Background: The project team proposes to carry out a treatment experiment to evaluate the extent to which access to remote internet-based cognitive behavior therapy (eCBT) in rural West Virginia (WV) will help improve treatment of patients with major depressive disorder (MDD). Based on a random selection, some clinicians in the study will have access to eCBT, and others will not. Mental health treatment resources are minimal—42nd out of 50 states—especially in rural parts of WV.
Episodes of MDD for which people seek treatment often have a chronic-recurrent course that can last for many years. MDD often co-occurs with various kinds of anxiety disorder and substance use disorder. MDD can have a devastating effect on the lives of the people who experience it as well as their family and friends, especially when it is chronic-recurrent and co-occurs with anxiety and/or substance use disorders.
The two main types of evidence-based first-line treatments for MDD are antidepressant medication (ADM) and psychotherapy. These two are equally effective in the aggregate, but many patients respond considerably better to one than the other, and some patients require both types of treatment to recover. The vast majority of patients treated for MDD in rural WV are treated exclusively with ADM in primary care. Telephone psychotherapy, while available, is scarce.
The most realistic prospect for this situation improving is through remote eCBT, which can be delivered much more efficiently and inexpensively than either face-to-face or telephone psychotherapy. For guided eCBT, a bachelor’s-level eCoach, working under the supervision of a clinical psychologist, leads patients through a computerized series of psychotherapy sessions via email, text, and telephone. The treatment can be delivered on a mass scale. Controlled treatment trials show that guided eCBT is as effective in treating MDD as live CBT.
Unguided eCBT is even less expensive to deliver and more scalable than guided eCBT. Controlled treatment trials show that MDD symptoms improve significantly more with unguided eCBT than in waiting list control groups. Even though guided eCBT is more effective than unguided eCBT for many patients, more is not always better, because unguided eCBT can be better than guided eCBT for patients who prefer not to interact with a therapist. Furthermore, ADM-alone can be better than ADM with unguided or guided eCBT when lack of engagement in psychotherapy leads the patient to drop out of treatment entirely compared to recovering if treated with ADM-alone. Because of this, it is important not only to evaluate the aggregate effects of adding either unguided or guided eCBT to treatment-as-usual (TAU), but also to carry out systematic analyses of the predictors of differential response to ADM-alone, ADM plus unguided eCBT, and ADM plus guided eCBT. This type of analysis will be a central part of the study. It is referred to technically as analysis of heterogeneity of treatment effects (HTE).
Prior research has found significant patient-reported predictors of MDD HTE with respect to uncontrolled aspects of treatment. The project team plans to study this type of HTE as an exploratory aim in the study. Two uncontrolled aspects of treatment will be studied: treatment with one of three broad types of ADM (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], or bupropion) for which there is some evidence of HTE; and treatment with ADM combined either with live psychotherapy or with one of the two types of eCBT the team will randomize.
Projected Outcomes: The attractiveness of eCBT is undeniable due to its combination of low expense, scalability, and effectiveness, resulting in the recent wide dissemination of eCBT in health plans throughout the country. This means that eCBT will almost certainly be coming to rural WV in the near future. However, current evidence gaps often lead to decisional dilemmas for patients and treatment providers in rural areas regarding which patients are likely to benefit from either guided or unguided eCBT. The project team’s research aims to address these evidence gaps and make it possible for patients with MDD and their clinicians to make informed decisions about the extent to which guided or unguided eCBT might be helpful.
Other Clinical Interventions
Other Health Services Interventions
Shared Decision Making
Training and Education Interventions
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.