Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      Elevated depressive symptomatology is a widespread public health concern and individuals with
      elevated depressive symptoms most frequently report such symptoms to primary care physicians
      (PCPs). PCPs have few evidence-based resources beyond antidepressant medication for treating
      elevated depressive symptoms, which results in negative outcomes for their depressed
      patients. Mobile technologies offer an ideal strategy to meet widespread treatment needs. The
      purpose of the proposed project is to\ customize Behavioral Activation (BA), a
      straightforward, empirically supported treatment for elevated depressive symptoms, for a
      mobile format (Moodivate) in order to address the currently unmet needs of PCPs and their
      patients with elevated depressive symptoms.
    

Detailed description: 
      Depressive symptoms are associated with heightened risk of developing major depressive
      disorder (MDD), significant public health costs, and mortality rates equal to MDD .
      Individuals experiencing impairment due to depressive symptomatology most frequently report
      their depressive symptoms to a primary care physician . Despite conflicting data regarding
      efficacy, PCPs typically prescribe antidepressant medication for the treatment of
      subthreshold depression and have few other resources at their disposal . The current lack of
      evidence-based resources available to PCPs for treating depressive symptoms results in a
      number of negative outcomes for patients including: 1) the majority not receiving appropriate
      treatment , 2) a decreased likelihood of reporting depressive symptoms again in the future ,
      and 3) heightened mortality risk. As the most likely initial contact for patients with
      elevated depressive symptoms, PCPs are in a unique position to provide interventions for
      depression .

      Mobile technologies offer an ideal strategy to meet widespread treatment needs. Mobile
      technologies broadly, and mobile phones more specifically, have dramatically increased in
      both affordability and ubiquity, with current estimates suggesting that there are over 3.2
      billion unique mobile users worldwide . Moreover, the vast majority of physicians report
      using mobile apps in their clinical practice . Despite these factors supporting the use of
      mobile apps in clinical practice, there are currently no mobile apps for depressive symptoms
      available to PCPs that are both evidence-based and simple enough to be recommended to their
      patients.

      One treatment that is particularly amenable to a mobile platform and to referral by PCPs is
      Behavioral Activation. Across studies, BA is effective for reducing depressive symptoms among
      individuals with subthreshold depression as well as individuals with MDD and meets the
      criteria to be established as an empirically support treatment . Moreover, numerous research
      studies support the superiority of BA as a treatment component to competitor treatments,
      including Cognitive Behavioral Therapy (CBT) and Cognitive Therapy (CT). The cornerstone of
      BA is regular self-monitoring to 1) examine already occurring daily activities and 2)
      facilitate incorporation of new activities consistent with individualized values and goals
      across life areas. Empirical evidence indicates that mobile customization of BA would work as
      intended to facilitate reduction of depressive symptomatology, while also addressing the
      unmet need for evidence-based and easily disseminable resources for use by PCPs with their
      patients with depressive symptomatology. Moreover, as BA has an evidence-base for smoking
      cessation, a mobile customization of BA may also hold promise for promoting smoking
      cessation.

      With STTR funding from NIMH, our team is currently completing the development of a self-help
      BA mobile application named Moodivate for referral by PCPs to their patients with elevated
      depressive symptoms. App development will be complete by March, 2016 in preparation for a
      small clinical trial at MUSC. The closest competitor apps for Moodivate are Cognitive
      Behavioral Therapy (CBT)-based mobile applications. The most popular CBT-based mobile
      applications include iCouch CBT, Live Happy, MoodPanda, and MoodKit. Of this group of
      CBT-based mobile applications, MoodKit most closely adheres to standard CBT. As clinical
      trials of standard BATD frequently compare BATD to CBT, an appropriate analogue of this line
      of work is to compare Moodivate, a BATD based mobile app, to MoodKit, a CBT based mobile app.
      Although MoodKit appears to adhere to CBT, no clinical trials to date have been completed
      examining utilization of MoodKit among individuals with elevated depressive symptoms or among
      individuals referred by a PCP.

      In the current study, we will conduct a small-scale randomized clinical trial with 60 adults
      with elevated depressive symptoms (Beck Depression Inventory-II (BDI-II) > 14; above the
      "minimal depression" range on the measure) referred from physicians in the Department of
      Family Medicine (Drs. Vanessa Diaz and Marty Player) at MUSC. Participants will be randomized
      to one of three conditions: 1) Moodivate, 2) a Cognitive Behavioral Therapy-based mobile
      application (MoodKit), or 3) Treatment As Usual (TAU). The purpose of this step is to examine
      Moodivate treatment feasibility, acceptability, adherence, and change in depressive symptoms
      associated with Moodivate as compared to MoodKit and TAU. Considering that BA also has an
      evidence base for smoking cessation, within this group of 60 participants, we plan to recruit
      10 participants who are current smokers who will receive Moodivate. Although this will be a
      small sample of smokers receiving the BA mobile therapy, we believe collecting pilot data
      examining utilization of Moodivate among a group of smokers will provide valuable insight
      into the feasibility of utilizing a BA mobile app to promote smoking cessation.
    

Intervention name(s): Behavioral Activation; Cognitvie Based Therapy; Treatment as Usual
Intervention type(s): Other; Other; Other
Intervention description(s): BA is based in behavioral principles of depression that suggest that depression is caused by a lack of reinforcement in the environment for positive, non-depressed behaviors. As such, the goal of BA is to help the patient reengage in positive, non-depressed activities. In clinical trials, BA as a treatment component has been consistently superior to no treatment and treatment as usual control groups, and a large body of research has found that BA is either equally or more effective than CBT, CT, and antidepressant medications (Cuijpers, Van Straten, & Warmerdam, 2007; Dimidjian et al., 2006; Jacobson et al., 1996).; CBT explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts, people with mental illness can modify their patterns of thinking to improve coping; Individuals will be provided with one on one therapy sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mobile Technologies