Improving Depression Outcome by Enhancing Memory for Cognitive Therapy

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Vanderbilt University
Information provided by (Responsible Party):
Allison Harvey, University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT01790919
First received: February 6, 2013
Last updated: September 16, 2015
Last verified: September 2015

February 6, 2013
September 16, 2015
February 2013
March 2015   (final data collection date for primary outcome measure)
  • Inventory of Depressive Symptomatology, Self Report (IDS-SR) [ 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) to 6-month followup ] [ Designated as safety issue: No ]
    Primary mood outcome
  • Global Assessment of Functioning (GAF) [ Time Frame: Change in GAF scores from pre-treatment to post-treatment (defined as within 2 weeks of completing the course of treatment, which is 14 sessions) to 6-month followup ] [ Designated as safety issue: No ]
    Primary impairment outcome
  • 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
Complete list of historical versions of study NCT01790919 on ClinicalTrials.gov Archive Site
  • 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 ]
    To determine the presence or absence of current DSM-IV-TR defined episodes of depression
  • 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 ]
    Time to relapse or recurrence
  • ACNP defined Response, Remission, Relapse, Recurrence using the IDS, SCID and LIFE [ Time Frame: Pre-treatment; within 2 weeks of completing the course of treatment (14 sessions); 6-month followup ] [ Designated as safety issue: No ]
Not Provided
  • Memory Support Rating Scale (MSRS). [ Time Frame: All patients receive 14 sessions of cognitive therapy for depression. The treatment sessions are video taped. A random subset of 20% of the tapes are selected for MSRS scoring. Average MSRS scores will be compared across the 2 groups. ] [ Designated as safety issue: No ]
    This is a measure of the use of memory support by treatment providers.
  • Patient Recall Task. [ Time Frame: Completed at the end of Session 7, 14 and at 6 month FU. Patient Recall Task scores will be compared across the two treatment arms and over the three assessment points. ] [ Designated as safety issue: No ]
    This is a measure of the content of treatment that patient's remember
  • National Adult Reading Test (NART). [ Time Frame: This measure is taken at baseline (pre-treatment) and will be compared across the two treatment arms ] [ Designated as safety issue: No ]
    Estimate of IQ. Used to determine if IQ is a moderator of treatment.
  • Episodic Face Naming Task. [ Time Frame: This measure is taken at baseline (pre-treatment) and will be compared across the two treatment arms ] [ Designated as safety issue: No ]
    Measure of declarative memory. used to determine if baseline memory is a moderator of treatment outcome.
  • Cognitive Therapy Rating Scale (CTRS) [ Time Frame: CTRS coding will be conducted on randomly selected recordings of treatment sessions. Average CTRS scores will be compared across the two treatment arms ] [ Designated as safety issue: No ]
    Measure of the quality of cognitive therapy
  • Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: The CEQ scores, measured at the end of the first therapy session, will be compared across the two treatment arms ] [ Designated as safety issue: No ]
    A measure of treatment expectancies
  • Demographics form [ Time Frame: This measure is taken at baseline (pre-treatment) and will be compared across the two treatment arms ] [ Designated as safety issue: No ]
    Assesses demographics including age, years of education and chronicity of depression that are used in moderator analysis
  • 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 ]
 
Improving Depression Outcome by Enhancing Memory for Cognitive Therapy
Improving Depression Outcome by Enhancing Memory for Cognitive Therapy
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.

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 a strategy 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+Cognitive Support, 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 = 48) who will be randomized to one of two groups: (a) CT+Cognitive Support (n = 24) or (b) 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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder (MDD)
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.

  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
March 2015
March 2015   (final data collection date for primary outcome measure)

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)-Clinician 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01790919
R34MH094535-01A1, R34MH094535-01A1
Yes
Not Provided
Not Provided
Allison Harvey, University of California, Berkeley
University of California, Berkeley
  • National Institute of Mental Health (NIMH)
  • Vanderbilt University
Not Provided
University of California, Berkeley
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP