Ontology highlight
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.
SUBMITTER: Hart T
PROVIDER: S-EPMC7853388 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
Hart Tessa T Rabinowitz Amanda A Vaccaro Monica M Chervoneva Inna I Wilson Julianne J
Archives of rehabilitation research and clinical translation 20190927 3-4
<h4>Objective</h4>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.<h4>Design</h4>Randomized controlled trial with masked outcome assessment.<h4>Setting</h4>Outpatient catchment area of 1 TBI treatment center.<h4>Participants</h4>Community- ...[more]