Telehealth Interventions for Caregiver Well-being

(WellCAST Trial)

Overseen By Bridgette L Kelleher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Purdue University

Disqualifiers: Serious mental illness, Active addiction, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

800 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are actively in treatment that overlaps with the trial's offerings, you may not be eligible to participate.

What data supports the effectiveness of the treatment Telehealth Interventions for Caregiver Well-being?

Research shows that culturally adapted cognitive behavioral therapy (CBT) can be effective for Chinese clients by aligning with their cultural values, suggesting that similar adaptations in telehealth interventions could enhance caregiver well-being. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for caregivers?

Research on Acceptance and Commitment Therapy (ACT) for caregivers, including those caring for people with dementia, suggests it is generally safe. Studies have shown that both face-to-face and online versions of ACT are effective and do not report any significant safety concerns. ^{6 7 8 9 10}

How is the Telehealth Interventions for Caregiver Well-being treatment different from other treatments for caregiver support?

This treatment is unique because it uses telehealth to deliver various evidence-based therapies like ACT, CICBT, and DBT remotely, making it more accessible and convenient for caregivers who may face geographical or logistical barriers to in-person therapy. The use of telehealth allows for flexible, culturally informed, and self-guided interventions that have been shown to improve caregiver well-being and reduce problem behaviors in care recipients. ^{10 11 12 13 14}

What is the purpose of this trial?

The goal of this clinical trial is to learn which types of telehealth-based treatments best fit the needs of caregivers of people with rare neurogenetic conditions. The main questions it plans to answer are: * Which telehealth support programs best meet the needs of rare disorder caregivers? * How can individuals be matched to support programs that are right for them? What aspects of an individual (e.g., demographics, mental health symptoms, family characteristics, lifestyle) predict whether treatment will be a good fit? * Does peer-to-peer coaching help improve patients' experiences during telehealth treatment? Participants will be asked to complete a 12-week treatment program, which may include self-guided resources, individual therapies, group therapies, and/or peer-to-peer coaching. Before, during, and after treatment, participants will complete questionnaires to help researchers understand their experiences, symptoms, and impressions of their support program. Questionnaires will include both standard forms (administered up to 5 times throughout the study) and brief "snapshot surveys" that participants complete on their smartphones up to 3 times per day. Some participants will be assigned to a waitlist control, which means that they will provide data while they are not yet completing a support program. These participants will be assigned to a support program in the next treatment phase.

Research Team

Bridgette Kelleher, PhD

Principal Investigator

Purdue University

Eligibility Criteria

This trial is for caregivers and legal guardians of children aged 2-35 with neurogenetic conditions that cause moderate to severe intellectual disability. Participants must live in the US, be fluent in English, and seek support for their mental health or caregiving needs.

Inclusion Criteria

Reside in US

Fluent in English (spoken and written)

I am looking for mental health or caregiving support.

Exclusion Criteria

Serious mental illness or active addiction that would be inadequately addressed through dosage of treatments

Actively in treatment that would be redundant with those offered in the protocol

Child's syndrome is not commonly associated with life expectancy less than 35 years or deterioration of previously gained skills

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (virtual)

Baseline

Caregivers complete initial study forms and 'snapshot surveys' sent three times per day via smartphones

2 weeks

Daily virtual surveys

Treatment

Participants complete a 12-week telehealth support program, which may include self-guided resources, individual therapies, group therapies, and/or peer-to-peer coaching

12 weeks

3 daily virtual surveys, periodic study forms

Follow-up

Participants complete follow-up forms and a 2-week period of 'snapshot surveys' to assess changes post-treatment

2 weeks

Daily virtual surveys

Treatment Details

Interventions

• Acceptance and Commitment Therapy (ACT)
• Culturally Informed Cognitive Behavioral Therapy (CICBT)
• Dialectical Behavioral Therapy (DBT)
• Durand Sleep Intervention
• Naturalistic Communication Intervention (NCI)
• Participation Enhancement Intervention (PEI)
• RUBI Intervention
• Self-Guided Resources

Trial Overview The study tests various telehealth-based treatments like individual/group therapies and peer coaching to see which best supports caregivers of people with rare disorders. It involves a 12-week program with questionnaires before, during, after treatment, plus daily surveys on smartphones.

Participant Groups

Group I: No Algorithm + Participation Enhancement Intervention Experimental Treatment 9 Interventions

Participants are randomly assigned to support program without use of a personalized health algorithm AND receive the participation enhancement intervention.

Group II: No Algorithm + No Participation Enhancement Intervention Experimental Treatment 8 Interventions

Participants are randomly assigned to support program without use of a personalized health algorithm AND do not receive the participation enhancement intervention.

Group III: Algorithm 3 + Participation Enhancement Intervention Experimental Treatment 9 Interventions

Participants are assigned to support programs using Algorithm 3 AND receive the participation enhancement intervention.

Group IV: Algorithm 3 + No Participation Enhancement Intervention Experimental Treatment 8 Interventions

Participants are assigned to support programs using Algorithm 3 AND do not receive the participation enhancement intervention.

Group V: Algorithm 2 + Participation Enhancement Intervention Experimental Treatment 9 Interventions

Participants are assigned to support programs using Algorithm 2 AND receive the participation enhancement intervention.

Group VI: Algorithm 2 + No Participation Enhancement Intervention Experimental Treatment 8 Interventions

Participants are assigned to support programs using Algorithm 2 AND do not receive the participation enhancement intervention.

Group VII: Algorithm 1 + Participation Enhancement Intervention Experimental Treatment 9 Interventions

Participants are assigned to support programs using Algorithm 1 AND receive the participation enhancement intervention.

Group VIII: Algorithm 1 + No Participation Enhancement Intervention Experimental Treatment 8 Interventions

Participants are assigned to support programs using Algorithm 1 AND do not receive the participation enhancement intervention.

Group IX: Waitlist Control Active Control 1 Intervention

Participants are enrolled in the waitlist control condition, which includes identical data collection procedures to participants enrolled in support programs. Waitlist controls are offered the opportunity to enroll in future cycles.

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

University of Canterbury

Collaborator

Trials

4

Recruited

840+

University of Oregon

Collaborator

Trials

91

Recruited

46,700+

Georgia State University

Collaborator

Trials

71

Recruited

33,600+

University of Missouri-Columbia

Collaborator

Trials

387

Recruited

629,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Findings from Research

The study involved 15 mental health professionals who provided feedback on the cultural and linguistic adaptation of Meaning-Centered Psychotherapy for Chinese patients with advanced cancer, indicating high acceptability and relevance across various domains.

Recommendations for improving the intervention include enhancing flexibility for tailoring content to individual patient needs, simplifying the material for better comprehension, and providing additional training for providers to ensure effective implementation in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refinement of a Meaning-Centered Counseling Program for Chinese Patients with Advanced Cancer: Integrating Cultural Adaptation and Implementation Science Approaches. Lui, F., Zhang, Q., Bao, G., et al.[2023]

Cognitive Behaviour Therapy (CBT) shows a strong compatibility with core values of Chinese culture, suggesting it can be effectively used without needing to create entirely new therapies.

Chinese clients may particularly benefit from CBT by challenging irrational beliefs tied to social norms, indicating that minor adjustments to CBT could enhance its effectiveness in this cultural context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Would Confucius benefit from psychotherapy? The compatibility of cognitive behaviour therapy and Chinese values. Hodges, J., Oei, TP.[2022]

A study involving 70 mental health professionals and 54 Latino patients with advanced cancer showed that culturally and linguistically adapted meaning-centered psychotherapy is highly acceptable and relevant for this population.

Qualitative interviews with 24 Latino patients highlighted the importance of simplifying language, using culturally relevant metaphors, and ensuring that the intervention aligns with Latino cultural values to improve psychological adjustment and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meaning-Centered Psychotherapy for Latino Patients with Advanced Cancer: Cultural Adaptation Process. Costas-Muñiz, R., Torres-Blasco, N., Castro-Figueroa, EM., et al.[2021]

A multicultural paradigm shift in the USA is leading to a demand for prevention programs that are culturally responsive, as traditional interventions often fail to resonate with diverse ethnic minority populations.

The adaptation of a national model prevention curriculum for American Indian youth involved a community-based participatory research (CBPR) approach, ensuring that cultural elements were integrated while maintaining the core principles of the original program, enhancing its relevance and effectiveness for urban native youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Indian cultures: how CBPR illuminated intertribal cultural elements fundamental to an adaptation effort. Jumper-Reeves, L., Dustman, PA., Harthun, ML., et al.[2022]

A culture-tailored, web-based intervention for Turkish immigrant inpatients in Germany was found to be more effective than a control condition, with participants feeling better prepared for therapy after using it.

The intervention led to increased self-efficacy and reduced external-fatalistic control beliefs among participants, indicating its potential to enhance engagement in psychotherapy, although some users required assistance with the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Turkish Immigrants in Psychotherapy: Development and Proof-of-Concept Study of a Culture-Tailored, Web-Based Intervention. Reich, H., Zürn, D., Mewes, R.[2023]

The study successfully recruited 33 family carers of people with dementia, exceeding the target of 30 participants, and 91% completed at least two online sessions of the guided self-help Acceptance and Commitment Therapy (ACT).

The high completion rate of 70% for seven or more sessions indicates that the internet-delivered ACT is feasible and well-accepted among family carers, suggesting potential for further research into its clinical and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered guided self-help acceptance and commitment therapy for family carers of people with dementia (iACT4CARERS): a feasibility study. Kishita, N., Gould, RL., Farquhar, M., et al.[2023]

Breast cancer survivors (BCSs) and healthcare providers (HCPs) showed high acceptability for a co-developed Acceptance and Commitment Therapy (ACT) intervention aimed at improving medication adherence and quality of life, based on focus groups and interviews with 34 participants.

The preferred format for the ACT intervention included face-to-face sessions led by a clinical psychologist, combining individual and group formats, with a focus on values and self-compassion, indicating a tailored approach to meet the needs of BCSs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and health care professional co-development of an Acceptance and Commitment Therapy intervention to support hormone therapy decision-making and well-being in women with breast cancer. Hall, LH., Clark, J., Smith, SG., et al.[2022]

Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT) have distinct philosophical foundations, with MI focusing on the content of language and ACT emphasizing the process of language.

Clinically, ACT uniquely encourages clients to accept their thoughts and feelings, while MI emphasizes the therapeutic relationship and client language, suggesting that both therapies can complement each other in promoting behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of motivational interviewing with acceptance and commitment therapy: a conceptual and clinical review. Bricker, J., Tollison, S.[2021]

Both Acceptance and Commitment Therapy (ACT) and Cognitive-Behavioral Therapy (CBT) significantly reduced depressive symptoms in dementia caregivers compared to a control group, with effect sizes indicating strong efficacy (ACT: d = 1.17, CBT: d = 0.98).

ACT was more effective than CBT in reducing anxiety at postintervention, with 36.36% of ACT participants showing clinically significant improvement, compared to 23.33% in CBT, highlighting ACT's potential as a beneficial treatment for caregivers dealing with anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy (CBT) versus acceptance and commitment therapy (ACT) for dementia family caregivers with significant depressive symptoms: Results of a randomized clinical trial. Losada, A., Márquez-González, M., Romero-Moreno, R., et al.[2018]

The pilot online Acceptance and Commitment Therapy (ACT) program for dementia caregivers, involving 51 participants, significantly reduced depressive symptoms, caregiver burden, and stress reactions, while enhancing quality of life and positive aspects of caregiving, with effects sustained over a 4-week follow-up.

Despite low usage of additional educational materials, the improvements in caregiver well-being were primarily attributed to the ACT sessions, demonstrating that this self-guided, community-based approach is an effective and accessible alternative to traditional therapist-led interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes from a pilot online Acceptance and Commitment Therapy program for dementia family caregivers. Fauth, EB., Novak, JR., Levin, ME.[2022]

Telehealth coaching effectively trained nine caregivers of children with disabilities across three Asian countries, leading to a significant reduction in problem behaviors to near-zero levels for most participants.

Caregivers implemented the training procedures with high integrity and found the assessment and treatment highly acceptable, indicating that telehealth is a feasible and culturally adaptable method for delivering interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and Acceptability of Telehealth-Based Coaching for Caregivers in Asian Countries. Tsami, L., Nguyen, JT., Alphonso, N., et al.[2023]

A systematic review of 65 studies on telehealth interventions for family caregivers found that over 95% reported significant improvements in caregiver outcomes, indicating high efficacy of these interventions.

Caregivers expressed satisfaction and comfort with telehealth technologies, which included various methods like video and telephone, suggesting that telehealth can effectively support chronic disease management and home care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of telehealth tools and interventions to support family caregivers. Chi, NC., Demiris, G.[2018]

Psychoeducational videoconferencing interventions are effective in enhancing caregiving skills and wellness among informal caregivers, as shown in a systematic review of 14 randomized controlled trials published between 2012 and 2022.

Caregivers reported high satisfaction with these interventions, appreciating their usability and structure, although some faced technical issues; improving connectivity and incorporating respite care could further enhance the feasibility and effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, usability, and acceptability of psychoeducational videoconferencing interventions for informal caregivers: A systematic review of randomized controlled trials. Sang, E., Hirschman, KB., Bowles, KH.[2023]

A virtual adaptation of the WHO Caregiver Skills Training (CST) was delivered effectively, showing significant improvements in caregiver competence compared to treatment as usual, although it received lower acceptability ratings from caregivers and facilitators.

Qualitative feedback highlighted the benefits of virtual CST, such as flexibility and convenience, but also noted challenges like technological issues and emotional distance, suggesting that while it is a viable alternative, improvements are needed for better engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting Caregivers Remotely During a Pandemic: Comparison of WHO Caregiver Skills Training Delivered Online Versus in Person in Public Health Settings in Italy. Ferrante, C., Sorgato, P., Fioravanti, M., et al.[2023]

References

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

Refinement of a Meaning-Centered Counseling Program for Chinese Patients with Advanced Cancer: Integrating Cultural Adaptation and Implementation Science Approaches. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Would Confucius benefit from psychotherapy? The compatibility of cognitive behaviour therapy and Chinese values. [2022]

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

Meaning-Centered Psychotherapy for Latino Patients with Advanced Cancer: Cultural Adaptation Process. [2021]

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

American Indian cultures: how CBPR illuminated intertribal cultural elements fundamental to an adaptation effort. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Engaging Turkish Immigrants in Psychotherapy: Development and Proof-of-Concept Study of a Culture-Tailored, Web-Based Intervention. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Internet-delivered guided self-help acceptance and commitment therapy for family carers of people with dementia (iACT4CARERS): a feasibility study. [2023]

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

Patient and health care professional co-development of an Acceptance and Commitment Therapy intervention to support hormone therapy decision-making and well-being in women with breast cancer. [2022]

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

Comparison of motivational interviewing with acceptance and commitment therapy: a conceptual and clinical review. [2021]

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

Cognitive-behavioral therapy (CBT) versus acceptance and commitment therapy (ACT) for dementia family caregivers with significant depressive symptoms: Results of a randomized clinical trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Outcomes from a pilot online Acceptance and Commitment Therapy program for dementia family caregivers. [2022]

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

Outcomes and Acceptability of Telehealth-Based Coaching for Caregivers in Asian Countries. [2023]

12. England pubmed.ncbi.nlm.nih.gov

A systematic review of telehealth tools and interventions to support family caregivers. [2018]

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

Feasibility, usability, and acceptability of psychoeducational videoconferencing interventions for informal caregivers: A systematic review of randomized controlled trials. [2023]

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

Supporting Caregivers Remotely During a Pandemic: Comparison of WHO Caregiver Skills Training Delivered Online Versus in Person in Public Health Settings in Italy. [2023]