Efficacy of a group-based education intervention for people with traumatic brain injury: supplementary results from a 12-month randomized controlled trial.

OBJECTIVE: Our team developed an attention control condition, called the Brain Health Group (BHG), for a randomized controlled trial (RCT; NCT03594734). The focus of the BHG was on brain health education and self-management. The objectives of this supplementary analysis are to (1) Describe compliance with the 12-month BHG; (2) Examine efficacy for improving general self-efficacy (GSE, primary) and secondary outcomes; and (3) Describe findings from the program evaluation. DESIGN: English-speaking adults (18-64 years old) who were ≥6 months post a moderate-to-severe TBI were randomized to the BHG (n = 29) or active intervention (n = 28). Data were collected at baseline and 12 months, including GSE, depression, satisfaction with life (SWL), self-rated abilities for health practices (SRAHP), and alcohol use. Program evaluation was conducted at 12 months. RESULTS: Attendance was 89%, and goal tracking was 63%. Within group analysis showed a significant increase in SRAHP scores (p = 0.018). Non-significant increases in GSE and SWL were observed, and participants perceived the BHG as helpful. No significant changes in depression or alcohol use were reported. CONCLUSION: People with TBI can engage in and benefit from the BHG and perceive the program as helpful for improving knowledge about brain health and awareness of self-management skills.

Providing equal attention: designing control groups for intensive lifestyle interventions after brain injury.

PRIMARY OBJECTIVE: Interventions are needed to address chronic health conditions, such as obesity and diabetes, faced by adults with traumatic brain injury (TBI). The objective of this narrative is to present the justification for and an exemplar of an active attention control condition as a needed comparison group in clinical trials for intensive lifestyle interventions after TBI. RESEARCH DESIGN: Narrative review. METHODS AND PROCEDURES: N/A. MAIN OUTCOMES AND RESULTS: Despite the historical use in scientific research, integration of appropriate control conditions to account for not only the placebo effect, but also to isolate the "active ingredients" of behavioural interventions, remains a challenge. This is particularly true for intensive lifestyle interventions, especially with the increasing use of mobile health (mHealth) to augment these interventions. Herein we describe the design, content, and implementation of a group-based, attention control condition, referred to as the Brain Health Group, as an exemplar active comparison to an intensive lifestyle intervention for weight-loss among individuals with TBI (GLB-TBI). CONCLUSIONS: Intervention studies should incorporate strong scientific designs and active control conditions to assess effectiveness and aid in replication. Following recommended guidelines, we provide an active control condition for future group-based intensive lifestyle interventions post-TBI.