The investigators aim to examine the magnitude of non-specific effects in the treatment of depressive episodes with esketamine, by providing patients in the intervention group with a pretreatment presentation and post-treatment follow up session, to assess whether nonspecific effects can be used effectively to improve the effectiveness of treatment with esketamine.
Primary Objective: To determine whether a positive presentation before first treatment improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment. Secondary Objectives: To determine whether a post-treatment follow up session to provide encouragement and reassurance improves expectation of improvement from treatment in patients receiving esketamine for a depressive episode within 24 hours after the first treatment. To determine whether a positive presentation results in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score within 24 hours after the first treatment. To determine whether a positive presentation before first treatment, combined with a posttreatment follow up session after first treatment, result in an improved response from treatment in patients receiving esketamine for a depressive episode as measured by MADRS score by the end of the acute course of esketamine treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
SINGLE
Enrollment
1
A short presentation provided to the participants within 72 hours prior to the first treatment of the acute course. The presentation will emphasize the effectiveness of the treatment, and provide notable encouragement and reassurance. The intervention group will additionally receive a follow up session within 24 hours after the first treatment to provide encouragement and reassurance
Yale Psychiatry Hospital Interventional Psychiatry Services (IPS) unit
New Haven, Connecticut, United States
Group Difference in Change in Question 6 Score on Treatment Credibility and Expectancy Scale (CEQ-6)
Participants' expectations will be assessed by the change in the group score of item 6 of the CEQ-6 at baseline and after the presentation (before treatment 1). Item 6 is scored from 0% (not at all) to 100% (very much). Higher scores indicates expectations have been met.
Time frame: baseline and after presentation (before treatment 1), up to 30 days
Group Difference in Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score
MADRS score will be used to assess whether a positive presentation results in an improved response from treatment in participants receiving esketamine for a depressive episode within 24 hours after the first treatment. MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes. Each item is rated on a 0-6 scale, resulting in a maximum total score of 60 points, with higher scores indicative of greater depressive symptomology.
Time frame: baseline and within 24 hours post treatment 1
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