Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?

NCT ID: NCT02938559

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-08-05

Brief Summary

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 in major depressive disorder (MDD) and cognitive therapy (CT).

Detailed Description

Background. Major depressive disorder (MDD) is one of the most prevalent psychiatric disorders and a leading cause of disability worldwide. Existing therapies fail to produce complete recovery. Progress toward improving outcome must include innovations that are safe, powerful, inexpensive and simple (for fast and effective dissemination). The proposed research seeks to test one such innovation. The investigators seek to improve outcome by improving memory for the content of cognitive therapy (CT) sessions. CT is one of the most promising approaches to the treatment of MDD, yet there is room for improvement.

It is proposed that adding memory enhancing strategies to CT may improve MDD outcome because: (a) MDD is often characterized by memory impairment, (b) there is evidence that the memory impairment is modifiable, (c) CT typically entails the activation of emotion, (d) emotion can impair or bias memory and (e) there is evidence that memory for the content of therapy sessions is poor.

Hence, the overall goal is to evaluate if integrating strategies designed to enhance memory for the content of CT sessions improves treatment outcome for MDD. Cognitive support involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory. It is hypothesized that CT+Memory Support, relative to CT-as-usual, will be associated with improved illness course and functional outcome at the end of treatment as well as 6 and 12 months post-treatment.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cognitive Therapy plus Memory Support

Group Type: EXPERIMENTAL

Cognitive Therapy (CT) for depression + Memory Support

Intervention Type: BEHAVIORAL

The Memory Support Intervention will be delivered interwoven with CT. The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. It is comprised of eight memory promoting strategies: attention recruitment, categorization, evaluation, application, repetition, practice remembering, cued-based reminder and praise recall. These strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.

Cognitive Therapy-as-usual

Group Type: ACTIVE_COMPARATOR

Cognitive Therapy (CT) for depression

Intervention Type: BEHAVIORAL

There is evidence that CT for major depressive disorder (MDD) can be as effective as antidepressant medication for the initial treatment of moderate to severe MDD. Moreover, following the withdrawal of treatment, patients treated with CT are significantly less likely to relapse than patients treated with antidepressant medication and CT is at least as effective as antidepressant medication in preventing subsequent relapse. CT aims to alter the symptomatic expression of depression and reduce risk for subsequent episodes by correcting the negative beliefs and maladaptive information processing presumed to underlie the disorder and alter the systematic tendency to misperceive reality in a pessimistic fashion.

Interventions

Cognitive Therapy (CT) for depression

There is evidence that CT for major depressive disorder (MDD) can be as effective as antidepressant medication for the initial treatment of moderate to severe MDD. Moreover, following the withdrawal of treatment, patients treated with CT are significantly less likely to relapse than patients treated with antidepressant medication and CT is at least as effective as antidepressant medication in preventing subsequent relapse. CT aims to alter the symptomatic expression of depression and reduce risk for subsequent episodes by correcting the negative beliefs and maladaptive information processing presumed to underlie the disorder and alter the systematic tendency to misperceive reality in a pessimistic fashion.

Intervention Type: BEHAVIORAL

Cognitive Therapy (CT) for depression + Memory Support

The Memory Support Intervention will be delivered interwoven with CT. The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. It is comprised of eight memory promoting strategies: attention recruitment, categorization, evaluation, application, repetition, practice remembering, cued-based reminder and praise recall. These strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18+ years
• Willing and able to give full consent
• English language fluency
• Diagnosis of major depressive disorder (MDD), first episode, recurrent or chronic, according to DSM-5
• Minimum score 26 or above on the Inventory of Depressive Symptomatology, Self-Report (IDS-SR). This cutoff denotes at least 'moderate' depression
• If taking medications for mood, medications must be stable for the past four weeks

Exclusion Criteria

• History of Bipolar Disorder
• History of Psychosis or psychotic features
• Lifetime history of failure to respond to 4 or more sessions of CBT/CT for depression
• Current non-psychotic disorder if it constitutes the principal diagnosis and if it requires treatment other than that offered in the project. 'Principal' is defined as the disorder currently most distressing and disabling, using a widely accepted severity rating scale capturing distress and interference (0-8, 4+ indicates clinical severity)
• Moderate or severe substance use in the past 6 months where 'moderate' is defined as 4-5 symptoms and 'severe' is defined as 6+ listed in DSM-5 for each of the substance-related disorders
• Evidence of any medical disorder or condition that could cause depression, preclude participation in CT, or is associated with memory problems, that is not currently stabilized and/or managed under the care of a physician or the presence of an active and progressive physical illness or neurological degenerative disease,
• Current suicide risk sufficient to preclude treatment on an outpatient basis (assessed by the Columbia-Suicide Severity Rating Scale) or current homicide risk (assessed by our staff, a case manager or psychiatrist)
• Pregnancy or breastfeeding
• Not able/willing to participate in and/or complete the pre-treatment assessments

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Allison Harvey

Professor of Clinical Psychology,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California, Berkeley

Berkeley, California, United States

Countries

United States

References

Sarfan LD, Zieve G, Gumport NB, Xiong M, Harvey AG. Optimizing outcomes, mechanisms, and recall of Cognitive Therapy for depression: Dose of constructive memory support strategies. Behav Res Ther. 2023 Jul;166:104325. doi: 10.1016/j.brat.2023.104325. Epub 2023 May 13.

Reference Type: DERIVED

PMID: 37210887 (View on PubMed)

Gumport NB, Zieve GG, Dong L, Harvey AG. The Development and Validation of the Memory Support Treatment Provider Checklist. Behav Ther. 2021 Jul;52(4):932-944. doi: 10.1016/j.beth.2020.11.005. Epub 2020 Dec 17.

Reference Type: DERIVED

PMID: 34134832 (View on PubMed)

Other Identifiers

R01MH108657

Identifier Type: NIH

Identifier Source: org_study_id

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