Depression in Old AgeREDS IINCT04289298

Reaching and Engaging Depressed Senior Center Clients

A study testing Engage-A and Training and utilizing Engage-A therapy in people with Depression in Old Age, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test the feasibility of one type of therapy session, Virtual Augmented Engage (Engage-A). The research is being done because the researchers are trying to learn if these approaches could be used by therapists in the community social service agencies to treat older adults with… Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Depression in Old Age
What is being tested?: Engage-A and Training and utilizing Engage-A therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 3 Sep 2020to 31 Aug 2022
Phase: Interventional
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 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 55 years' old
PHQ-9 Score of ≥ 10
English or Spanish speaking
MOCA ≥ 24 or mini-telephone MOCA ≥ 11
Member of/attends one of the REDS Senior Centers
Capacity to provide written consent for both research assessment and the Engage-A intervention.

Who cannot join

Current active suicidal ideation defined by MADRS Suicide Item ≥ 4 (probably better off dead. Suicidal thoughts are common, and suicide is considered as a possible solution, but without specific plans or intention).
Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-IV.
Severe or life-threatening medical illness (e.g., end stage organ failure).
Currently seeing an individual psychotherapist *(if individuals are willing to go on a hiatus from their individual psychotherapist for the 15 weeks of the study, and meet all inclusion criteria, they will be considered eligible).

Trial locations and contacts

1 site in 1 country.

United States1 site

Weill Cornell Medicine
White Plains, New York, 10605

Other trials in United States

About this study

Official title: Reaching and Engaging Depressed Senior Center Clients Phase II

Conditions: Depression in Old Age
Being tested: Engage-A, Training and utilizing Engage-A therapy
Keywords: depression, geriatric, psychotherapy, group
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Engage-ABehavioural
Also called Augmented Engage
Therapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. 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.
Training and utilizing Engage-A therapyOther
Therapist will be trained in Engage-A therapy and given supervision while utilizing this therapy.

Study groups in NCT04289298
Study group	Role	What they receive
Engage-A	Experimental	Participants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding. Receives: Behavioral: Engage-A
Clinician	Experimental	Clinicians will be trained in Engage-A and supervised while utilizing the therapy. Receives: Other: Training and utilizing Engage-A therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session
Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session
Measured: 9 Weeks
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
The Client Satisfaction Questionnaire (CSQ) assesses the clients' satisfaction with the services they are receiving. The CSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the program. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the services received. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood of wanting to receive similar services in the future. Higher scores for all three domains indicate a better outcome.
Measured: 6 weeks, 9 weeks, 12 weeks
Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ
The Therapist Satisfaction Questionnaire (TSQ) assesses the therapists' satisfaction with the Alacrity therapy training and intervention. The TSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the skills obtained through training. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the therapy type. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood that the therapist would use this therapy in their own practice. Higher scores for all three domains indicate better outcomes.
Measured: 2 years

Secondary outcomes (2)

Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D
Hamilton Depression Rating Score (HAM-D) assesses the severity of depression in patients. The HAM-D ranges from 0 to 52, with higher scores indicating higher severity of depression.
Measured: Baseline, 6 week, 9 week, 12 week
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
The Behavioral Activation for Depression Scale (BADS) measures levels of behavioral activation.
The BADS ranges from 0 to 150, with higher scores indicating lower levels of behavioral activation. Domain 1 scores range from 0-42. Higher scores (better outcome) indicate greater activation. Domain 2 scores range from 0-48. Higher scores (worse outcome) indicate greater Avoidance and Rumination. Domain 3 scores range from 0-30. Higher scores (worse outcome) indicate greater Work/School impairment. Domain 4 scores range from 0-30. Higher scores (worse outcome) indicate greater social impairment.
Measured: Baseline, 6 week, 9 week, 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 202031 Aug 2022

First posted28 Feb 2020
Study start3 Sep 2020
Primary completion31 Aug 2022
Study completion31 Aug 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.
Other trials for Depression in Old AgeStudies of the same condition, open and under way.
More trials run by Weill Medical College of Cornell UniversityThe 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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04289298
Sponsor's protocol ID: 19-09020810-02
Other IDs: 5P50MH113838-03
Acronym: REDS II
Status last verified: Aug 2023
First submitted: 26 Feb 2020
Last updated: 23 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression in Old Age trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reaching and Engaging Depressed Senior Center Clients Phase II
ClinicalTrials.gov ID: NCT04289298
Acronym / sponsor ID: REDS II / 19-09020810-02
Conditions: Depression in Old Age
Keywords: depression, geriatric, psychotherapy, group
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 3 Sep 2020 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 28 Feb 2020 (actual)
Results: Posted 23 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Engage-A	Experimental	Behavioral: Engage-AParticipants receive 9 individual in-person or remote therapy sessions. Each session will last approximately 60 minutes. During the sessions, the therapist will encourage the participant to engage in physical and social activities that are pleasurable or rewarding.
Clinician	Experimental	Other: Training and utilizing Engage-A therapyClinicians will be trained in Engage-A and supervised while utilizing the therapy.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age ≥ 55 years' old
PHQ-9 Score of ≥ 10
English or Spanish speaking
MOCA ≥ 24 or mini-telephone MOCA ≥ 11
Member of/attends one of the REDS Senior Centers

Key exclusion criteria (4 listed)

Current active suicidal ideation defined by MADRS Suicide Item ≥ 4 (probably better off dead. Suicidal thoughts are common, and suicide is considered as a possible solution, but without specific plans or intention).
Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder by SCID-IV.
Severe or life-threatening medical illness (e.g., end stage organ failure).
Currently seeing an individual psychotherapist *(if individuals are willing to go on a hiatus from their individual psychotherapist for the 15 weeks of the study, and meet all inclusion criteria, they will be considered eligible).

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-AAlso: Augmented EngageTherapist will encourage participants to engage in physical and social activities that are pleasurable or rewarding. 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.	Behavioural	Engage-A
Training and utilizing Engage-A therapyTherapist will be trained in Engage-A therapy and given supervision while utilizing this therapy.	Other	Clinician

Primary outcome

Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session
Time frame: 9 Weeks
Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session
Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ
Time frame: 6 weeks, 9 weeks, 12 weeks
The Client Satisfaction Questionnaire (CSQ) assesses the clients' satisfaction with the services they are receiving. The CSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the program. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the services received. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood of wanting to receive similar services in the future. Higher scores for all three domains indicate a better outcome.
Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ
Time frame: 2 years
The Therapist Satisfaction Questionnaire (TSQ) assesses the therapists' satisfaction with the Alacrity therapy training and intervention. The TSQ ranges from 1-4, with higher scores indicating higher satisfaction. Domain 1 scores range from 1-4, with higher scores indicating higher satisfaction with the skills obtained through training. Domain 2 scores range from 1-4, with higher scores indicating higher satisfaction with the therapy type. Domain 3 scores range from 1-4, with higher scores indicating higher likelihood that the therapist would use this therapy in their own practice. Higher scores for all three domains indicate better outcomes.

2 secondary outcomes

Change in Depressive Symptoms of Virtual ENGAGE-A Participants as Measured by HAM-D
Time frame: Baseline, 6 week, 9 week, 12 week
Change in Behavioral Activation of Virtual ENGAGE-A Participants as Measured by the BADS
Time frame: Baseline, 6 week, 9 week, 12 week

Results and safety

Results posted to the registry on 23 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Engage-A	22	15
Clinician Participants	4	4

Primary outcome: Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session

Time frame: 9 Weeks. Count of participants. Unit: Participants

Measure	Engage-A n = 17	Clinician Participants n = 0
Value	17	–

Population analysed: The total number of participants that completed all scheduled therapy sessions at week 9. The number of participants analyzed at week 9 for this measure (17) is higher than the number analyzed for the other measures at week 9 (16) because one participant attended the week 9 therapy session but left the study before having completed the week 9 assessment, during which the remaining measures are completed. Clinician Participants were not analyzed for this measure as it does not apply to them.

Primary outcome: Change in Average Satisfaction Score of Virtual ENGAGE-A Participants as Measured by the CSQ

Time frame: 6 weeks, 9 weeks, 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Engage-A n = 18	Clinician Participants n = 0
Domain 1- week 6	2.5 (0.62)	–
Domain 2- week 6	2.89 (0.76)	–
Domain 3- week 6	2.83 (0.79)	–
Domain 1- week 9	2.5 (0.63)	–
Domain 2- week 9	3.31 (0.79)	–
Domain 3- week 9	3.33 (0.90)	–
Domain 1- week 12	2.73 (0.88)	–
Domain 2- week 12	3.40 (0.74)	–

Population analysed: The number of participants analyzed at week 6 was 18, at week 9 was 16, and at week 12 was 15 due to loss to follow up and participant withdrawal. Clinician Participants were not analyzed for this measure as it does not apply to them.

Primary outcome: Average Satisfaction Score of Community Clinicians (LCSW) as Measured by the TSQ

Time frame: 2 years. Mean (Standard Deviation). Unit: units on a scale

Measure	Engage-A n = 0	Clinician Participants n = 4
Domain 1	–	4.0 (0.00)
Domain 2	–	4.0 (0.00)
Domain 3	–	4.0 (0.00)

Population analysed: Engage-A participants were not analyzed as part of this measure as it does not apply to them.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected over 12 weeks for each Engage-A participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Engage-A	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Clinician Participants	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.

Related trials for Depression in Old Age

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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.

Patricia Marino, PhD principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Engage-A and Training and utilizing Engage-A therapy in people with Depression in Old Age, run by Weill Medical College of Cornell University 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 6 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 23 Aug 2023. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2023). 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?

Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session (time frame: 9 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04289298.

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 Aug 2023.