Reaching and Engaging Depressed Senior Center Clients

Depression in Old Age Clinical Trial

— REDS II  

Official title:

Reaching and Engaging Depressed Senior Center Clients Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289298
• Other study ID #: 19-09020810-02
• Secondary ID: 5P50MH113838-03
• Status: Completed
• Phase: N/A
• Start date: September 3, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 depression. The research will also measure clinician satisfaction after training and supervision of utilization of Engage-A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Depression
• Depression in Old Age

Intervention

Behavioral:
• Engage-A
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.

Other:
• Training and utilizing Engage-A therapy
Therapist will be trained in Engage-A therapy and given supervision while utilizing this therapy.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Virtual ENGAGE-A Participants Who Attend Every Scheduled Therapy Session	Number of Virtual ENGAGE-A Participants who Attend Every Scheduled Therapy Session	9 Weeks
Primary	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.	6 weeks, 9 weeks, 12 weeks
Primary	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.	2 years
Secondary	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.	Baseline, 6 week, 9 week, 12 week
Secondary	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.	Baseline, 6 week, 9 week, 12 week