Improving Depression Outcome by Enhancing Memory for Cognitive Therapy

This study is currently recruiting participants.

Verified February 2013 by National Institute of Mental Health (NIMH)

Sponsor:

Collaborator:

Vanderbilt University

Information provided by (Responsible Party):

Allison Harvey, University of California, Berkeley

ClinicalTrials.gov Identifier:

NCT01790919

First received: February 6, 2013

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 6, 2013
Last Updated Date	February 12, 2013
Start Date ^ICMJE	February 2013
Estimated Primary Completion Date	February 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 12, 2013)	Inventory of Depressive Symptomatology (IDS) [ Time Frame: Change in IDS scores from pre-treatment to post-treatment (defined as within 2 weeks of completing the course of treatment, which is 14 sessions) ] [ Designated as safety issue: Yes ] Longitudinal Interval Followup Evaluation (LIFE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] Time to relapse
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01790919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE (submitted: February 12, 2013)	Structured Clinical Interview for DSM-IV (SCID) [ Time Frame: Pre-treatment; Within 2 weeks of completing the course of treatment (14 sessions); 6 month followup ] [ Designated as safety issue: No ] Longitudinal Interval Follow-up Evaluation (LIFE) [ Time Frame: Pre-treatment; within 2 weeks of completing the course of treatment (14 sessions); 6-month followup ] [ Designated as safety issue: No ]
Original Other Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Improving Depression Outcome by Enhancing Memory for Cognitive Therapy
Official Title ^ICMJE	Improving Depression Outcome by Enhancing Memory for Cognitive Therapy
Brief Summary	Existing drug and talking therapies for major depressive disorder (MDD) fail to produce complete recovery. This study will determine if substantial improvements to one of the most promising therapies, cognitive therapy (CT), can be achieved by administering a carefully designed procedure to improve memory for the content of CT sessions. This is important because (a) memory deficits are common in MDD patients and (b) each CT therapy session typically covers a complex array of topics and various skills are taught.
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. We 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. We believe 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. Aim. To evaluate if two strategies designed to enhance memory for the content of CT sessions improve treatment outcome for MDD. Cognitive support involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory. Sleep enhancement is based on robust evidence that insufficient sleep before learning impairs initial memory encoding, and that sleep after learning plays a critical role in the subsequent consolidation of memories. It is hypothesized that CT+Cognitive Support and CT+Sleep Enhancement, relative to CT-as-usual, will be associated with improved depression outcome at the end of treatment and 6 months after the completion of treatment. Research Plan. A small pilot feasibility RCT will be conducted on adults with MDD (n = 72) who will be randomized to one of three groups: (a) CT+Cognitive Support (n = 24), (b) CT+Sleep Enhancement (n = 24) or (c) CT-as-usual (n = 24). Outcome measures will be taken at baseline, end of treatment, and 6 months after treatment. Long-term objective. To provide the pilot data needed to prepare a larger scale intervention study focused on improving outcomes by improving memory for the content of therapy sessions. The outcomes, if positive, will have major public health implications because simple, inexpensive memory enhancing strategies can be readily included as a standard feature in all psychosocial treatments for a broad range of mental illness. Project
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Major Depressive Disorder (MDD)
Intervention ^ICMJE	Behavioral: Cognitive therapy for depression 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. Over 14 sessions 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. Cognitive support. An intervention to improve memory for the contents of therapy. Cognitive support involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory.
Study Arm (s)	Experimental: Cognitive Therapy plus Cognitive Support Cognitive therapy for depression with cognitive support added Intervention: Behavioral: Cognitive therapy for depression Active Comparator: Cognitive therapy Cognitive therapy for depression Intervention: Behavioral: Cognitive therapy for depression
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	48
Estimated Completion Date	February 2016
Estimated Primary Completion Date	February 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: diagnosis of major depressive disorder (MDD), first episode, recurrent or chronic, according to DSM-IV-TR criteria score of 24 or above on the Inventory of Depressive Symptomatology (IDS)-Clinican and 26 or above on the IDS-Self-report older than 18 years of age if taking medications for mood, medications must be stable for the past 4 weeks able and willing to give informed consent Exclusion Criteria: history of bipolar disorder history of psychosis (including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic organic brain syndrome) current non-psychotic Axis I disorder if it constitutes the principal diagnosis and if it requires treatment other than that offered in the project (including anxiety disorders including active PTSD, somatoform disorders, dissociative disorders, or eating disorders, etc.) history of substance dependence in the past six months IQ below 80 evidence of any medical disorder or condition that could cause depression or preclude participation in CT current suicide risk sufficient to preclude treatment on an outpatient basis
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01790919
Other Study ID Numbers ^ICMJE	R34 MH094535-01A1
Has Data Monitoring Committee	Yes
Responsible Party	Allison Harvey, University of California, Berkeley
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE	Vanderbilt University
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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