DepressionPhase 4MOSAICNCT01201967
A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients
A Phase 4 study testing Collaborative care in people with Depression and Generalized Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
For this trial, the investigators propose a prospective trial of a collaborative care program to identify and treat depression, generalized anxiety disorder, and panic disorder among patients admitted to the hospital for an acute cardiac illness (acute coronary syndrome, congestive heart failure, or arrhythmia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Generalized Anxiety Disorder, Panic Disorder
- What is being tested?
- Collaborative care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age 18-up)admitted to inpatient cardiac unit at Massachusetts General Hospital
- Primary diagnosis of acute coronary syndrome, congestive heart failure, or arrhythmia
- Positive anxiety or depression screen during initial nursing intake interview that is performed as part of usual clinical care
- Meets criteria for clinical depression, generalized anxiety disorder, or panic disorder
Who cannot join
- Bipolar disorder
- Substance use disorder
- Psychosis
- Cognitive disorder
- Active suicidal ideation
- Medical condition with likely survival less than 6 months
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients (MOSAIC)
For this trial, the investigators propose a prospective trial of a collaborative care program to identify and treat depression, generalized anxiety disorder, and panic disorder among patients admitted to the hospital for an acute cardiac illness (acute coronary syndrome, congestive heart failure, or arrhythmia). Such assessment and treatment for depression/generalized anxiety disorder/panic disorder will begin in the hospital, and ongoing management will continue for six months following discharge.
The investigators hypothesize that this model will lead to increased treatment rates, improved mood, reduced anxiety, and improved medical outcomes in this vulnerable population. If this model is effective, it could be implemented clinically to provide better and more complete care to patients hospitalized with acute cardiac illness, for whom depression and anxiety may be a risk factor for complications and death.
Read more
This will be a two-arm, single-blind randomized controlled trial, with one-half of patients randomized to collaborative care and one-half randomized to the control condition (usual care). Psychiatric treatment in the intervention arm will be provided in concert with patients' primary care physicians-with primary care physicians prescribing all medications-within a framework supervised by a psychiatrist.
The investigators will enroll patients who have any (or all) of the three included psychiatric diagnoses to improve the utility of the intervention. The investigators have chosen to enroll patients with several different cardiac diagnoses. This will allow the researchers to include patients with heterogeneous diagnoses and illness severity to determine if our intervention is effective in a broad population of patients with heart disease. The investigators will study an intervention targeting depression, generalized anxiety disorder, and panic disorder: all three disorders are disabling and associated with adverse cardiovascular outcomes, treatments for the conditions are highly similar, the investigators can treat patients who have more than one disorder, and a prior outpatient program successfully simultaneously addressed more than one mental health condition.
The project will involve: (1) screening patients for depression, generalized anxiety disorder, and panic disorder as part of usual clinical care, (2) evaluation of positive-screen patients by a study social work care manager, (3) a multicomponent in-hospital intervention (for collaborative care patients) that involves patient education, specialist-provided treatment recommendations, and a goal of in-hospital treatment initiation, and (4), after discharge, continued phone-based evaluation and care coordination with primary care physicians to provide stepwise treatment in the collaborative care arm. The intervention has been designed to be low-cost, low-burden, and easily generalizable to other settings.
Read the detailed description
- Primary in-hospital outcome measure:
- Adequate treatment by discharge (percent rates)
- Primary overall study measure:
- Change from baseline mental health-related quality of life (Short Form-12 Mental Component Score)
- Depression outcome measures:
- Change from baseline depression (Patient Health Questionnaire-9)
- Anxiety outcome measures:
- Change from baseline anxiety (Hospital Anxiety and Depression Scale-Anxiety Subscale)
- Medical outcome measures:
- Change from baseline physical function (Duke Activity Status Index)
- Change from baseline adherence (Medical Outcomes Study Specific Adherence Scale)
- Change from baseline physical health-related quality of life (Short Form-12 Physical Component Score)
- Change in rates of cardiac rehospitalizations at 24 weeks (exploratory aim)
- 24 weeks is primary endpoint for all post-discharge analyses *
- Conditions
- Depression, Generalized Anxiety Disorder, Panic Disorder
- Being tested
- Collaborative care, Usual care
- Keywords
- Collaborative care, Cardiovascular disease, Depression, Anxiety
- Medical subject headings
- Depression, Generalized Anxiety Disorder, Panic Disorder, Cardiovascular Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative careOther
Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.
Usual careOther
Patient's primary medical physician informed of mental health symptoms/diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Collaborative care | Experimental | Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy. Receives: Other: Collaborative care |
| Usual care | Placebo comparator | Patient's physicians are informed of diagnosis of depression/anxiety disorder Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mental Health-related Quality of Life From Baseline to 24 Weeks
Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.
Measured: Baseline, 24 weeks
Secondary outcomes (8)
Change in Depression Symptoms From Baseline to 24 Weeks
Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.
Measured: Baseline, 24 weeks
Change in Anxiety Symptoms From Baseline to 24 Weeks
Anxiety symptoms measured with the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The HADS-A is a 7-item scale used to measure anxiety severity. Each question asks about a specific symptom of anxiety and offers four answers: 0 = Never / Not at all, 1 = A little / Time to time, 2 = Quite often / Usually, 3 = Most of the time / Very often. Scores are totaled and range from 0-21. A higher score means more anxiety.
Measured: Baseline, 24 weeks
Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment
Adequate treatment was defined as:
(1) Prescription of a standard dose of an established first-line treatment for depression, generalized anxiety disorder, or panic disorder, and/or (2) referral to evidence-based psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborative Care arm of the study).
Patients already engaged in #1 and/or #2 at the time of enrollment had a different process. Subjects must have been engaged in at least 4 weeks of treatment prior to enrollment while still meeting criteria for the disorder. For this population, adequate treatment was defined as:
(1) Prescription dose increase/augmentation/switch, and/or (2) referral to psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborate Care arm).
Timeframe of "5 days after enrollment" was determined by calculating the median length of hospitalization for all subjects.
Measured: 5 days after enrollment
Change in Adherence to Health Behaviors From Baseline to 24 Weeks
Adherence to health behaviors is measured with the Medical Outcome Study Specific Adherence Scale (MOS-SAS). The MOS-SAS is a 3-item scale used to assess medication adherence, physical activity adherence, and diet adherence. Each question asks how often the subject adheres to the behavior, providing the following options: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. Scores are totaled and range from (3 to 18). A low score indicates poorer adherence to healthy behaviors.
Measured: Baseline, 24 weeks
Number of Rehospitalizations From Baseline to 24 Weeks
The number of rehospitalizations from baseline to 24 weeks was measured by contacting subjects' medical providers at 24 weeks and by asking subjects about rehospitalizations during each follow-up phone call.
Measured: 24 weeks
Change in Health Status From Baseline to 24 Weeks
Health status measured by the Euro Quality of Life-5 Domain (EQ5D). The EQ5D is a 5-item scale that assesses quality of life. Each question asks about difficulties with certain areas of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and offer three possible answers: No problems, Moderate problems, Extreme problems. Scores can range from 0.000-1.000, with lower scores indicating less quality of life, and higher scores indicating higher quality of life.
Measured: Baseline, 24 weeks
Change in Physical Function From Baseline to 24 Weeks
Physical function is measured with the Duke Activity Status Index (DASI). The DASI is a 12-item scale that measures physical function. Each question asks about whether the subject can complete a physical activity and are given the following options: Scores range from 0 to 58.2. Lower scores indicate lower levels of physical function.
Measured: Baseline, 24 weeks
Change in Physical Health-related Quality of Life From Baseline to 24 Weeks
Physical health-related quality of life is measured with the Short Form-12 Physical Component Score (SF-12 PCS). The SF-12 PCS a 6-item scale that assesses physical health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average physical health-related quality of life. Higher scores represent higher than average physical health-related quality of life, and lower scores represent lower physical health-related quality of life.
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2013
- Study completionJun 2013
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 (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
- Investigators
- Jeff C Huffman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201967
- Sponsor's protocol ID
- 2010P-001414
- Acronym
- MOSAIC
- Status last verified
- Sep 2014
- First submitted
- 7 Sep 2010
- Last updated
- 25 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Huffman JC, Mastromauro CA, Beach SR, Celano CM, DuBois CM, Healy BC, Suarez L, Rollman BL, Januzzi JL. Collaborative care for depression and anxiety disorders in patients with recent cardiac events: the Management of Sadness and Anxiety in Cardiology (MOSAIC) randomized clinical trial. JAMA Intern Med. 2014 Jun;174(6):927-35. doi: 10.1001/jamainternmed.2014.739.
PubMed 24733277Celano CM, Suarez L, Mastromauro C, Januzzi JL, Huffman JC. Feasibility and utility of screening for depression and anxiety disorders in patients with cardiovascular disease. Circ Cardiovasc Qual Outcomes. 2013 Jul;6(4):498-504. doi: 10.1161/CIRCOUTCOMES.111.000049. Epub 2013 Jun 11.
PubMed 23759474
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients (MOSAIC)
- ClinicalTrials.gov ID
- NCT01201967
- Acronym / sponsor ID
- MOSAIC / 2010P-001414
- Conditions
- Depression, Generalized Anxiety Disorder, Panic Disorder
- Keywords
- Collaborative care, Cardiovascular disease, Depression, Anxiety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Sep 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For this trial, the investigators propose a prospective trial of a collaborative care program to identify and treat depression, generalized anxiety disorder, and panic disorder among patients admitted to the hospital for an acute cardiac illness (acute coronary syndrome, congestive heart failure, or arrhythmia). Such assessment and treatment for depression/generalized anxiety disorder/panic disorder will begin in the hospital, and ongoing management will continue for six months following discharge.
The investigators hypothesize that this model will lead to increased treatment rates, improved mood, reduced anxiety, and improved medical outcomes in this vulnerable population. If this model is effective, it could be implemented clinically to provide better and more complete care to patients hospitalized with acute cardiac illness, for whom depression and anxiety may be a risk factor for complications and death.
This will be a two-arm, single-blind randomized controlled trial, with one-half of patients randomized to collaborative care and one-half randomized to the control condition (usual care). Psychiatric treatment in the intervention arm will be provided in concert with patients' primary care physicians-with primary care physicians prescribing all medications-within a framework supervised by a psychiatrist.
The investigators will enroll patients who have any (or all) of the three included psychiatric diagnoses to improve the utility of the intervention. The investigators have chosen to enroll patients with several different cardiac diagnoses. This will allow the researchers to include patients with heterogeneous diagnoses and illness severity to determine if our intervention is effective in a broad population of patients with heart disease. The investigators will study an intervention targeting depression, generalized anxiety disorder, and panic disorder: all three disorders are disabling and associated with adverse cardiovascular outcomes, treatments for the conditions are highly similar, the investigators can treat patients who have more than one disorder, and a prior outpatient program successfully simultaneously addressed more than one mental health condition.
The project will involve: (1) screening patients for depression, generalized anxiety disorder, and panic disorder as part of usual clinical care, (2) evaluation of positive-screen patients by a study social work care manager, (3) a multicomponent in-hospital intervention (for collaborative care patients) that involves patient education, specialist-provided treatment recommendations, and a goal of in-hospital treatment initiation, and (4), after discharge, continued phone-based evaluation and care coordination with primary care physicians to provide stepwise treatment in the collaborative care arm. The intervention has been designed to be low-cost, low-burden, and easily generalizable to other settings.
Detailed description
- Primary in-hospital outcome measure:
- Adequate treatment by discharge (percent rates)
- Primary overall study measure:
- Change from baseline mental health-related quality of life (Short Form-12 Mental Component Score)
- Depression outcome measures:
- Change from baseline depression (Patient Health Questionnaire-9)
- Anxiety outcome measures:
- Change from baseline anxiety (Hospital Anxiety and Depression Scale-Anxiety Subscale)
- Medical outcome measures:
- Change from baseline physical function (Duke Activity Status Index)
- Change from baseline adherence (Medical Outcomes Study Specific Adherence Scale)
- Change from baseline physical health-related quality of life (Short Form-12 Physical Component Score)
- Change in rates of cardiac rehospitalizations at 24 weeks (exploratory aim)
- 24 weeks is primary endpoint for all post-discharge analyses *
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative care | Experimental | Other: Collaborative careStudy care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy. |
| Usual care | Placebo comparator | Other: Usual carePatient's physicians are informed of diagnosis of depression/anxiety disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (age 18-up)admitted to inpatient cardiac unit at Massachusetts General Hospital
- Primary diagnosis of acute coronary syndrome, congestive heart failure, or arrhythmia
- Positive anxiety or depression screen during initial nursing intake interview that is performed as part of usual clinical care
- Meets criteria for clinical depression, generalized anxiety disorder, or panic disorder
Key exclusion criteria (7 listed)
- Bipolar disorder
- Substance use disorder
- Psychosis
- Cognitive disorder
- Active suicidal ideation
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 |
|---|---|---|
| Collaborative careStudy care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians. | Other | Collaborative care |
| Usual carePatient's primary medical physician informed of mental health symptoms/diagnosis | Other | Usual care |
Primary outcome
Change in Mental Health-related Quality of Life From Baseline to 24 Weeks
Time frame: Baseline, 24 weeks
Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.
8 secondary outcomes
Change in Depression Symptoms From Baseline to 24 Weeks
Time frame: Baseline, 24 weeks
Change in Anxiety Symptoms From Baseline to 24 Weeks
Time frame: Baseline, 24 weeks
Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment
Time frame: 5 days after enrollment
Change in Adherence to Health Behaviors From Baseline to 24 Weeks
Time frame: Baseline, 24 weeks
Number of Rehospitalizations From Baseline to 24 Weeks
Time frame: 24 weeks
Change in Health Status From Baseline to 24 Weeks
Time frame: Baseline, 24 weeks
Change in Physical Function From Baseline to 24 Weeks
Time frame: Baseline, 24 weeks
Change in Physical Health-related Quality of Life From Baseline to 24 Weeks
Time frame: Baseline, 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24733277Huffman JC, Mastromauro CA, Beach SR, Celano CM, DuBois CM, Healy BC, Suarez L, Rollman BL, Januzzi JL. Collaborative care for depression and anxiety disorders in patients with recent cardiac events: the Management of Sadness and Anxiety in Cardiology (MOSAIC) randomized clinical trial. JAMA Intern Med. 2014 Jun;174(6):927-35. doi: 10.1001/jamainternmed.2014.739.
- Derived from this study: PubMed 23759474Celano CM, Suarez L, Mastromauro C, Januzzi JL, Huffman JC. Feasibility and utility of screening for depression and anxiety disorders in patients with cardiovascular disease. Circ Cardiovasc Qual Outcomes. 2013 Jul;6(4):498-504. doi: 10.1161/CIRCOUTCOMES.111.000049. Epub 2013 Jun 11.
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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.
Jeff C Huffman, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collaborative care in people with Depression and Generalized Anxiety Disorder, run by Massachusetts General Hospital 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 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2014). 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?
Change in Mental Health-related Quality of Life From Baseline to 24 Weeks (time frame: Baseline, 24 weeks). 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 NCT01201967, which also lists 2 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 25 Sep 2014.