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

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, 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

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.

Keywords: Cognitive therapy; Depression; Experimental therapeutics; Memory support; Transdiagnostic.

Conflict of interest statement

Ethics approval and consent to participate

The University of California, Berkeley, Committee for the Protection of Human Subjects (CPHS) approved the study (Protocol ID: 2011-11-3795). As depicted in Fig. 2, verbal informed consent is obtained during the initial eligibility assessment which is typically conducted over the telephone. 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. Adverse events and other unintended effects will be report to CPHS and NIH, following the rules stipulated by these two oversight bodies. If important protocol modifications are made these will be reviewed by CPHS and reported on ClinicalTrials.gov.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Anticipated patient flow for the randomized clinical trial
Fig. 2
Fig. 2
Standard Protocol Items: SPIRIT Figure: Schedule of enrollment, interventions, and assessments

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