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Open Access 01-12-2017 | Study protocol

Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial

Authors: Allison G. Harvey, Lu Dong, Jason Y. Lee, Nicole B. Gumport, Steven D. Hollon, Sophia Rabe-Hesketh, Kerrie Hein, Kirsten Haman, Mary E. McNamara, Claire Weaver, Armando Martinez, Haruka Notsu, Garret Zieve, Courtney C. Armstrong

Published in: Trials | Issue 1/2017

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Abstract

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.
Appendix
Available only for authorised users
Footnotes
1
This was added in July, 2017. NIH/NIMH data-sharing requirements necessitated reconsent of participants already randomized. If a patient does not agree to data sharing we have been instructed to exclude them from the analysis.
 
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Metadata
Title
Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial
Authors
Allison G. Harvey
Lu Dong
Jason Y. Lee
Nicole B. Gumport
Steven D. Hollon
Sophia Rabe-Hesketh
Kerrie Hein
Kirsten Haman
Mary E. McNamara
Claire Weaver
Armando Martinez
Haruka Notsu
Garret Zieve
Courtney C. Armstrong
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2276-x

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