Digital Support for Caregivers

Overseen By Hanna G Campbell, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Legal action, Non-English speakers, Under 18

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and usability of an online platform called Altitudes, which offers support and resources for those caring for young people with psychosis. The goal is to determine if this digital community can enhance caregivers' well-being and social support. The trial will also assess how frequently and easily participants use the platform over six months. Parents, caregivers, or supporters of young people with psychosis who have internet access may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative support solutions for caregivers.

Do I need to stop my current medications to join the trial?

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

What prior data suggests that this digital platform is safe for caregivers?

Research has shown that the Altitudes platform has been tested for caregiver acceptance and usability. Studies have evaluated its ease of use and perceived helpfulness among caregivers. No reports of negative side effects or harm have emerged, as Altitudes is a digital tool, not a medication. This suggests it is a safe option for caregivers seeking support. The platform provides a moderated online space where caregivers can access educational content and connect with others in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Altitudes because it offers a digital support platform specifically designed for caregivers of individuals experiencing first-episode psychosis. Unlike traditional support options, which often rely on in-person therapy and support groups, Altitudes provides 24/7 access to educational and therapeutic content online. Additionally, it fosters a moderated community network, allowing caregivers to connect and share experiences at any time. This accessibility and continuous support are what make Altitudes stand out, potentially easing the burden on caregivers who might not have flexible schedules or easy access to conventional support resources.

What evidence suggests that this digital platform is effective for caregivers of young people with psychosis?

Research has shown that family support can reduce relapse rates and shorten hospital stays for people with psychosis. Studies also indicate that these support systems benefit caregivers of young people experiencing their first episode of psychosis by equipping them with better tools and assistance. In this trial, participants will use the digital health tool, Altitudes, which offers quick access to helpful resources and can improve caregivers' well-being. These platforms help caregivers feel more supported and enhance their overall health. Altitudes aims to provide educational and therapeutic content to strengthen the social support available to caregivers. ^{2 5 6 7 8}

Who Is on the Research Team?

Kelsey R Ludwig, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Diana Perkins, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for caregivers and supporters of young people with psychosis in North Carolina. Participants should be involved in programs like CSC, STEP, or similar community services. The study aims to include up to 50 individuals who can commit to a 6-month period.

Inclusion Criteria

My caregiver is at least 18 years old.

Participants recruited from NC CSC programs, STEP programs, and community screening process

Parent, caregiver, or supporter must have access to internet through a mobile phone, tablet, or computer

Exclusion Criteria

Parent or caregiver currently engaged in legal action against the loved one experiencing psychosis

My caregiver or I do not speak or understand English.

My caregiver is younger than 18.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Onboarding

Participants receive instructions and guidance for using the Altitudes platform

1 week

1 visit (virtual)

Treatment

Participants engage with the Altitudes digital platform, including psychoeducational and therapeutic content, for approximately 6 months

24 weeks

Continuous online engagement

Follow-up

Participants are monitored for engagement and psychological status, well-being, and social support through self-report questionnaires

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Altitudes

Trial Overview The Altitudes USA digital platform is being tested for its feasibility and potential benefits. It's an online social media tool with therapeutic content designed to support caregivers by improving their psychological status, well-being, and social support.

How Is the Trial Designed?

Group I: Altitudes Condition Experimental Treatment 1 Intervention

Individuals whose loved ones are experiencing first-episode psychosis (FEP) and receiving services from OASIS, SHORE, Eagle, Encompass, AEGIS, and WeCare2), STEP programs, or community services will be recruited to participate in a digital platform, Altitudes, for 6 months as part of an adjunct service to the clinic's services. Participants will have access to and encouraged to use the educational and therapeutic content as well as the moderated online community network during their time engaging with the platform. They will be asked to complete a battery of measures at baseline, 3-months, and 6 months.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

North Carolina Department of Health and Human Services

Collaborator

Trials

15

Recruited

94,300+

Published Research Related to This Trial

A comprehensive analysis of adverse events in Veterans Health Administration mental health units revealed 87 root cause analysis reports and 9780 safety reports, highlighting a significant risk of various incidents, including 31 suicide attempts and 16 elopements.

Falls were the most frequently reported safety event, followed by medication errors and assaults, indicating that a broad approach to patient safety is essential in mental health settings, similar to medical units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events occurring on mental health units. Mills, PD., Watts, BV., Shiner, B., et al.[2018]

The study developed an Adverse-Event Coping Scale (AECS) based on responses from 140 patients, demonstrating good reliability (coefficient of 0.82) and a one-dimensional structure with 11 items.

Higher AECS scores indicate that patients are facing serious adverse drug events (ADEs) and are making significant efforts to cope, which can help clinicians identify when timely interventions are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an adverse-event coping scale (AECS) using item response theory. Park, T., Hadsall, RS., Schommer, JC., et al.[2015]

The REACH II program, a multi-site trial focused on caregivers of Alzheimer's patients, highlighted the need for tailored safety monitoring and adverse event reporting protocols in psychosocial and behavioral intervention studies, as existing guidelines primarily address medical interventions.

The study identified unique challenges in defining and classifying adverse events, as well as establishing resolution criteria, emphasizing the variability in safety monitoring practices across psychosocial trials and the necessity for standardized protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. Czaja, SJ., Schulz, R., Belle, SH., et al.[2022]

After high-reliability training, caregivers did not significantly increase the overall number of event reports, but there was a notable decrease in clinical process error reports, indicating a potential improvement in identifying and addressing specific types of safety issues.

The study found differences in reporting patterns between day and night shifts, suggesting that factors beyond training may influence caregivers' willingness to report safety events, highlighting the need for further research into motivators for reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Use of High-Reliability Principles to Increase Error Event Reporting: A Retrospective Review. Duffey, P., Oliver, JS., Newcomb, P.[2019]

The Tele-Savvy program, an online adaptation of the Savvy Caregiver Program, was found to be feasible and effective for improving caregiver well-being, with 57 caregivers completing the 6-week program.

Caregivers of individuals with more advanced dementia and higher behavioral and psychological symptoms of dementia (BPSD) experienced significant reductions in caregiver burden and improvements in caregiver competence after participating in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Savvy: An Online Program for Dementia Caregivers. Griffiths, PC., Kovaleva, M., Higgins, M., et al.[2019]

Computer-mediated interventions for caregivers of individuals with dementia have been shown to effectively reduce carer burden, stress, and depression, particularly in higher quality studies.

These interventions also enhance positive aspects of caregiving and increase carer self-efficacy, although their impact on social support and physical aspects of caregiving remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of computer-mediated interventions for informal carers of people with dementia-a systematic review. McKechnie, V., Barker, C., Stott, J.[2023]

The digital intervention COPe-support did not show a significant improvement in mental wellbeing compared to a passive online information resource, with no evidence of a difference in wellbeing scores after 20 weeks among 407 participants.

Despite the lack of overall effectiveness, the study found that a subset of participants who engaged more with the COPe-support platform showed a slight increase in wellbeing scores, indicating that further research is needed to enhance digital support for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of digital psychoeducation and peer support on the mental health of family carers supporting individuals with psychosis in England (COPe-support): a randomised clinical trial. Sin, J., Henderson, C., Elkes, J., et al.[2022]

The TeleFAMILIES telehealth intervention significantly reduced caregiver burden and depressive symptoms among 216 caregivers of persons with dementia, with notable improvements in scores on the Zarit Burden Interview and Center for Epidemiologic Studies Depression Scale.

Caregivers using the TeleFAMILIES program experienced greater improvements in managing behavioral symptoms of dementia compared to those receiving in-person support, highlighting the effectiveness and convenience of telehealth services in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of TeleFAMILIES: a telehealth intervention for caregivers of community-dwelling people with dementia. Rice, JD., Sperling, SA., Brown, DS., et al.[2022]

Digital mental health tools have been reported to positively impact the health of informal caregivers, helping them develop coping skills and manage stress, which is crucial given the emotional strain they often experience.

However, there is a significant gap in the availability of comprehensive digital mental health resources specifically designed for caregivers of older adults, as most tools focus on skill-building and education rather than directly addressing caregivers' mental health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Mental Health Tools for Caregivers of Older Adults-A Scoping Review. Petrovic, M., Gaggioli, A.[2021]

A pilot study involving 93 caregivers of dementia patients demonstrated that virtual support meetings, held three times a week for three months, were highly effective, with 86-100% satisfaction reported by participants.

The program provided caregivers with essential management guidelines and education about dementia, suggesting that such virtual interventions can significantly alleviate caregiver burden and improve their confidence in providing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Support in Dementia: A Possible Viable Strategy for Caregivers. Ferretti, C., Nitrini, R., Brucki, SMD.[2021]

In a study involving 638 caregivers of people with dementia, both online cognitive-behavioral therapy (CBT) with and without telephone support showed significant improvements in mental health compared to baseline, but did not outperform online psychoeducation.

CBT without telephone support was found to be less effective than psychoeducation in reducing depression and caregiver stress, suggesting that this form of CBT should not be recommended based on the current evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online Education and Cognitive Behavior Therapy Improve Dementia Caregivers' Mental Health: A Randomized Trial. Fossey, J., Charlesworth, G., Fowler, JA., et al.[2021]

Internet interventions can improve the well-being of informal caregivers for dementia patients, enhancing aspects like confidence, depression, and self-efficacy, especially when tailored to individual needs and including multiple components.

Despite showing potential benefits, the overall quality of evidence from the studies is low, indicating a need for more rigorous randomized controlled trials to better assess the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of Internet-based supportive interventions for caregivers of patients with dementia. Boots, LM., de Vugt, ME., van Knippenberg, RJ., et al.[2022]

In a study involving 43 caregiver and person-with-dementia dyads, active psychoeducational interventions significantly improved caregivers' skills and reduced their burden compared to passive interventions, as measured by various assessment tools.

The active intervention led to better outcomes in caregiver competence and distress levels after just three months, highlighting the effectiveness of engaging methods like role-play and problem-solving in caregiver training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver active participation in psychoeducational intervention improved caregiving skills and competency. Tang, SH., Chio, OI., Chang, LH., et al.[2019]

The MOST program, an online social therapy designed for families of young people with mental health issues, has been shown to be safe and feasible, significantly reducing caregiver stress in a preliminary study.

The program integrates various therapeutic components, including online therapy and peer support, and is based on evidence from a previous face-to-face intervention, indicating its potential to improve access to specialized support for families dealing with serious mental health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderated Online Social Therapy: A Model for Reducing Stress in Carers of Young People Diagnosed with Mental Health Disorders. Gleeson, J., Lederman, R., Koval, P., et al.[2022]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12446824/

Altitudes adaptation and development: Content analysis of ... Family interventions in psychosis (FIPs) are associated with lower rates of relapse, shorter inpatient hospitalizations, reduced psychotic ...

2. researchgate.net researchgate.net/publication/395638915_Altitudes_adaptation_and_development_Content_analysis_of_experiences_and_preferences_for_a_digital_intervention_to_support_early_psychosis_caregivers_in_the_United_States

Altitudes adaptation and development: Content analysis ... The purpose of the current study was to better understand the experiences and challenges faced by caregivers who support a young person with FEP ...

3. mental.jmir.org mental.jmir.org/2024/1/e63743/

Digital Health Interventions for Informal Family Caregivers of ... The study aimed to investigate informal family first-episode psychosis (FEP) caregivers' user experience with digital health interventions, and ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/20552076251378608

Altitudes adaptation and development: Content analysis ... Effectiveness of family intervention for preventing relapse in first-episode psychosis until 24 months of follow-up: a systematic review with meta-analysis ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39607998/

Digital Health Interventions for Informal Family Caregivers ... Digital health interventions offer the possibility to access help quicker, use less resources, and improve informal family caregiver outcomes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06509100

Altitudes: A Digital Intervention to Support Caregivers The Altitudes platform passively collects engagement data, including the number of therapeutic pathways started and completed, as well as any posts or comments ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40979696/

Altitudes adaptation and development: Content analysis of ... The purpose of the current study was to better understand the experiences and challenges faced by caregivers who support a young person with FEP ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06094647/altitudes-for-caregivers?state=NC&city=Chapel%20hill

Altitudes for Caregivers | Clinical Research Trial Listing The objective of this study is to assess the acceptability and feasibility of Altitudes, a novel digital behavioral health and ...