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.