Design and Implementation of an Intervention Development Study: Retaining Cognition While Avoiding Late-Life Depression (ReCALL)

Abstract

Objective: To discuss the design, rationale, and implementation of an intervention development study addressing indicated and selective prevention of depression and anxiety in individuals 60 years and older with mild cognitive impairment (MCI) and in their caregivers.

Methods: In Phase I, now completed, we developed and standardized problem-solving therapy (PST) and the combined PST + moderate-intensity physical exercise (PE) intervention to be administered to participants with MCI and their caregivers together, dyadically, with both participants working with the same interventionist in the same therapy sessions. In Phase II we have been testing the interventions against enhanced usual care (EUC) and have addressed challenges to recruitment. Randomization was to one of three cells: PST + PE, PST, or EUC.

Results: Although we set out to intervene dyadically, many individuals with MCI lived alone or did not have a support person who could participate in the study with them. Consequently, we modified the study to include MCI participants with and without support persons. Ninety-four participants were enrolled: 20 with MCI together with their support persons (N = 20 dyads) and 54 MCI participants without accompanying support persons. Most participants have been satisfied with the usefulness of the interventions in managing stress and cognitive problems.

Conclusion: PST and moderate-intensity PE are acceptable interventions for depression and anxiety prevention in older adults with MCI and their available caregivers.

Trial registration: ClinicalTrials.gov NCT01886586.

Keywords: aged; depression prevention; mild cognitive impairment; physical exercise; problem-solving therapy.