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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

* Aim 1: To determine the preliminary effect sizes of al ActiveHeal EST (Engage-Sustain-Triumph) Program on occupational resilience. * Aim 2: To determine the preliminary effect sizes of ActiveHeal EST (Engage-Sustain-Triumph) on health status \[quality of life (QoL) and Psychological wellbeing (PWB)\]. * Aim 3: To determine the extent to which ActiveHeal EST (Engage-Sustain-Triumph) Program is an acceptable and feasible Intervention for breast and prostate 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 data supports the effectiveness of the treatment ActiveHeal for stress management?

Research shows that stress management programs, including mindfulness and meditative techniques, can help reduce stress. For example, a study found that a meditative stress coping program improved emotional well-being in 55% of participants. Another study showed that a one-time stress management intervention, which included relaxation techniques, was helpful for 93% of young participants. ^{1 2 3 4 5}

How does the treatment ActiveHeal differ from other stress management treatments?

ActiveHeal is unique because it combines psychological methods with personal health technologies to support daily stress and recovery management, emphasizing self-management and empowerment, which is different from traditional treatments that may not integrate technology or focus on self-management. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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 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]

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]

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]

References

1. Italy 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. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

[Meditative stress coping program with psychosomatic patients]. [2008]

3. Sweden pubmed.ncbi.nlm.nih.gov

Evaluation of cognitive behavioural training and physical activity for patients with stress-related illnesses: a randomized controlled study. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Multidisciplinary program for stress-related disease in primary health care. [2021]

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

Stress Management Intervention: A Pilot Evaluation in an Urban Adolescent Medicine Clinic. [2019]

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

A concept to empower self-management of psychophysiological wellbeing: preliminary user study experiences. [2020]

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

Does a meditation protocol supported by a mobile application help people reduce stress? Suggestions from a controlled pragmatic trial. [2022]

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

MyStudentBody-Stress: an online stress management intervention for college students. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Positive technology: a free mobile platform for the self-management of psychological stress. [2018]

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

Mechanical massage and mental training programmes affect employees' anxiety, stress susceptibility and detachment-a randomised explorative pilot study. [2022]