Does Integrating Cognitive and Psychological Interventions Enhance Wellbeing After Acquired Brain Injury? Study Protocol for a Phase II Randomized Controlled Trial of the VaLiANT (Valued Living After Neurological Trauma) Group Program.
Nick Sathananthan, Eric M J Morris, David Gillanders, Lucy Knox, Bleydy Dimech-Betancourt, Bradley J Wright, Roshan das Nair, Dana Wong
PMID 36188858WHAT IT FOUND
This paper describes the plan for a trial of a group therapy program for people with acquired brain injury.
It reports no results from the trial itself. The only data are from an earlier small study, so this paper cannot tell you whether the treatment works.
What this paper is
This is a study protocol for a Phase II randomized controlled trial of the VaLiANT group program for people with acquired brain injury. It describes the planned intervention, outcome measures, and statistical analysis, but reports no results from the trial itself. The only data presented are from a previous Phase I study, which showed improvements in wellbeing and mood for eight participants. There are no findings from this trial to report, so there is nothing here to change your practice on.
The easy way to misread this
Do not read the Phase I results mentioned in the introduction as evidence that the VaLiANT program works. The Phase I study had only eight participants and used a single-case design, which cannot rule out chance or other factors. This paper reports no results from the Phase II trial.