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Behavioral Intervention

Cognitive Behavioral Intervention for Caregiver Stress Syndrome (ENCODE Trial)

Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
No or only mild cognitive impairment
Screening 3 weeks
Treatment Varies
Follow Up assessments at week 1, week2, week 3 and 40 day follow-up
Awards & highlights
No Placebo-Only Group

ENCODE Trial Summary

This trial is designed to help caregivers of patients with Alzheimer's manage their pain and needs better by providing them with a cognitive behavioral intervention informed by the relational model of stress.

Who is the study for?
This trial is for family or informal caregivers of hospice patients with Alzheimer's or related dementias who are at least 18 years old, speak English, have at least a 6th-grade education level, and are concerned about managing their care recipient's pain. Caregivers should not have significant cognitive impairment or hearing loss that prevents telephone conversations.Check my eligibility
What is being tested?
The ENCODE intervention is being tested to help caregivers identify and communicate pain management challenges when caring for someone with dementia. Participants will either receive standard hospice care plus social support through 'friendly video-calls' or the same standard care along with the ENCODE program.See study design
What are the potential side effects?
Since this trial involves a non-medical intervention focusing on caregiver support rather than medication, traditional physical side effects are not applicable. However, participants may experience emotional discomfort discussing caregiving challenges.

ENCODE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 18 years old or older.
My thinking and memory skills are mostly fine.
I can speak and read English and have completed at least the 6th grade.

ENCODE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessments at week 1, week2, week 3 and 40 day follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessments at week 1, week2, week 3 and 40 day follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Caregiver Quality of Life-Index (CQLI-R) scores
Secondary outcome measures
Change in Generalized Anxiety Disorder (GAD-7) for caregivers
Change in the Depression Scale of the Patient Health Questionnaire (PHQ-9)
Change in the Pain Assessment in Advanced Dementia (PAINAD) Scale score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

ENCODE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ENCODE GroupExperimental Treatment1 Intervention
The intervention consists of three weekly video-conferencing sessions scheduled at the caregiver's convenience. Each session is scheduled to last approximately 40 minutes. The ENCODE intervention is manualized and has related curriculum designed specifically for caregivers of patients with ADRD. The agenda for the first session (week 1) includes an assessment of caregivers' pain management challenges and concerns. Once the barriers or challenges are identified, the interventionist works specific problem solving therapy steps covered over the three sessions.
Group II: Attention Control GroupActive Control1 Intervention
Caregivers in the attention control group will receive standard hospice services and complete the same measures and receive the same number of contacts as participants in the intervention group. Three video-conferencing calls will be scheduled based on the caregiver's availability following, if possible, a timeline between days 5 and 30 of the hospice admission. During these calls, the interventionist will allow caregivers in the attention control group to discuss their feelings, thoughts, and relationships. This "friendly call" intervention controls for the nonspecific aspects of treatment, i.e., the passage of time, amount of contact with a researcher, and the general support of an empathic, concerned and skilled professional and is based on the principles of nondirective supportive therapy.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,986 Previous Clinical Trials
42,850,506 Total Patients Enrolled
1 Trials studying Caregiver Stress Syndrome
30 Patients Enrolled for Caregiver Stress Syndrome

Media Library

ENCODE (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05336344 — N/A
Caregiver Stress Syndrome Research Study Groups: Attention Control Group, ENCODE Group
Caregiver Stress Syndrome Clinical Trial 2023: ENCODE Highlights & Side Effects. Trial Name: NCT05336344 — N/A
ENCODE (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336344 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are research teams currently recruiting for this trial?

"Affirmative, according to the data posted on clinicaltrials.gov this investigational trial is actively seeking volunteers. It was initially made available for recruitment on July 15th 2022 and most recently updated on August 1st 2022. The study demands 300 participants at a single site."

Answered by AI

What is the current quota for participants in this scientific experiment?

"Affirmative, the clinicaltrials.gov database indicates that this medical trial is presently enlisting participants. Initially posted on July 15th 2022 and most recently modified on August 1st 2022, 300 patients are sought after from a single centre."

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
~197 spots leftby May 2027