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Unified Protocol for Depression, Emotional Distress, and Anxiety
N/A
Waitlist Available
Led By Katherine Ramos, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
are age 65+
Report moderate or higher emotional distress
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post treatment, up to 7 weeks
Awards & highlights
Study Summary
This trial will adapt an existing evidence-based intervention, the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), to increase activity in older adults by reducing emotional distress.
Who is the study for?
This trial is for people aged 65 or older who are experiencing moderate to severe emotional distress and have noticed a decrease in their daily activities. Participants must be open to telehealth sessions. It's not suitable for those with urgent mental health conditions, current psychotherapy, dementia, recent changes in psychiatric meds, or who can't read/speak English.Check my eligibility
What is being tested?
The study tests the Unified Protocol (UP), an intervention aiming to reduce emotional distress and increase activity among older adults. Initially, UP will be delivered via telehealth; feedback will help create a self-guided version. Later on, both versions will be compared for effectiveness.See study design
What are the potential side effects?
Since this trial involves psychological therapy rather than medication, traditional side effects are not expected. However, participants may experience discomfort discussing personal issues or temporary increases in distress as they work through the therapeutic process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 years old or older.
Select...
I feel a significant amount of emotional distress.
Select...
I feel a significant amount of emotional distress.
Select...
I am 65 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post treatment, up to 7 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post treatment, up to 7 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PROMIS-anxiety
Change in PROMIS-depression
Change in Patient Specific Functional Scale (PSFS)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Therapist Delivered Unified ProtocolExperimental Treatment1 Intervention
This is a five session psychotherapy designed to help people with problems such as anxiety and depression.
Group II: Self-Guided Unified ProtocolExperimental Treatment1 Intervention
This is a five session treatment that patients can complete independently.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Unified Protocol
2020
N/A
~390
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,017,043 Total Patients Enrolled
1 Trials studying Emotional Distress
Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,420,202 Total Patients Enrolled
4 Trials studying Emotional Distress
423 Patients Enrolled for Emotional Distress
Katherine Ramos, PhDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to have appointments over the phone or internet.I am 65 years old or older.I am currently in psychotherapy.I am less active in my daily routines than before.I feel a significant amount of emotional distress.I am willing to have health appointments online.I have not changed my psychiatric medications in the last six weeks.I am less active in my daily routines than before.I cannot communicate in English.I feel a significant amount of emotional distress.I am willing to participate in health appointments via phone or computer.I am 65 years old or older.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Therapist Delivered Unified Protocol
- Group 2: Self-Guided Unified Protocol
Emotional Distress Patient Testimony for trial: Trial Name: NCT04837521 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation still open to participants?
"Clinicaltrials.gov confirms that this particular research project has closed its doors to new participants; the trial was initially posted on January 15th 2023 and last updated December 1st 2022. Fortunately, there are 1348 other trials still accepting patients at the moment."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve taken 3 different antidepressants but haven’t noticed any improvement. I enjoy therapy but it hasn’t improved my depressive symptoms. I believe I have atypical depression. I’m generally sad, have low energy, low motivation, and a lack of enthusiasm but can enjoy fun oriented socializing. I was widowed three years ago and, while not as acute now, I still grieve.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
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