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We investigated if improving a patient's memory for the content of their treatment, via the Memory Support Intervention, improves illness course and functional outcomes. The platform for investigating this question was major depressive disorder (MDD) and cognitive therapy (CT). Adults diagnosed with MDD (N = 178) were randomly allocated to CT + Memory Support (n = 91) or CT-as-usual (n = 87). Both treatments were comprised of 20-26, 50-min sessions over 16 weeks. Blind assessments were conducted before and immediately following treatment (post-treatment) and 6 months later (6FU). Patient memory for treatment, assessed with a free recall task, was higher in CT + Memory Support for past session recall at post-treatment. Both treatment arms were associated with reductions in depressive symptoms and functional impairment except: CT + Memory Support exhibited lower depression severity at 6FU (b = -3.09, p = 0.050, d = -0.27), and greater reduction in unhealthy days from baseline to 6FU (b = -4.21, p = 0.010, d = -1.07), compared to CT-as-usual. While differences in illness course and functional outcomes between the two treatment arms were limited, it is possible that future analyses of the type of memory supports and longer follow-up may yield more encouraging outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT01790919. Registered October 6, 2016., Competing Interests: Declaration of competing interest Allison Harvey has received research support from the National Institutes of Health and book royalties from American Psychological Association, Guilford Press, and Oxford University Press., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: The Memory Support Intervention was developed in response to evidence showing that: (1) patient memory for treatment is poor, (2) poor memory for treatment is associated with poorer adherence and poorer outcome, (3) the impact of memory impairment can be minimized by the use of memory support strategies and (4) improved memory for treatment improves outcome. The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT)., Method/design: Adults with MDD (n = 178, including 20% for potential attrition) will be randomly allocated to CT + Memory Support or CT-as-usual and will be assessed at baseline, post treatment and at 6 and 12 months' follow-up (6FU and 12FU). We will compare the effects of CT + Memory Support vs. CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3)., Discussion: The Memory Support Intervention has been developed to be "transdiagnostic" (relevant to a broad range of mental disorders) and "pantreatment" (relevant to a broad range of types of treatment). This study protocol describes a "next step" in the treatment development process by testing the Memory Support Intervention for major depressive disorder (MDD) and cognitive therapy (CT). If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings., Trial Registration: ClinicalTrials.gov, ID: NCT01790919 . Registered on 6 October 2016.