Methodological Recommendations for Trials of Psychological Interventions.

Recent years have seen major developments in psychotherapy research that suggest the need to address critical methodological issues. These recommendations, developed by an international group of researchers, do not replace those for randomized controlled trials, but rather supplement strategies that need to be taken into account when considering psychological treatments. The limitations of traditional taxonomy and assessment methods are outlined, with suggestions for consideration of staging methods. Active psychotherapy control groups are recommended, and adaptive and dismantling study designs offer important opportunities. The treatments that are used, and particularly their specific ingredients, need to be described in detail for both the experimental and the control groups. Assessment should be performed blind before and after treatment and at long-term follow-up. A combination of observer- and self-rated measures is recommended. Side effects of psychotherapy should be evaluated using appropriate methods. Finally, the number of participants who deteriorate after treatment should be noted according to the methods that were used to define response or remission.

Cognitive skill learning in healthy older adults after 2 months of double-blind treatment with piribedil.

RATIONALE: Cognitive skill learning, as assessed by repeated testing on the Tower of Toronto (TT) task, has been found to be impaired in normal aging. There is evidence that this impairment might be accounted for by the well-documented, age-dependent decline of dopamine D2-like receptor availability. OBJECTIVES: This study was an investigation of whether the D2/D3 dopaminergic agonist piribedil improves cognitive skill learning in older adults. METHODS: Healthy elderly volunteers were assessed using the TT paradigm. Subjects were evaluated at baseline, and after 2 months of a placebo or piribedil (50 mg daily) treatment in a double-blind, crossover design. Two components of cognitive skill learning were considered--the ability to learn to solve the puzzle and the acquisition of a problem-solving routine. RESULTS: Piribedil showed a beneficial effect on the acquisition of a problem-solving routine, depending on the age of subjects, as revealed by solution reliability indexes measures. The effect of piribedil on the ability to learn to solve the puzzle was found to be dependent on the subject's working memory capacities. CONCLUSIONS: The present results suggest that piribedil is likely to enhance cognitive skill learning in healthy older adults and give further evidence that age-related dopamine decline plays an important role in cognitive impairment occurring in normal aging.