The psychological effects of differential treatment of a high risk sample in a randomized clinical trial.
A study was carried out using 616 participants in a randomized clinical trial at the Harvard MRFIT (Multiple Risk Factor Intervention Trial) Clinical Center, to test if there were differences in the psychological dimensions of anxiety, depression, and functional heart symptoms in groups given different levels of treatment in a CHD (Coronary Heart Disease) Intervention Program. A theoretical framework was given to justify a number of hypotheses as to the induction of adverse psychological effects. At the end of two years in the MRFIT Program there were no significant differences between the special intervention group (SI) and the usual care group (UC) in the selected psychological variables.
D001007:Anxiety / Q000209:etiology*; D002986:Clinical Trials as Topic; D003327:Coronary Disease / Q000517:prevention & control*; D003863:Depression / Q000209:etiology*; D005500:Follow-Up Studies; D006331:Heart Diseases / Q000523:psychology*; D006801:Humans; D008297:Male; D008404:Massachusetts; D008875:Middle Aged; D011602:Psychophysiologic Disorders / Q000209:etiology*; D011897:Random Allocation; D012306:Risk