ENCODE Group for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pennsylvania, Philadelphia, PA
Depression+3 More
ENCODE - Behavioral
Eligibility
18+
All Sexes
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Study Summary

Based on preliminary work, whereby investigators examined pain management challenges and needs of caregivers of hospice patients with dementia, this team designed a cognitive behavioral intervention informed by the relational model of stress, entitled ENCODE (Empowering Caregivers of Patients with Dementia) to assist caregivers in effectively identifying and communicating their pain management challenges and needs. The investigators propose a 5-year randomized clinical trial in which caregivers of patients with Alzheimer's Disease and Related Dementias (ADRD) will be randomly assigned to a group receiving standard hospice care with the addition of "friendly video-calls" providing social support (attention control group) or a group receiving standard hospice care with the addition of the ENCODE intervention (intervention group).

Eligible Conditions

  • Depression
  • Caregiver Stress Syndrome
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: assessments at week 1, week2, week 3 and 40 day follow-up

Week 3
Change in Caregiver Quality of Life-Index (CQLI-R) scores
Change in Generalized Anxiety Disorder (GAD-7) for caregivers
Change in the Depression Scale of the Patient Health Questionnaire (PHQ-9)
Week 3
Change in the Pain Assessment in Advanced Dementia (PAINAD) Scale score

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Attention Control Group
1 of 2
ENCODE Group
1 of 2
Active Control
Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: ENCODE Group · No Placebo Group · N/A

ENCODE Group
Behavioral
Experimental Group · 1 Intervention: ENCODE · Intervention Types: Behavioral
Attention Control GroupNoIntervention Group · 1 Intervention: Attention Control Group · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessments at week 1, week2, week 3 and 40 day follow-up

Trial Background

Prof. George Demiris, PhD
Principal Investigator
University of Pennsylvania
Closest Location: University of Pennsylvania · Philadelphia, PA
Photo of Hospital of the University of Pennsylvania  1Photo of Hospital of the University of Pennsylvania  2Photo of University of Pennsylvania  3
2011First Recorded Clinical Trial
40 TrialsResearching Depression
1048 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a caregiver of a hospice patient with primary or secondary diagnosis of Alzheimer's disease or other related dementia.
You must be at least 18 years old.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.