We have located links that may give you full text access.
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Comparison of blinding effectiveness between sham tDCS and placebo sertraline in a 6-week major depression randomized clinical trial.
Clinical Neurophysiology : Official Journal of the International Federation of Clinical Neurophysiology 2014 Februrary
OBJECTIVE: To compare blinding integrity and associated factors for transcranial direct current stimulation (tDCS) vs. placebo-pill, the gold standard blinding method.
METHODS: Parallel trial. Depressed participants were randomized to verum/placebo sertraline and active/sham tDCS (2mA, 30-min 10-daily sessions and two additional, fortnight sessions) over 6weeks. Blinding was assessed in completers (n=102) and in a random subgroup (n=35) of raters and participants, in which we also inquired to qualitatively describe their strongest guessing reason.
RESULTS: Participants and raters presented similar performance for predicting treatment assignment at endpoint, correctly guessing tDCS and sertraline beyond chance. Nevertheless, clinical response was associated with correct prediction and tDCS non-responders failed to predict the allocation group. For tDCS, "trouble concentrating" was inversely associated with correct prediction. "Skin redness" was more reported for active-tDCS, but did not predict the allocation group. The qualitative reasons for raters' guessing were not associated with correct prediction, whereas for participants clinical response and adverse effects were directly and inversely associated with correct prediction, respectively.
CONCLUSION: Blinding integrity of tDCS and sertraline were comparable and mainly associated with efficacy rather than blinding failure.
SIGNIFICANCE: TDCS blinding can be improved by adopting parallel designs and avoiding subjects' awareness of skin redness.
METHODS: Parallel trial. Depressed participants were randomized to verum/placebo sertraline and active/sham tDCS (2mA, 30-min 10-daily sessions and two additional, fortnight sessions) over 6weeks. Blinding was assessed in completers (n=102) and in a random subgroup (n=35) of raters and participants, in which we also inquired to qualitatively describe their strongest guessing reason.
RESULTS: Participants and raters presented similar performance for predicting treatment assignment at endpoint, correctly guessing tDCS and sertraline beyond chance. Nevertheless, clinical response was associated with correct prediction and tDCS non-responders failed to predict the allocation group. For tDCS, "trouble concentrating" was inversely associated with correct prediction. "Skin redness" was more reported for active-tDCS, but did not predict the allocation group. The qualitative reasons for raters' guessing were not associated with correct prediction, whereas for participants clinical response and adverse effects were directly and inversely associated with correct prediction, respectively.
CONCLUSION: Blinding integrity of tDCS and sertraline were comparable and mainly associated with efficacy rather than blinding failure.
SIGNIFICANCE: TDCS blinding can be improved by adopting parallel designs and avoiding subjects' awareness of skin redness.
Full text links
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app