Improving Depression Outcome by Enhancing Memory for Cognitive Therapy

NCT01790919 | Completed Phase 2 DMC

• 1 other identifier: R34MH094535-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Depression, Adults

Outcome Measures

Primary Outcomes (2)

• Inventory of Depressive Symptomatology, Self Report (IDS-SR)

  Primary mood outcome

  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

• Global Assessment of Functioning (GAF)

  Primary impairment outcome

  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 (3)

• Structured Clinical Interview for DSM-IV (SCID)

  Pre-treatment; Within 2 weeks of completing the course of treatment (14 sessions); 6 month followup

• Longitudinal Interval Follow-up Evaluation (LIFE)

  Pre-treatment; within 2 weeks of completing the course of treatment (14 sessions); 6-month followup

• ACNP defined Response, Remission, Relapse, Recurrence using the IDS, SCID and LIFE

  Pre-treatment; within 2 weeks of completing the course of treatment (14 sessions); 6-month followup

Other Outcomes (7)

• Memory Support Rating Scale (MSRS).

  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.

• Patient Recall Task.

  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.

• National Adult Reading Test (NART).

  This measure is taken at baseline (pre-treatment) and will be compared across the two treatment arms

Study Arms (2)

Cognitive Therapy plus Cognitive Support

EXPERIMENTAL

Cognitive therapy for depression with cognitive support added

Behavioral: Cognitive therapy for depression

Cognitive therapy

ACTIVE COMPARATOR

Cognitive therapy for depression

Behavioral: Cognitive therapy for depression

Interventions

Cognitive therapy for depression BEHAVIORAL

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.

Cognitive Therapy plus Cognitive Support; Cognitive therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Berkeley: lead
• National Institute of Mental Health (NIMH): collaborator
• Vanderbilt University: collaborator

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720, United States

Location

Related Publications (3)

• 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.

  PMID: 35963181 DERIVED

• 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.

  PMID: 29137655 DERIVED

• 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.

  PMID: 27089159 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 13, 2013
• Study Start: February 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

US (1)