Cognitive Behavioral Intervention for Caregiver Stress Syndrome

(ENCODE Trial)

Overseen By Ann Muramatsu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Significant hearing loss

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

412 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist caregivers of patients with Alzheimer's or related dementias in managing the stress of pain management through a program called ENCODE (Empowering Caregivers of Patients with Dementia). Caregivers will either receive standard hospice care with supportive video calls or participate in the ENCODE intervention, which includes three video sessions focused on identifying and solving pain management challenges. Ideal participants are family caregivers concerned about managing their loved one's pain who can speak and read English. As an unphased trial, this study provides caregivers with a unique opportunity to gain valuable skills and support in managing their loved one's pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the ENCODE intervention is safe for caregivers?

Research has shown that programs like ENCODE, designed to assist caregivers of people with dementia, are generally safe and well-received. These programs typically emphasize teaching, support, and problem-solving instead of medications, thereby avoiding side effects. For instance, an educational program called "The Empowered Caregiver" demonstrated good results without reports of harm. This suggests that participants in the ENCODE program might benefit without major safety concerns. By using video sessions to address caregiving challenges, it aligns with other proven and safe support programs for caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENCODE intervention for caregiver stress syndrome because it offers a structured, problem-solving approach specifically tailored for caregivers of patients with Alzheimer's Disease and Related Dementias (ADRD). Unlike traditional support methods that primarily focus on emotional support, ENCODE involves manualized curriculum sessions that actively address caregivers' pain management challenges and concerns. This targeted, solution-oriented strategy aims to empower caregivers with practical skills to manage stress, potentially leading to improved well-being in a shorter timeframe.

What evidence suggests that the ENCODE intervention is effective for caregiver stress syndrome?

Research has shown that cognitive behavioral therapy (CBT), a component of the ENCODE program, effectively reduces depression, anxiety, and stress in caregivers of dementia patients. In this trial, participants in the ENCODE Group will receive this intervention. Similar programs have also lessened caregiver burden and reduced depressive symptoms while boosting self-confidence. The ENCODE program specifically aids caregivers in addressing pain management through clear, step-by-step problem-solving. This method, based on empowerment theory, has improved caregivers' knowledge and skills in managing dementia-related challenges. These findings suggest that ENCODE could support caregivers of patients with Alzheimer's Disease and related dementias. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My thinking and memory skills are mostly fine.

I am concerned about managing my care recipient's pain effectively.

Enrolled as a family/informal caregiver of a hospice patient with primary or secondary diagnosis of Alzheimer's disease or other related dementia

Exclusion Criteria

Significant hearing loss that does not allow the participant to conduct telephone conversations as assessed by the research staff (by questioning and observing the caregiver)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers receive the ENCODE intervention or attention control intervention through three weekly video-conferencing sessions

3 weeks

3 video-conferencing sessions

Follow-up

Participants are monitored for changes in caregiver quality of life, anxiety, depression, and patient pain

40 days

Assessments at week 1, week 3, and 40-day follow-up

What Are the Treatments Tested in This Trial?

Interventions

• ENCODE

Trial Overview 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.

How Is the Trial Designed?

Group I: ENCODE Group Experimental Treatment 1 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 Group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

The integrative stress reduction program (ISRP) significantly decreased caregiver stress and improved sleep quality, as measured by the Relative Stress Scale and Pittsburgh Sleep Quality Index, in a study involving 12 family caregivers over 4 weeks.

Care recipients also showed a reduction in behavioral and psychological symptoms of dementia (BPSD), indicating that the ISRP not only benefits caregivers but also positively impacts the well-being of those they care for.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrative Stress Reduction Program for Family Caregivers of Persons With Advanced Dementia: A Pilot Study. Sanprakhon, P., Chaimongkol, N., Hengudomsub, P., et al.[2022]

Psychoeducational interventions significantly help family caregivers of people with dementia by reducing their burden and improving their mental health, with technology-based interventions particularly effective for burden and group-based interventions addressing anxiety, depression, and overall quality of life.

The review analyzed 18 randomized controlled trials, highlighting that these interventions enhance caregivers' knowledge, problem-solving skills, and social support, which are crucial for managing the challenges of caregiving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a psychoeducational intervention for caregivers of People With Dementia with regard to burden, anxiety and depression: A systematic review. Frias, CE., Garcia-Pascual, M., Montoro, M., et al.[2020]

An 8-week mindfulness-based stress reduction (MBSR) training course significantly improved psychological resilience in non-professional caregivers of Alzheimer's patients, indicating its potential as an effective intervention for caregiver stress.

The study identified specific biomarkers in blood that predict which caregivers are likely to benefit from MBSR, providing insights into the mechanisms behind its health benefits and paving the way for personalized approaches in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. Ho, L., Bloom, PA., Vega, JG., et al.[2021]

Cognitive Behavioral Therapy (CBT) significantly reduces depression and stress in caregivers of dementia patients, with a standardized mean difference of -0.34 for depression and -0.36 for stress, based on a meta-analysis of 25 studies.

Group formats of CBT are more effective than individual formats, and limiting the therapy to eight sessions or fewer is just as effective as longer sessions, suggesting a cost-effective approach to support caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Depression, Anxiety, and Stress in Caregivers of Dementia Patients: A Systematic Review and Meta-Analysis. Hopkinson, MD., Reavell, J., Lane, DA., et al.[2020]

A pictorial tool called a fotonovela (FN) significantly reduced depressive symptoms in Latino dementia caregivers compared to standard informational materials, as shown in a study with 110 participants.

Caregivers using the FN found it more helpful and referred to it more often, highlighting its effectiveness in addressing the unique needs of Latino caregivers facing stress and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a fotonovela for reducing depression and stress in Latino dementia family caregivers. Gallagher-Thompson, D., Tzuang, M., Hinton, L., et al.[2022]

The Caregiver Efficacy Scale, developed to measure caregiver confidence in managing behavioral and psychological symptoms of dementia (BPSD), showed strong validity and reliability in a study with 245 family caregivers, indicating it is a useful tool for assessing caregiver efficacy.

Higher scores on the Caregiver Efficacy Scale were significantly associated with lower frequency and severity of BPSD, as well as reduced negative outcomes like depression and anxiety, suggesting that improving caregiver efficacy could lead to better management of dementia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring family caregiver efficacy for managing behavioral and psychological symptoms in dementia: a psychometric evaluation. Crellin, N., Charlesworth, G., Orrell, M.[2022]

The Northern Manhattan Hispanic Caregiver intervention Effectiveness Study (NHiCE) is a 6-month randomized controlled trial involving 200 Hispanic caregivers, designed to compare the effectiveness of two established interventions, NYUCI and REACH, in reducing caregiver burden and depressive symptoms.

The study will measure changes in caregiver stress and depression using validated scales, ensuring a rigorous analysis of which intervention is more effective for Hispanic caregivers of individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Northern Manhattan Hispanic Caregiver Intervention Effectiveness Study: protocol of a pragmatic randomised trial comparing the effectiveness of two established interventions for informal caregivers of persons with dementia. Luchsinger, JA., Burgio, L., Mittelman, M., et al.[2021]

The program 'Learning to feel better… and help better' was successfully implemented in French-speaking Switzerland, showing high acceptance and strong participant engagement among informal caregivers of persons with dementia.

Participants experienced significant improvements in caregiver burden, psychological distress, and self-efficacy, indicating that the intervention effectively helps caregivers manage stress and apply learned coping strategies in their daily lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping with dementia caregiving: a mixed-methods study on feasibility and benefits of a psycho-educative group program. Pihet, S., Kipfer, S.[2019]

The Balance Study, involving 78 family caregivers of individuals with dementia, found that mindfulness-based stress reduction (MBSR) significantly improved mental health, reduced stress, and decreased depression compared to community caregiver education and support (CCES).

Both MBSR and CCES were effective in enhancing caregiver mental health, but MBSR showed superior benefits, suggesting it could be a valuable intervention for caregivers dealing with the chronic stress of caring for a family member with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. Whitebird, RR., Kreitzer, M., Crain, AL., et al.[2022]

A study involving 44 primary caregivers of dementia patients found that the Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol (EMDR-IGTP) significantly reduced stress, anxiety, and depression symptoms in caregivers who received immediate treatment compared to those who waited.

Improvements in emotional distress were most notable immediately after treatment, particularly in stress-related symptoms, but only the reduction in stress was maintained at a two-month follow-up, highlighting the potential effectiveness of EMDR-IGTP for caregiver syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol (EMDR-IGTP) Applied to Caregivers of Patients With Dementia. Passoni, S., Curinga, T., Toraldo, A., et al.[2023]

This study is the first randomized controlled trial testing the effectiveness of the New York University Caregiver Intervention (NYUCI) specifically in Hispanic caregivers of persons with dementia, including a broader range of relatives beyond just spouses.

The intervention, which lasts for 6 months, aims to reduce depression and caregiver burden, with outcomes measured using the Geriatric Depression Scale and the Zarit Caregiver Burden Scale, highlighting its potential to address significant psychosocial stressors in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Northern Manhattan Caregiver Intervention Project: a randomised trial testing the effectiveness of a dementia caregiver intervention in Hispanics in New York City. Luchsinger, J., Mittelman, M., Mejia, M., et al.[2021]

The Caregivers for Alzheimer's disease Problems Scale (CAPS) effectively identifies family caregivers at risk for anxiety and depression, showing high sensitivity and specificity based on interviews with 153 caregivers.

The CAPS highlights five key areas of concern that can inform interventions, including the mental health of the care recipient and the caregiver's physical health, suggesting that addressing these factors can improve caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Caregivers for Alzheimer's disease Problems Scale (CAPS): development of a new scale within the LASER-AD study. Livingston, G., Mahoney, R., Regan, C., et al.[2016]

Citations

1. withpower.com withpower.com/trial/phase-depression-4-2022-53fa5

Cognitive Behavioral Intervention for Caregiver Stress ... Research shows that cognitive behavioral therapy (CBT), which is a part of ENCODE, can help reduce depression, anxiety, and stress in caregivers of dementia ...

2. reporter.nih.gov reporter.nih.gov/project-details/10550182

Supporting Family Caregivers of Persons with Dementia The proposed research study explores the delivery a supportive intervention for caregivers of patients with dementia in order to improve pain management.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7302999/

Effectiveness of Powerful Tools for Caregivers on ... Intent-to-treat analyses found PTC reduced caregiver burden (d= −0.48), depressive symptoms (d= −0.53), and increase self-confidence (d= 0.68), but found no ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525861019308138

Effectiveness of Powerful Tools for Caregivers on ... Intent-to-treat analyses found PTC reduced caregiver burden (d = −0.48) and depressive symptoms (d = −0.53), and increased self-confidence (d = 0.68), but found ...

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1393823/full

The impact of empowerment theory-based health ... This trial investigated the impact and effectiveness of an empowerment theory-based approach to health education in improving dementia knowledge ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11385866/

The impact of empowerment theory-based ... Outcome measures included dementia knowledge, caregiver readiness (primary outcomes), positive caregiving emotions, anxiety, and depression ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9392839/

Impact of Alzheimer's Disease on Caregivers in the United ... The results indicate that most AD caregivers are family members (78%). AD often strains the caregiver's relationship with the patient (47.5%), ...

8. johnahartford.org johnahartford.org/resources/view/best-programs-for-caregiving-database-of-proven-dementia-caregiving-programs-for-caregivers-and-service-providers

Best Programs for Caregiving: Database of Proven ... This first-of-its-kind online directory details nearly 50 top-rated dementia support programs, including local availability, program outcomes and enrollment ...

9. tandfonline.com tandfonline.com/doi/full/10.1080/28324897.2025.2496170

Full article: Caring for the caregivers: a reflection on the ... Caring for an older adult with dementia is associated with high levels of chronic stress that may negatively impact the health of the caregiver.

10. alz.org alz.org/help-support/resources/empowered-caregiver

The Empowered Caregiver This educational program helps caregivers navigate the responsibilities of caring for someone with Alzheimer's or another dementia.