DepressionENGAGE-IINCT01698255
Psychotherapy for Late Life Depression
A study testing ENGAGE in people with Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
This randomized pilot study will test the feasibility of a behavioral intervention for late life depression. Enrolled participants will receive 9 weeks of a specialized form of psychotherapy we call "ENGAGE" or standard of care psychotherapy. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- ENGAGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Apr 2015
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current client of Westchester Jewish Community Services;
- Age 60 years or older;
- Diagnosis of depression as determined by WJCS therapists;
- Command of English sufficient to participate in talking therapy;
- Age 60 years or older;
- Depression as determined by a Patient Health Questionnaire-9 score of 6 or higher (with at least one item being "depressed mood" or "loss of interest/pleasure");
- Command of English sufficient to participate in talking therapy;
Who cannot join
- Dementia: Mini Mental State Exam score below 24 or clinical diagnosis of dementia by Diagnostic and Statistical Manual IV;
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- History of psychiatric diagnoses other than major depressive disorder or generalized anxiety disorder (including bi-polar depression, psychotic depression, schizoaffective disorders).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Westchester Jewish Community Services
Hartsdale, New York, 10530
Weill Cornell Medical College
White Plains, New York, 10605
About this study
This randomized pilot study will test the feasibility of a behavioral intervention for late life depression. Enrolled participants will receive 9 weeks of a specialized form of psychotherapy we call "ENGAGE" or standard of care psychotherapy. ENGAGE is a stepped care psychotherapy based on what is currently known about older adults' response to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until individuals recover from their depression. The treatment components of ENGAGE were selected to match the most common problems seen in older adults with depression. They include instructing the participant in basic problem solving techniques and encouraging re-engagement in rewarding activities.
Participants will be depressed, older adult clients of Westchester Jewish Community Services or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry. In addition to receiving therapy, study participants will also undergo research assessments at the beginning of the study and then at weeks 6 and 9.
Read the detailed description
A concern about existing psychotherapies is that, while effective in depression, community clinicians find them difficult to implement in older people, particularly those with medical illnesses or disability. As a consequence evidence-based psychotherapies are utilized by a small number of specialized clinicians and offered to small number of select patients.
ENGAGE approaches these problems with a four prong strategy: 1) It developed a brief treatment program consisting of psychotherapeutic components of known efficacy. 2) Among them, ENGAGE selected components most pertinent to older adults. 3) ENGAGE distilled and simplified these components so that they can be accessible to most depressed older patients and taught to large numbers of clinicians. 4) To further simplify and personalize its administration, ENGAGE relies on a stepped approach focusing on engagement in rewarding social and physical activities (a form of behavioral activation), and when needed, adding techniques for management of emotionality (emotional control), negativity bias, and apathy. The self-correcting and least restrictive nature of stepped care approaches has appeal from patient cost/time efficiency and personalized treatment perspective. This project aims to further develop ENGAGE, to study the feasibility of training professionals (master's level social workers) offering care to depressed elderly patients in the community, to obtain preliminary data of its efficacy compared to community-based therapy (CT), and to prepare for an effectiveness (R01) study.
- Conditions
- Depression
- Being tested
- ENGAGE, Standard of Care Psychotherapy
- Keywords
- Depression, Geriatrics
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENGAGEBehavioural
Standard of Care PsychotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| ENGAGE | Experimental | ENGAGE is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression. The steps of ENGAGE are:
1. basic social and physical engagement, which has been found to be a very effective depression strategy for most older adults;
2. the addition of strategies to address clinical features of depression interfering with treatment engagement, namely affect regulation, pessimism, and disorganization. Receives: Behavioral: ENGAGE |
| Standard of Care Psychotherapy | Active comparator | The comparison group for this study will be the current standard of care psychotherapy offered by Westchester Jewish Community Services (WJCS) therapists. This type of psychotherapy is often supportive or eclectic in nature. Therapists will focus on helping the subject to express feelings and focus on strengths and abilities in working through current difficulties and transitions. Therapists assigned to provide standard psychotherapy to eligible participants will receive training and supervision from WJCS staff consistent with agency practice. Receives: Behavioral: Standard of Care Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression
To compare the effectiveness of the ENGAGE intervention in reducing depressive symptoms with that of the standard of care psychotherapy. We will assess severity of depression at Baseline. 6 weeks and 3 months using the Hamilton Depression Rating Scale as the primary measure.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- George Alexopoulos, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698255
- Sponsor's protocol ID
- 1108011880
- Other IDs
- 11108011880, P30MH085943-05
- Acronym
- ENGAGE-II
- Status last verified
- Feb 2017
- First submitted
- 2 Aug 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Alexopoulos GS, O'Neil R, Banerjee S, Raue PJ, Victoria LW, Bress JN, Pollari C, Arean PA. "Engage" therapy: Prediction of change of late-life major depression. J Affect Disord. 2017 Oct 15;221:192-197. doi: 10.1016/j.jad.2017.06.037. Epub 2017 Jun 19.
PubMed 28647669Alexopoulos GS, Raue PJ, Kiosses DN, Seirup JK, Banerjee S, Arean PA. Comparing engage with PST in late-life major depression: a preliminary report. Am J Geriatr Psychiatry. 2015 May;23(5):506-13. doi: 10.1016/j.jagp.2014.06.008. Epub 2014 Jun 26.
PubMed 25081818
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy for Late Life Depression
- ClinicalTrials.gov ID
- NCT01698255
- Acronym / sponsor ID
- ENGAGE-II / 1108011880
- Conditions
- Depression
- Keywords
- Depression, Geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Oct 2012 (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.
This randomized pilot study will test the feasibility of a behavioral intervention for late life depression. Enrolled participants will receive 9 weeks of a specialized form of psychotherapy we call "ENGAGE" or standard of care psychotherapy. ENGAGE is a stepped care psychotherapy based on what is currently known about older adults' response to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until individuals recover from their depression. The treatment components of ENGAGE were selected to match the most common problems seen in older adults with depression. They include instructing the participant in basic problem solving techniques and encouraging re-engagement in rewarding activities.
Participants will be depressed, older adult clients of Westchester Jewish Community Services or outpatient research subjects recruited by the Cornell Institute of Geriatric Psychiatry. In addition to receiving therapy, study participants will also undergo research assessments at the beginning of the study and then at weeks 6 and 9.
Detailed description
A concern about existing psychotherapies is that, while effective in depression, community clinicians find them difficult to implement in older people, particularly those with medical illnesses or disability. As a consequence evidence-based psychotherapies are utilized by a small number of specialized clinicians and offered to small number of select patients.
ENGAGE approaches these problems with a four prong strategy: 1) It developed a brief treatment program consisting of psychotherapeutic components of known efficacy. 2) Among them, ENGAGE selected components most pertinent to older adults. 3) ENGAGE distilled and simplified these components so that they can be accessible to most depressed older patients and taught to large numbers of clinicians. 4) To further simplify and personalize its administration, ENGAGE relies on a stepped approach focusing on engagement in rewarding social and physical activities (a form of behavioral activation), and when needed, adding techniques for management of emotionality (emotional control), negativity bias, and apathy. The self-correcting and least restrictive nature of stepped care approaches has appeal from patient cost/time efficiency and personalized treatment perspective. This project aims to further develop ENGAGE, to study the feasibility of training professionals (master's level social workers) offering care to depressed elderly patients in the community, to obtain preliminary data of its efficacy compared to community-based therapy (CT), and to prepare for an effectiveness (R01) study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENGAGE | Experimental | Behavioral: ENGAGEENGAGE is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression. The steps of ENGAGE are: 1. basic social and physical engagement, which has been found to be a very effective depression strategy for most older adults; 2. the addition of strategies to address clinical features of depression interfering with treatment engagement, namely affect regulation, pessimism, and disorganization. |
| Standard of Care Psychotherapy | Active comparator | Behavioral: Standard of Care PsychotherapyThe comparison group for this study will be the current standard of care psychotherapy offered by Westchester Jewish Community Services (WJCS) therapists. This type of psychotherapy is often supportive or eclectic in nature. Therapists will focus on helping the subject to express feelings and focus on strengths and abilities in working through current difficulties and transitions. Therapists assigned to provide standard psychotherapy to eligible participants will receive training and supervision from WJCS staff consistent with agency practice. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Current client of Westchester Jewish Community Services;
- Age 60 years or older;
- Diagnosis of depression as determined by WJCS therapists;
- Command of English sufficient to participate in talking therapy;
- Age 60 years or older;
Key exclusion criteria (3 listed)
- Dementia: Mini Mental State Exam score below 24 or clinical diagnosis of dementia by Diagnostic and Statistical Manual IV;
- High suicide risk, i.e. intent or plan to attempt suicide in near future;
- History of psychiatric diagnoses other than major depressive disorder or generalized anxiety disorder (including bi-polar depression, psychotic depression, schizoaffective disorders).
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 |
|---|---|---|
| ENGAGE | Behavioural | ENGAGE |
| Standard of Care Psychotherapy | Behavioural | Standard of Care Psychotherapy |
Primary outcome
Change in Depression
Time frame: 3 months
To compare the effectiveness of the ENGAGE intervention in reducing depressive symptoms with that of the standard of care psychotherapy. We will assess severity of depression at Baseline. 6 weeks and 3 months using the Hamilton Depression Rating Scale as the primary measure.
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 23 Feb 2017.
- Derived from this study: PubMed 28647669Alexopoulos GS, O'Neil R, Banerjee S, Raue PJ, Victoria LW, Bress JN, Pollari C, Arean PA. "Engage" therapy: Prediction of change of late-life major depression. J Affect Disord. 2017 Oct 15;221:192-197. doi: 10.1016/j.jad.2017.06.037. Epub 2017 Jun 19.
- Derived from this study: PubMed 25081818Alexopoulos GS, Raue PJ, Kiosses DN, Seirup JK, Banerjee S, Arean PA. Comparing engage with PST in late-life major depression: a preliminary report. Am J Geriatr Psychiatry. 2015 May;23(5):506-13. doi: 10.1016/j.jagp.2014.06.008. Epub 2014 Jun 26.
- 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.
George Alexopoulos, M.D. principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENGAGE in people with Depression, run by Weill Medical College of Cornell University 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 7 inclusion and 3 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 23 Feb 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?
Change in Depression (time frame: 3 months). 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 NCT01698255, 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 23 Feb 2017.