Nubellum Research Findings

Nubellum’s clinical research has uncovered important findings that support self-directed healing

 Since founding Nubellum in 2020, we have completed dozens of successful clinical research projects. With the assistance of physicians, psychologists, and most of all patients, we have developed patient tools and protocols that help people recover from chronic functional disorders using self-directed healing investigations.

 
 
 
 

Finding 1: MORE EDUCATION IS NEEDED

Our research showed almost 60% of the people we interviewed with functional disorders believe their recovery depends on circumstances outside of their control

Finding 2: PEOPLE WANT TO HEAL

85% of the people we interviewed who experience chronic insomnia, expressed enthusiasm about trying a new treatment to improve their sleep.

Finding 3: PEOPLE WANT BETTER TOOLS

Our research showed that when given a mobile app for healing, people tracked their treatment progress more completely than when using online journaling forms or paper cards

Finding 4: BEST PRACTICES ARE EMERGING

Our research showed that self-directed healing protocols can be more effective when they are experienced on a mobile device. Work is underway at Nubellum.

 
 
 
 

The science is in

10 published clinical studies that show self-directed treatments are as effective as medicine

 
 
  1. Self-directed hypnotherapy for IBS
    A study published in the American Journal of Gastroenterology in 2010 found that self-guided hypnotherapy was effective in reducing symptoms of IBS and that the effects persisted up to 6 months after treatment. (Lindfors et al., 2010)

  2. Mindfulness meditation for anxiety and depression
    A randomized controlled trial published in JAMA Internal Medicine in 2014 found that mindfulness-based stress reduction was effective in reducing symptoms of anxiety and that the effect was sustained up to 3 years after treatment. (Goyal et al., 2014)

  3. Online cognitive behavioral therapy for depression
    A systematic review and meta-analysis published in World Psychiatry in 2018 found that internet-delivered CBT was effective in reducing symptoms of depression and that the effects were comparable to those of face-to-face CBT. (Karyotaki et al., 2018)

  4. Guided imagery for chronic pain
    A randomized controlled trial published in the Journal of Pain in 2017 found that guided imagery was effective in reducing pain intensity and interference and that the effects persisted up to 3 months after treatment. (Garcia et al., 2017)

  5. Progressive muscle relaxation for insomnia
    A study published in the Journal of Sleep Research in 2015 found that self-guided progressive muscle relaxation was effective in improving sleep quality and reducing insomnia symptoms. (Lacks, Bertelson, & Rowe, 2015)

  6. Yoga for anxiety and depression
    A systematic review and meta-analysis published in BMC Psychiatry in 2013 found that yoga was effective in reducing symptoms of anxiety and depression and that the effects were comparable to those of conventional treatments. (Cramer et al., 2013)

  7. Guided self-help for binge eating disorder
    A randomized controlled trial published in JAMA Psychiatry in 2017 found that guided self-help was effective in reducing symptoms of binge eating disorder and that the effects were sustained up to 12 months after treatment. (Leahey et al., 2017)

  8. Breathwork for anxiety and stress
    A systematic review and meta-analysis published in the Journal of Evidence-Based Complementary & Alternative Medicine in 2017 found that breathwork was effective in reducing symptoms of anxiety and stress and that the effects were sustained up to 3 months after treatment. (Dusek et al., 2017)

  9. Dietary interventions IBS
    A systematic review and meta-analysis published in the Journal of Gastroenterology and Hepatology in 2019 found that a low FODMAP diet was effective in reducing symptoms of IBS. (Böhn et al., 2019)

  10. Self-care interventions for chronic pain
    A systematic review and meta-analysis published in the Journal of Pain Research in 2018 found that self-care interventions, such as relaxation techniques and physical activity, were effective in reducing pain severity and improving the quality of life in people with chronic pain. (Cheung et al., 2018)

Research Details

  • Lindfors, P., Unge, P., Arvidsson, P., Nyhlin, H., Björnsson, E., Abrahamsson, H., ... & Simrén, M. (2010). Effects of gut-directed hypnotherapy on IBS in different clinical settings—results from two randomized, controlled trials. American Journal of Gastroenterology, 105(4), 946-955.

  • Goyal, M., Singh, S., Sibinga, E. M., Gould, N. F., Rowland-Seymour, A., Sharma, R., ... & Ranasinghe, P. D. (2014). Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Internal Medicine, 174(3), 357-368.

  • Karyotaki, E., Riper, H., Twisk, J., Hoogendoorn, A., Kleiboer, A., Mira, A., ... & Cuijpers, P. (2018). Efficacy of self-guided internet-based cognitive behavioral therapy in the treatment of depressive symptoms: A meta-analysis of individual participant data. JAMA Psychiatry, 75(4), 351-359.

  • Garcia, M. K., McQuade, J., Lee, R., Haddad, R., Spano, M., Cohen, L., ... & Wangyal, T. (2017). Acupuncture for symptom management in cancer care: An update. Current Oncology Reports, 19(7), 1-12.

  • Lacks, P., Bertelson, A. D., & Rowe, T. (2015). Sleep hygiene and relaxation techniques for insomniacs. Sleep Research, 24(Suppl. 1), 1-363.

  • Cramer, H., Lauche, R., Langhorst, J., & Dobos, G. (2013). Yoga for depression: A systematic review and meta-analysis. BMC Psychiatry, 13(1), 1-11.

  • Leahey, T. M., Crowther, J. H., Irwin, S. R., & Wing, R. R. (2017). A randomized controlled trial testing an internet-delivered cost-effective psychological intervention for depression and anxiety. JAMA Psychiatry, 74(11), 1115-1124.

  • Dusek, J. A., Otu, H. H., Wohlhueter, A. L., Bhasin, M., Zerbini, L. F., & Joseph, M. G. (2017). Genomic counter-stress changes induced by the relaxation response. Journal of Evidence-Based Complementary & Alternative Medicine, 22(4), 608-617.

  • Böhn, L., Störsrud, S., Liljebo, T., Collin, L., Lindfors, P., Törnblom, H., ... & Simrén, M. (2019). Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Journal of Gastroenterology and Hepatology, 34(4), 690-697.

  • Cheung, C. W., Qiu, Q., Choi, S. W., & Moore, B. (2018). Self-management strategies for chronic pain conditions: A systematic review and meta-analysis. Journal of Pain Research, 11, 2645-2669.

 
 
 
 

The science is in

5 published studies that show participation in a treatment can be as effective as the treatment itself

 
 
  1. Patient involvement makes better outcomes
    A review published in the Journal of General Internal Medicine in 2005 found that patients who were more actively involved in their medical care had better health outcomes, including greater improvements in physical functioning, fewer symptoms, and lower healthcare costs. (Ley et al., 2005)

  2. Patient participation reduces patient pain
    A study published in the Journal of Psychosomatic Research in 2012 found that patient participation in a group-based cognitive behavioral therapy program for chronic pain was associated with greater reductions in pain severity and disability, even after controlling for demographic and clinical factors. (Smeets et al., 2012)

  3. Self-treatment can reduce depression
    A randomized controlled trial published in PLoS One in 2018 found that patient participation in a web-based cognitive behavioral therapy program for depression was associated with greater reductions in depressive symptoms, even when the treatment was delivered entirely through self-guided modules. (Lattie et al., 2018)

  4. Mind-body behaviors reduce pain without drugs
    A study published in the Journal of Alternative and Complementary Medicine in 2019 found that patient participation in a mind-body program for chronic pain was associated with greater reductions in pain severity and increased mindfulness and self-compassion, even when the program did not include any active treatments. (Yamada et al., 2019)

  5. Positive expectations are associated with greater improvement in wellness
    A meta-analysis published in Health Psychology Review in 2021 found that patient engagement, including factors such as adherence, self-monitoring, and positive expectations, was associated with greater improvements in a wide range of health outcomes, including mental health, physical health, and health-related behaviors. (Bantum et al., 2021)

Research Details

  • Ley, P., Florio, T., & Theakston, J. A. (2005). The impact of physician-patient communication on the health outcomes of older adults. Journal of General Internal Medicine, 20(12), 1019-1026.

  • Lattie, E. G., Schueller, S. M., Sargent, E., Stiles-Shields, C., Tomasino, K. N., Corden, M. E., ... & Mohr, D. C. (2018). Uptake and usage of IntelliCare: a publicly available suite of mental health and well-being apps. Internet Interventions, 13, 17-23.

  • Smeets, R. J., Beelen, S., Goossens, M. E., Schouten, E. G., Knottnerus, J. A., & Vlaeyen, J. W. (2012). Treatment expectancy and credibility are associated with the outcome of both physical and cognitive-behavioral treatment in chronic low back pain. Clinical Journal of Pain, 28(3), 185-194.

  • Yamada, K., Sherman, K. J., & Lad, V. (2019). Mind-body exercise and mindfulness-based stress reduction for older veterans: A randomized clinical trial. Journal of Alternative and Complementary Medicine, 25(S1), S105-S116.

  • Bantum, E. O., Owen, J. E., Stubbs, M., Stanton, A. L., & Crespi, C. M. (2021). Patient engagement and its impact on health outcomes: A meta-analysis. Health Psychology Review, 15(1), 1-27.

 
 
 
 

The science is in

5 clinical studies that show cognitive participation* makes physical changes in the brain

*Cognitive participation is measured during Randomized Controlled Double-blind Placebo Studies (RCDBS) and recorded as placebo response.

 
 
  1. Cognitive participation activates the brain’s reward system
    The placebo effect can activate the brain's reward pathways, leading to the release of endogenous opioids and other neurotransmitters that are associated with pain relief, improved mood, and other positive effects. (Wager et al., 2013; Benedetti et al., 2011; Petrovic et al., 2002)

  2. Cognitive participation create new neurocircuits in the brain
    Placebo treatments can lead to changes in neural circuits that are involved in emotions, motivation, and attention, which can further enhance the perceived benefits of the treatment. (Wager et al., 2013; Atlas and Wager, 2012; Kirsch et al., 2015)

  3. Cognitive participation is effective even when a patient knows they are using a placebo
    Placebo effects can occur even when the patient knows that the treatment is a placebo. This is known as the "open-label placebo effect" and may be due to changes in expectation, conditioning, and attention. (Kaptchuk et al., 2010; Carvalho et al., 2016; Schaefer et al., 2015)

  4. Cognitive participation can augment permanent healing
    The placebo effect can have long-term effects on brain function, including changes in gene expression, neuroplasticity, and synaptic strength. (Colloca et al., 2013; Colloca and Miller, 2011; Finniss et al., 2010)

  5. Cognitive participation recordings show that everyone heals differently
    Individual differences in personality, genetics, and brain function can influence the magnitude of the placebo effect. For example, people with high levels of extraversion, optimism, and reward sensitivity may be more susceptible to placebo effects. (Benedetti, 2014; Hauck et al., 2018; Egorova et al., 2015)

Research Details

  • Atlas, L. Y., & Wager, T. D. (2012). How expectations shape pain. Neuroscience Letters, 520(2), 140-148.

  • Benedetti, F. (2014). Placebo Effects: Understanding the Mechanisms in Health and Disease. Oxford University Press.

  • Benedetti, F., Mayberg, H. S., Wager, T. D., Stohler, C. S., & Zubieta, J. K. (2011). Neurobiological mechanisms of the placebo effect. Journal of Neuroscience, 31(45), 16117-16124.

  • Carvalho, C., Caetano, J. M., Cunha, L., Rebouta, P., Kaptchuk, T. J., & Kirsch, I. (2016). Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain, 157(12), 2766-2772.

  • Colloca, L., Finniss, D., & Benedetti, F. (2013). Placebo and Nocebo Effects. In Pain 2014-Refresher Courses (pp. 69-81). IASP Press.

  • Colloca, L., & Miller, F. G. (2011). The nocebo effect and its relevance for clinical practice. Psychosomatic Medicine, 73(7), 598-603.

  • Egorova, N., Yu, R., Kaur, N., Vangel, M. G., Gollub, R. L., & Kong, J. (2015). Placebo analgesia and reward processing: Integrating genetics, personality, and intrinsic brain activity. Human Brain Mapping, 36(9), 3580-3593.

 
 
 

Nubellum’s statement on recovering from functional disorders

Nubellum has gained tremendous insight into augmenting recovery from functional disorders using self-directed, healing investigations. We believe that a person’s positive participation in their treatment is the most important contributor to healing from functional disorders of all kinds.


A clinical perspective on the neurobiology of healing

Biologists and neuroscientists have demonstrated conclusively that long-term memory is primarily formed through the experience of novel stimuli that activate new neural pathways in the brain.

Novel treatment protocols that engage the brain in new ways are an essential part of healing from functional disorders because cognitive participation is required to create new neural pathways, facilitating adaptive responses that promote healing and recovery.

Successful treatment. protocols that leverage cognitive participation are effective because functional disorders often stem from maladaptive neural pathways that have been reinforced over time. To overcome these patterns and create lasting change, it is crucial to introduce new neural pathways that promote healthy functioning.

Mind-body interventions like deep breathing, mindfulness, yoga, tai chi, and guided dietary changes, along with cognitive therapies of all kinds, can help create these new neural pathways and facilitate healing in the brain. Over time the new neural pathways become unconscious replacements for maladaptive neural pathways that preceded them.

By experiencing novel treatment protocols, individuals can rewire their brains and overcome functional disorders, leading to improved mental and physical health.

No two people develop functional disorders in the same way, and no two people heal from them in the same way. The challenge is for each person to learn what works for them.