Virtual Stress Management for Caregiver Stress

(eCare Trial)

Not currently recruiting at 1 trial location

Overseen By Heather Rouse

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Steroids

Disqualifiers: Serious medical condition, Pregnancy, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 11

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how stress management programs can reduce stress and depression in caregivers of cancer patients. It will compare usual care with two stress management techniques: Pep-Pal, which includes online video modules, and PEPRR, which offers virtual one-on-one sessions. The trial is ideal for caregivers who live with and are partners of cancer patients and are currently working at least 20 hours a week. As an unphased trial, it offers caregivers the opportunity to access innovative stress management techniques that could enhance their well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using steroid medications chronically, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both Pep-Pal and PEPRR are safe and easy for caregivers to use. Caregivers of patients with advanced cancer found Pep-Pal acceptable and provided positive feedback on its ease of use. They appreciated the online video lessons, though some suggested improvements for topics like intimacy.

Research indicates that PEPRR, which stands for PsychoEducation, Paced Respiration, and Relaxation, reduces stress in caregivers. Caregivers reported the program as practical and acceptable, experiencing less stress after using it.

Overall, both programs are safe options for managing stress in caregivers, with users finding them easy to use and effective in reducing stress levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Stress Management trial because it explores innovative methods to help caregivers manage stress. Unlike traditional in-person therapy or medication, the Pep-Pal treatment offers self-directed, web-accessible video modules, making stress management more accessible and flexible for busy caregivers. The PEPRR treatment stands out by providing virtual one-on-one sessions focused on psychoeducation and paced relaxation, combining personalized interaction with the convenience of online access. Both approaches aim to offer caregivers effective stress management tools without the need for regular clinic visits, potentially transforming how caregiver stress is managed.

What evidence suggests that this trial's treatments could be effective for managing caregiver stress?

Research has shown that the Pep-Pal program, available to participants in this trial, helps reduce stress in caregivers. It includes videos that caregivers can access anytime to manage stress. Users found it easy to use and helpful for stress management.

Another method under study in this trial is PEPRR, which also lowers stress in caregivers. This approach combines learning with breathing and relaxation exercises. Both programs have proven effective in helping caregivers reduce stress in challenging situations. ^{1 5 6 7 8}

Who Is on the Research Team?

Cathy J Bradley, PhD

Principal Investigator

University of Colorado Denver (Anschutz Medical Campus)

Are You a Good Fit for This Trial?

This trial is for spouses or partners who have been caregivers for at least a year to someone with any stage of solid tumor cancer and are starting treatment. Caregivers must live with the patient, work at least 20 hours per week, be willing to use a smartphone, and show signs of depression or anxiety.

Inclusion Criteria

Able to read and speak the English language

I am willing to use a Smartphone.

A primary caregiver for the patient with a diagnosis of solid tumor cancer

Exclusion Criteria

You have not had a mental illness in the past year and a half that is not related to your role as a caregiver.

I do not take chronic steroid medications.

I don't have a serious illness that could affect my hormone levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers participate in stress management interventions, including Virtual-PEPRR or Pep-Pal, or receive treatment as usual (TAU).

12 months

8 sessions (Virtual-PEPRR), 11 modules (Pep-Pal)

Follow-up

Participants are monitored for psychological and physiological outcomes, including assessments and biomarker collection.

12 months

Assessments at baseline, 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Pep-Pal
• PEPRR

Trial Overview The study tests two virtual stress management programs: Pep-Pal and PEPRR. It aims to see if these can reduce psychological distress in caregivers of solid tumor cancer patients by providing psychoeducation tailored for employed individuals.

How Is the Trial Designed?

Group I: Caregiver Self-Directed Experimental Treatment 1 Intervention

biomarker analysis; questionnaire administration; survey administration; Pep-Pal web-accessible video modules of the psychoeducation and stress management intervention.

Group II: Caregiver Intervention Experimental Treatment 1 Intervention

biomarker analysis; questionnaire administration; survey administration; PsychoEducation Paced Respiration and Relaxation (PEPRR), which includes virtual one-on-one psychoeducation and stress management intervention.

Group III: Caregiver Control Active Control 1 Intervention

biomarker analysis; questionnaire administration; survey administration; treatment as usual

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Home-based caregivers of individuals with dementia experience significant stress primarily due to challenges in medication management, memory loss, hygiene care, and disruptive behaviors, highlighting the need for targeted support.

Professional caregivers have better access to resources and technology, which could be beneficial if adapted for home-based caregivers, but any new technology must be designed with a focus on the human experience to effectively support both caregivers and those with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress in the Volunteer Caregiver: Human-Centric Technology Can Support Both Caregivers and People with Dementia. Huelat, B., Pochron, ST.[2021]

The iCare Stress Management e-Training Program significantly reduced perceived stress among dementia family caregivers compared to an Education/Information-Only condition, indicating its potential efficacy in stress management.

Despite the positive results, the study faced a high dropout rate of about one-third of participants, highlighting the need for strategies to enhance engagement and retention in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the effectiveness of an internet-based program for reducing caregiver distress using the iCare Stress Management e-Training Program. Kajiyama, B., Thompson, LW., Eto-Iwase, T., et al.[2022]

A systematic review of 24 trials (8 open-label and 16 randomized) found that internet-based interventions can effectively reduce caregiver stress, with 6 out of 16 randomized trials showing positive benefits.

While many interventions were effective, there was no consistent pattern in study variables that predicted better outcomes, indicating a need for further research to optimize these interventions for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing caregiver stress with internet-based interventions: a systematic review of open-label and randomized controlled trials. Hu, C., Kung, S., Rummans, TA., et al.[2022]

The study aims to develop and test a user-friendly stress management toolkit for people living with dementia and their care partners, using simple, nonpharmacologic tools like animatronic pets and aromatherapy, to help manage stress effectively.

By employing a human-centered design approach and involving dementia caring dyads in the co-design process, the intervention is expected to be more acceptable and feasible for real-world use, with preliminary data supporting its potential for implementation in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. Harris, M., Van Houtven, C., Hastings, S.[2022]

The Baycrest Quick-Response Caregiver ToolTM (BQRCT) was found to be highly feasible and helpful for 21 family caregivers managing neuropsychiatric symptoms of dementia, allowing them to effectively recognize and manage their emotions in real time.

Healthcare providers also found the tool useful, with most recommending it to others, highlighting its potential as a valuable online resource for caregivers who may struggle to access in-person support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Instrument for Caregivers in Managing Neuropsychiatric Symptoms of Dementia: Baycrest Quick-Response Caregiver ToolTM. Madan, R., Natadiria, M., Berall, A., et al.[2022]

An eight-session stress management intervention for caregivers of allogeneic hematopoietic stem cell transplant recipients was effective in reducing distress, with 70% of the 74 participants completing all sessions, indicating good acceptability.

Challenges included low usage of a biofeedback device and high dropout rates due to patient illness or death, suggesting that future interventions may benefit from more flexible delivery methods like phone or video sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based stress management intervention for allogeneic hematopoietic stem cell transplant caregivers: development, feasibility and acceptability. Simoneau, TL., Kilbourn, K., Spradley, J., et al.[2018]

The study successfully adapted an in-person stress management intervention for caregivers of cancer patients into a mobile-friendly format called Pep-Pal, which consists of 9 sessions focused on various stress management topics.

Feedback from caregivers and palliative care experts indicated that Pep-Pal was acceptable and user-friendly, suggesting it could effectively reach and support caregivers in managing their stress and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Intervention for Addressing Distress in Caregivers of Patients Receiving Stem Cell Transplants: Formative Evaluation With Qualitative Interviews and Focus Groups Pensak, NA., Joshi, T., Simoneau, T., et al.[2020]

A pilot study involving 23 family caregivers showed that an internet-based psychological intervention significantly reduced care-associated stress, anxiety, and depressive symptoms after treatment.

Participants also experienced a notable increase in self-efficacy, suggesting that this online intervention is effective in helping caregivers manage their psychological stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An internet-based intervention for health promotion in family caregivers--results of a pilot study]. Böttche, M., Klasen, M., Knaevelsrud, C.[2018]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK608993

Using a Program to Lower Stress for Caregivers of Patients ... We have shown that our PsychoEducation, Paced Respiration, and Relaxation (PEPRR) intervention reduces caregiver psychological distress.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04739696

Study Details | NCT04739696 | Developing a Virtual Stress ... This randomized control trial will investigate the ability of an effective stress management psychoeducation program for employed caregivers to mitigate ...

3. withpower.com withpower.com/trial/phase-glioma-10-2021-75fb6

Cereset for Caregiver Stress · Info for Participants The caregiver stress management intervention, PsychoEducation, Paced Respiration, and Relaxation (PEPRR), significantly reduced caregiver distress over 3 ...

4. researchgate.net researchgate.net/figure/A-shows-the-proportions-of-caregivers-who-reported-visiting-a-mental-health-professional_fig1_263965359

A) shows the proportions of caregivers who reported ... Findings indicate that participation in a psychoeducation, paced respiration, and relaxation intervention, compared to treatment as usual, had favorable ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6554248/

Psychological Interventions for Dementia Caregivers Whitebird and colleagues found positive results for the two interventions tested (MBSR vs. a community caregiver education and support), ...

6. withpower.com withpower.com/trial/phase-8-2021-ddb9d

Stress Management for Caregiver Stress Is the Stress Management for Caregiver Stress treatment safe for humans? The research articles provided do not contain specific safety data for the Stress ...

7. astctjournal.org astctjournal.org/article/S2666-6367(25)01147-9/pdf

Multicenter Study on Caregiver Experiences in Pediatric ... programs like PEPRR (Psychoeducation, Paced. Respiration, and Relaxation), can reduce caregiver stress and improve coping, ultimately enhancing patient care ...

8. researchgate.net researchgate.net/publication/314648913_An_evidence-based_stress_management_intervention_for_allogeneic_hematopoietic_stem_cell_transplant_caregivers_development_feasibility_and_acceptability

An evidence-based stress management intervention for ... We created an eight-session individual stress management intervention for caregivers of allogeneic hematopoietic stem cell transplant (Allo-HSCT) ...