Clinical trial NCT01790919: Improving Depression Outcome by Enhancing Memory for Cognitive Therapy
Official title: Improving Depression Outcome by Enhancing Memory for Cognitive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder (MDD)
Keywords: Depression, Adults
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Vanderbilt University
First posted: 2013-02-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Inventory of Depressive Symptomatology, Self Report (IDS-SR)
timeFrame: 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
measure: Global Assessment of Functioning (GAF)
timeFrame: 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
Secondary outcomes:
measure: Structured Clinical Interview for DSM-IV (SCID)
timeFrame: Pre-treatment; Within 2 weeks of completing the course of treatment (14 sessions); 6 month followup
measure: Longitudinal Interval Follow-up Evaluation (LIFE)
timeFrame: Pre-treatment; within 2 weeks of completing the course of treatment (14 sessions); 6-month followup
measure: ACNP defined Response, Remission, Relapse, Recurrence using the IDS, SCID and LIFE
timeFrame: Pre-treatment; within 2 weeks of completing the course of treatment (14 sessions); 6-month followup
Other outcomes:
measure: Memory Support Rating Scale (MSRS).
timeFrame: 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.
measure: Patient Recall Task.
timeFrame: 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.
measure: National Adult Reading Test (NART).
timeFrame: This measure is taken at baseline (pre-treatment) and will be compared across the two treatment arms
measure: Episodic Face Naming Task.
timeFrame: This measure is taken at baseline (pre-treatment) and will be compared across the two treatment arms
measure: Cognitive Therapy Rating Scale (CTRS)
timeFrame: CTRS coding will be conducted on randomly selected recordings of treatment sessions. Average CTRS scores will be compared across the two treatment arms
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: The CEQ scores, measured at the end of the first therapy session, will be compared across the two treatment arms
measure: Demographics form
timeFrame: This measure is taken at baseline (pre-treatment) and will be compared across the two treatment arms
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
References:
citation: Dong L, Zieve G, Gumport NB, Armstrong CC, Alvarado-Martinez CG, Martinez A, Howlett S, Fine E, Tran M, McNamara ME, Weaver C, Tuck AB, Hilmoe HE, Agnew E, Fisher K, Diaz M, Lee JY, Hollon SD, Notsu H, Harvey AG. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? A randomized controlled trial. Behav Res Ther. 2022 Oct;157:104167. doi: 10.1016/j.brat.2022.104167. Epub 2022 Aug 6.
citation: Harvey AG, Dong L, Lee JY, Gumport NB, Hollon SD, Rabe-Hesketh S, Hein K, Haman K, McNamara ME, Weaver C, Martinez A, Notsu H, Zieve G, Armstrong CC. Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial. Trials. 2017 Nov 14;18(1):539. doi: 10.1186/s13063-017-2276-x.
citation: Harvey AG, Lee J, Smith RL, Gumport NB, Hollon SD, Rabe-Hesketh S, Hein K, Dolsen EA, Haman KL, Kanady JC, Thompson MA, Abrons D. Improving outcome for mental disorders by enhancing memory for treatment. Behav Res Ther. 2016 Jun;81:35-46. doi: 10.1016/j.brat.2016.03.007. Epub 2016 Apr 2.