Trial Outcomes & Findings for A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients (NCT NCT01201967)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

183 participants

Primary outcome timeframe

Baseline, 24 weeks

Results posted on

2014-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Collaborative Care 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care Patient's physicians are informed of diagnosis of depression/anxiety disorder Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis
Overall Study STARTED	92	91
Overall Study COMPLETED	86	86
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Collaborative Care 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care Patient's physicians are informed of diagnosis of depression/anxiety disorder Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis
Overall Study Lost to Follow-up	6	5

Baseline Characteristics

A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis	Total n=183 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 12.7 • n=39 Participants	60.1 years STANDARD_DEVIATION 12.8 • n=41 Participants	60.5 years STANDARD_DEVIATION 12.7 • n=35 Participants
Sex: Female, Male Female	43 Participants n=39 Participants	43 Participants n=41 Participants	86 Participants n=35 Participants
Sex: Female, Male Male	49 Participants n=39 Participants	48 Participants n=41 Participants	97 Participants n=35 Participants
Region of Enrollment United States	92 participants n=39 Participants	91 participants n=41 Participants	183 participants n=35 Participants
Patient Health Questionnaire-9	15.9 units on a scale STANDARD_DEVIATION 4.2 • n=39 Participants	15.6 units on a scale STANDARD_DEVIATION 5.0 • n=41 Participants	15.8 units on a scale STANDARD_DEVIATION 4.6 • n=35 Participants
Hospital Anxiety and Depression Scale - Anxiety Subscale	10.9 units on a scale STANDARD_DEVIATION 4.0 • n=39 Participants	11.5 units on a scale STANDARD_DEVIATION 3.9 • n=41 Participants	11.2 units on a scale STANDARD_DEVIATION 3.9 • n=35 Participants
Duke Activity Status Index	19.7 units on a scale STANDARD_DEVIATION 15.8 • n=39 Participants	21.4 units on a scale STANDARD_DEVIATION 16.9 • n=41 Participants	20.5 units on a scale STANDARD_DEVIATION 16.3 • n=35 Participants
Medical Outcomes Study - Specific Adherence Scale	13.0 units on a scale STANDARD_DEVIATION 3.5 • n=39 Participants	14.2 units on a scale STANDARD_DEVIATION 3.1 • n=41 Participants	13.6 units on a scale STANDARD_DEVIATION 3.3 • n=35 Participants
SF-12 Mental Component Score	34.2 units on a scale STANDARD_DEVIATION 9.7 • n=39 Participants	36.3 units on a scale STANDARD_DEVIATION 8.9 • n=41 Participants	35.2 units on a scale STANDARD_DEVIATION 9.3 • n=35 Participants
SF-12 Physical Component Score	32.9 units on a scale STANDARD_DEVIATION 10.8 • n=39 Participants	33.8 units on a scale STANDARD_DEVIATION 11.0 • n=41 Participants	32.9 units on a scale STANDARD_DEVIATION 10.5 • n=35 Participants
Euro Quality of Life-5 Domain	0.40 units on a scale STANDARD_DEVIATION 0.34 • n=39 Participants	0.44 units on a scale STANDARD_DEVIATION 0.33 • n=41 Participants	0.42 units on a scale STANDARD_DEVIATION 0.34 • n=35 Participants

PRIMARY outcome

Timeframe: Baseline, 24 weeks

Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.

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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder. Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis.
Change in Mental Health-related Quality of Life From Baseline to 24 Weeks	8.87 units on a scale Interval 5.67 to 12.06	8.39 units on a scale Interval 5.38 to 11.4

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.

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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder. Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis.
Change in Depression Symptoms From Baseline to 24 Weeks	-6.99 units on a scale Interval -8.61 to -5.36	-7.67 units on a scale Interval -9.04 to -6.3

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.

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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder. Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis.
Change in Anxiety Symptoms From Baseline to 24 Weeks	-3.43 units on a scale Interval -4.62 to -2.24	-4.85 units on a scale Interval -5.94 to -3.76

SECONDARY outcome

Timeframe: 5 days after enrollment

Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.

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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder. Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis.
Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment	69 participants	6 participants

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.

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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder. Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis.
Change in Adherence to Health Behaviors From Baseline to 24 Weeks	2.2 units on a scale Interval 1.3 to 3.1	1.70 units on a scale Interval 0.8 to 2.59

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder. Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis.
Number of Rehospitalizations From Baseline to 24 Weeks	29 readmissions	30 readmissions

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.

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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder. Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis.
Change in Health Status From Baseline to 24 Weeks	0.16 units on a scale Interval 0.08 to 0.23	0.18 units on a scale Interval 0.1 to 0.27

SECONDARY outcome

Timeframe: Baseline, 24 weeks

Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.

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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder. Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis.
Change in Physical Function From Baseline to 24 Weeks	8.96 units on a scale Interval 5.49 to 12.44	9.52 units on a scale Interval 6.1 to 12.94

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Collaborative Care n=92 Participants 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. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.	Usual Care n=91 Participants Patient's physicians are informed of diagnosis of depression/anxiety disorder. Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis.
Change in Physical Health-related Quality of Life From Baseline to 24 Weeks	2.75 units on a scale Interval 0.2 to 5.31	4.21 units on a scale Interval 1.65 to 6.76

Adverse Events

Collaborative Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeff C. Huffman, MD

Massachusetts General Hospital

Phone: 6177242910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place