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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
1,059 Previous Clinical Trials
1,315,855 Total Patients Enrolled
66 Trials studying Depression
16,110 Patients Enrolled for Depression
University of WashingtonLead Sponsor
1,749 Previous Clinical Trials
1,838,356 Total Patients Enrolled
84 Trials studying Depression
87,191 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,798 Previous Clinical Trials
2,660,630 Total Patients Enrolled
672 Trials studying Depression
253,055 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
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