Evidence-based or evidence-informed treatment? Confused? You are not alone. Often used interchangeably, the terms “evidence-based” and “evidence-informed” in healthcare are two very different things. So, what do they really mean?

What is evidence-based treatment?

Evidence-based care is considered the gold standard in treating behavioral health conditions. Typically, “evidence-based” refers to an individual intervention that is based on quantitative research studies conducted in controlled, blinded settings and proven to be effective across a wide range of environments and people. Medications and other treatments that receive U.S. Food and Drug Administration (FDA) approval for a certain indication are also considered evidence-based.

What is evidence-informed treatment?  

 Evidence-informed care is an approach that shows promise but lacks enough proof of success to be viewed as a gold standard. Practitioners take bits and pieces from a variety of research, including evidence-based interventions and apply them to a condition. This produces something uniquely tailored to a certain need. Unlike evidence-based treatments, evidence-informed treatments don’t have results from research in controlled settings that demonstrate their effectiveness across a wide range of settings and people. When considering medication and other drug-like treatments, evidence-informed interventions have not received FDA approval for the condition they are treating. This is called “off-label” use.

Examples of evidence-based treatments

• Cognitive behavioral therapy (CBT) is a type of talk therapy that has proved effective in the treatment of anxiety, depression, addictions, phobias and certain physical health conditions. CBT focuses on changing automatic negative thoughts that can contribute to and worsen mental health and substance use symptoms. CBT has more evidence supporting it than any other psychological therapy.
• Acceptance and commitment therapy (ACT) is a type of mindful talk therapy that helps individuals stay focused on the present moment and accept thoughts and feelings without judgment. Over 200 randomized controlled trials have proven ACT is an effective treatment for depression, psychosis, chronic pain, substance use disorder, post-traumatic stress disorder, obsessive-compulsive disorder, panic disorder and social phobia.
• Dialectical behavior therapy (DBT) is a type of talk therapy based on CBT and specially adapted for people who experience emotions very intensely. Nine published randomized controlled trials and five controlled trials of DBT have proven its effectiveness for treating borderline personality disorder, including in highly suicidal women.
• Exposure and response prevention (ERP) therapy is a form of CBT that encourages individuals to engage with their obsessive thoughts without carrying out their associated compulsions. Treatment begins with placing individuals in situations which cause a tolerable level of anxiety and gradually build up to settings they find more difficult. ERP has been proven effective for treating obsessive-compulsive disorder in numerous clinical trials.
• Eye movement desensitization and reprocessing (EMDR) therapy is a mental health treatment technique that involves moving your eyes a specific way while you process traumatic memories. The goal of EMDR is to help individuals heal from trauma or other distressing life experiences. Since the first EMDR clinical trial in 1989, dozens of other clinical trials have proven this technique is effective and faster for the treatment of post-traumatic stress disorder.
• Transcranial magnetic stimulation (TMS) is a noninvasive treatment that was first used to treat depression in individuals who were nonresponsive to other treatments. TMS involves using a magnetic coil to influence the brain’s natural electrical activity and has full FDA approval for the treatment of major depressive disorder, obsessive-compulsive disorder, migraines and smoking cessation.
• Esketamine is an FDA-approved nasal spray used to treat severe treatment-resistant depression. Esketamine was found effective in a phase 3, double-blind, active-controlled study conducted at 39 outpatient centers from August 2015 to June 2017. The study involved nearly 200 adults with moderate to severe depression and a history of not responding to at least two antidepressants.
• Fluoextine is an antidepressant medication that is approved by the FDA to treat depression, obsessive-compulsive disorder, bulimia nervosa, premenstrual dysphoric disorder and panic disorder. It belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs) and works by increasing the activity of serotonin in the brain. Data based on a group of 9,087 patients who were included in 87 different randomized clinical trials confirms that fluoxetine is safe and effective in the treatment of depression from the first week of therapy.

 Examples of evidence-informed treatments   

Response Disequilibrium Therapy (RDx)—Based on the response disequilibrium model, RDx puts patients in charge of implementing their own treatment procedure outside of therapy sessions in the same environments that trigger their symptoms so they can learn new behaviors to replace and control their previous responses to distressing situations.

While preliminary findings from case studies involving 19 participants with OCD suggest RDx may be a promising alternative to traditional OCD treatments, future research is needed to determine its effectiveness across a wide range of settings, people and problems to classify it as an evidence-based intervention.

• Pregabalin (an FDA-approved anticonvulsant medication and fibromyalgia treatment) has been used off-label to treat generalized anxiety disorder, social anxiety disorder, bipolar disorder, insomnia and chronic pain conditions other than fibromyalgia. For pregabalin to be used for these conditions in an evidence-based manner, the FDA would have to approve their use for each specific condition.
• Risperidone (an atypical antipsychotic medication approved by the FDA for the treatment of schizophrenia, bipolar disorder and autism-associated irritability) has been used in a variety of off-label ways, including to treat borderline personality disorder, post-traumatic stress disorder (PTSD) and bipolar disorder. To date, the FDA has not approved risperidone to treat these three conditions.

Are mental health and wellness apps evidence-based or evidence-informed?

These days, you can’t browse the web or use most apps on your phone without seeing an ad for a wellbeing or therapy program or app. Used alone or to supplement traditional treatment and promote wellbeing, not all mental health, substance use and wellbeing apps use evidence-based practices, nor have they been extensively researched in treating specific conditions. Wellbeing and therapy apps are typically considered:

• Evidence-based when evidence-based interventions are fully implemented on the platform and followed by users in the same manner they would be if they were being delivered during face-to-face treatment. For example, the original evidence-based model below is used in a wellbeing app that delivers CBT digitally and all steps are followed as listed.
  1. Identify troubling situations or conditions in your life.
  2. Become aware of your thoughts, emotions and beliefs about these problems.
  3. Identify negative or inaccurate thinking.
  4. Reshape negative or inaccurate thinking.
• Evidence-informed when only certain components of evidence-based interventions are implemented on the platform, and/or the app only fully implements or uses components of evidence-informed interventions. For instance, if a wellbeing app provides CBT and only asks users to identify troubling thoughts and become aware of their thoughts, emotions and beliefs about these problems, it is evidence-informed because it does not ask users to identify and reshape negative or inaccurate thinking.

When considering using an app for yourself, your patients, your employees or your members, ask yourself these questions:

• Are the treatments used in the app based on quantitative research?
  • Were the studies conducted in controlled, blinded settings?
  • Are the treatments proven to be effective across a wide range of environments and people?
• Are all treatment steps included in the process, or has the process been watered down?
• Have the treatments used in the app received FDA approval for a certain indication, if FDA approval is possible?

Magellan’s approach to evidence-based versus evidence-informed treatments and mental health, wellbeing and substance use apps

The American Psychiatric Association and the American Psychological Association both consider evidence-based interventions preferred approaches for the treatment of psychological conditions.

At Magellan, we are leading the way in providing innovative, impactful behavioral healthcare solutions. When developing new and enhancing existing offerings , like our digital cognitive behavioral therapy (DCBT) programs, we always start with evidence-based treatments and adhere fully to all tenets. Magellan Healthcare’s DCBTs have been heavily researched in the studies below:

• FearFighter® for anxiety, panic and phobia (now available online in Spanish)
  • Computer-aided CBT self-help for anxiety and depressive disorders: Experience of a London clinic and future directions. L. Gega, I. Marks, D. Mataix-Cols. Journal of Clinical Psychology: In Session (2004), Vol. 60 (2), 147-157.
  • Computer-aided vs. tutor-delivered teaching of exposure therapy for phobia/panic: Randomized controlled trial with pre-registration nursing students. L. Gega, I.J. Norman and I.M. Marks. International Journal of Nursing Studies 44 (2007) 397-405.
  • The feasibility and effectiveness of computer-guided (CBT) (FearFighter) in a rural area. L. Hayward, A.D. MacGregor, D.F. Peck, P. Wilkes. Behavioural and Cognitive Psychotherapy (2007) 35, 409-419.
• MoodCalmer for depression (now available online in Spanish)
  • Saving clinician’s time by delegating routine aspects of therapy to a computer: A randomized controlled trial in phobia/panic. I.M. Marks, M. Kenwright, M. McDonough, M. Whitaker and D. Mataix-Cols (2004).
  • Technology-based advances in the management of depression: Focus on the COPE program. Disease Management and Health Outcomes. J.H. Greist, D.J. Osgood-Hynes, L. Baer and I.M. Marks (2000) 7, 4.
• RESTORE® for insomnia and other sleep difficulties (now available online in Spanish)
  • Implementing computer-based psychotherapy among veterans in outpatient treatment for substance use disorders. E.D.A. Hermes and R.A. Rosenheck. Psychiatric Services 67:2, February 2016, 176-183.
  • Cognitive behavioral therapy for insomnia enhances depression outcomes in patients with comorbid major depressive disorder and insomnia. R. Manber, J.D. Edinger, J.L. Gress, M.G. San Pedro-Salcedo, T.F. Kuo, T. Kalista. SLEEP, Vol. 31, No. 4, 2008, 489-495.
  • Logging on for better sleep: RCT of the effectiveness of online treatment for insomnia. N. Vincent and S. Lewycky. SLEEP, Vol. 32, No. 6, 2009, 807-815.
  • Sleep locus of control and computerized cognitive-behavioral therapy (cCBT). N. Vincent, K. Walsh, and S. Lewycky. Behaviour Research and Therapy, 48 (2010), 779-783.
• SHADE for substance use disorder
  • Randomized controlled trial of cognitive-behavioural therapy for coexisting depression and alcohol problems: Short-term outcome. A.L. Baker, D.J. Kavanagh, F.J. Kay-Lambkin, S.A. Hunt, T.J. Lewin, V.J. Carr and J. Connolly. Addiction, 105, (2009) 87-99.
  • Clinician-assisted computerised versus therapist-delivered treatment for depressive and addictive disorders: A randomised controlled trial. F.J. Kay-Lambkin, A.L. Baker, B. Kelly and T.J. Lewin. Medical Journal Australia, 195, 3, 1 August 2011.
  • Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: A randomized controlled trial of clinical efficacy. F.J. Kay-Lambkin, A.L. Baker, T.J. Lewin and V.J. Carr. Addiction, 104, 278-388 (2009).
• ComfortAble® for chronic pain
  • Cognitive-behavioral therapy for individuals with chronic pain: Efficacy, innovations, and directions for research. D.M. Ehde, T.M. Dillworth and J.A. Turner. American Psychologist (2014), Vol. 69, No. 2, 153-166.

We further validate this research with outcomes from practical application of our solutions. By doing this, we ensure our clients and members receive only high-quality products and services that work in the real world—where it really matters.

SOURCES:

• ACT is an Empirically-Supported Therapy: Background and Clinical Evidence
• Act Theory: Acceptance and Commitment Therapy Explained
• CBT Explained: An Overview & Summary of CBT
• Dialectical Behavior Therapy
• EDMR Therapy
• Exposure and Response Prevention in the Treatment of Obsessive-Compulsive Disorder: Current Perspectives – PMC
• The Evidence for Cognitive Behavioural Therapy in any Condition, Population or Context: A Meta-review of Systematic Reviews and Panoramic Meta-analysis
• Fluoxetine: a review on evidence-based medicine
• National Library of Medicine: Pregabalin
• National Library of Medicine: Risperidone
• New Therapy Shows Promise for Swift Treatment of Obsessive Compulsive Disorder – Association for Psychological Science – APS
• Psychiatry.org – Study Supports Effectiveness of New Fast-Acting Antidepressant, Esketamine Nasal Spray
• Transcranial Magnetic Stimulation
• VR therapy for OCD Can Enhance the Delivery of Exposure Response Prevention
• What is Evidence-Based Therapy: 3 EBT Interventions

Among those who experience a mental health illness, more than half do not receive treatment.[1] The 2019 National Survey on Drug Use and Health reveals no treatment was received by:

• 90% of the 20.4 million individuals aged 12+ who have a substance use disorder (SUD)
• 55% of the 51.5 million individuals aged 18+ who have any mental illness (AMI)
• 35% of the 13.1 million individuals aged 18+ who have a serious mental illness
• 90% of the 9.5 million individuals aged 18+ who have a co-occurring SUD and AMI
• 57% of the 3.8 million individuals aged 12-17 who have had a major depressive episode

In fact, what we’ve seen in our data is that 60% of patients who are admitted to inpatient care were first seen in a primary care setting within 6-12 months of the admission and the mental health condition was either missed or not addressed.

Through effective screening for mental health conditions on your own or through a physician or mental health professional, it is possible to identify problem areas and get help, so you can live a happier and healthier life.

Mental health self-screening tools

Magellan Healthcare provides links to reputable, free self-assessments of behavioral/mental health, substance use and more.* Once you complete an assessment, be sure to review your results and any recommendations with your doctor.

• Addiction(CAGE-AID)
• Alcohol consumption (AUDIT-10)
• Anxiety (GAD-7)
• Bipolar disorder
• Child depression (CES-DC)
• Child trauma (CTS)
• Depression (PHQ-8)
• Drug abuse (DAST-10)
• Eating disorder (SWED)
• Insomnia (ISI-7)
• Obsessive compulsive disorder (OCD) (Y-BOCS)
• Pain (PEG-3)
• Parent mental health
• Postpartum depression
• Post traumatic stress disorder (PTSD) (PC-PTSD)
• Psychosis (PQ-B)
• Youth mental health

*Note these are links to outside websites that are not monitored by or affiliated with Magellan Healthcare. If your screening results indicate you are at high risk, call 911 or go to the emergency room immediately.

We encourage you to watch a recording of our webinar, “Depression is more than just a rough patch,” and find additional resources addressing depression at MagellanHealthcare.com/Mental-Health.

[1] https://www.samhsa.gov/data/sites/default/files/reports/rpt29392/Assistant-Secretary-nsduh2019_presentation/Assistant-Secretary-nsduh2019_presentation.pdf

Trouble sleeping? You are not alone. Sleep problems and insomnia affect nearly 40 percent of Americans each year. Not only is insomnia very common, it is also associated with increased risk of stroke,^[1] diabetes,^[2] obesity,^[3] alcohol misuse,^[4] depression^[5] and anxiety.^[6]  When individuals have insomnia and another one of these conditions, it can be particularly problematic. Cognitive behavioral therapy (CBT) is widely recognized as the gold standard for long-term management of insomnia.^{[7],[8],[9],[10]} However, CBT can be difficult to access and is relatively inaccessible for individuals with limited economic security.

Through increasing access to quality, well-studied CBT programs, Magellan seeks to reduce the overall cost-of-care and improve individual health outcomes. Team members at Magellan recently collaborated with academic researchers on a project to make Magellan’s computerized CBT programs, referred to as Cobalt, accessible to patients with insomnia in a community health setting. Participants included individuals who lived in shelters and community homes, as well as individuals with serious mental illness.

Participants received access to RESTORE^TM, one of several data-driven programs in the Cobalt suite, which has been shown to be effective in randomized controlled trials. RESTORE^TM has also won praise from the American Academy of Sleep Medicine ^[11] and received the highest rating from the Substance Abuse and Mental Health Administration’s (SAMHSA) National Registry of Evidence-based Programs and Practices. The research findings, published in the Journal of Clinical Sleep Medicine, demonstrated significant improvements in sleep quality. This suggests that implementing RESTORE^TM in a community mental health center setting may make accessing effective tools for improving sleep a straightforward process.[12]

Magellan continues to lead in the healthcare field through collaborations like this one, where academic partners are collecting real-world data that demonstrate how its industry leading Cobalt programs can help increase access, lower costs, and improve individual health outcomes. We are excited by the power of technology to improve care and access to care for individuals regardless of their economic status, as we work to lead humanity to healthy, vibrant lives.

[1] Elwood, P., Hack, M., Pickering, J., Hughes, J., & Gallacher, J. (2006). Sleep disturbance, stroke, and heart disease events: evidence from Caerphilly cohort. Journal of Epidemiology Community Health 0:69-73.

[2] Cappuccio, F., D’Elia L., Strazzullo P., & Miller, M.A. (2010). Quantity and quality of sleep and incidence of type 2 diabetes. Diabetes Care; 33:414-20.

[3] Gangwisch, J., Malaspina, D., Boden-Albala, B., & Heymsfield, S.B. (2005). Inadequate sleep as a risk factor for obesity: analyses of the NHANES I. Sleep; 28:1289-96.

[4] Crum, R.M., Storr, C.L., Chan, Y-F., Ford, D.E. (2004). Sleep disturbance and risk for alcohol-related problems. American Journal of Psychiatry;61:1197-203.

[5] Riemann, D., Voderholzer, U. (2003). Primary insomnia: a risk factor to develop depression? Journal of Affect Disorder; 76:255-9.

[6] Breslau, N., Roth, T., Rosenthal, L., Andreski, P. (1996). Sleep disturbance and psychiatric disorders: a longitudinal epidemiological study of young adults.  Biological Psychiatry;39:411-8.

[7] Schatzberg, A. F., & Nemeroff, C. B. (2009). The American Psychiatric Publishing textbook of psychopharmacology. Washington, D.C: American Psychiatric Pub.

[8] American Psychological Association. (2004). Getting a Good Night’s Sleep with the Help of Psychology.

[9] American Academy of Sleep Medicine (2013). Evaluation and Management of Chronic Insomnia in Adults.

[10] Agency for Healthcare Research and Quality. (2013). Clinical practice guidelines for the management of patients with insomnia in primary care.

[11] American Academy of Sleep Medicine. (2009). Online Cognitive Behavioral Therapy is Effective in Treating Chronic Insomnia.

[12] Feuerstein, S.D., Hodges, S. Keenaghan, B.C., Bessette, A., Forselius, E., & Morgan, P.T. (2016). Computerized Cognitive Behavioral Therapy for Insomnia in a Community Health Setting. Journal of Clinical Sleep Medicine.

Consumerization of products continues to drive new innovations across the marketplace. For example, you can use your smartphone as a GPS device, to request a car service directly to your house and to shop for a new car online, seeing the prices other people paid in real time. In banking, we’ve seen the transition from teller to the ATM to online banking, smartphone banking and now, using your smartphone as a smart pay device. Underscoring all of these innovations is the desire to make whatever experience the consumer is engaging in easier, simpler and more personalized.

Healthcare is no different. Across the healthcare continuum, companies like ours are finding new and innovative ways to enhance member engagement and participation in the healthcare journey, particularly through computerized or mobile devices. Think about how healthcare has changed over the past 50 years – house calls from doctors to office visits to telephone triage and now, computerized therapy and text therapy.

At Magellan, we’ve invested in a unique type of computerized therapy – Computerized Cognitive Behavioral Therapy (CCBT) – to help individuals seek the therapy they need, in the comfort, convenience and privacy of their own home. Our CCBT programs were originally developed more than 20 years ago, for stand-alone personal computer use, but have since been developed for use on the internet and mobile devices, in both English and Spanish.

 The following five conditions make up more than 90 percent of behavioral health complaints in adults, and are present in more than 25 percent of adults:

• Insomnia
• Depression
• Anxiety
• Substance Abuse
• Obsessive Compulsive Disorder

Within each condition, studies have shown CCBT to be effective at reducing symptoms and severity. Importantly, our CCBT programs have undergone clinical trials involving more than 1,000 patients and have received endorsements and recognition from the American Academy of Sleep Medicine, the United Kingdom’s National Institute of Clinical Excellence, Accreditation Canada and the Substance Abuse and Mental Health Administration’s National Registry. Underscoring all of the studies and reviews, what can members expect? Sixty-nine percent of users show meaningful improvement within 30 days.

But CCBT isn’t just for members. We’ve found that providers can use a tool called Smart Screening to help screen individuals and triage them to the most appropriate levels of care on the CCBT platform, and in person, for the most serious cases. Various levels of screening can help direct individuals to CCBT, directly to an in-person counselor or a mix of both. Through this triage system, 90 percent of engaged participants rate this program as helpful and useful, and 75 percent of individuals actually prefer a non-medication care option when asked.

The most important thing about innovation in any industry – healthcare, banking or electronics – is refusing to rest on your laurels. There are new start-ups launched everyday whose mission it is to disrupt the status quo and provide new ways of doing things. As healthcare evolves, we plan to do the same.