Subjects will be recruited at the beginning of the weekly meetings, through flyers, the DBSA website, and word of mouth. 200 current DBSA members and 60 new DBSA members will be assessed for Aims 1 and 2, respectively. 100 people who have never attended a DBSA will be assessed for Aim 3 and will be recruited from MGH and McLean Hospitals through the use of flyers, clinic announcements, and via our online clinical and research infrastructures. Participants in all Aims must be 18 years or older and self-report a diagnosis of any type of mood disorder. For Aims 1 and 2, participants must have attended at least one DBSA meeting.
Key inclusion criteria (12 listed)
- Aim 1:
- 18 years of age or older
- Self-report a diagnosis of any type of mood disorder
- Attend DBSA meetings
- Aim 2:
Key exclusion criteria (10 listed)
- Aim 1:
- Do not report a diagnosis of any type of mood disorder
- Have not attended a DBSA meeting
- Aim 2:
- Do not report a diagnosis of any type of mood disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systematically gather empirical estimates of the characteristics of current DBSA participants through a cross-sectional survey of demographics, clinical service, and past and current DBSA attendance, involvement, and subjective benefits.
Time frame: Up to 24 months
The goal is to describe and characterize DBSA participants and obtain information on subjective benefits.
Provide estimates of rates of attendance, retention in, and discontinuation from DBSA for new DBSA members with mood disorders.
Time frame: Up to 24 months
Determine which DBSA participants are more likely to attend more frequently/become more engaged.
Conduct a prospective between-group investigation comparing new DBSA members to a matched control group with no prior exposure to DBSA in order to test for beneficial affects of DBSA over a 6-month follow up.
Time frame: Up to 24 months
Compare new DBSA members to a matched control group in order to test for any potential incremental beneficial effects from DBSA participation.
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 29 Aug 2017.
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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.
John F Kelly, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Bipolar Disorders, run by Massachusetts General Hospital 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 12 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 29 Aug 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?
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?
Systematically gather empirical estimates of the characteristics of current DBSA participants through a cross-sectional survey of demographics, clinical service, and past and current DBSA attendance, involvement, and subjective benefits. (time frame: Up to 24 months). The study lists 3 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 29 Aug 2017.