Your session is about to expire
← Back to Search
Do More, Feel Better - Behavioral Activation for Depression
Verified Trial
N/A
Recruiting
Led By Patrick J Raue, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Off antidepressants or on a stable dose for 12 weeks.
Capacity to provide consent for all study procedures
Timeline
Screening 2 days
Treatment 9 weeks
Follow Up 4 days
Awards & highlights
Study Summary
This trial is testing whether a layperson-delivered intervention called "Do More, Feel Better" is effective in reducing depression symptoms in comparison to a similar intervention delivered by a social worker.
Who is the study for?
This trial is for English-speaking seniors aged 60+ with mild cognitive function (MMSE ≥ 24 or mTICS ≥ 19) and depression (PHQ-9 score of ≥10, HAM-D>14). They must attend a participating senior center in Seattle, NYC, or Tampa. Volunteers need to be stable if on antidepressants. Exclusions include severe medical illness, active suicidal thoughts, substance abuse issues, and certain psychiatric diagnoses.Check my eligibility
What is being tested?
The study tests whether Behavioral Activation therapy for depression can be effectively delivered by trained volunteers compared to master's level clinicians. The goal is to see if this approach reduces depressive symptoms in elderly clients by encouraging engagement in rewarding activities.See study design
What are the potential side effects?
Since the interventions involve non-medical behavioral therapy techniques provided by either volunteers or clinicians without medication changes involved, there are no direct side effects like those seen with drugs; however participants may experience emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not been on antidepressants or have been on a stable dose for 12 weeks.
Select...
I can understand and agree to the study's procedures.
Timeline
Screening ~ 2 days0 visits
Treatment ~ 9 weeks0 visits
Follow Up ~ 4 days0 visits
Screening ~ 2 days
Treatment ~ 9 weeks
Follow Up ~4 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Behavioral Activation Scale (BADS)
Hamilton Rating Scale for Depression (HAM-D)
Secondary outcome measures
Client Satisfaction with Treatment (CSQ)- 3 Item
World Health Organization Disability Assessment Schedule (WHODAS II)
Other outcome measures
Intervention Fidelity
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Volunteer-delivered Behavioral Activation - "Do More, Feel Better"Experimental Treatment1 Intervention
"Do More, Feel Better" (DMFB) is a streamlined, simplified version of Behavioral Activation (BA) delivered by lay volunteers to depressed senior center clients.
Group II: Master's Level Clinician-delivered Behavioral ActivationActive Control1 Intervention
Traditional Behavioral Activation (BA) delivered by master's level mental health clinicians
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Volunteer-delivered Behavioral Activation
2017
N/A
~60
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityOTHER
1,055 Previous Clinical Trials
1,316,007 Total Patients Enrolled
66 Trials studying Depression
16,110 Patients Enrolled for Depression
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,478 Total Patients Enrolled
84 Trials studying Depression
87,194 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,411 Total Patients Enrolled
666 Trials studying Depression
251,296 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 60 years old or older.You have a PHQ-9 score of ≥10.I do not have a severe illness like end-stage organ failure.I have not been on antidepressants or have been on a stable dose for 12 weeks.I have been diagnosed with either major depression or generalized anxiety, but no other psychiatric conditions.I have not been on antidepressants or have been on a stable dose for 12 weeks.I can understand and agree to the study's procedures.You scored 10 or higher on a routine screening questionnaire called PHQ-9 that assesses your mental health.You must score at least 24 on the Mini-Mental Status Exam (MMSE) or 19 on the modified Telephone Interview for Cognitive Status (mTICS).You must attend one of the 18 participating senior centers in Seattle, New York, or Tampa.I speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Volunteer-delivered Behavioral Activation - "Do More, Feel Better"
- Group 2: Master's Level Clinician-delivered Behavioral Activation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 2 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 9 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 4 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04621877 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts currently open for this research endeavor?
"Clinicaltrials.gov data confirms that the recruitment process of this study is still ongoing, as it was initially posted on January 27th 2021 and last modified July 25th 2022."
Answered by AI
How many participants have volunteered to participate in this trial?
"This study requires 288 participants to meet its set criteria. Eligible individuals can participate from either Progress Village Senior Center in Seattle, Washington or GenPride Senior Center in Brandon, New york."
Answered by AI
Are there many centers offering this research in the municipality?
"Currently, this trial is running at 8 distinct sites across the United States of America. Locations that have been identified include Seattle, Brandon and New york City, among others. For patient convenience, it may be beneficial to select a location that requires minimal travel if enrolment is desired."
Answered by AI
Who else is applying?
What state do they live in?
Washington
Florida
New York
Other
How old are they?
18 - 65
What site did they apply to?
Brandon Senior Center
Goddard Riverside Community Center and NORC
SAGE Center Brooklyn at Stonewall House
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+
Why did patients apply to this trial?
Depressed. Would like to feel better. To help the next generation while helping myself.
PatientReceived 1 prior treatment
I am seeking more ways of dealing with my bipolar disorder. I am on lamotrigine and sertraline, but I feel like I'm still having a hard time with my depression.
PatientReceived 2+ prior treatments
I have tried at least 8 different antidepressants without long-term improvement. I can't afford other types of treatments at this time and I'm barely holding on without feeling suicidal.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- SAGE Center Brooklyn at Stonewall House: < 24 hours
- Brandon Senior Center: < 24 hours
- Hudson Guild Fulton Senior Center: < 48 hours
Average response time
- < 2 Days
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger