DepressionPhase 4NCT03688100
Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
A Phase 4 study testing Behavioral Activation Therapy and Medication Management in people with Depression and Heart Failure, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Heart Failure
- What is being tested?
- Behavioral Activation Therapy and Medication Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 6 May 2022
- 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
- HF New York Heart Association classes: II-IV.
- Life expectancy of more than 6 months.
- PHQ-9 score ≥10.
- Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), and Depressive Disorder Unspecified, as confirmed by the MINI 7.02.
Who cannot join
- Imminent danger to self or others.
- Cognitive impairments with a MOCA score of < 23.
- Bipolar, Psychotic, and Substance-induced Disorders.
- Patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.
Read the detailed description
Aim 1: To compare the effectiveness of BA vs. MEDS, for depressed AHF patients. Hypothesis 1: Compared to depressed AHF patients who receive MEDS, patients receiving BA will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the PHQ-9 at 6-month follow-up. Significantly greater improvements will also be detected in the secondary outcomes of general physical and mental HRQoL (SF-12v2), heart failure-specific HRQoL (KCCQ), and caregiver burden (CBQ-HF) at 3, 6, and 12 months.
Aim 2: To compare the impact of BA vs. MEDS on disadvantageous outcomes of Morbidity (as evidenced by ED visits, hospital readmissions, total days in the hospital), and Mortality among depressed AHF patients.
Hypothesis 2: Compared to depressed AHF patients who receive MEDS, those receiving BA will have significantly less Morbidity (as evidenced by less frequent ED visits, lower readmission rates, fewer total days in the hospital), and reduced Mortality at the data collection points of 3, 6, and 12 months.
- Conditions
- Depression, Heart Failure
- Being tested
- Behavioral Activation Therapy, Medication Management
- Medical subject headings
- Depression, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation TherapyBehavioural
Also called BA
The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement.
Medication ManagementDrug
Also called MEDS
Collaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Patients: Medication Management (MEDS) | Active comparator | The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. Receives: Drug: Medication Management |
| Patients: Behavioral Activation Therapy (BA) | Active comparator | BA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. Receives: Behavioral: Behavioral Activation Therapy |
| Caregivers: Medication Management (MEDS) | No intervention | Caregivers of patients receiving the the above described Medication Management (MEDS) intervention were monitored for caregiver burden at 3, 6, and 12 months. |
| Caregivers: Behavioral Activation Psychotherapy (BA) | No intervention | Caregivers of patients receiving the the above described Behavioral Activation Psychotherapy (BA) intervention were monitored for caregiver burden at 3, 6, and 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up
PHQ-9 is used to measure depressive symptoms severity. The PHQ-9 is a self-report instrument that corresponds with the validated Primary Care Evaluation of Mental Disorders PRIME-MD clinician-administered instrument. The PHQ-9 measures all nine dimensions of depression assessed in the DSM criteria for MDD on a 0-3 scale. Minimum score = 0 (no depression). Maximum scores = 21 (worst depression)
Measured: 6 months from baseline enrollment.
Secondary outcomes (7)
Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results
The SF-12v2 is a 12-item questionnaire used to assess Health-related Quality of Life (HRQoL) from the patient's perspective. The SF-12v2 consists of 12 questions from the SF-36 that evaluate the same eight health domains: physical function, the role-physical, bodily pain, general health, vitality, social function, the role-emotional, and mental health. The Physical Component Summary (PCS) and Mental Component Summary (MCS) scores are norm-based scores ranging from 0 to 100 calculated from the responses to the 12 questions using scoring software from QualityMetric.com. In the general US population, the mean normal score is 50, with a standard deviation (SD) of 10. Higher scores indicate better outcomes with better HRQoL. Health-related Quality of Life - Physical Health as measured by SF-12 physical component and Health
Measured: 3 month, 6 month, and 12 months from baseline enrollment
Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results.
The KCCQ is a 23-item, self-administered instrument that quantifies 6 domains and yields 2 summary scores. The 6 domains are physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The 2 summary scores are the Clinical Summary Score and the Overall Summary Score. The Clinical Summary score includes total symptom and physical function scores to correspond with NYHA Classification. The Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores. Domain scores and summary scores are scaled from the raw item scores using a software available from the authors (SPERTUSJ@UMKC.EDU) to a range from 0 (worst) to 100 (best), in which higher scores reflect better heart-failure-specific quality of life and health status. Heart failure-specific quality of life are measured by the KCCQ Overall Summary Score and the Clinical Summary Score .
Measured: 3 month, 6 month, and 12 months from baseline enrollment
Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results.
The Caregiver Burden Questionnaire - Heart Failure Version 3.0 (CBQ-HF) is a quantitative survey of 26 questions covering the past four weeks of the caregiver's experience is evaluated as caregiver burden. The scale uses a 5-point Likert severity scale (Not at all=0, A little=1, Somewhat=2, Quite a lot=3, A lot=4) assessing 4 domains of physical, emotional/psychological, social and lifestyle burdens. The score is summed from all the questions for each domain, and then summed to a total score that ranges from 0 (no burden) to 104 (worst burden), in which higher scores reflect worse outcomes of higher burden on the caregiver. We will measure the caregiver burden measured by the CBQ-HF.
Measured: 3 month, 6 month, and 12 months from baseline enrollment
Mean Number of Emergency Department Visits
We recorded the number of emergency department visits.
Measured: 3 month, 6 month, and 12 months from baseline enrollment
Mean Number of Readmissions (Hospitalization)
We recorded the number of readmissions to the hospital.
Measured: 3 month, 6 month, and 12 months from baseline enrollment
If Hospitalized, Mean Number of Total Days in the Hospital
We recorded the number of total days in the hospital if they were hospitalized.
Measured: 3 month, 6 month, and 12 months from baseline enrollment
Mortality Was Also Measured
We recorded mortality data on the patients.
Measured: 3 month, 6 month, and 12 months from baseline enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start9 Nov 2018
- Primary completion25 Oct 2021
- Study completion6 May 2022
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 Cedars-Sinai Medical CenterThe 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
- None (open label)
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Waguih William IsHak, MD, FAPA, Cedars-Sinai Medical Center
- Investigators
- Waguih W IsHak, MD, FAPA, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688100
- Sponsor's protocol ID
- Pro00054483
- Status last verified
- Feb 2024
- First submitted
- 26 Sep 2018
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
IsHak WW, Hamilton MA, Korouri S, Diniz MA, Mirocha J, Hedrick R, Chernoff R, Black JT, Aronow H, Vanle B, Dang J, Edwards G, Darwish T, Messineo G, Collier S, Pasini M, Tessema KK, Harold JG, Ong MK, Spiegel B, Wells K, Danovitch I. Comparative Effectiveness of Psychotherapy vs Antidepressants for Depression in Heart Failure: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352094. doi: 10.1001/jamanetworkopen.2023.52094.
PubMed 38231511IsHak WW, Korouri S, Darwish T, Vanle B, Dang J, Edwards G, Black JT, Aronow H, Kimchi A, Spiegel B, Hedrick R, Chernoff R, Diniz MA, Mirocha J, Manoukian V, Harold J, Ong MK, Wells K, Hamilton M, Danovitch I. Personalized treatments for depressive symptoms in patients with advanced heart failure: A pragmatic randomized controlled trial. PLoS One. 2021 Jan 7;16(1):e0244453. doi: 10.1371/journal.pone.0244453. eCollection 2021.
PubMed 33412562
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT03688100
- Acronym / sponsor ID
- Pro00054483
- Conditions
- Depression, Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure. There are two evidence-based treatment approaches to treating depression in patients with advanced heart failure, behavioral action psychotherapy and treatment with anti-depressant medications. In this study we want to compare the effectiveness of these two treatment options to learn which treatment works better.
Detailed description
Aim 1: To compare the effectiveness of BA vs. MEDS, for depressed AHF patients. Hypothesis 1: Compared to depressed AHF patients who receive MEDS, patients receiving BA will have significantly greater improvements in the primary outcome of depressive symptom severity as measured with the PHQ-9 at 6-month follow-up. Significantly greater improvements will also be detected in the secondary outcomes of general physical and mental HRQoL (SF-12v2), heart failure-specific HRQoL (KCCQ), and caregiver burden (CBQ-HF) at 3, 6, and 12 months.
Aim 2: To compare the impact of BA vs. MEDS on disadvantageous outcomes of Morbidity (as evidenced by ED visits, hospital readmissions, total days in the hospital), and Mortality among depressed AHF patients.
Hypothesis 2: Compared to depressed AHF patients who receive MEDS, those receiving BA will have significantly less Morbidity (as evidenced by less frequent ED visits, lower readmission rates, fewer total days in the hospital), and reduced Mortality at the data collection points of 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients: Medication Management (MEDS) | Active comparator | Drug: Medication ManagementThe medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. |
| Patients: Behavioral Activation Therapy (BA) | Active comparator | Behavioral: Behavioral Activation TherapyBA is an evidence-based psychotherapy with more than 25 randomized trials showing effectiveness in depression. The therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. |
| Caregivers: Medication Management (MEDS) | No intervention | –Caregivers of patients receiving the the above described Medication Management (MEDS) intervention were monitored for caregiver burden at 3, 6, and 12 months. |
| Caregivers: Behavioral Activation Psychotherapy (BA) | No intervention | –Caregivers of patients receiving the the above described Behavioral Activation Psychotherapy (BA) intervention were monitored for caregiver burden at 3, 6, and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HF New York Heart Association classes: II-IV.
- Life expectancy of more than 6 months.
- PHQ-9 score ≥10.
- Diagnosis of Major Depressive Disorder, Persistent Depressive Disorder (Dysthymia), and Depressive Disorder Unspecified, as confirmed by the MINI 7.02.
Key exclusion criteria (4 listed)
- Imminent danger to self or others.
- Cognitive impairments with a MOCA score of < 23.
- Bipolar, Psychotic, and Substance-induced Disorders.
- Patients in active treatment of depression who are already on antidepressants, psychotherapy, or both.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation TherapyAlso: BAThe therapy group will consist of an introductory in person 50-minute treatment session, followed by 12 weekly telephone 50-minute outpatient treatment sessions, then 3 monthly telephone 50-minute outpatient maintenance sessions. A typical BA session will last 50 minutes and include a review of the previous session and completed daily monitoring record forms, an in-depth discussion of life areas and value, and verbal reinforcement of activity engagement. | Behavioural | Patients: Behavioral Activation Therapy (BA) |
| Medication ManagementAlso: MEDSCollaborative care model will be used. The medication management group will meet with the patient in a one 50 minute in person introductory antidepressant medication treatment session to educate the patient about depression and medication options. Patients will get prescribed a standard of care anti-depressant medication by treating physician, followed by 12 weekly follow up telephone visits, then on a monthly basis for 3 months, and then as needed thereafter. | Drug | Patients: Medication Management (MEDS) |
Primary outcome
Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up
Time frame: 6 months from baseline enrollment.
PHQ-9 is used to measure depressive symptoms severity. The PHQ-9 is a self-report instrument that corresponds with the validated Primary Care Evaluation of Mental Disorders PRIME-MD clinician-administered instrument. The PHQ-9 measures all nine dimensions of depression assessed in the DSM criteria for MDD on a 0-3 scale. Minimum score = 0 (no depression). Maximum scores = 21 (worst depression)
7 secondary outcomes
Change From Baseline in the 12-item Questionnaire Used to Assess Health-related Quality of Life (SF-12v2) Scale Results
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Change From Baseline on the Kansas City Cardiomyopathy Questionnaire (KCCQ ) Scale Results.
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Change From Baseline on the Caregiver Burden Questionnaire-Heart Failure (CBQ-HF) Scale Results.
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Mean Number of Emergency Department Visits
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Mean Number of Readmissions (Hospitalization)
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
If Hospitalized, Mean Number of Total Days in the Hospital
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Mortality Was Also Measured
Time frame: 3 month, 6 month, and 12 months from baseline enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38231511IsHak WW, Hamilton MA, Korouri S, Diniz MA, Mirocha J, Hedrick R, Chernoff R, Black JT, Aronow H, Vanle B, Dang J, Edwards G, Darwish T, Messineo G, Collier S, Pasini M, Tessema KK, Harold JG, Ong MK, Spiegel B, Wells K, Danovitch I. Comparative Effectiveness of Psychotherapy vs Antidepressants for Depression in Heart Failure: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352094. doi: 10.1001/jamanetworkopen.2023.52094.
- Derived from this study: PubMed 33412562IsHak WW, Korouri S, Darwish T, Vanle B, Dang J, Edwards G, Black JT, Aronow H, Kimchi A, Spiegel B, Hedrick R, Chernoff R, Diniz MA, Mirocha J, Manoukian V, Harold J, Ong MK, Wells K, Hamilton M, Danovitch I. Personalized treatments for depressive symptoms in patients with advanced heart failure: A pragmatic randomized controlled trial. PLoS One. 2021 Jan 7;16(1):e0244453. doi: 10.1371/journal.pone.0244453. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waguih W IsHak, MD, FAPA principal investigator
Cedars-Sinai Medical Center
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 Behavioral Activation Therapy and Medication Management in people with Depression and Heart Failure, run by Cedars-Sinai Medical Center 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 4 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 19 Mar 2024. 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.
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 19 Mar 2024). 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?
Depressive Symptom Severity as Measured by the Patient Health Questionnaire (PHQ-9) Depression Scale Results at 6 Months Follow up (time frame: 6 months from baseline enrollment.). 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 NCT03688100, 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 19 Mar 2024.