ActiveHeal for Stress Management

Overseen By Bernard AK Muriithi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: No internet, Unwilling to participate

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called ActiveHeal to determine if it helps breast or prostate cancer survivors feel better and manage work stress more effectively. Researchers aim to assess whether the program can improve quality of life and mental well-being. Participants will either receive telehealth therapy or meet online without therapy. This trial may suit someone recently treated for breast or prostate cancer who is open to participating in online activities. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on stress management and does not mention medication changes.

What prior data suggests that the ActiveHeal EST Program is safe for breast and prostate cancer survivors?

Research shows that ActiveHeal, particularly in telehealth occupational therapy, is generally well-received by patients. Telehealth therapy has proven effective and safe for teaching home safety to older adults. This suggests that using ActiveHeal similarly for stress management could be safe for most people. Although specific information on side effects of ActiveHeal for stress management is unavailable, its use in other areas hasn't raised major safety concerns. The study might be in the early stages, as it doesn't mention a trial phase, so detailed safety information might not yet be available. However, the safe use of telehealth therapy in other contexts is reassuring regarding its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ActiveHeal for stress management because it offers a novel approach by delivering occupational therapy via telehealth. Unlike traditional stress management therapies that often require in-person sessions, ActiveHeal provides convenient access to therapy from home, making it more accessible and flexible for participants. This method could potentially expand the reach of effective stress management interventions, allowing more people to benefit from professional guidance without the need for travel or rigid scheduling.

What evidence suggests that the ActiveHeal program is effective for stress management?

Research has shown that telehealth occupational therapy, such as the ActiveHeal program, can effectively manage stress. In this trial, Group A will receive telehealth occupational therapy services through ActiveHeal for 12 weeks. One study found that online stress management programs significantly reduced stress and boosted confidence in work-related tasks for employees. Another study demonstrated that online occupational therapy successfully managed ADHD, receiving positive feedback from parents. Telehealth has proven to be as effective as in-person therapy without requiring more time. These findings suggest that ActiveHeal, as a telehealth program, may enhance resilience and quality of life for cancer survivors. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Adults aged 18-75 diagnosed with prostate or breast cancer within the last 6 months and scoring 80-90 on the KPSS, which measures their ability to carry out daily activities. They must be able to attend sessions at the University of Arkansas for Medical Sciences in Fayetteville.

Inclusion Criteria

I was diagnosed with prostate or breast cancer less than 6 months ago.

I am mostly independent but may need help with some activities.

Exclusion Criteria

I cannot go to the University of Arkansas for sessions.

I am unable or unwilling to participate in activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Recruitment and informed consent process

Pretests

Administer Occupational Resilience Measure, WHO Quality of Life Scale, and Psychological Wellbeing Scale

2 weeks

Completed via Zoom

Treatment

ActiveHeal EST Program with group and individualized sessions focusing on occupational therapy

12 weeks

Weekly Teams or phone visits

Control Group Meetings

Control group meetings via Zoom to check in with participants

Throughout the study

3 meetings via Zoom

Posttests

Re-administer Occupational Resilience Measure, WHO Quality of Life Scale, and Psychological Wellbeing Scale

2 weeks

Completed via Zoom

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ActiveHeal

Trial Overview

The trial is testing ActiveHeal EST Program's impact on occupational resilience, quality of life, and psychological wellbeing among breast and prostate cancer survivors. It also assesses if this program is a practical option for these individuals.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Group A will receive telehealth occupational therapy services for 12 weeks

Group II: Control Active Control 1 Intervention

Group B will meet three times via zoom but not receive an intervention

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

U of A

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

The study evaluated the effects of a mechanical massage armchair and mental training on employee anxiety and stress levels, involving 97 participants across five groups over eight weeks.

While no significant differences were found between groups overall, the massage group showed a notable decrease in 'Somatic Trait Anxiety', and the massage plus mental training group experienced reduced 'Stress Susceptibility', suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical massage and mental training programmes affect employees' anxiety, stress susceptibility and detachment-a randomised explorative pilot study. Muller, J., Handlin, L., Harlén, M., et al.[2022]

A mindfulness-based training program called Focusing significantly reduced perceived stress among 20 healthcare workers, with stress levels decreasing from an average of 21.4 to 17.5 after the intervention (P=0.0195).

Participants reported qualitative improvements such as increased calmness, better emotional self-regulation, and enhanced coping skills, indicating that the training effectively helped them manage work-related stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The educational intervention "Focusing" as a strategy to stress reduction among health care workers: a pilot study in an Italian teaching hospital. Rinaldi, A., Tecchio, R., Perugino, S., et al.[2020]

In a study of 75 patients with stress-related illnesses, both cognitive behavioral training and physical activity programs showed minimal differences in improving autonomic activity and pain thresholds immediately after a 10-week intervention, with no significant differences at 6 and 12 months follow-up.

However, patients who underwent cognitive behavioral training reported better general health ratings compared to those in the physical activity group throughout the study, suggesting a potential advantage of cognitive approaches for long-term health perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of cognitive behavioural training and physical activity for patients with stress-related illnesses: a randomized controlled study. Heiden, M., Lyskov, E., Nakata, M., et al.[2019]

The P4Well concept, designed for working-age individuals, emphasizes the importance of self-management in mental health and chronic disease prevention, integrating psychological methods with personal health technologies.

Preliminary user studies involving middle-aged men managing mild depression and entrepreneurs coping with stress highlight the critical roles of expert guidance, technology, and peer support in enhancing mental wellbeing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A concept to empower self-management of psychophysiological wellbeing: preliminary user study experiences. Happonen, AP., Kaipainen, K., Väätänen, A., et al.[2020]

A stress management training program for psychosomatic patients, which included meditative body relaxation and cognitive restructuring, showed that 55% of participants improved compared to only 14% in the control group, indicating its potential efficacy.

However, the overall results were considered clinically unsatisfactory, and the study noted a possible contraindication for patients with abdominal complaints, suggesting that further refinements to the intervention are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Meditative stress coping program with psychosomatic patients]. Störmer-Labonté, M., Machemer, P., Hardinghaus, W.[2008]

A one-time stress management intervention for 30 adolescents led to a clinically significant decrease in subjective distress, indicating its effectiveness in reducing stress-related symptoms.

Ninety-three percent of participants found the intervention helpful and felt equipped to use stress management techniques independently, suggesting it can be easily integrated into primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management Intervention: A Pilot Evaluation in an Urban Adolescent Medicine Clinic. Burkhart, K., Mason, E., Lazebnik, R.[2019]

The MyStudentBody-Stress online intervention did not show significant differences in primary stress control outcomes compared to control groups, but it did lead to increased physical activity and improved stress management techniques among participants.

Participants in the MyStudentBody-Stress group reported decreased anxiety and family problems, suggesting that the program may have beneficial effects on overall well-being for college students under stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MyStudentBody-Stress: an online stress management intervention for college students. Chiauzzi, E., Brevard, J., Thum, C., et al.[2022]

A 3-week mindfulness protocol delivered via a smartphone app did not show significant differences in stress reduction compared to a control group listening to relaxing music, but both groups reported improvements in coping with stress.

Participants in both the meditation and music groups experienced a significant decrease in heart rate after each session, indicating a physiological response to the interventions that may contribute to stress reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a meditation protocol supported by a mobile application help people reduce stress? Suggestions from a controlled pragmatic trial. Carissoli, C., Villani, D., Riva, G.[2022]

The Positive Technology app, designed for self-management of psychological stress, includes guided relaxation, 3D biofeedback, and stress tracking, showing promise in reducing perceived stress levels based on user feedback from a trial with 32 participants.

Participants reported satisfactory experiences with the app, and those using it with a wrist sensor demonstrated enhanced capabilities for monitoring and managing stress, indicating potential for further development in usability and advanced features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive technology: a free mobile platform for the self-management of psychological stress. Gaggioli, A., Cipresso, P., Serino, S., et al.[2018]

A multidisciplinary stress-management program involving an occupational therapist and a physiotherapist significantly improved self-perceived health and reduced burnout in 13 patients over a 3-month period, as indicated by statistical measures (p = 0.000 for health and p = 0.001 for burnout).

Patients reported high satisfaction with the program (median score of 3.7), and while improvements in health and burnout were maintained after six months, physical activity levels did not show the same sustained improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary program for stress-related disease in primary health care. Ekvall Hansson, E., Håkansson, E., Raushed, A., et al.[2021]

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The SMI was effective in reducing stress and improving occupational self-efficacy in employees despite them experiencing an effort-reward imbalance at work.

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This study shows that tele-OT interventions can be an effective approach as part of the management of ADHD in children and that parents overall were satisfied ...

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In a pilot study by Dreyer et al, (2001) IP and remote site therapist were reported to have reached 94.12% agreement of the Kohlman Evaluation ...

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Clinical Resources

A series of evaluations assessing the efficacy of Activheal Aquafiber® for use on chronic and surgical wounds in the primary care setting.

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ActivHeal-Catalogue.pdf

The alginate dressings are proven to be safe and effective, are indicated for moderately to highly exuding wounds. Alginate dressings are known to donate ...

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After taking photographs of past home safety challenges, six participants experienced three web-based occupational therapy sessions each.