Cognitive Behavioral Intervention for Caregiver Stress Syndrome

(ENCODE Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Significant hearing loss

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the treatment ENCODE for caregiver stress syndrome?

Research shows that cognitive behavioral therapy (CBT), which is a part of ENCODE, can help reduce depression, anxiety, and stress in caregivers of dementia patients. Additionally, a similar approach using a pictorial tool called a fotonovela was effective in reducing depression and stress in Latino caregivers, suggesting that tailored interventions can be beneficial. ^{1 2 3 4 5}

Is the Cognitive Behavioral Intervention for Caregiver Stress Syndrome safe for humans?

The studies reviewed focus on the effectiveness of various interventions for caregiver stress, but they do not provide specific safety data for the Cognitive Behavioral Intervention for Caregiver Stress Syndrome or its related programs like ENCODE. Generally, behavioral interventions like these are considered safe, as they involve non-invasive techniques such as counseling and stress management. ^{5 6 7 8 9}

How does the ENCODE treatment differ from other treatments for caregiver stress syndrome?

The ENCODE treatment is unique because it specifically focuses on empowering caregivers of patients with dementia through cognitive behavioral interventions, which are designed to address the psychological stress and improve coping strategies, unlike other treatments that may focus more on general stress reduction or psycho-educative approaches. ^{4 7 10 11 12}

Eligibility Criteria

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 18 years old or older.

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

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)

Trial Timeline

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

Treatment Details

Interventions

• ENCODE (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Measuring family caregiver efficacy for managing behavioral and psychological symptoms in dementia: a psychometric evaluation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a fotonovela for reducing depression and stress in Latino dementia family caregivers. [2022]

3. England 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Depression, Anxiety, and Stress in Caregivers of Dementia Patients: A Systematic Review and Meta-Analysis. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Biomarkers of Resilience in Stress Reduction for Caregivers of Alzheimer's Patients. [2021]

6. England 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. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Eye Movement Desensitization and Reprocessing Integrative Group Treatment Protocol (EMDR-IGTP) Applied to Caregivers of Patients With Dementia. [2023]

8. England 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The Caregivers for Alzheimer's disease Problems Scale (CAPS): development of a new scale within the LASER-AD study. [2016]

10. United States pubmed.ncbi.nlm.nih.gov

An Integrative Stress Reduction Program for Family Caregivers of Persons With Advanced Dementia: A Pilot Study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

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

12. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. [2022]