Behavioral Activation Augmented With Mobile Technology for Depression and Anxiety in Chronic Moderate-Severe Traumatic Brain Injury: Protocol for a Randomized Controlled Trial

OBJECTIVE: To describe and provide the rationale for a randomized controlled trial for depression or anxiety after moderate to severe traumatic brain injury (TBI), which will test 2 treatments based on behavioral activation (BA), a promising model to promote both positive mood and increased activity in this population. DESIGN: Randomized controlled trial with masked outcome assessment. SETTING: Outpatient catchment area of 1 TBI treatment center. PARTICIPANTS: Community-dwelling persons (N=60) with moderate-severe TBI at least 6 months prior to enrollment and greater than mild depression or anxiety. INTERVENTIONS: Participants will be randomized 2:1 into an 8-session treatment, behavioral activation with technology, consisting of 6 face-to-face sessions and 2 via phone, with mood and activity monitoring conducted via ecological momentary assessment on a smartphone; or a single session incorporating BA principles followed by 8 weeks of activity reminders in the form of implementation intentions, delivered as text messages. MAIN OUTCOME MEASURES: Brief Symptom Inventory-18 (primary outcome); Environmental Reward Observation Scale, Behavioral Activation for Depression Scale, Participation Assessment with Recombined Tools-Objective, Diener Satisfaction With Life Scale, Quality of Life after Brain Injury scale, Patient Global Impression of Change. Outcomes are measured midway through intervention, after treatment cessation (primary outcome), and at 2-month follow-up. A treatment enactment interview is administered after the follow-up to ascertain to what extent participants continue to engage in activities and use strategies promoted during trial participation. RESULTS: N/A. CONCLUSIONS: N/A.