Haruka notsu6/19/2023 The authors declare that they have no competing interests. ![]() If important protocol modifications are made these will be reviewed by CPHS and reported on. Adverse events and other unintended effects will be report to CPHS and NIH, following the rules stipulated by these two oversight bodies. This is followed by a written informed consent which is obtained at the beginning of the pre-assessment, which confirms eligibility, by a member of the assessment team. 2, verbal informed consent is obtained during the initial eligibility assessment which is typically conducted over the telephone. The University of California, Berkeley, Committee for the Protection of Human Subjects (CPHS) approved the study (Protocol ID: 95). Registered on 6 October 2016.Ĭognitive therapy Depression Experimental therapeutics Memory support Transdiagnostic.Įthics approval and consent to participate If the results are promising, future directions will test the applicability to other kinds of interventions and disorders and in other settings.Ĭ, ID: NCT01790919. 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). 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). ![]() We will evaluate if previously reported poor treatment response subgroups moderate target engagement (aim 3). We will determine if patient memory for treatment mediates the relationship between treatment condition and outcome (aim 2). CT-as-usual to determine if the new intervention improves the course of illness and reduces functional impairment (aim 1). ![]() We will compare the effects of CT + Memory Support vs. As a "platform" for the next step in investigating this approach, we focus on major depressive disorder (MDD) and cognitive therapy (CT).Īdults 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). 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. 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.
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