Physical exercise augmented cognitive behaviour therapy for older adults with generalized anxiety disorder – scientific rationale, study protocol, and preliminary findings for the Pexacog trial.

Generalised anxiety disorder (GAD) is a severe and frequently occurring anxiety disorder, with peak prevalence in the second half of life. GAD also increases the risk for both other mental disorders and somatic conditions, including depression and coronary heart disease. The disorder has a chronic course if untreated, and the societal costs of GAD have been demonstrated to be substantial. As recommended treatments have been found to be less efficacious for older adults, treatment development has focused on augmenting the effects of existing interventions such as cognitive behaviour therapy (CBT). Physical exercise has a strong scientific rational for improving the effects of CBT, as it has the potential to offset age-related cognitive changes and reliably increases the levels of neurotrophins that have been shown to be predictive of the outcomes of CBT for anxiety. 18 participants, from a projected sample of 70 older adults aged 60–75 years with a primary diagnosis of GAD have so far been included and randomised to CBT combined with either physical exercise or telephone support. Primary outcome measure is the Penn State Worry Questionnaire. Secondary measures include patient-rated outcome measures, clinical interviews, neuropsychological measures, and physiological and biological measures including functional magnetic resonance imaging, heart rate variability, and levels of neurotrophic factors. Details of the recently published protocol and the scientific rationale will be presented in detail. Preliminary findings, adherence, challenges, and experiences related to the implementation and execution of the study will be presented and discussed.