Transdiagnostic Tailored Internet- and Mobile-Based Guided Treatment for Major Depressive Disorder and Comorbid Anxiety: Study Protocol of a Randomized Controlled Trial

Abstract

Introduction: Depression is highly prevalent and often accompanied by comorbid anxiety disorder. Internet-based interventions have shown to be one effective treatment modality; however, comorbidities are often not targeted. Transdiagnostic tailored internet-and mobile-based interventions (IMIs) might be promising to overcome such issues.Aim: This study aims to evaluate the efficacy, moderators, and cost-effectiveness of a transdiagnostic tailored internet- and mobile-based guided intervention for depression and comorbid anxiety in individuals with major depressive disorder (MDD).Method: Two-hundred participants with MDD will be randomly assigned to an 8-week guided self-help internet intervention (IC) or a 6-month wait-list control group (WLC). Participants of the IC will receive weekly content-focused feedback on module completion as well as monitored adherence reminders from an eCoach. The primary outcome is clinician-rated depression severity (QIDS-C) at post-assessment assessed by diagnostic raters blind to study condition. Secondary outcomes include, e.g., change in diagnostic status (MDD and anxiety disorders), remission and response rates, disorder symptom severity, health related quality of life, incongruence related to needs and values, and behavioral activation. Assessments will take place at baseline (T1), post-assessment (T2), 6-month follow-up (T3), and 12-month follow-up in the IC. Data will be analyzed on an intention-to-treat basis and per protocol. A large number of a priori defined moderators of treatment outcome will be assessed at baseline and tested in predicting treatment outcome. Cost-effectiveness will be evaluated from a societal perspective.Discussion: The present study will provide evidence on the efficacy, potential cost-effectiveness, and moderators of a transdiagnostic tailored guided internet- and mobile-based treatment protocol.Trial Registration: German Register of Clinical Studies DRKS00011690 (https://www.drks.de/drks_web/).

Mental disorder comorbidity and suicidal thoughts and behaviors in the World Health Organization World Mental Health Surveys International College Student initiative

“…By targeting core therapeutic processes (e.g., alliance and adherence), phenotypes, and/or biological markers that are shared among a range of disorders, the goal is to determine why psychotherapeutic and pharmacologic interventions are effective as a means of improving outcomes that have remained relatively stagnant in recent decades (e.g., DeRubeis et al, ; Dimidjian et al, ). Nevertheless, as transdiagnostic approaches may disregard important differences between participants, a promising alternative might be a person‐specific approach in which treatment modules—specifically using internet‐based treatments—are based on the comorbidity, symptoms, and other characteristics tailored to each individual student (e.g., Weisel et al, ). As a whole, given high rates of comorbidity coupled with suboptimal treatment response rates with traditional tracks of care, there is an urgency to design and disseminate interventions that are effective across different profiles of disorders that are commonplace in college students.…”

“…Nevertheless, as transdiagnostic approaches may disregard important differences between participants, a promising alternative might be a person-specific approach in which treatment modules-specifically using internet-based treatments-are based on the comorbidity, symptoms, and other characteristics tailored to each individual student (e.g., Weisel et al, 2018). As a whole, given high rates of comorbidity coupled with suboptimal treatment response rates with traditional tracks of care, there is an urgency to design and disseminate interventions that are effective across different profiles of disorders that are commonplace in college students.…”

User Experience and Effects of an Individually Tailored Transdiagnostic Internet-Based and Mobile-Supported Intervention for Anxiety Disorders: Mixed-Methods Study

“…Participants were recruited via German health insurance companies, a study webpage, and open recruitment strategies such as social media and Google Ads for a primary trial on the prevention of depression and anxiety [ 31 ]. Individuals with a clinical diagnosis of a major depressive disorder in the screening process were referred to another trial [ 32 ]. If they did not fulfill the criteria of the prevention trial due to a clinical diagnosis of an anxiety disorder and did not have a clinical diagnosis of major depressive disorder, they were referred to this study.…”

“…Participants were eligible to participate in the study if they fulfilled the following inclusion criteria of having a current diagnosis of an anxiety disorder (generalized anxiety disorder, panic disorder, agoraphobia, social phobia) assessed in the diagnostic interview based on the Mini International Neuropsychiatric Interview (MINI) [ 33 ] and signed informed consent without any of the following exclusion criteria: (1) history of psychosis, (2) bipolar disorder, (3) psychological treatment in the past 6 months, (4) currently on a waiting list for psychological treatment, (5) heightened suicidality, (6) having a current, or past 6 months, episode of a major depressive disorder. To increase internal validity, we decided not to include individuals with a major depressive disorder and redirected them to a different trial [ 32 ] as we assumed they might have other characteristics and needs.…”

A qualitative study of university students' experience of Internet‐based CBT for depression

“…All participants in this study made use of a transdiagnostic semiguided iCBT intervention (known as ICare) (Weisel et al, 2018;Weisel et al, 2019). This Internet-based intervention was developed to address the symptoms of, and risk factors associated with, major depressive disorder and generalised anxiety disorder.…”