Clinical trial NCT02498132: Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems
Official title: Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Mobile Technologies
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: MOUNTAINPASS TECHNOLOGY, LLC
name: Medical University of South Carolina
First posted: 2015-07-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Participants will be screened by phone. Inclusion criteria:

Participants must:

1. be between the ages of 18 and 65,
2. report current elevated depressive symptoms, and
3. currently own an iOS-compatible mobile phone.

Exclusion Criteria:

Participants will be excluded if they:

1. are currently receiving psychotherapy or psychotropic medication,
2. plan to seek psychotherapy within the next 3 months (score \> 5 on a self-report 1-10 scale of likelihood to seek treatment),
3. endorse current suicidal ideation defined as either

   1. a response of "I would like to kill myself" or "I would kill myself if I had the chance" on the suicidal thoughts or wishes item of the BDI-II or
   2. an indication of past month suicidal ideation on the MDD module of the SCID-IV (see Protection of Human Subjects for additional details), or
4. meet current diagnostic criteria for MDD; although BA has been used to treat MDD, Moodivate is targeted specifically to elevated symptoms, not major depressive episodes.

Primary outcomes:
measure: Average Decrease of Beck Depression Inventory-II Score
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Client Treatment Adherence
timeFrame: Once a week for 8 weeks
measure: Changes Among User Feasibility and Acceptability
timeFrame: Once a week for 8 weeks
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Once a week for 8 weeks
measure: EROS ( Emotion Regulation of Others and Self)
timeFrame: Once a week for 8 weeks
measure: Profile of Mood States (POMS)
timeFrame: Once a week for 8 weeks
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: Once a week for 8 weeks
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: Once a week for 8 weeks
measure: Beck Anxiety Inventory (BAI)
timeFrame: Once a week for 8 weeks
measure: The Addiction Severity Index (ASI) i
timeFrame: Once a week for 8 weeks
measure: Fagerstrom Test For Nicotine Dependence (FTND)
timeFrame: Once a week for 8 weeks
measure: Timeline Followback Method Assessment
timeFrame: Once a week for 8 weeks
measure: Contemplation Ladder
timeFrame: Once a week for 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Maryland, College Park
name: Carl Lejuez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, College Park
name: Jennifer Dahne, MS
role: STUDY_CHAIR
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