Citation

Hart T, Rabinowitz A, Vaccaro M, Chervoneva I, Wilson J. Arch. Rehabil. Res. Clin. Transl. 2019; 1(3-4): e100027.

Copyright

(Copyright © 2019, Elsevier Publishing)

DOI

10.1016/j.arrct.2019.100027

PMID

33543057

Abstract

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.

Language: en

Keywords

Depression; Rehabilitation; TBI, traumatic brain injury; ANOVA, analysis of variance; Anxiety disorders; BA, behavioral activation; BADS, Behavioral Activation for Depression Scale; BAT, Behavioral Activation with Technology intervention arm; Brain injuries; BSI-18, Brief Symptom Inventory-18; EMA, ecological momentary assessment; EROS, Environmental Reward Observation Scale; FTF, face-to-face; GSI, Global Severity Index; INT, intention; PART-O, Participation Assessment with Recombined Tools-Objective; PGIC, Patient Global Impression of Change; QOLIBRI, Quality of Life after Brain Injury; RCT, randomized controlled trial; SMS, short message service; SWLS, Satisfaction With Life Scale